CODE OF FEDERAL REGULATIONS PARTS 1300 … OF FEDERAL REGULATIONS PARTS 1300-1308 TABLE OF CONTENTS CHAPTER II DRUG ENFORCEMENT ADMINISTRATION, ... any drug or hormonal …

CODE OF FEDERAL REGULATIONS PARTS 1300-1308

TABLE OF CONTENTS CHAPTER II DRUG ENFORCEMENT ADMINISTRATION,

DEPARTMENT OF JUSTICE

PART 1300

• DEFINITIONS PART 1301

• REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES

• REGISTRATION • EXCEPTIONS TO REGISTRATION AND FEES • ACTION ON APPLICATION FOR REGISTRATION: REVOCATION OR SUSPENSION OF

REGISTRATION • HEARINGS • MODIFICATION, TRANSFER AND TERMINATION OF REGISTRATION • EMPLOYEE SCREENING-NON- PRACTITIONERS

PART 1302

• LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES PART 1303

• QUOTAS • AGGREGATE PRODUCTION AND PROCUREMENT QUOTAS • INDIVIDUAL MANUFACTURING QUOTAS • HEARINGS

PART 1304

• RECORDS AND REPORTS OF REGISTRANTS • INVENTORY REQUIREMENTS • CONTINUING RECORDS • REPORTS

PART 1305

• ORDER FORMS PART 1306

• PRESCRIPTIONS • CONTROLLED SUBSTANCES LISTED IN SCHEDULE II • CONTROLLED SUBSTANCES LISTED IN SECHEDULES III, IV AND V

PART 1307

• MISCELLANEOUS • SPECIAL EXCEPTIONS FOR MANUFACTURE AND DISTRIBUTION OF CONTROLLED

SUBSTANCES • DISPOSAL OF CONTROLLED SUBSTANCES • SPECIAL EXEMPT PERSONS

PART 1308

• SCHEDULE OF CONTROLLED SUBSTANCES

5

PART 1300—DEFINITIONS

Sec.1300.01 Definitions relating to controlled

substances.1300.02 Definitions relating to listed chemi-

cals.

AUTHORITY: 21 U.S.C. 802, 871(b), 951, 958(f)

SOURCE: 62 FR 13941, Mar. 24, 1997, unlessotherwise noted.

§ 1300.01 Definitions relating to con-trolled substances.

(a) Any term not defined in this partshall have the definition set forth insection 102 of the Act (21 U.S.C. 802),except that certain terms used in part1316 of this chapter are defined at thebeginning of each subpart of that part.

(b) As used in parts 1301 through 1308and part 1312 of this chapter, the fol-lowing terms shall have the meaningsspecified:

(1) The term Act means the Con-trolled Substances Act, as amended (84Stat. 1242; 21 U.S.C. 801) and/or the Con-trolled Substances Import and ExportAct, as amended (84 Stat. 1285; 21 U.S.C.951).

(2) The term Administration meansthe Drug Enforcement Administration.

(3) The term Administrator means theAdministrator of the Drug Enforce-ment Administration. The Adminis-trator has been delegated authorityunder the Act by the Attorney General(28 CFR 0.100).

(4) The term anabolic steroid meansany drug or hormonal substance,chemically and pharmacologically re-lated to testosterone (other than estro-gens, progestins, and corticosteroids)that promotes muscle growth, and in-cludes:

(i) Boldenone;(ii) Chlorotestosterone (4-

chlortestosterone);(iii) Clostebol;(iv)

Dehydrochlormethyltestosterone;(v) Dihydrotestosterone (4-

dihydrotestosterone);(vi) Drostanolone;(vii) Ethylestrenol;(viii) Fluoxymesterone;(ix) Formebulone (formebolone);(x) Mesterolone;(xi) Methandienone;(xii) Methandranone;

(xiii) Methandriol;(xiv) Methandrostenolone;(xv) Methenolone;(xvi) Methyltestosterone;(xvii) Mibolerone;(xviii) Nandrolone;(xix) Norethandrolone;(xx) Oxandrolone;(xxi) Oxymesterone;(xxii) Oxymetholone;(xxiii) Stanolone;(xxiv) Stanozolol;(xxv) Testolactone;(xxvi) Testosterone;(xxvii) Trenbolone; and(xxviii) Any salt, ester, or isomer of a

drug or substance described or listed inthis paragraph, if that salt, ester, orisomer promotes muscle growth. Ex-cept such term does not include an an-abolic steroid which is expressly in-tended for administration through im-plants to cattle or other nonhumanspecies and which has been approved bythe Secretary of Health and HumanServices for such administration. Ifany person prescribes, dispenses, or dis-tributes such steroid for human use,such person shall be considered to haveprescribed, dispensed, or distributed ananabolic steroid within the meaning ofthis paragraph.

(5) The term basic class means, as tocontrolled substances listed in Sched-ules I and II:

(i) Each of the opiates, including itsisomers, esters, ethers, salts, and saltsof isomers, esters, and ethers wheneverthe existence of such isomers, esters,ethers, and salts is possible within thespecific chemical designation, listed in§ 1308.11(b) of this chapter;

(ii) Each of the opium derivatives, in-cluding its salts, isomers, and salts ofisomers whenever the existence of suchsalts, isomers, and salts of isomers ispossible within the specific chemicaldesignation, listed in § 1308.11(c) of thischapter;

(iii) Each of the hallucinogenic sub-stances, including its salts, isomers,and salts of isomers whenever the ex-istence of such salts, isomers, and saltsof isomers is possible within the spe-cific chemical designation, listed in§ 1308.11(d) of this chapter;

(iv) Each of the following substances,whether produced directly or indirectly

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21 CFR Ch. II (4–1–01 Edition)§ 1300.01

by extraction from substances of vege-table origin, or independently bymeans of chemical synthesis, or by acombination of extraction and chem-ical synthesis:

(A) Opium, including raw opium,opium extracts, opium fluid extracts,powdered opium, granulated opium, de-odorized opium and tincture of opium;

(B) Apomorphine;(C) Codeine;(D) Etorphine hydrochloride;(E) Ethylmorphine;(F) Hydrocodone;(G) Hydromorphone;(H) Metopon;(I) Morphine;(J) Oxycodone;(K) Oxymorphone;(L) Thebaine;(M) Mixed alkaloids of opium listed

in Section 1308.12(b)(2) of this chapter;(N) Cocaine; and(O) Ecgonine;(v) Each of the opiates, including its

isomers, esters, ethers, salts, and saltsof isomers, esters, and ethers wheneverthe existence of such isomers, esters,ethers, and salts is possible within thespecific chemical designation, listed in§ 1308.12(c) of this chapter; and

(vi) Methamphetamine, its salts, iso-mers, and salts of its isomers;

(vii) Amphetamine, its salts, opticalisomers, and salts of its optical iso-mers;

(viii) Phenmetrazine and its salts;(ix) Methylphenidate;(x) Each of the substances having a

depressant effect on the central nerv-ous system, including its salts, iso-mers, and salts of isomers wheneverthe existence of such salts, isomers,and salts of isomers is possible withinthe specific chemical designation, list-ed in § 1308.12(e) of this chapter.

(6) The term commercial containermeans any bottle, jar, tube, ampule, orother receptacle in which a substanceis held for distribution or dispensing toan ultimate user, and in addition, anybox or package in which the receptacleis held for distribution or dispensing toan ultimate user. The term commercialcontainer does not include any packageliner, package insert or other materialkept with or within a commercial con-tainer, nor any carton, crate, drum, orother package in which commercial

containers are stored or are used forshipment of controlled substances.

(7) The term compounder means anyperson engaging in maintenance or de-toxification treatment who also mixes,prepares, packages or changes the dos-age form of a narcotic drug listed inSchedules II, III, IV or V for use inmaintenance or detoxification treat-ment by another narcotic treatmentprogram.

(8) The term controlled substance hasthe meaning given in section 802(6) ofTitle 21, United States Code (U.S.C.).

(9) The term customs territory of theUnited States means the severalStates, the District of Columbia, andPuerto Rico.

(10) The term detoxification treatmentmeans the dispensing, for a period oftime as specified below, of a narcoticdrug or narcotic drugs in decreasingdoses to an individual to alleviate ad-verse physiological or psychological ef-fects incident to withdrawal from thecontinuous or sustained use of a nar-cotic drug and as a method of bringingthe individual to a narcotic drug-freestate within such period of time. Thereare two types of detoxification treat-ment: Short-term detoxification treat-ment and long-term detoxificationtreatment.

(i) Short-term detoxification treat-ment is for a period not in excess of 30days.

(ii) Long-term detoxification treat-ment is for a period more than 30 daysbut not in excess of 180 days.

(11) The term dispenser means an in-dividual practitioner, institutionalpractitioner, pharmacy or pharmacistwho dispenses a controlled substance.

(12) The term export means, with re-spect to any article, any taking out orremoval of such article from the juris-diction of the United States (whetheror not such taking out or removal con-stitutes an exportation within themeaning of the customs and relatedlaws of the United States).

(13) The term exporter includes everyperson who exports, or who acts as anexport broker for exportation of, con-trolled substances listed in any sched-ule.

(14) The term hearing means:(i) In part 1301 of this chapter, any

hearing held for the granting, denial,


7

Drug Enforcement Administration, Justice § 1300.01

revocation, or suspension of a registra-tion pursuant to sections 303, 304, and1008 of the Act (21 U.S.C. 823, 824 and958).

(ii) In part 1303 of this chapter, anyhearing held regarding the determina-tion of aggregate production quota orthe issuance, adjustment, suspension,or denial of a procurement quota or anindividual manufacturing quota.

(iii) In part 1308 of this chapter, anyhearing held for the issuance, amend-ment, or repeal of any rule issuablepursuant to section 201 of the Act (21U.S.C. 811).

(15) The term import means, with re-spect to any article, any bringing in orintroduction of such article into eitherthe jurisdiction of the United States orthe customs territory of the UnitedStates, and from the jurisdiction of theUnited States into the customs terri-tory of the United States (whether ornot such bringing in or introductionconstitutes an importation within themeaning of the tariff laws of theUnited States).

(16) The term importer includes everyperson who imports, or who acts as animport broker for importation of, con-trolled substances listed in any sched-ule.

(17) The term individual practitionermeans a physician, dentist, veteri-narian, or other individual licensed,registered, or otherwise permitted, bythe United States or the jurisdiction inwhich he/she practices, to dispense acontrolled substance in the course ofprofessional practice, but does not in-clude a pharmacist, a pharmacy, or aninstitutional practitioner.

(18) The term institutional practitionermeans a hospital or other person (otherthan an individual) licensed, reg-istered, or otherwise permitted, by theUnited States or the jurisdiction inwhich it practices, to dispense a con-trolled substance in the course of pro-fessional practice, but does not includea pharmacy.

(19) The term interested person meansany person adversely affected or ag-grieved by any rule or proposed ruleissuable pursuant to section 201 of theAct (21 U.S.C. 811).

(20) The term inventory means all fac-tory and branch stocks in finished formof a basic class of controlled substance

manufactured or otherwise acquired bya registrant, whether in bulk, commer-cial containers, or contained in phar-maceutical preparations in the posses-sion of the registrant (including stocksheld by the registrant under separateregistration as a manufacturer, im-porter, exporter, or distributor).

(21) The term isomer means the opti-cal isomer, except as used in § 1308.11(d)and § 1308.12(b)(4) of this chapter. Asused in § 1308.11(d) of this chapter, theterm isomer means the optical, posi-tional, or geometric isomer. As used in§ 1308.12(b)(4) of this chapter, the termisomer means the optical or geometricisomer.

(22) The term jurisdiction of the UnitedStates means the customs territory ofthe United States, the Virgin Islands,the Canal Zone, Guam, AmericanSamoa, and the Trust Territories ofthe Pacific Islands.

(23) The term label means any displayof written, printed, or graphic matterplaced upon the commercial containerof any controlled substance by anymanufacturer of such substance.

(24) The term labeling means all la-bels and other written, printed, orgraphic matter:

(i) Upon any controlled substance orany of its commercial containers orwrappers, or

(ii) Accompanying such controlledsubstance.

(25) The term Long Term Care Facility(LTCF) means a nursing home, retire-ment care, mental care or other facil-ity or institution which provides ex-tended health care to resident patients.

(26) The term maintenance treatmentmeans the dispensing for a period in ex-cess of twenty-one days, of a narcoticdrug or narcotic drugs in the treat-ment of an individual for dependenceupon heroin or other morphine-likedrug.

(27) The term manufacture means theproducing, preparation, propagation,compounding, or processing of a drugor other substance or the packaging orrepackaging of such substance, or thelabeling or relabeling of the commer-cial container of such substance, butdoes not include the activities of apractitioner who, as an incident to his/her administration or dispensing such


8

21 CFR Ch. II (4–1–01 Edition)§ 1300.01

substance in the course of his/her pro-fessional practice, prepares, com-pounds, packages or labels such sub-stance. The term manufacturer means aperson who manufactures a drug orother substance, whether under a reg-istration as a manufacturer or underauthority of registration as a re-searcher or chemical analyst.

(28) The term mid-level practitionermeans an individual practitioner, otherthan a physician, dentist, veterinarian,or podiatrist, who is licensed, reg-istered, or otherwise permitted by theUnited States or the jurisdiction inwhich he/she practices, to dispense acontrolled substance in the course ofprofessional practice. Examples of mid-level practitioners include, but are notlimited to, health care providers suchas nurse practitioners, nurse midwives,nurse anesthetists, clinical nurse spe-cialists and physician assistants whoare authorized to dispense controlledsubstances by the state in which theypractice.

(29) The term name means the officialname, common or usual name, chem-ical name, or brand name of a sub-stance.

(30) The term narcotic drug means anyof the following whether produced di-rectly or indirectly by extraction fromsubstances of vegetable origin or inde-pendently by means of chemical syn-thesis or by a combination of extrac-tion and chemical synthesis:

(i) Opium, opiates, derivatives ofopium and opiates, including their iso-mers, esters, ethers, salts, and salts ofisomers, esters, and ethers wheneverthe existence of such isomers, esters,ethers and salts is possible within thespecific chemical designation. Suchterm does not include the isoquinolinealkaloids of opium.

(ii) Poppy straw and concentrate ofpoppy straw.

(iii) Coca leaves, except coca leavesand extracts of coca leaves from whichcocaine, ecgonine and derivatives of ec-gonine or their salts have been re-moved.

(iv) Cocaine, its salts, optical andgeometric isomers, and salts of iso-mers.

(v) Ecgonine, its derivatives, theirsalts, isomers and salts of isomers.

(vi) Any compound, mixture, or prep-aration which contains any quantity ofany of the substances referred to inparagraphs (b)(31)(i) through (v) of thissection.

(31) The term narcotic treatment pro-gram means a program engaged inmaintenance and/or detoxificationtreatment with narcotic drugs.

(32) The term net disposal means, fora stated period, the quantity of a basicclass of controlled substance distrib-uted by the registrant to another per-son, plus the quantity of that basicclass used by the registrant in the pro-duction of (or converted by the reg-istrant into) another basic class of con-trolled substance or a noncontrolledsubstance, plus the quantity of thatbasic class otherwise disposed of by theregistrant, less the quantity of thatbasic class returned to the registrantby any purchaser, and less the quantityof that basic class distributed by theregistrant to another registered manu-facturer of that basic class for purposesother than use in the production of, orconversion into, another basic class ofcontrolled substance or a noncon-trolled substance or in the manufac-ture of dosage forms of that basic class.

(33) The term pharmacist means anypharmacist licensed by a State to dis-pense controlled substances, and shallinclude any other person (e.g., phar-macist intern) authorized by a State todispense controlled substances underthe supervision of a pharmacist li-censed by such State.

(34) The term person includes any in-dividual, corporation, government orgovernmental subdivision or agency,business trust, partnership, associa-tion, or other legal entity.

(35) The term prescription means anorder for medication which is dispensedto or for an ultimate user but does notinclude an order for medication whichis dispensed for immediate administra-tion to the ultimate user. (e.g., anorder to dispense a drug to a bed pa-tient for immediate administration ina hospital is not a prescription.)

(36) The term proceeding means all ac-tions taken for the issuance, amend-ment, or repeal of any rule issued pur-suant to section 201 of the Act (21U.S.C. 811), commencing with the pub-lication by the Administrator of the


9


proposed rule, amended rule, or repealin the FEDERAL REGISTER.

(37) The term purchaser means anyregistered person entitled to obtainand execute order forms pursuant to§§ 1305.04 and 1305.06.

(38) The term readily retrievablemeans that certain records are kept byautomatic data processing systems orother electronic or mechanized record-keeping systems in such a manner thatthey can be separated out from allother records in a reasonable time and/or records are kept on which certainitems are asterisked, redlined, or insome other manner visually identifi-able apart from other items appearingon the records.

(39) The terms register and registrationrefer only to registration required andpermitted by sections 303 or 1007 of theAct (21 U.S.C. 823 or 957).

(40) The term registrant means anyperson who is registered pursuant to ei-ther section 303 or section 1008 of theAct (21 U.S.C. 823 or 958).

(41) The term supplier means any reg-istered person entitled to fill orderforms pursuant to § 1305.08 of this chap-ter.

(42) The term freight forwarding facil-ity means a separate facility operatedby a distributing registrant throughwhich sealed, packaged controlled sub-stances in unmarked shipping con-tainers (i.e., the containers do not indi-cate that the contents include con-trolled substances) are, in the course ofdelivery to, or return from, customers,transferred in less than 24 hours. A dis-tributing registrant who operates afreight forwarding facility may use thefacility to transfer controlled sub-stances from any location the distrib-uting registrant operates that is reg-istered with the Administration tomanufacture, distribute, or import con-trolled substances, or, with respect toreturns, registered to dispense con-trolled substances, provided that thenotice required by § 1301.12(b)(4) of Part1301 of this chapter has been submittedand approved. For purposes of this defi-nition, a distributing registrant is aperson who is registered with the Ad-ministration as a manufacturer, dis-tributor, and/or importer.

[62 FR 13941, Mar. 24, 1997, as amended at 65FR 44678, July 19, 2000]

§ 1300.02 Definitions relating to listedchemicals.

(a) Any term not defined in this partshall have the definition set forth insection 102 of the Act (21 U.S.C. 802),except that certain terms used in part1316 of this chapter are defined at thebeginning of each subpart of that part.

(b) As used in parts 1309, 1310, and1313 of this chapter, the followingterms shall have the meaning specified:

(1) The term Act means the Con-trolled Substances Act, as amended (84Stat. 1242; 21 U.S.C. 801) and/or the Con-trolled Substances Import and ExportAct, as amended (84 Stat. 1285; 21 U.S.C.951) as amended.

(2) The term Administration meansthe Drug Enforcement Administration.

(3) The term Administrator means theAdministrator of the Drug Enforce-ment Administration. The Adminis-trator has been delegated authorityunder the Act by the Attorney General(28 CFR 0.100).

(4) The terms broker and trader meanany individual, corporation, corporatedivision, partnership, association, orother legal entity which assists in ar-ranging an international transaction ina listed chemical by—

(i) Negotiating contracts;(ii) Serving as an agent or inter-

mediary; or(iii) Fulfilling a formal obligation to

complete the transaction by bringingtogether a buyer and seller, a buyerand transporter, or a seller and trans-porter, or by receiving any form ofcompensation for so doing.

(5) The term chemical export meanstransferring ownership or control, orthe sending or taking of thresholdquantities of listed chemicals out ofthe United States (whether or not suchsending or taking out constitutes anexportation within the meaning of theCustoms and related laws of the UnitedStates).

(6) The term chemical exporter is aregulated person who, as the principalparty in interest in the export trans-action, has the power and responsi-bility for determining and controllingthe sending of the listed chemical outof the United States.

(7) The term chemical import meanswith respect to a listed chemical, any


10

21 CFR Ch. II (4–1–01 Edition)§ 1300.02

bringing in or introduction of such list-ed chemical into either the jurisdictionof the United States or into the Cus-toms territory of the United States(whether or not such bringing in or in-troduction constitutes an importationwithin the meaning of the tariff laws ofthe United States).

(8) The term chemical importer is aregulated person who, as the principalparty in interest in the import trans-action, has the power and responsi-bility for determining and controllingthe bringing in or introduction of thelisted chemical into the United States.

(9) The term chemical mixture means acombination of two or more chemicalsubstances, at least one of which is nota listed chemical, except that suchterm does not include any combinationof a listed chemical with anotherchemical that is present solely as animpurity or which has been created toevade the requirements of the Act.

(10) The term customs territory of theUnited States means the several States,the District of Columbia, and PuertoRico.

(11) The term encapsulating machinemeans any manual, semi-automatic, orfully automatic equipment which maybe used to fill shells or capsules withany powdered, granular, semi-solid, orliquid material.

(12) The term established business rela-tionship with a foreign customer meansthe regulated person has exported alisted chemical at least once withinthe past six months, or twice withinthe past twelve months to a foreignmanufacturer, distributor, or end userof the chemical that has an establishedbusiness in the foreign country with afixed street address. A person or busi-ness which functions as a broker orintermediary is not a customer for pur-poses of this definition. The term alsomeans that the regulated person hasprovided the Administration with thefollowing information in accordancewith the waiver of 15-day advance no-tice requirements of § 1313.24 of thischapter:

(i) The name and street address ofthe chemical exporter and of each reg-ular customer;

(ii) The telephone number, telexnumber, contact person, and whereavailable, the facsimile number for the

chemical exporter and for each regularcustomer;

(iii) The nature of the regular cus-tomer’s business (i.e., importer, ex-porter, distributor, manufacturer,etc.), and if known, the use to whichthe listed chemical or chemicals willbe applied;

(iv) The duration of the business rela-tionship;

(v) The frequency and number oftransactions occurring during the pre-ceding 12-month period;

(vi) the amounts and the listed chem-ical or chemicals involved in regulatedtransactions between the chemical ex-porter and regular customer;

(vii) The method of delivery (directshipment or through a broker or for-warding agent); and

(viii) Other information that thechemical exporter considers relevantfor determining whether a customer isa regular customer.

(13) The term established record as animporter means that the regulated per-son has imported a listed chemical atleast once within the past six months,or twice within the past twelve monthsfrom a foreign supplier. The term alsomeans that the regulated person hasprovided the Administration with thefollowing information in accordancewith the waiver of the 15-day advancenotice requirements of § 1313.15 of thischapter:

(i) The name, DEA registration num-ber (where applicable), street address,telephone number, telex number, and,where available, the facsimile numberof the regulated person and of each for-eign supplier; and

(ii) The frequency and number oftransactions occurring during the pre-ceding 12 month period.

(14) The term hearing means anyhearing held for the granting, denial,revocation, or suspension of a registra-tion pursuant to sections 303, 304, and1008 of the Act (21 U.S.C. 823, 824 and958).

(15) The term international transactionmeans a transaction involving theshipment of a listed chemical across aninternational border (other than aUnited States border) in which abroker or trader located in the UnitedStates participates.


11


(16) The term jurisdiction of the UnitedStates means the customs territory ofthe United States, the Virgin Islands,the Canal Zone, Guam, AmericanSamoa, and the Trust Territories ofthe Pacific Islands.

(17) The term listed chemical meansany List I chemical or List II chemical.

(18) The term List I chemical means achemical specifically designated by theAdministrator in § 1310.02(a) of thischapter that, in addition to legitimateuses, is used in manufacturing a con-trolled substance in violation of theAct and is important to the manufac-ture of a controlled substance.

(19) The term List II chemical means achemical, other than a List I chemical,specifically designated by the Adminis-trator in § 1310.02(b) of this chapterthat, in addition to legitimate uses, isused in manufacturing a controlledsubstance in violation of the Act.

(20) The term name means the officialname, common or usual name, chem-ical name, or brand name of a sub-stance.

(21) The term person includes any in-dividual, corporation, government orgovernmental subdivision or agency,business trust, partnership, associa-tion, or other legal entity.

(22) The term readily retrievablemeans that certain records are kept byautomatic data processing systems orother electronic or mechanized record-keeping systems in such a manner thatthey can be separated out from allother records in a reasonable time and/or records are kept on which certainitems are asterisked, redlined, or insome other manner visually identifi-able apart from other items appearingon the records.

(23) The terms register and registrationrefer only to registration required andpermitted by sections 303 or 1007 of theAct (21 U.S.C. 823 or 957).

(24) The term registrant means anyperson who is registered pursuant to ei-ther section 303 or section 1008 of theAct (21 U.S.C. 823 or 958).

(25) The term regular customer meansa person with whom the regulated per-son has an established business rela-tionship for a specified listed chemicalor chemicals that has been reported tothe Administration subject to the cri-teria established in § 1300.02(b)(12).

(26) The term regular importer means,with respect to a listed chemical, aperson that has an established recordas an importer of that listed chemicalthat is reported to the Administrator.

(27) The term regulated person meansany individual, corporation, partner-ship, association, or other legal entitywho manufactures, distributes, im-ports, or exports a listed chemical, atableting machine, or an encapsulatingmachine, or who acts as a broker ortrader for an international transactioninvolving a listed chemical, tabletingmachine, or encapsulating machine.

(28) The term regulated transactionmeans:

(i) A distribution, receipt, sale, im-portation, or exportation of a listedchemical, or an international trans-action involving shipment of a listedchemical, or if the Administrator es-tablishes a threshold amount for a spe-cific listed chemical, a thresholdamount as determined by the Adminis-trator, which includes a cumulativethreshold amount for multiple trans-actions, of a listed chemical, exceptthat such term does not include:

(A) A domestic lawful distribution inthe usual course of business betweenagents or employees of a single regu-lated person; in this context, agents oremployees means individuals under thedirect management and control of theregulated person;

(B) A delivery of a listed chemical toor by a common or contract carrier forcarriage in the lawful and usual courseof the business of the common or con-tract carrier, or to or by a warehouse-man for storage in the lawful and usualcourse of the business of the ware-houseman, except that if the carriageor storage is in connection with thedistribution, importation, or expor-tation of a listed chemical to a thirdperson, this paragraph does not relievea distributor, importer, or exporterfrom compliance with parts 1309, 1310,and 1313 of this chapter;

(C) Any category of transaction orany category of transaction for a spe-cific listed chemical or chemicals spec-ified by regulation of the Adminis-trator as excluded from this definitionas unnecessary for enforcement of theAct;


12

21 CFR Ch. II (4–1–01 Edition)Pt. 1301

(D) Any transaction in a listed chem-ical that is contained in a drug thatmay be marketed or distributed law-fully in the United States under theFederal Food, Drug, and Cosmetic Actunless—

(1)(i) The drug contains ephedrine orits salts, optical isomers, or salts of op-tical isomers; or

(ii) The Administrator has deter-mined pursuant to the criteria in1310.10 that the drug or group of drugsis being diverted to obtain the listedchemical for use in the illicit produc-tion of a controlled substance; and

(2) The quantity of ephedrine orother listed chemical contained in thedrug included in the transaction ormultiple transactions equals or exceedsthe threshold established for thatchemical.

(E) Any transaction in a chemicalmixture listed in § 1310.13 of this chap-ter.

(ii) A distribution, importation, orexportation of a tableting machine orencapsulating machine except thatsuch term does not include a domesticlawful distribution in the usual courseof business between agents and employ-ees of a single regulated person; in thiscontext, agents or employees means in-dividuals under the direct managementand control of the regulated person.

(29) The term retail distributor meansa grocery store, general merchandisestore, drug store, or other entity orperson whose activities as a distributorrelating to drug products containingpseudoephedrine, phenylpropanola-mine, or ephedrine are limited almostexclusively to sales for personal use,both in number of sales and volume ofsales, either directly to walk-in cus-tomers or in face-to-face transactionsby direct sales. For the purposes of thisparagraph, sale for personal use meansthe distribution of below-thresholdquantities in a single transaction to anindividual for legitimate medical use.Also for the purposes of this paragraph,a grocery store is an entity withinStandard Industrial Classification(SIC) code 5411, a general merchandisestore is an entity within SIC codes 5300through 5399 and 5499, and a drug storeis an entity within SIC code 5912.

(30) The term tableting machine meansany manual, semi-automatic, or fully

automatic equipment which may beused for the compaction or molding ofpowdered or granular solids, or semi-solid material, to produce coherentsolid tablets.

[62 FR 13941, Mar. 24, 1997; 62 FR 15392, Apr.1, 1997]

PART 1301—REGISTRATION OFMANUFACTURERS, DISTRIBUTORS,AND DISPENSERS OF CON-TROLLED SUBSTANCES

GENERAL INFORMATION

Sec.1301.01 Scope of this part 1301.1301.02 Definitions.1301.03 Information; special instructions.

REGISTRATION

1301.11 Persons required to register.1301.12 Separate registrations for separate

locations.1301.13 Application for registration; time

for application; expiration date; registra-tion for independent activities; applica-tion forms, fees, contents and signature;coincident activities.

1301.14 Filing of application; acceptance forfiling; defective applications.

1301.15 Additional information.1301.16 Amendments to and withdrawal of

applications.1301.17 Special procedures for certain appli-

cations.1301.18 Research protocols.

EXCEPTIONS TO REGISTRATION AND FEES

1301.21 Exception from fees.1301.22 Exemption of agents and employees;

affiliated practitioners.1301.23 Exemption of certain military and

other personnel.1301.24 Exemption of law enforcement offi-

cials.1301.25 Registration regarding ocean ves-

sels, aircraft, and other entities.1301.26 Exemptions from import or export

requirements for personal medical use.

ACTION ON APPLICATION FOR REGISTRATION:REVOCATION OR SUSPENSION OF REGISTRATION

1301.31 Administrative review generally.1301.32 Action on applications for research

in Schedule I substances.1301.33 Application for bulk manufacture of

Schedule I and II substances.1301.34 Application for importation of

Schedule I and II substances.1301.35 Certificate of registration; denial of

registration.1301.36 Suspension or revocation of registra-

tion; suspension of registration pending


13


final order; extension of registrationpending final order.

1301.37 Order to show cause.

HEARINGS

1301.41 Hearings generally.1301.42 Purpose of hearing.1301.43 Request for hearing or appearance;

waiver.1301.44 Burden of proof.1301.45 Time and place of hearing.1301.46 Final order.

MODIFICATION, TRANSFER, AND TERMINATIONOF REGISTRATION

1301.51 Modification in registration.1301.52 Termination of registration; transfer

of registration; distribution upon dis-continuance of business.

SECURITY REQUIREMENTS

1301.71 Security requirements generally.1301.72 Physical security controls for non-

practitioners; narcotic treatment pro-grams and compounders for narcotictreatment programs; storage areas.

1301.73 Physical security controls for non-practitioners; compounders for narcotictreatment programs; manufacturing andcompounding areas.

1301.74 Other security controls for non-practitioners; narcotic treatment pro-grams and compounders for narcotictreatment programs.

1301.75 Physical security controls for prac-titioners.

1301.76 Other security controls for practi-tioners.

1301.77 Security controls for freight for-warding facilities.

EMPLOYEE SCREENING—NON-PRACTITIONERS

1301.90 Employee screening procedures.1301.91 Employee responsibility to report

drug diversion.1301.92 Illicit activities by employees.1301.93 Sources of information for employee

checks.

AUTHORITY: 21 U.S.C. 821, 822, 823, 824,871(b), 875, 877.

SOURCE: 36 FR 7778, Apr. 24, 1971, unlessotherwise noted. Redesignated at 38 FR 26609,Sept. 24, 1973.

GENERAL INFORMATION

§ 1301.01 Scope of this part 1301.Procedures governing the registra-

tion of manufacturers, distributors,dispensers, importers, and exporters ofcontrolled substances pursuant to sec-tions 301–304 and 1007–1008 of the Act (21U.S.C. 821–824 and 957–958) are set forth

generally by those sections and specifi-cally by the sections of this part.

[62 FR 13945, Mar. 24, 1997]

§ 1301.02 Definitions.Any term used in this part shall have

the definition set forth in section 102 ofthe Act (21 U.S.C. 802) or part 1300 ofthis chapter.

[62 FR 13945, Mar. 24, 1997]

§ 1301.03 Information; special instruc-tions.

Information regarding proceduresunder these rules and instructionssupplementing these rules will be fur-nished upon request by writing to theRegistration Unit, Drug EnforcementAdministration, Department of Jus-tice, Post Office Box 28083, Central Sta-tion, Washington, DC 20005.

[36 FR 7778, Apr. 24, 1971. Redesignated at 38FR 26609, Sept. 23, 1973, and amended at 51FR 5319, Feb. 13, 1986]

REGISTRATION

§ 1301.11 Persons required to register.(a) Every person who manufactures,

distributes, dispenses, imports, or ex-ports any controlled substance or whoproposes to engage in the manufacture,distribution, dispensing, importationor exportation of any controlled sub-stance shall obtain a registration un-less exempted by law or pursuant to§§ 1301.22–1301.26. Only persons actuallyengaged in such activities are requiredto obtain a registration; related or af-filiated persons who are not engaged insuch activities are not required to beregistered. (For example, a stockholderor parent corporation of a corporationmanufacturing controlled substances isnot required to obtain a registration.)

(b) [Reserved]

[62 FR 13945, Mar. 24, 1997]

§ 1301.12 Separate registrations forseparate locations.

(a) A separate registration is re-quired for each principal place of busi-ness or professional practice at onegeneral physical location where con-trolled substances are manufactured,distributed, imported, exported, or dis-pensed by a person.


14

21 CFR Ch. II (4–1–01 Edition)§ 1301.13

(b) The following locations shall bedeemed not to be places where con-trolled substances are manufactured,distributed, or dispensed:

(1) A warehouse where controlledsubstances are stored by or on behalf ofa registered person, unless such sub-stances are distributed directly fromsuch warehouse to registered locationsother than the registered location fromwhich the substances were delivered orto persons not required to register byvirtue of subsection 302(c)(2) or sub-section 1007(b)(1)(B) of the Act (21U.S.C. 822(c)(2) or 957(b)(1)(B));

(2) An office used by agents of a reg-istrant where sales of controlled sub-stances are solicited, made, or super-vised but which neither contains suchsubstances (other than substances fordisplay purposes or lawful distributionas samples only) nor serves as a dis-tribution point for filling sales orders;and

(3) An office used by a practitioner(who is registered at another location)where controlled substances are pre-scribed but neither administered norotherwise dispensed as a regular part ofthe professional practice of the practi-tioner at such office, and where no sup-plies of controlled substances aremaintained.

(4) A freight forwarding facility, asdefined in § 1300.01 of this part, providedthat the distributing registrant oper-ating the facility has submitted writ-ten notice of intent to operate the fa-cility by registered mail, return re-ceipt requested (or other suitablemeans of documented delivery) andsuch notice has been approved. The no-tice shall be submitted to the SpecialAgent in Charge of the Administra-tion’s offices in both the area in whichthe facility is located and each area inwhich the distributing registrant main-tains a registered location that willtransfer controlled substances throughthe facility. The notice shall detail theregistered locations that will utilizethe facility, the location of the facil-ity, the hours of operation, the indi-vidual(s) responsible for the controlledsubstances, the security and record-keeping procedures that will be em-ployed, and whether controlled sub-stances returns will be processedthrough the facility. The notice must

also detail what state licensing re-quirements apply to the facility andthe registrant’s actions to comply withany such requirements. The SpecialAgent in Charge of the DEA Office inthe area where the freight forwardingfacility will be operated will providewritten notice of approval or dis-approval to the person within thirtydays after confirmed receipt of the no-tice. Registrants that are currently op-erating freight forwarding facilitiesunder a memorandum of understandingwith the Administration must providenotice as required by this section nolater than September 18, 2000 and re-ceive written approval from the Spe-cial Agent in Charge of the DEA Officein the area in which the freight for-warding facility is operated in order tocontinue operation of the facility.

[62 FR 13945, Mar. 24, 1997, as amended at 65FR 44678, July 19, 2000; 65 FR 45829, July 25,2000]

§ 1301.13 Application for registration;time for application; expirationdate; registration for independentactivities; application forms, fees,contents and signature; coincidentactivities.

(a) Any person who is required to beregistered and who is not so registeredmay apply for registration at any time.No person required to be registeredshall engage in any activity for whichregistration is required until the appli-cation for registration is granted and aCertificate of Registration is issued bythe Administrator to such person.

(b) Any person who is registered mayapply to be reregistered not more than60 days before the expiration date ofhis/her registration, except that a bulkmanufacturer of Schedule I or II con-trolled substances or an importer ofSchedule I or II controlled substancesmay apply to be reregistered no morethan 120 days before the expirationdate of their registration.

(c) At the time a manufacturer, dis-tributor, researcher, analytical lab, im-porter, exporter or narcotic treatmentprogram is first registered, that busi-ness activity shall be assigned to one oftwelve groups, which shall correspondto the months of the year. The expira-tion date of the registrations of all reg-istrants within any group will be the


15


last date of the month designated forthat group. In assigning any of theabove business activities to a group,the Administration may select a groupthe expiration date of which is lessthan one year from the date such busi-ness activity was registered. If thebusiness activity is assigned to a groupwhich has an expiration date less thanthree months from the date of whichthe business activity is registered, theregistration shall not expire until oneyear from that expiration date; in allother cases, the registration shall ex-pire on the expiration date followingthe date on which the business activityis registered.

(d) At the time a retail pharmacy,hospital/clinic, practitioner or teach-ing institution is first registered, thatbusiness activity shall be assigned toone of twelve groups, which shall cor-respond to the months of the year. Theexpiration date of the registrations ofall registrants within any group will bethe last day of the month designatedfor that group. In assigning any of theabove business activities to a group,the Administration may select a groupthe expiration date of which is not lessthan 28 months nor more than 39months from the date such business ac-tivity was registered. After the initialregistration period, the registrationshall expire 36 months from the initialexpiration date.

(e) Any person who is required to beregistered and who is not so registered,shall make application for registrationfor one of the following groups of con-

trolled substances activities, which aredeemed to be independent of eachother. Application for each registrationshall be made on the indicated form,and shall be accompanied by the indi-cated fee. Fee payments shall be madein the form of a personal, certified, orcashier’s check or money order madepayable to the ‘‘Drug Enforcement Ad-ministration’’. The application fees arenot refundable. Any person, when reg-istered to engage in the activities de-scribed in each subparagraph in thisparagraph, shall be authorized to en-gage in the coincident activities de-scribed without obtaining a registra-tion to engage in such coincident ac-tivities, provided that, unless specifi-cally exempted, he/she complies withall requirements and duties prescribedby law for persons registered to engagein such coincident activities. Any per-son who engages in more than onegroup of independent activities shallobtain a separate registration for eachgroup of activities, except as providedin this paragraph under coincident ac-tivities. A single registration to engagein any group of independent activitieslisted below may include one or morecontrolled substances listed in theschedules authorized in that group ofindependent activities. A person reg-istered to conduct research with con-trolled substances listed in Schedule Imay conduct research with any sub-stances listed in Schedule I for whichhe/she has filed and had approved a re-search protocol.

(1)

Business activity Controlled substances DEA applicationforms

Applica-tion fee(dollars)

Reg-istra-

tion pe-riod

(years)

Coincident activities allowed

(i) Manufacturing Schedules I through V New—225Renewal—225a

875875

1 Schedules I through V: May distributethat substance or class for whichregistration was issued; may notdistribute any substance or classfor which not registered. SchedulesII through V: May conduct chemicalanalysis and preclinical research(including quality control analysis)with substances listed in thoseschedules for which authorizationas a manufacturer was issued.

(ii) Distributing Schedules I through V New—225Renewal—225a

438438

1


16

21 CFR Ch. II (4–1–01 Edition)§ 1301.13



Reg-istra-

tion pe-riod

(years)


(iii) Dispensing orInstructing (In-cludes PractitionerHospital/Clinic,Retail Pharmacy,Teaching Institu-tion)

Schedules II through V New—224Renewal—224a

210210

3 May conduct research and instruc-tional activities with those sub-stances for which registration wasgranted, except that a mid-levelpractitioner may conduct such re-search only to the extent expresslyauthorized under state statute. Apharmacist may manufacture anaqueous or oleaginous solution orsolid dosage form containing a nar-cotic controlled substance inSchedule II through V in a propor-tion not exceeding 20 percent ofthe complete solution, compound,or mixture.

(iv) Research Schedule I New—225Renewal—225a

7070

1 A researcher may manufacture or im-port the basic class of substance orsubstances for which registrationwas issued, provided that suchmanufacture or import is set forth inthe protocol required in Section1301.18 and to distribute suchclass to persons registered or au-thorized to conduct research withsuch class of substance or reg-istered or authorized to conductchemical analysis with controlledsubstances.

(v) Research Schedules II through V New—225Renewal—225a

7070

1 May conduct chemical analysis withcontrolled substances in thoseschedules for which registrationwas issued; manufacture such sub-stances if and to the extent thatsuch manufacture is set forth in astatement filed with the applicationfor registration or reregistration andprovided that the manufacture isnot for the purposes of dosageform development; import suchsubstances for research purposes;distribute such substances to per-sons registered or authorized toconduct chemical analysis, instruc-tional activities, or research withsuch substances, and to personsexempted from registration pursu-ant to Section 1301.24; and con-duct instructional activities with con-trolled substances.

(vi) Narcotic Treat-ment Program (in-cludingcompounder)

Narcotic Drugs inSchedules II throughV

New—363Renewal—363a

7070

1

(vii) Importing Schedules I through V New—225Renewal—225a

438438

1 May distribute that substance or classfor which registration was issued;may not distribute any substance orclass for which not registered.

(viii) Exporting Schedules I through V New—225Renewal—225a

438438

1


17




Reg-istra-

tion pe-riod

(years)


(ix) Chemical Anal-ysis

Schedules I through V New—225Renewal—225a

7070

1 May manufacture and import con-trolled substances for analytical orinstructional activities; may dis-tribute such substances to personsregistered or authorized to conductchemical analysis, instructional ac-tivities, or research with such sub-stances and to persons exemptedfrom registration pursuant to Sec-tion 1301.24; may export such sub-stances to persons in other coun-tries performing chemical analysisor enforcing laws relating to con-trolled substances or drugs in thosecountries; and may conduct instruc-tional activities with controlled sub-stances.

(2) DEA Forms 224, 225, and 363 maybe obtained at any area office of theAdministration or by writing to theRegistration Unit, Drug EnforcementAdministration, Department of Jus-tice, Post Office Box 28083, Central Sta-tion, Washington, DC 20005.

(3) DEA Forms 224a, 225a, and 363awill be mailed, as applicable, to eachregistered person approximately 60days before the expiration date of his/her registration; if any registered per-son does not receive such forms within45 days before the expiration date ofhis/her registration, he/she mustpromptly give notice of such fact andrequest such forms by writing to theRegistration Unit of the Administra-tion at the foregoing address.

(f) Each application for registrationto handle any basic class of controlledsubstance listed in Schedule I (exceptto conduct chemical analysis with suchclasses), and each application for reg-istration to manufacture a basic classof controlled substance listed in Sched-ule II shall include the AdministrationControlled Substances Code Number, asset forth in part 1308 of this chapter,for each basic class to be covered bysuch registration.

(g) Each application for registrationto import or export controlled sub-stances shall include the Administra-tion Controlled Substances Code Num-ber, as set forth in part 1308 of thischapter, for each controlled substancewhose importation or exportation is tobe authorized by such registration.

Registration as an importer or ex-porter shall not entitle a registrant toimport or export any controlled sub-stance not specified in such registra-tion.

(h) Each application for registrationto conduct research with any basicclass of controlled substance listed inSchedule II shall include the Adminis-tration Controlled Substances CodeNumber, as set forth in part 1308 of thischapter, for each such basic class to bemanufactured or imported as a coinci-dent activity of that registration. Astatement listing the quantity of eachsuch basic class of controlled substanceto be imported or manufactured duringthe registration period for which appli-cation is being made shall be includedwith each such application. For pur-poses of this paragraph only, manufac-turing is defined as the production of acontrolled substance by synthesis, ex-traction or by agricultural/horti-cultural means.

(i) Each application shall include allinformation called for in the form, un-less the item is not applicable, inwhich case this fact shall be indicated.

(j) Each application, attachment, orother document filed as part of an ap-plication, shall be signed by the appli-cant, if an individual; by a partner ofthe applicant, if a partnership; or by anofficer of the applicant, if a corpora-tion, corporate division, association,trust or other entity. An applicant mayauthorize one or more individuals, whowould not otherwise be authorized to


18

21 CFR Ch. II (4–1–01 Edition)§ 1301.14

do so, to sign applications for the ap-plicant by filing with the RegistrationUnit of the Administration a power ofattorney for each such individual. Thepower of attorney shall be signed by aperson who is authorized to sign appli-cations under this paragraph and shallcontain the signature of the individualbeing authorized to sign applications.The power of attorney shall be validuntil revoked by the applicant.

[62 FR 13946, Mar. 24, 1997]

§ 1301.14 Filing of application; accept-ance for filing; defective applica-tions.

(a) All applications for registrationshall be submitted for filing to theRegistration Unit, Drug EnforcementAdministration, Department of Jus-tice, Post Office Box 28083, Central Sta-tion, Washington, DC 20005. The appro-priate registration fee and any requiredattachments must accompany the ap-plication.

(b) Any person required to obtainmore than one registration may submitall applications in one package. Eachapplication must be complete andshould not refer to any accompanyingapplication for required information.

(c) Applications submitted for filingare dated upon receipt. If found to becomplete, the application will be ac-cepted for filing. Applications failingto comply with the requirements ofthis part will not generally be acceptedfor filing. In the case of minor defectsas to completeness, the Administratormay accept the application for filingwith a request to the applicant for ad-ditional information. A defective appli-cation will be returned to the applicantwithin 10 days following its receiptwith a statement of the reason for notaccepting the application for filing. Adefective application may be correctedand resubmitted for filing at any time;the Administrator shall accept for fil-ing any application upon resubmissionby the applicant, whether complete ornot.

(d) Accepting an application for fil-ing does not preclude any subsequentrequest for additional information pur-suant to § 1301.15 and has no bearing on

whether the application will be grant-ed.

[62 FR 13948, Mar. 24, 1997]

§ 1301.15 Additional information.

The Administrator may require anapplicant to submit such documents orwritten statements of fact relevant tothe application as he/she deems nec-essary to determine whether the appli-cation should be granted. The failure ofthe applicant to provide such docu-ments or statements within a reason-able time after being requested to do soshall be deemed to be a waiver by theapplicant of an opportunity to presentsuch documents or facts for consider-ation by the Administrator in grantingor denying the application.

[62 FR 13948, Mar. 24, 1997]

§ 1301.16 Amendments to and with-drawal of applications.

(a) An application may be amendedor withdrawn without permission ofthe Administrator at any time beforethe date on which the applicant re-ceives an order to show cause pursuantto § 1301.37. An application may beamended or withdrawn with permissionof the Administrator at any timewhere good cause is shown by the ap-plicant or where the amendment orwithdrawal is in the public interest.

(b) After an application has been ac-cepted for filing, the request by the ap-plicant that it be returned or the fail-ure of the applicant to respond to offi-cial correspondence regarding the ap-plication, when sent by registered orcertified mail, return receipt re-quested, shall be deemed to be a with-drawal of the application.

[62 FR 13949, Mar. 24, 1997]

§ 1301.17 Special procedures for cer-tain applications.

(a) If, at the time of application forregistration of a new pharmacy, thepharmacy has been issued a licensefrom the appropriate State licensingagency, the applicant may include withhis/her application an affidavit as tothe existence of the State license inthe following form:


19


Affidavit for New Pharmacy

I, llllllllll, thellllllllll (Title of officer, official,partner, or other position) ofllllllllll (Corporation, partner-ship, or sole proprietor), doing business asllllllllll (Store name) atllllllllll (Number and Street),llllllllll (City) llllll (State)llllll (Zip code), hereby certify thatsaid store was issued a pharmacy permit No.llll by the llllllll (Board ofPharmacy or Licensing Agency) of the Stateof llllll on llllll (Date).

This statement is submitted in order to ob-tain a Drug Enforcement Administrationregistration number. I understand that ifany information is false, the Administrationmay immediately suspend the registrationfor this store and commence proceedings torevoke under 21 U.S.C. 824(a) because of thedanger to public health and safety. I furtherunderstand that any false information con-tained in this affidavit may subject me per-sonally and the above-named corporation/partnership/business to prosecution under 21U.S.C. 843, the penalties for conviction ofwhich include imprisonment for up to 4years, a fine of not more than $30,000 or both.llllllllllllllllllllllll

Signature (Person who signs Application forRegistration)State of lllllllllllllllllll

County of llllllllllllllllll

Subscribed to and sworn before me thisllll day of llll, 19lll.llllllllllllllllllllllll

Notary Public

(b) Whenever the ownership of apharmacy is being transferred from oneperson to another, if the transfereeowns at least one other pharmacy li-censed in the same State as the one theownership of which is being trans-ferred, the transferee may apply forregistration prior to the date of trans-fer. The Administrator may registerthe applicant and authorize him to ob-tain controlled substances at the timeof transfer. Such registration shall notauthorize the transferee to dispensecontrolled substances until the phar-macy has been issued a valid State li-cense. The transferee shall includewith his/her application the followingaffidavit:

Affidavit for Transfer of Pharmacy

I, llllllllll, thellllllllll (Title of officer, official,partner or other position) ofllllllllll (Corporation, partner-ship, or sole proprietor), doing business as

llllllllll (Store name) hereby cer-tify:

(1) That said company was issued a phar-macy permit No.llllllby thellllllllll (Board of Pharmacy ofLicensing Agency) of the State ofllllll and a DEA Registration Numberllllllllll for a pharmacy located atllllllllll (Number and Street)llllll (City) llllll (State)llllll (Zip Code); and

(2) That said company is acquiring thepharmacy business of llllllllll

(Name of Seller) doing businessasllllllllllwith DEA RegistrationNumber llllll on or about llllll

(Date of Transfer) and that said company hasapplied (or will apply on llllll (Date)for a pharmacy permit from the board ofpharmacy (or licensing agency) of the Stateof llllll to do business asllllllllll (Store name) atllllllllll (Number and Street)llllllllll (City) llllll (State)llllll (Zip Code).

This statement is submitted in orderto obtain a Drug Enforcement Admin-istration registration number.

I understand that if a DEA registrationnumber is issued, the pharmacy may acquirecontrolled substances but may not dispensethem until a pharmacy permit or license isissued by the State board of pharmacy or li-censing agency.

I understand that if any information isfalse, the Administration may immediatelysuspend the registration for this store andcommence proceedings to revoke under 21U.S.C. 824(a) because of the danger to publichealth and safety. I further understand thatany false information contained in this affi-davit may subject me personally to prosecu-tion under 21 U.S.C. 843, the penalties forconviction of which include imprisonmentfor up to 4 years, a fine of not more than$30,000 or both.

llllllllllllllllllllllll

Signature (Person who signs Application forRegistration)State of lllllllllllllllllll

County of llllllllllllllllll

Subscribed to and sworn before methisllday ofllllll, 19ll.llllllllllllllllllllllll

Notary Public

(c) The Administrator shall followthe normal procedures for approving anapplication to verify the statements inthe affidavit. If the statements proveto be false, the Administrator may re-voke the registration on the basis ofsection 304(a)(1) of the Act (21 U.S.C.824(a)(1)) and suspend the registration


20

21 CFR Ch. II (4–1–01 Edition)§ 1301.18

immediately by pending revocation onthe basis of section 304(d) of the Act (21U.S.C. 824(d)). At the same time, theAdministrator may seize and placeunder seal all controlled substancespossessed by the applicant under sec-tion 304(f) of the Act (21 U.S.C. 824(f)).Intentional misuse of the affidavit pro-cedure may subject the applicant toprosecution for fraud under section403(a)(4) of the Act (21 U.S.C. 843(a)(4)),and obtaining controlled substancesthrough registration by fraudulentmeans may subject the applicant toprosecution under section 403(a)(3) ofthe Act (21 U.S.C. 843(a)(3)). The pen-alties for conviction of either offenseinclude imprisonment for up to 4 years,a fine not exceeding $30,000 or both.

[62 FR 13949, Mar. 24, 1997]

§ 1301.18 Research protocols.(a) A protocol to conduct research

with controlled substances listed inSchedule I shall be in the followingform and contain the following infor-mation where applicable:

(1) Investigator:(i) Name, address, and DEA registra-

tion number; if any.(ii) Institutional affiliation.(iii) Qualifications, including a cur-

riculum vitae and an appropriate bibli-ography (list of publications).

(2) Research project:(i) Title of project.(ii) Statement of the purpose.(iii) Name of the controlled sub-

stances or substances involved and theamount of each needed.

(iv) Description of the research to beconducted, including the number andspecies of research subjects, the dosageto be administered, the route andmethod of administration, and the du-ration of the project.

(v) Location where the research willbe conducted.

(vi) Statement of the security provi-sions for storing the controlled sub-stances (in accordance with § 1301.75)and for dispensing the controlled sub-stances in order to prevent diversion.

(vii) If the investigator desires tomanufacture or import any controlledsubstance listed in paragraph (a)(2)(iii)of this section, a statement of thequantity to be manufactured or im-ported and the sources of the chemicals

to be used or the substance to be im-ported.

(3) Authority:(i) Institutional approval.(ii) Approval of a Human Research

Committee for human studies.(iii) Indication of an approved active

Notice of Claimed Investigational Ex-emption for a New Drug (number).

(iv) Indication of an approved fundedgrant (number), if any.

(b) In the case of a clinical investiga-tion with controlled substances listedin Schedule I, the applicant shall sub-mit three copies of a Notice of ClaimedInvestigational Exemption for a NewDrug (IND) together with a statementof the security provisions (as pro-scribed in paragraph (a)(2)(vi) of thissection for a research protocol) to, andhave such submission approved by, theFood and Drug Administration as re-quired in 21 U.S.C. 355(i) and § 130.3 ofthis title. Submission of this Noticeand statement to the Food and DrugAdministration shall be in lieu of a re-search protocol to the Administrationas required in paragraph (a) of this sec-tion. The applicant, when applying forregistration with the Administration,shall indicate that such notice hasbeen submitted to the Food and DrugAdministration by submitting to theAdministration with his/her DEA Form225 three copies of the following certifi-cate:

I hereby certify that on llllllllll

(Date), pursuant to 21 U.S.C. 355(i) and 21CFR 130.3, I, llllllllll (Name andAddress of IND Sponsor) submitted a Noticeof Claimed Investigational Exemption for aNew Drug (IND) to the Food and Drug Ad-ministration for:


(Name of Investigational Drug).


(Date)


(Signature of Applicant).

(c) In the event that the registrantdesires to increase the quantity of acontrolled substance used for an ap-proved research project, he/she shallsubmit a request to the RegistrationUnit, Drug Enforcement Administra-tion, Post Office Box 28083, CentralStation, Washington, DC 20005, by reg-istered mail, return receipt requested.The request shall contain the following


21


information: DEA registration number;name of the controlled substance orsubstances and the quantity of eachauthorized in the approved protocol;and the additional quantity of each de-sired. Upon return of the receipt, theregistrant shall be authorized to pur-chase the additional quantity of thecontrolled substance or substancesspecified in the request. The Adminis-tration shall review the letter and for-ward it to the Food and Drug Adminis-tration together with the Administra-tion comments. The Food and Drug Ad-ministration shall approve or deny therequest as an amendment to the pro-tocol and so notify the registrant. Ap-proval of the letter by the Food andDrug Administration shall authorizethe registrant to use the additionalquantity of the controlled substance inthe research project.

(d) In the event the registrant desiresto conduct research beyond the vari-ations provided in the registrant’s ap-proved protocol (excluding any in-crease in the quantity of the controlledsubstance requested for his/her re-search project as outlined in paragraph(c) of this section), he/she shall submitthree copies of a supplemental protocolin accordance with paragraph (a) ofthis section describing the new re-search and omitting information in thesupplemental protocol which has beenstated in the original protocol. Supple-mental protocols shall be processed andapproved or denied in the same manneras original research protocols.

[62 FR 13949, Mar. 24, 1997]

EXCEPTIONS TO REGISTRATION AND FEES

§ 1301.21 Exemption from fees.(a) The Administrator shall exempt

from payment of an application fee forregistration or reregistration:

(1) Any hospital or other institutionwhich is operated by an agency of theUnited States (including the U.S.Army, Navy, Marine Corps., Air Force,and Coast Guard), of any State, or anypolitical subdivision or agency thereof.

(2) Any individual practitioner who isrequired to obtain an individual reg-istration in order to carry out his orher duties as an official of an agency ofthe United States (including the U.S.Army, Navy, Marine Corps, Air Force,

and Coast Guard), of any State, or anypolitical subdivision or agency thereof.

(b) In order to claim exemption frompayment of a registration or rereg-istration application fee, the registrantshall have completed the certificationon the appropriate application form,wherein the registrant’s superior (ifthe registrant is an individual) or offi-cer (if the registrant is an agency) cer-tifies to the status and address of theregistrant and to the authority of theregistrant to acquire, possess, or han-dle controlled substances.

(c) Exemption from payment of a reg-istration or reregistration applicationfee does not relieve the registrant ofany other requirements or duties pre-scribed by law.

[62 FR 13950, Mar. 24, 1997]

§ 1301.22 Exemption of agents and em-ployees; affiliated practitioners.

(a) The requirement of registration iswaived for any agent or employee of aperson who is registered to engage inany group of independent activities, ifsuch agent or employee is acting in theusual course of his/her business or em-ployment.

(b) An individual practitioner who isan agent or employee of another prac-titioner (other than a mid-level practi-tioner) registered to dispense con-trolled substances may, when acting inthe normal course of business or em-ployment, administer or dispense(other than by issuance of prescription)controlled substances if and to the ex-tent that such individual practitioneris authorized or permitted to do so bythe jurisdiction in which he or shepractices, under the registration of theemployer or principal practitioner inlieu of being registered him/herself.

(c) An individual practitioner who isan agent or employee of a hospital orother institution may, when acting inthe normal course of business or em-ployment, administer, dispense, or pre-scribe controlled substances under theregistration of the hospital or other in-stitution which is registered in lieu ofbeing registered him/herself, providedthat:

(1) Such dispensing, administering orprescribing is done in the usual courseof his/her professional practice;


22

21 CFR Ch. II (4–1–01 Edition)§ 1301.23

(2) Such individual practitioner is au-thorized or permitted to do so by thejurisdiction in which he/she is prac-ticing;

(3) The hospital or other institutionby whom he/she is employed hasverified that the individual practi-tioner is so permitted to dispense, ad-minister, or prescribe drugs within thejurisdiction;

(4) Such individual practitioner isacting only within the scope of his/heremployment in the hospital or institu-tion;

(5) The hospital or other institutionauthorizes the individual practitionerto administer, dispense or prescribeunder the hospital registration anddesignates a specific internal codenumber for each individual practi-tioner so authorized. The code numbershall consist of numbers, letters, or acombination thereof and shall be a suf-fix to the institution’s DEA registra-tion number, preceded by a hyphen(e.g., APO123456–10 or APO123456–A12);and

(6) A current list of internal codesand the corresponding individual prac-titioners is kept by the hospital orother institution and is made availableat all times to other registrants andlaw enforcement agencies upon requestfor the purpose of verifying the author-ity of the prescribing individual practi-tioner.

[62 FR 13950, Mar. 24, 1997]

§ 1301.23 Exemption of certain mili-tary and other personnel.

(a) The requirement of registration iswaived for any official of the U.S.Army, Navy, Marine Corps, Air Force,Coast Guard, Public Health Service, orBureau of Prisons who is authorized toprescribe, dispense, or administer, butnot to procure or purchase, controlledsubstances in the course of his/her offi-cial duties. Such officials shall followprocedures set forth in part 1306 of thischapter regarding prescriptions, butshall state the branch of service oragency (e.g., ‘‘U.S. Army’’ or ‘‘PublicHealth Service’’) and the service iden-tification number of the issuing officialin lieu of the registration number re-quired on prescription forms. The serv-ice identification number for a Public

Health Service employee is his/her So-cial Security identification number.

(b) The requirement of registration iswaived for any official or agency of theU.S. Army, Navy, Marine Corps, AirForce, Coast Guard, or Public HealthService who or which is authorized toimport or export controlled substancesin the course of his/her official duties.

(c) If any official exempted by thissection also engages as a private indi-vidual in any activity or group of ac-tivities for which registration is re-quired, such official shall obtain a reg-istration for such private activities.

[62 FR 13951, Mar. 24, 1997]

§ 1301.24 Exemption of law enforce-ment officials.

(a) The requirement of registration iswaived for the following persons in thecircumstances described in this sec-tion:

(1) Any officer or employee of the Ad-ministration, any officer of the U.S.Customs Service, any officer or em-ployee of the United States Food andDrug Administration, and any otherFederal officer who is lawfully engagedin the enforcement of any Federal lawrelating to controlled substances,drugs or customs, and is duly author-ized to possess or to import or exportcontrolled substances in the course ofhis/her official duties; and

(2) Any officer or employee of anyState, or any political subdivision oragency thereof, who is engaged in theenforcement of any State or local lawrelating to controlled substances and isduly authorized to possess controlledsubstances in the course of his/her offi-cial duties.

(b) Any official exempted by this sec-tion may, when acting in the course ofhis/her official duties, procure any con-trolled substance in the course of aninspection, in accordance with§ 1316.03(d) of this chapter, or in thecourse of any criminal investigationinvolving the person from whom thesubstance was procured, and may pos-sess any controlled substance and dis-tribute any such substance to anyother official who is also exempted bythis section and acting in the course ofhis/her official duties.

(c) In order to enable law enforce-ment agency laboratories, including


23


laboratories of the Administration, toobtain and transfer controlled sub-stances for use as standards in chem-ical analysis, such laboratories shallobtain annually a registration to con-duct chemical analysis. Such labora-tories shall be exempted from paymentof a fee for registration. Laboratorypersonnel, when acting in the scope oftheir official duties, are deemed to beofficials exempted by this section andwithin the activity described in section515(d) of the Act (21 U.S.C. 885(d)). Forpurposes of this paragraph, laboratoryactivities shall not include field orother preliminary chemical tests by of-ficials exempted by this section.

(d) In addition to the activities au-thorized under a registration to con-duct chemical analysis pursuant to§ 1301.13(e)(1)(ix), laboratories of theAdministration shall be authorized tomanufacture or import controlled sub-stances for any lawful purpose, to dis-tribute or export such substances toany person, and to import and exportsuch substances in emergencies with-out regard to the requirements of part1312 of this chapter if a report con-cerning the importation or exportationis made to the Drug Operations Sectionof the Administration within 30 days ofsuch importation or exportation.

[62 FR 13951, Mar. 24, 1997]

§ 1301.25 Registration regarding oceanvessels, aircraft, and other entities.

(a) If acquired by and dispensed underthe general supervision of a medical of-ficer described in paragraph (b) of thissection, or the master or first officer ofthe vessel under the circumstances de-scribed in paragraph (d) of this section,controlled substances may be held forstocking, be maintained in, and dis-pensed from medicine chests, first aidpackets, or dispensaries:

(1) On board any vessel engaged ininternational trade or in trade betweenports of the United States and anymerchant vessel belonging to the U.S.Government;

(2) On board any aircraft operated byan air carrier under a certificate of per-mit issued pursuant to the FederalAviation Act of 1958 (49 U.S.C. 1301);and

(3) In any other entity of fixed ortransient location approved by the Ad-

ministrator as appropriate for applica-tion of this section (e.g., emergencykits at field sites of an industrial firm).

(b) A medical officer shall be:(1) Licensed in a state as a physician;(2) Employed by the owner or oper-

ator of the vessel, aircraft or other en-tity; and

(3) Registered under the Act at eitherof the following locations:

(i) The principal office of the owneror operator of the vessel, aircraft orother entity or

(ii) At any other location providedthat the name, address, registrationnumber and expiration date as they ap-pear on his/her Certificate of Registra-tion (DEA Form 223) for this locationare maintained for inspection at saidprincipal office in a readily retrievablemanner.

(c) A registered medical officer mayserve as medical officer for more thanone vessel, aircraft, or other entityunder a single registration, unless he/she serves as medical officer for morethan one owner or operator, in whichcase he/she shall either maintain a sep-arate registration at the location ofthe principal office of each such owneror operator or utilize one or more reg-istrations pursuant to paragraph(b)(3)(ii) of this section.

(d) If no medical officer is employedby the owner or operator of a vessel, orin the event such medical officer is notaccessible and the acquisition of con-trolled substances is required, the mas-ter or first officer of the vessel, whoshall not be registered under the Act,may purchase controlled substancesfrom a registered manufacturer or dis-tributor, or from an authorized phar-macy as described in paragraph (f) ofthis section, by following the procedureoutlined below:

(1) The master or first officer of thevessel must personally appear at thevendor’s place of business, presentproper identification (e.g., Seaman’sphotographic identification card) and awritten requisition for the controlledsubstances.

(2) The written requisition must beon the vessel’s official stationery orpurchase order form and must includethe name and address of the vendor,the name of the controlled substance,description of the controlled substance


24

21 CFR Ch. II (4–1–01 Edition)§ 1301.25

(dosage form, strength and number orvolume per container) number of con-tainers ordered, the name of the vessel,the vessel’s official number and coun-try of registry, the owner or operatorof the vessel, the port at which the ves-sel is located, signature of the vessel’sofficer who is ordering the controlledsubstances and the date of the requisi-tion.

(3) The vendor may, after verifyingthe identification of the vessel’s officerrequisitioning the controlled sub-stances, deliver the control substancesto that officer. The transaction shallbe documented, in triplicate, on arecord of sale in a format similar tothat outlined in paragraph (d)(4) of thissection. The vessel’s requisition shallbe attached to copy 1 of the record of

sale and filed with the controlled sub-stances records of the vendor, copy 2 ofthe record of sale shall be furnished tothe officer of the vessel and retainedaboard the vessel, copy 3 of the recordof sale shall be forwarded to the near-est DEA Division Office within 15 daysafter the end of the month in which thesale is made.

(4) The vendor’s record of sale shouldbe similar to, and must include all theinformation contained in, the belowlisted format.

SALE OF CONTROLLED SUBSTANCES TO

VESSELS

(Name of registrant) llllllllllll

(Address of registrant) lllllllllll

(DEA registration number) lllllllll

Line No. Number of pack-ages ordered Size of packages Name of product Packages distrib-

uted Date distributed

1 ...................................... .............................. .............................. ............................ .............................. ............................2 ...................................... .............................. .............................. ............................ .............................. ............................3 ...................................... .............................. .............................. ............................ .............................. ............................

FOOTNOTE: Line numbers may be continued according to needs of the vendor.

Number of lines completed lllllllll

Name of vessel lllllllllllllll

Vessel’s official number lllllllllll

Vessel’s country of registry lllllllll

Owner or operator of the vessel lllllll

Name and title of vessel’s officer who pre-sented the requisition llll

Signature of vessel’s officer who presentedthe requisition llll

(e) Any medical officer described inparagraph (b) of this section shall, inaddition to complying with all require-ments and duties prescribed for reg-istrants generally, prepare an annualreport as of the date on which his/herregistration expires, which shall givein detail an accounting for each vessel,aircraft, or other entity, and a sum-mary accounting for all vessels, air-craft, or other entities under his/hersupervision for all controlled sub-stances purchased, dispensed or dis-posed of during the year. The medicalofficer shall maintain this report withother records required to be kept underthe Act and, upon request, deliver acopy of the report to the Administra-tion. The medical officer need not bepresent when controlled substances aredispensed, if the person who actuallydispensed the controlled substances is

responsible to the medical officer tojustify his/her actions.

(f) Any registered pharmacy thatwishes to distribute controlled sub-stances pursuant to this section shallbe authorized to do so, provided:

(1) The registered pharmacy notifiesthe nearest Division Office of the Ad-ministration of its intention to so dis-tribute controlled substances prior tothe initiation of such activity. This no-tification shall be by registered mailand shall contain the name, address,and registration number of the phar-macy as well as the date upon whichsuch activity will commence; and

(2) Such activity is authorized bystate law; and

(3) The total number of dosage unitsof all controlled substances distributedby the pharmacy during any calendaryear in which the pharmacy is reg-istered to dispense does not exceed thelimitations imposed upon such dis-tribution by § 1307.11(a)(4) and (b) ofthis chapter.

(g) Owners or operators of vessels,aircraft, or other entities described inthis section shall not be deemed to pos-sess or dispense any controlled sub-stance acquired, stored and dispensed


25


in accordance with this section. Addi-tionally, owners or operators of ves-sels, aircraft, or other entities de-scribed in this section or in Article 32of the Single Convention on NarcoticDrugs, 1961, or in Article 14 of the Con-vention on Psychotropic Substances,1971, shall not be deemed to import orexport any controlled substances pur-chased and stored in accordance withthat section or applicable article.

(h) The Master of a vessel shall pre-pare a report for each calendar yearwhich shall give in detail an account-ing for all controlled substances pur-chased, dispensed, or disposed of duringthe year. The Master shall file this re-port with the medical officer employedby the owner or operator of his/her ves-sel, if any, or, if not, he/she shall main-tain this report with other records re-quired to be kept under the Act and,upon request, deliver a copy of the re-port to the Administration.

(i) Controlled substances acquiredand possessed in accordance with thissection shall not be distributed to per-sons not under the general supervisionof the medical officer employed by theowner or operator of the vessel, air-craft, or other entity, except in accord-ance with § 1307.21 of this chapter.

[62 FR 13951, Mar. 24, 1997]

§ 1301.26 Exemptions from import orexport requirements for personalmedical use.

Any individual who has in his/herpossession a controlled substance listedin schedules II, III, IV, or V, which he/she has lawfully obtained for his/herpersonal medical use, or for adminis-tration to an animal accompanyinghim/her, may enter or depart theUnited States with such substance not-withstanding sections 1002–1005 of theAct (21 U.S.C. 952–955), providing thefollowing conditions are met:

(a) The controlled substance is in theoriginal container in which it was dis-pensed to the individual; and

(b) The individual makes a declara-tion to an appropriate official of theU.S. Customs Service stating:

(1) That the controlled substance ispossessed for his/her personal use, orfor an animal accompanying him/her;and

(2) The trade or chemical name andthe symbol designating the schedule ofthe controlled substance if it appearson the container label, or, if such namedoes not appear on the label, the nameand address of the pharmacy or practi-tioner who dispensed the substance andthe prescription number, if any; and

(c) The importation of the controlledsubstance for personal medical use isauthorized or permitted under otherFederal laws and state law.

[62 FR 13952, Mar. 24, 1997]

ACTION ON APPLICATION FOR REGISTRA-TION: REVOCATION OR SUSPENSION OFREGISTRATION

§ 1301.31 Administrative review gen-erally.

The Administrator may inspect, orcause to be inspected, the establish-ment of an applicant or registrant, pur-suant to subpart A of part 1316 of thischapter. The Administrator shall re-view the application for registrationand other information gathered by theAdministrator regarding an applicantin order to determine whether the ap-plicable standards of section 303 (21U.S.C. 823) or section 1008 (21 U.S.C. 958)of the Act have been met by the appli-cant.

[62 FR 13953, Mar. 24, 1997]

§ 1301.32 Action on applications for re-search in Schedule I substances.

(a) In the case of an application forregistration to conduct research withcontrolled substances listed in Sched-ule I, the Administrator shall processthe application and protocol and for-ward a copy of each to the Secretary ofHealth and Human Services (Secretary)within 7 days after receipt. The Sec-retary shall determine the qualifica-tions and competency of the applicant,as well as the merits of the protocol(and shall notify the Administrator ofhis/her determination) within 21 daysafter receipt of the application andcomplete protocol, except that in thecase of a clinical investigation, theSecretary shall have 30 days to makesuch determination and notify the Ad-ministrator. The Secretary, in deter-mining the merits of the protocol, shallconsult with the Administrator as to


26

21 CFR Ch. II (4–1–01 Edition)§ 1301.33

effective procedures to safeguard ade-quately against diversion of such con-trolled substances from legitimatemedical or scientific use.

(b) An applicant whose protocol is de-fective shall be notified by the Sec-retary within 21 days after receipt ofsuch protocol from the Administrator(or in the case of a clinical investiga-tion within 30 days), and he/she shall berequested to correct the existing de-fects before consideration shall begiven to his/her submission.

(c) If the Secretary determines theapplicant qualified and competent andthe research protocol meritorious, he/she shall notify the Administrator inwriting of such determination. The Ad-ministrator shall issue a certificate ofregistration within 10 days after re-ceipt of this notice, unless he/she deter-mines that the certificate of registra-tion should be denied on a ground spec-ified in section 304(a) of the Act (21U.S.C. 824(a)). In the case of a supple-mental protocol, a replacement certifi-cate of registration shall be issued bythe Administrator.

(d) If the Secretary determines thatthe protocol is not meritorious and/orthe applicant is not qualified or com-petent, he/she shall notify the Adminis-trator in writing setting forth the rea-sons for such determination. If the Ad-ministrator determines that groundsexist for the denial of the application,he/she shall within 10 days issue anorder to show cause pursuant to§ 1301.37 and, if requested by the appli-cant, hold a hearing on the applicationpursuant to § 1301.41. If the grounds fordenial of the application include a de-termination by the Secretary, the Sec-retary or his duly authorized agentshall furnish testimony and documentspertaining to his determination at suchhearing.

(e) Supplemental protocols will beprocessed in the same manner as origi-nal research protocols. If the proc-essing of an application or researchprotocol is delayed beyond the timelimits imposed by this section, the ap-plicant shall be so notified in writing.

[62 FR 13953, Mar. 24, 1997]

§ 1301.33 Application for bulk manu-facture of Schedule I and II sub-stances.

(a) In the case of an application forregistration or reregistration to manu-facture in bulk a basic class of con-trolled substance listed in Schedule Ior II, the Administrator shall, upon thefiling of such application, publish inthe FEDERAL REGISTER a notice namingthe applicant and stating that such ap-plicant has applied to be registered asa bulk manufacturer of a basic class ofnarcotic or nonnarcotic controlled sub-stance, which class shall be identified.A copy of said notice shall be mailedsimultaneously to each person reg-istered as a bulk manufacturer of thatbasic class and to any other applicanttherefor. Any such person may, within60 days from the date of publication ofthe notice in the FEDERAL REGISTER,file with the Administrator writtencomments on or objections to theissuance of the proposed registration.

(b) In order to provide adequate com-petition, the Administrator shall notbe required to limit the number ofmanufacturers in any basic class to anumber less than that consistent withmaintenance of effective controlsagainst diversion solely because asmaller number is capable of producingan adequate and uninterrupted supply.

(c) This section shall not apply to themanufacture of basic classes of con-trolled substances listed in Schedules Ior II as an incident to research orchemical analysis as authorized in§ 1301.13(e)(1).

[62 FR 13953, Mar. 24, 1997]

§ 1301.34 Application for importationof Schedule I and II substances.

(a) In the case of an application forregistration or reregistration to importa controlled substance listed in Sched-ule I or II, under the authority of sec-tion 1002(a)(2)(B) of the Act (21 U.S.C.952(a)(2)(B)), the Administrator shall,upon the filing of such application,publish in the FEDERAL REGISTER a no-tice naming the applicant and statingthat such applicant has applied to beregistered as an importer of a ScheduleI or II controlled substance, which sub-stance shall be identified. A copy ofsaid notice shall be mailed simulta-neously to each person registered as a


27


bulk manufacturer of that controlledsubstance and to any other applicanttherefor. Any such person may, within30 days from the date of publication ofthe notice in the FEDERAL REGISTER,file written comments on or objectionsto the issuance of the proposed reg-istration, and may, at the same time,file a written request for a hearing onthe application pursuant to § 1301.43. Ifa hearing is requested, the Adminis-trator shall hold a hearing on the ap-plication in accordance with § 1301.41.Notice of the hearing shall be publishedin the FEDERAL REGISTER, and shall bemailed simultaneously to the applicantand to all persons to whom notice ofthe application was mailed. Any suchperson may participate in the hearingby filing a notice of appearance in ac-cordance with § 1301.43 of this chapter.Notice of the hearing shall contain asummary of all comments and objec-tions filed regarding the applicationand shall state the time and place forthe hearing, which shall not be lessthan 30 days after the date of publica-tion of such notice in the FEDERALREGISTER. A hearing pursuant to thissection may be consolidated with ahearing held pursuant to § 1301.35 or§ 1301.36 of this part.

(b) The Administrator shall registeran applicant to import a controlledsubstance listed in Schedule I or II ifhe/she determines that such registra-tion is consistent with the public inter-est and with U.S. obligations underinternational treaties, conventions, orprotocols in effect on May 1, 1971. Indetermining the public interest, thefollowing factors shall be considered:

(1) Maintenance of effective controlsagainst diversion of particular con-trolled substances and any controlledsubstance in Schedule I or II com-pounded therefrom into other than le-gitimate medical, scientific research,or industrial channels, by limiting theimportation and bulk manufacture ofsuch controlled substances to a numberof establishments which can producean adequate and uninterrupted supplyof these substances under adequatelycompetitive conditions for legitimatemedical, scientific, research, and in-dustrial purposes;

(2) Compliance with applicable Stateand local law;

(3) Promotion of technical advancesin the art of manufacturing these sub-stances and the development of newsubstances;

(4) Prior conviction record of appli-cant under Federal and State laws re-lating to the manufacture, distribu-tion, or dispensing of such substances;

(5) Past experience in the manufac-ture of controlled substances, and theexistence in the establishment of effec-tive control against diversion;

(6) That the applicant will be per-mitted to import only:

(i) Such amounts of crude opium,poppy straw, concentrate of poppystraw, and coca leaves as the Adminis-trator finds to be necessary to providefor medical, scientific, or other legiti-mate purposes; or

(ii) Such amounts of any controlledsubstances listed in Schedule I or II asthe Administrator shall find to be nec-essary to provide for the medical, sci-entific, or other legitimate needs of theUnited States during an emergency inwhich domestic supplies of such sub-stances are found by the Administratorto be inadequate; or

(iii) Such amounts of any controlledsubstance listed in Schedule I or II asthe Administrator shall find to be nec-essary to provide for the medical, sci-entific, or other legitimate needs of theUnited States in any case in which theAdministrator finds that competitionamong domestic manufacturers of thecontrolled substance is inadequate andwill not be rendered adequate by theregistration of additional manufactur-ers under section 303 of the Act (21U.S.C. 823); or

(iv) Such limited quantities of anycontrolled substance listed in ScheduleI or II as the Administrator shall findto be necessary for scientific, analyt-ical or research uses; and

(7) Such other factors as may be rel-evant to and consistent with the publichealth and safety.

(c) In determining whether the appli-cant can and will maintain effectivecontrols against diversion within themeaning of paragraph (b) of this sec-tion, the Administrator shall consideramong other factors:

(1) Compliance with the security re-quirements set forth in §§ 1301.71–1301.76; and


28

21 CFR Ch. II (4–1–01 Edition)§ 1301.35

(2) Employment of security proce-dures to guard against in-transit losseswithin and without the jurisdiction ofthe United States.

(d) In determining whether competi-tion among the domestic manufactur-ers of a controlled substance is ade-quate within the meaning of para-graphs (b)(1) and (b)(6)(iii) of this sec-tion, as well as section 1002(a)(2)(B) ofthe Act (21 U.S.C. 952(a)(2)(B)), the Ad-ministrator shall consider:

(1) The extent of price rigidity in thelight of changes in:

(i) raw materials and other costs and(ii) conditions of supply and demand;(2) The extent of service and quality

competition among the domestic man-ufacturers for shares of the domesticmarket including:

(i) Shifts in market shares and(ii) Shifts in individual customers

among domestic manufacturers;(3) The existence of substantial dif-

ferentials between domestic prices andthe higher of prices generally pre-vailing in foreign markets or the pricesat which the applicant for registrationto import is committed to undertaketo provide such products in the domes-tic market in conformity with the Act.In determining the existence of sub-stantial differentials hereunder, appro-priate consideration should be given toany additional costs imposed on domes-tic manufacturers by the requirementsof the Act and such other cost-relatedand other factors as the Administratormay deem relevant. In no event shallan importer’s offering prices in theUnited States be considered if they arelower than those prevailing in the for-eign market or markets from whichthe importer is obtaining his/her sup-ply;

(4) The existence of competitive re-straints imposed upon domestic manu-facturers by governmental regulations;and

(5) Such other factors as may be rel-evant to the determinations requiredunder this paragraph.

(e) In considering the scope of the do-mestic market, consideration shall begiven to substitute products which arereasonably interchangeable in terms ofprice, quality and use.

(f) The fact that the number of exist-ing manufacturers is small shall not

demonstrate, in and of itself, that ade-quate competition among them doesnot exist.

[62 FR 13953, Mar. 24, 1997]

§ 1301.35 Certificate of registration;denial of registration.

(a) The Administrator shall issue aCertificate of Registration (DEA Form223) to an applicant if the issuance ofregistration or reregistration is re-quired under the applicable provisionsof sections 303 or 1008 of the Act (21U.S.C. 823 and 958). In the event thatthe issuance of registration or rereg-istration is not required, the Adminis-trator shall deny the application. Be-fore denying any application, the Ad-ministrator shall issue an order toshow cause pursuant to § 1301.37 and, ifrequested by the applicant, shall hold ahearing on the application pursuant to§ 1301.41.

(b) If in response to a show causeorder a hearing is requested by an ap-plicant for registration or reregistra-tion to manufacture in bulk a basicclass of controlled substance listed inSchedule I or II, notice that a hearinghas been requested shall be publishedin the FEDERAL REGISTER and shall bemailed simultaneously to the applicantand to all persons to whom notice ofthe application was mailed. Any personentitled to file comments or objectionsto the issuance of the proposed reg-istration pursuant to § 1301.33(a) mayparticipate in the hearing by filing no-tice of appearance in accordance with§ 1301.43. Such persons shall have 30days to file a notice of appearance afterthe date of publication of the notice ofa request for a hearing in the FEDERALREGISTER.

(c) The Certificate of Registration(DEA Form 223) shall contain thename, address, and registration num-ber of the registrant, the activity au-thorized by the registration, the sched-ules and/or Administration ControlledSubstances Code Number (as set forthin part 1308 of this chapter) of the con-trolled substances which the registrantis authorized to handle, the amount offee paid (or exemption), and the expira-tion date of the registration. The reg-istrant shall maintain the certificateof registration at the registered loca-tion in a readily retrievable manner


29


and shall permit inspection of the cer-tificate by any official, agent or em-ployee of the Administration or of anyFederal, State, or local agency engagedin enforcement of laws relating to con-trolled substances.

[62 FR 13954, Mar. 24, 1997]

§ 1301.36 Suspension or revocation ofregistration; suspension of registra-tion pending final order; extensionof registration pending final order.

(a) For any registration issued undersection 303 of the Act (21 U.S.C. 823),the Administrator may:

(1) Suspend the registration pursuantto section 304(a) of the Act (21 U.S.C.824(a)) for any period of time.

(2) Revoke the registration pursuantto section 304(a) of the Act (21 U.S.C.824(a)).

(b) For any registration issued undersection 1008 of the Act (21 U.S.C. 958),the Administrator may:

(1) Suspend the registration pursuantto section 1008(d) of the Act (21 U.S.C.958(d)) for any period of time.

(2) Revoke the registration pursuantto section 1008(d) of the Act (21 U.S.C.958(d)) if he/she determines that suchregistration is inconsistent with thepublic interest as defined in section1008 or with the United States obliga-tions under international treaties, con-ventions, or protocols in effect on Oc-tober 12, 1984.

(c) The Administrator may limit therevocation or suspension of a registra-tion to the particular controlled sub-stance, or substances, with respect towhich grounds for revocation or sus-pension exist.

(d) Before revoking or suspendingany registration, the Administratorshall issue an order to show cause pur-suant to § 1301.37 and, if requested bythe registrant, shall hold a hearingpursuant to § 1301.41.

(e) The Administrator may suspendany registration simultaneously withor at any time subsequent to the serv-ice upon the registrant of an order toshow cause why such registrationshould not be revoked or suspended, inany case where he/she finds that thereis an imminent danger to the publichealth or safety. If the Administratorso suspends, he/she shall serve with theorder to show cause pursuant to

§ 1301.37 an order of immediate suspen-sion which shall contain a statement ofhis findings regarding the danger topublic health or safety.

(f) Upon service of the order of theAdministrator suspending or revokingregistration, the registrant shall im-mediately deliver his/her Certificate ofRegistration, any order forms, and anyimport or export permits in his/her pos-session to the nearest office of the Ad-ministration. The suspension or rev-ocation of a registration shall suspendor revoke any individual manufac-turing or procurement quota fixed forthe registrant pursuant to part 1303 ofthis chapter and any import or exportpermits issued to the registrant pursu-ant to part 1312 of this chapter. Also,upon service of the order of the Admin-istrator revoking or suspending reg-istration, the registrant shall, as in-structed by the Administrator:

(1) Deliver all controlled substancesin his/her possession to the nearest of-fice of the Administration or to au-thorized agents of the Administration;or

(2) Place all controlled substances inhis/her possession under seal as de-scribed in sections 304(f) or 1008(d)(6) ofthe Act (21 U.S.C. 824(f) or 958(d)(6)).

(g) In the event that revocation orsuspension is limited to a particularcontrolled substance or substances, theregistrant shall be given a new Certifi-cate of Registration for all substancesnot affected by such revocation or sus-pension; no fee shall be required to bepaid for the new Certificate of Reg-istration. The registrant shall deliverthe old Certificate of Registration and,if appropriate, any order forms in his/her possession to the nearest office ofthe Administration. The suspension orrevocation of a registration, when lim-ited to a particular basic class or class-es of controlled substances, shall sus-pend or revoke any individual manu-facturing or procurement quota fixedfor the registrant for such class orclasses pursuant to part 1303 of thischapter and any import or export per-mits issued to the registrant for suchclass or classes pursuant to part 1312 ofthis chapter. Also, upon service of theorder of the Administrator revoking orsuspending registration, the registrant


30

21 CFR Ch. II (4–1–01 Edition)§ 1301.37

shall, as instructed by the Adminis-trator:

(1) Deliver to the nearest office of theAdministration or to authorized agentsof the Administration all of the par-ticular controlled substance or sub-stances affected by the revocation orsuspension which are in his/her posses-sion; or

(2) Place all of such substances underseal as described in sections 304(f) or958(d)(6) of the Act (21 U.S.C. 824(f) or958(d)(6)).

(h) Any suspension shall continue ineffect until the conclusion of all pro-ceedings upon the revocation or sus-pension, including any judicial reviewthereof, unless sooner withdrawn bythe Administrator or dissolved by acourt of competent jurisdiction. Anyregistrant whose registration is sus-pended under paragraph (e) of this sec-tion may request a hearing on the rev-ocation or suspension of his/her reg-istration at a time earlier than speci-fied in the order to show cause pursu-ant to § 1301.37. This request shall begranted by the Administrator, whoshall fix a date for such hearing asearly as reasonably possible.

(i) In the event that an applicant forreregistration (who is doing businessunder a registration previously grantedand not revoked or suspended) has ap-plied for reregistration at least 45 daysbefore the date on which the existingregistration is due to expire, and theAdministrator has issued no order onthe application on the date on whichthe existing registration is due to ex-pire, the existing registration of theapplicant shall automatically be ex-tended and continue in effect until thedate on which the Administrator soissues his/her order. The Administratormay extend any other existing reg-istration under the circumstances con-templated in this section even thoughthe registrant failed to apply for rereg-istration at least 45 days before expira-tion of the existing registration, withor without request by the registrant, ifthe Administrator finds that such ex-tension is not inconsistent with thepublic health and safety.

[62 FR 13955, Mar. 24, 1997]

§ 1301.37 Order to show cause.(a) If, upon examination of the appli-

cation for registration from any appli-cant and other information gatheredby the Administration regarding theapplicant, the Administrator is unableto make the determinations requiredby the applicable provisions of section303 and/or section 1008 of the Act (21U.S.C. 823 and 958) to register the appli-cant, the Administrator shall serveupon the applicant an order to showcause why the registration should notbe denied.

(b) If, upon information gathered bythe Administration regarding any reg-istrant, the Administrator determinesthat the registration of such registrantis subject to suspension or revocationpursuant to section 304 or section 1008of the Act (21 U.S.C. 824 and 958), theAdministrator shall serve upon the reg-istrant an order to show cause why theregistration should not be revoked orsuspended.

(c) The order to show cause shall callupon the applicant or registrant to ap-pear before the Administrator at atime and place stated in the order,which shall not be less than 30 daysafter the date of receipt of the order.The order to show cause shall also con-tain a statement of the legal basis forsuch hearing and for the denial, revoca-tion, or suspension of registration anda summary of the matters of fact andlaw asserted.

(d) Upon receipt of an order to showcause, the applicant or registrantmust, if he/she desires a hearing, file arequest for a hearing pursuant to§ 1301.43. If a hearing is requested, theAdministrator shall hold a hearing atthe time and place stated in the order,pursuant to § 1301.41.

(e) When authorized by the Adminis-trator, any agent of the Administra-tion may serve the order to showcause.

[62 FR 13955, Mar. 24, 1997]

HEARINGS

§ 1301.41 Hearings generally.(a) In any case where the Adminis-

trator shall hold a hearing on any reg-istration or application therefor, theprocedures for such hearing shall be


31


governed generally by the adjudicationprocedures set forth in the Administra-tive Procedure Act (5 U.S.C. 551–559)and specifically by sections 303, 304,and 1008 of the Act (21 U.S.C. 823–824and 958), by §§ 1301.42–1301.46 of thispart, and by the procedures for admin-istrative hearings under the Act setforth in §§ 1316.41–1316.67 of this chap-ter.

(b) Any hearing under this part shallbe independent of, and not in lieu of,criminal prosecutions or other pro-ceedings under the Act or any otherlaw of the United States.

[62 FR 13956, Mar. 24, 1997]

§ 1301.42 Purpose of hearing.If requested by a person entitled to a

hearing, the Administrator shall hold ahearing for the purpose of receivingfactual evidence regarding the issuesinvolved in the denial, revocation, orsuspension of any registration, and thegranting of any application for reg-istration to import or to manufacturein bulk a basic class of controlled sub-stance listed in Schedule I or II. Exten-sive argument should not be offeredinto evidence but rather presented inopening or closing statements of coun-sel or in memoranda or proposed find-ings of fact and conclusions of law.

[62 FR 13956, Mar. 24, 1997]

§ 1301.43 Request for hearing or ap-pearance; waiver.

(a) Any person entitled to a hearingpursuant to § 1301.32 or §§ 1301.34–1301.36and desiring a hearing shall, within 30days after the date of receipt of theorder to show cause (or the date of pub-lication of notice of the application forregistration in the FEDERAL REGISTERin the case of § 1301.34), file with theAdministrator a written request for ahearing in the form prescribed in§ 1316.47 of this chapter.

(b) Any person entitled to participatein a hearing pursuant to § 1301.34 or§ 1301.35(b) and desiring to do so shall,within 30 days of the date of publica-tion of notice of the request for a hear-ing in the FEDERAL REGISTER, file withthe Administrator a written notice ofintent to participate in such hearing inthe form prescribed in § 1316.48 of thischapter. Any person filing a request for

a hearing need not also file a notice ofappearance.

(c) Any person entitled to a hearingor to participate in a hearing pursuantto § 1301.32 or §§ 1301.34–1301.36 may,within the period permitted for filing arequest for a hearing or a notice of ap-pearance, file with the Administrator awaiver of an opportunity for a hearingor to participate in a hearing, togetherwith a written statement regardingsuch person’s position on the mattersof fact and law involved in such hear-ing. Such statement, if admissible,shall be made a part of the record andshall be considered in light of the lackof opportunity for cross-examination indetermining the weight to be attachedto matters of fact asserted therein.

(d) If any person entitled to a hearingor to participate in a hearing pursuantto § 1301.32 or §§ 1301.34–1301.36 fails tofile a request for a hearing or a noticeof appearance, or if such person so filesand fails to appear at the hearing, suchperson shall be deemed to have waivedthe opportunity for a hearing or to par-ticipate in the hearing, unless suchperson shows good cause for such fail-ure.

(e) If all persons entitled to a hearingor to participate in a hearing waive orare deemed to waive their opportunityfor the hearing or to participate in thehearing, the Administrator may cancelthe hearing, if scheduled, and issue his/her final order pursuant to § 1301.46without a hearing.

[62 FR 13956, Mar. 24, 1997]

§ 1301.44 Burden of proof.

(a) At any hearing on an applicationto manufacture any controlled sub-stance listed in Schedule I or II, the ap-plicant shall have the burden of prov-ing that the requirements for such reg-istration pursuant to section 303(a) ofthe Act (21 U.S.C. 823(a)) are satisfied.Any other person participating in thehearing pursuant to § 1301.35(b) shallhave the burden of proving any propo-sitions of fact or law asserted by suchperson in the hearing.

(b) At any hearing on the granting ordenial of an applicant to be registeredto conduct a narcotic treatment pro-gram or as a compounder, the appli-cant shall have the burden of proving


32

21 CFR Ch. II (4–1–01 Edition)§ 1301.45

that the requirements for each reg-istration pursuant to section 303(g) ofthe Act (21 U.S.C. 823(g)) are satisfied.

(c) At any hearing on the granting ordenial of an application to be reg-istered to import or export any con-trolled substance listed in Schedule Ior II, the applicant shall have the bur-den of proving that the requirementsfor such registration pursuant to sec-tions 1008(a) and (d) of the Act (21U.S.C. 958 (a) and (d)) are satisfied. Anyother person participating in the hear-ing pursuant to § 1301.34 shall have theburden of proving any propositions offact or law asserted by him/her in thehearings.

(d) At any other hearing for the de-nial of a registration, the Administra-tion shall have the burden of provingthat the requirements for such reg-istration pursuant to section 303 or sec-tion 1008(c) and (d) of the Act (21 U.S.C.823 or 958(c) and (d)) are not satisfied.

(e) At any hearing for the revocationor suspension of a registration, the Ad-ministration shall have the burden ofproving that the requirements for suchrevocation or suspension pursuant tosection 304(a) or section 1008(d) of theAct (21 U.S.C. 824(a) or 958(d)) are satis-fied.

[62 FR 13956, Mar. 24, 1997]

§ 1301.45 Time and place of hearing.The hearing will commence at the

place and time designated in the orderto show cause or notice of hearing pub-lished in the FEDERAL REGISTER (unlessexpedited pursuant to § 1301.36(h)) butthereafter it may be moved to a dif-ferent place and may be continuedfrom day to day or recessed to a laterday without notice other than an-nouncement thereof by the presidingofficer at the hearing.

[62 FR 13956, Mar. 24, 1997]

§ 1301.46 Final order.As soon as practicable after the pre-

siding officer has certified the recordto the Administrator, the Adminis-trator shall issue his/her order on thegranting, denial, revocation, or suspen-sion of registration. In the event thatan application for registration to im-port or to manufacture in bulk a basicclass of any controlled substance listed

in Schedule I or II is granted, or anyapplication for registration is denied,or any registration is revoked or sus-pended, the order shall include thefindings of fact and conclusions of lawupon which the order is based. Theorder shall specify the date on which itshall take effect. The Administratorshall serve one copy of his/her orderupon each party in the hearing.

[62 FR 13956, Mar. 24, 1997]

MODIFICATION, TRANSFER AND

TERMINATION OF REGISTRATION

§ 1301.51 Modification in registration.

Any registrant may apply to modifyhis/her registration to authorize thehandling of additional controlled sub-stances or to change his/her name oraddress, by submitting a letter of re-quest to the Registration Unit, DrugEnforcement Administration, Depart-ment of Justice, Post Office Box 28083,Central Station, Washington, DC 20005.The letter shall contain the reg-istrant’s name, address, and registra-tion number as printed on the certifi-cate of registration, and the substancesand/or schedules to be added to his/herregistration or the new name or ad-dress and shall be signed in accordancewith § 1301.13(j). If the registrant isseeking to handle additional controlledsubstances listed in Schedule I for thepurpose of research or instructional ac-tivities, he/she shall attach three cop-ies of a research protocol describingeach research project involving the ad-ditional substances, or two copies of astatement describing the nature, ex-tent, and duration of such instruc-tional activities, as appropriate. No feeshall be required to be paid for themodification. The request for modifica-tion shall be handled in the same man-ner as an application for registration.If the modification in registration isapproved, the Administrator shall issuea new certificate of registration (DEAForm 223) to the registrant, who shallmaintain it with the old certificate ofregistration until expiration.

[62 FR 13956, Mar. 24, 1997]


33


§ 1301.52 Termination of registration;transfer of registration; distributionupon discontinuance of business.

(a) Except as provided in paragraph(b) of this section, the registration ofany person shall terminate if and whensuch person dies, ceases legal exist-ence, or discontinues business or pro-fessional practice. Any registrant whoceases legal existence or discontinuesbusiness or professional practice shallnotify the Administrator promptly ofsuch fact.

(b) No registration or any authorityconferred thereby shall be assigned orotherwise transferred except upon suchconditions as the Administration mayspecifically designate and then onlypursuant to written consent. Any per-son seeking authority to transfer a reg-istration shall submit a written re-quest, providing full details regardingthe proposed transfer of registration,to the Deputy Assistant Administrator,Office of Diversion Control, Drug En-forcement Administration, Departmentof Justice, Washington, DC 20537.

(c) Any registrant desiring to dis-continue business activities altogetheror with respect to controlled sub-stances (without transferring suchbusiness activities to another person)shall return for cancellation his/hercertificate of registration, and anyunexecuted order forms in his/her pos-session, to the Registration Unit, DrugEnforcement Administration, Depart-ment of Justice, Post Office Box 28083,Central Station, Washington, DC 20005.Any controlled substances in his/herpossession may be disposed of in ac-cordance with § 1307.21 of this chapter.

(d) Any registrant desiring to dis-continue business activities altogetheror with respect to controlled substance(by transferring such business activi-ties to another person) shall submit inperson or by registered or certifiedmail, return receipt requested, to theSpecial Agent in Charge in his/herarea, at least 14 days in advance of thedate of the proposed transfer (unlessthe Special Agent in Charge waivesthis time limitation in individual in-stances), the following information:

(1) The name, address, registrationnumber, and authorized business activ-ity of the registrant discontinuing thebusiness (registrant-transferor);

(2) The name, address, registrationnumber, and authorized business activ-ity of the person acquiring the business(registrant-transferee);

(3) Whether the business activitieswill be continued at the location reg-istered by the person discontinuingbusiness, or moved to another location(if the latter, the address of the new lo-cation should be listed);

(4) Whether the registrant-transferorhas a quota to manufacture or procureany controlled substance listed inSchedule I or II (if so, the basic class orclass of the substance should be indi-cated); and

(5) The date on which the transfer ofcontrolled substances will occur.

(e) Unless the registrant-transferor isinformed by the Special Agent inCharge, before the date on which thetransfer was stated to occur, that thetransfer may not occur, the registrant-transferor may distribute (withoutbeing registered to distribute) con-trolled substances in his/her possessionto the registrant-transferee in accord-ance with the following:

(1) On the date of transfer of the con-trolled substances, a complete inven-tory of all controlled substances beingtransferred shall be taken in accord-ance with § 1304.11 of this chapter. Thisinventory shall serve as the final in-ventory of the registrant-transferorand the initial inventory of the reg-istrant-transferee, and a copy of the in-ventory shall be included in the recordsof each person. It shall not be nec-essary to file a copy of the inventorywith the Administration unless re-quested by the Special Agent inCharge. Transfers of any substanceslisted in Schedule I or II shall requirethe use of order forms in accordancewith part 1305 of this chapter.

(2) On the date of transfer of the con-trolled substances, all records requiredto be kept by the registrant-transferorwith reference to the controlled sub-stances being transferred, under part1304 of this chapter, shall be trans-ferred to the registrant-transferee. Re-sponsibility for the accuracy of recordsprior to the date of transfer remainswith the transferor, but responsibilityfor custody and maintenance shall beupon the transferee.


34

21 CFR Ch. II (4–1–01 Edition)§ 1301.71

(3) In the case of registrants requiredto make reports pursuant to part 1304of this chapter, a report marked‘‘Final’’ will be prepared and submittedby the registrant-transferor showingthe disposition of all the controlledsubstances for which a report is re-quired; no additional report will be re-quired from him, if no further trans-actions involving controlled substancesare consummated by him. The initialreport of the registrant-transfereeshall account for transactions begin-ning with the day next succeeding thedate of discontinuance or transfer ofbusiness by the transferor-registrantand the substances transferred to himshall be reported as receipts in his/herinitial report.

[62 FR 13957, Mar. 24, 1997]


§ 1301.71 Security requirements gen-erally.

(a) All applicants and registrantsshall provide effective controls andprocedures to guard against theft anddiversion of controlled substances. Inorder to determine whether a reg-istrant has provided effective controlsagainst diversion, the Administratorshall use the security requirements setforth in §§ 1301.72–1301.76 as standardsfor the physical security controls andoperating procedures necessary to pre-vent diversion. Materials and construc-tion which will provide a structuralequivalent to the physical securitycontrols set forth in §§ 1301.72, 1301.73and 1301.75 may be used in lieu of thematerials and construction describedin those sections.

(b) Substantial compliance with thestandards set forth in §§ 1301.72–1301.76may be deemed sufficient by the Ad-ministrator after evaluation of theoverall security system and needs ofthe applicant or registrant. In evalu-ating the overall security system of aregistrant or applicant, the Adminis-trator may consider any of the fol-lowing factors as he may deem relevantto the need for strict compliance withsecurity requirements:

(1) The type of activity conducted(e.g., processing of bulk chemicals, pre-paring dosage forms, packaging, label-ing, cooperative buying, etc.);

(2) The type and form of controlledsubstances handled (e.g., bulk liquidsor dosage units, usable powders or non-usable powders);

(3) The quantity of controlled sub-stances handled;

(4) The location of the premises andthe relationship such location bears onsecurity needs;

(5) The type of building constructioncomprising the facility and the generalcharacteristics of the building or build-ings;

(6) The type of vault, safe, and secureenclosures or other storage system(e.g., automatic storage and retrievalsystem) used;

(7) The type of closures on vaults,safes, and secure enclosures;

(8) The adequacy of key control sys-tems and/or combination lock controlsystems;

(9) The adequacy of electric detectionand alarm systems, if any includinguse of supervised transmittal lines andstandby power sources;

(10) The extent of unsupervised publicaccess to the facility, including thepresence and characteristics of perim-eter fencing, if any;

(11) The adequacy of supervision overemployees having access to manufac-turing and storage areas;

(12) The procedures for handling busi-ness guests, visitors, maintenance per-sonnel, and nonemployee service per-sonnel;

(13) The availability of local policeprotection or of the registrant’s or ap-plicant’s security personnel, and;

(14) The adequacy of the registrant’sor applicant’s system for monitoringthe receipt, manufacture, distribution,and disposition of controlled sub-stances in its operations.

(c) When physical security controlsbecome inadequate as a result of a con-trolled substance being transferred to adifferent schedule, or as a result of anoncontrolled substance being listed onany schedule, or as a result of a signifi-cant increase in the quantity of con-trolled substances in the possession ofthe registrant during normal businessoperations, the physical security con-trols shall be expanded and extendedaccordingly. A registrant may adjustphysical security controls within therequirements set forth in §§ 1301.72–


35


1301.76 when the need for such controlsdecreases as a result of a controlledsubstance being transferred to a dif-ferent schedule, or a result of a con-trolled substance being removed fromcontrol, or as a result of a significantdecrease in the quantity of controlledsubstances in the possession of the reg-istrant during normal business oper-ations.

(d) Any registrant or applicant desir-ing to determine whether a proposedsecurity system substantially complieswith, or is the structural equivalent of,the requirements set forth in §§ 1301.72–1301.76 may submit any plans, blue-prints, sketches or other materials re-garding the proposed security systemeither to the Special Agent in Chargein the region in which the system willbe used, or to the Diversion OperationsSection, Drug Enforcement Adminis-tration, Department of Justice, Wash-ington, DC 20537.

(e) Physical security controls of loca-tions registered under the HarrisonNarcotic Act or the Narcotics Manufac-turing Act of 1960 on April 30, 1971,shall be deemed to comply substan-tially with the standards set forth in§§ 1301.72, 1301.73 and 1301.75. Any newfacilities or work or storage areas con-structed or utilized for controlled sub-stances, which facilities or work orstorage areas have not been previouslyapproved by the Administration, shallnot necessarily be deemed to complysubstantially with the standards setforth in §§ 1301.72, 1301.73 and 1301.75,notwithstanding that such facilities orwork or storage areas have physical se-curity controls similar to those pre-viously approved by the Administra-tion.

[36 FR 18729, Sept. 21, 1971. Redesignated at38 FR 26609, Sept. 24, l973, and amended at 46FR 28841, May 29, 1981; 47 FR 41735, Sept. 22,1982; 51 FR 5319, Feb. 13, 1986]

§ 1301.72 Physical security controls fornon-practitioners; narcotic treat-ment programs and compoundersfor narcotic treatment programs;storage areas.

(a) Schedules I and II. Raw material,bulk materials awaiting further proc-essing, and finished products which arecontrolled substances listed in Sched-ule I or II (except GHB that is manu-

factured or distributed in accordancewith an exemption under section 505(i)of the FFDCA which shall be subject tothe requirements of paragraph (b) ofthis section) shall be stored in one ofthe following secured areas:

(1) Where small quantities permit, asafe or steel cabinet;

(i) Which safe or steel cabinet shallhave the following specifications or theequivalent: 30 man-minutes againstsurreptitious entry, 10 man-minutesagainst forced entry, 20 man-hoursagainst lock manipulation, and 20 man-hours against radiological techniques;

(ii) Which safe or steel cabinet, if itweighs less than 750 pounds, is boltedor cemented to the floor or wall in sucha way that it cannot be readily re-moved; and

(iii) Which safe or steel cabinet, ifnecessary, depending upon the quan-tities and type of controlled substancesstored, is equipped with an alarm sys-tem which, upon attempted unauthor-ized entry, shall transmit a signal di-rectly to a central protection companyor a local or State police agency whichhas a legal duty to respond, or a 24-hour control station operated by theregistrant, or such other protection asthe Administrator may approve.

(2) A vault constructed before, orunder construction on, September 1,1971, which is of substantial construc-tion with a steel door, combination orkey lock, and an alarm system; or

(3) A vault constructed after Sep-tember 1, 1971:

(i) The walls, floors, and ceilings ofwhich vault are constructed of at least8 inches of reinforced concrete or othersubstantial masonry, reinforcedvertically and horizontally with 1⁄2-inchsteel rods tied 6 inches on center, orthe structural equivalent to such rein-forced walls, floors, and ceilings;

(ii) The door and frame unit of whichvault shall conform to the followingspecifications or the equivalent: 30man-minutes against surreptitiousentry, 10 man-minutes against forcedentry, 20 man-hours against lock ma-nipulation, and 20 man-hours againstradiological techniques;

(iii) Which vault, if operations re-quire it to remain open for frequent ac-cess, is equipped with a ‘‘day-gate’’which is self-closing and self-locking,


36

21 CFR Ch. II (4–1–01 Edition)§ 1301.72

or the equivalent, for use during thehours of operation in which the vaultdoor is open;

(iv) The walls or perimeter of whichvault are equipped with an alarm,which upon unauthorized entry shalltransmit a signal directly to a centralstation protection company, or a localor State police agency which has alegal duty to respond, or a 24-hour con-trol station operated by the registrant,or such other protection as the Admin-istrator may approve, and, if nec-essary, holdup buttons at strategicpoints of entry to the perimeter area ofthe vault;

(v) The door of which vault isequipped with contact switches; and

(vi) Which vault has one of the fol-lowing: Complete electrical lacing ofthe walls, floor and ceilings; sensitiveultrasonic equipment within the vault;a sensitive sound accumulator system;or such other device designed to detectillegal entry as may be approved by theAdministration.

(b) Schedules III, IV and V. Raw mate-rial, bulk materials awaiting furtherprocessing, and finished products whichare controlled substances listed inSchedules III, IV, and V, and GHB whenit is manufactured or distributed in ac-cordance with an exemption under sec-tion 505(i) of the FFDCA, shall bestored in the following secure storageareas:

(1) A safe or steel cabinet as de-scribed in paragraph (a)(1) of this sec-tion;

(2) A vault as described in paragraph(a)(2) or (3) of this section equippedwith an alarm system as described inparagraph (b)(4)(v) of this section;

(3) A building used for storage ofSchedules III through V controlled sub-stances with perimeter security whichlimits access during working hours andprovides security after working hoursand meets the following specifications:

(i) Has an electronic alarm system asdescribed in paragraph (b)(4)(v) of thissection,

(ii) Is equipped with self-closing, self-locking doors constructed of substan-tial material commensurate with thetype of building construction, provided,however, a door which is kept closedand locked at all times when not in useand when in use is kept under direct

observation of a responsible employeeor agent of the registrant is permittedin lieu of a self-closing, self-lockingdoor. Doors may be sliding or hinged.Regarding hinged doors, where hingesare mounted on the outside, suchhinges shall be sealed, welded or other-wise constructed to inhibit removal.Locking devices for such doors shall beeither of the multiple-position com-bination or key lock type and:

(a) In the case of key locks, shall re-quire key control which limits accessto a limited number of employees, or;

(b) In the case of combination locks,the combination shall be limited to aminimum number of employees andcan be changed upon termination ofemployment of an employee havingknowledge of the combination;

(4) A cage, located within a buildingon the premises, meeting the followingspecifications:

(i) Having walls constructed of notless than No. 10 gauge steel fabricmounted on steel posts, which postsare:

(a) At least one inch in diameter;(b) Set in concrete or installed with

lag bolts that are pinned or brazed; and(c) Which are placed no more than

ten feet apart with horizontal one andone-half inch reinforcements everysixty inches;

(ii) Having a mesh construction withopenings of not more than two and one-half inches across the square,

(iii) Having a ceiling constructed ofthe same material, or in the alter-native, a cage shall be erected whichreaches and is securely attached to thestructural ceiling of the building. Alighter gauge mesh may be used for theceilings of large enclosed areas if wallsare at least 14 feet in height,

(iv) Is equipped with a door con-structed of No. 10 gauge steel fabric ona metal door frame in a metal doorflange, and in all other respects con-forms to all the requirements of 21 CFR1301.72(b)(3)(ii), and

(v) Is equipped with an alarm systemwhich upon unauthorized entry shalltransmit a signal directly to a centralstation protection agency or a local orstate police agency, each having alegal duty to respond, or to a 24-hour


37


control station operated by the reg-istrant, or to such other source of pro-tection as the Administrator may ap-prove;

(5) An enclosure of masonry or othermaterial, approved in writing by theAdministrator as providing securitycomparable to a cage;

(6) A building or enclosure within abuilding which has been inspected andapproved by DEA or its predecessoragency, BND, and continues to provideadequate security against the diversionof Schedule III through V controlledsubstances, of which fact written ac-knowledgment has been made by theSpecial Agent in Charge of DEA for thearea in which such building or enclo-sure is situated;

(7) Such other secure storage areas asmay be approved by the Administratorafter considering the factors listed in§ 1301.71(b), (1) through (14);

(8)(i) Schedule III through V con-trolled substances may be stored withSchedules I and II controlled sub-stances under security measures pro-vided by 21 CFR 1301.72(a);

(ii) Non-controlled drugs, substancesand other materials may be stored withSchedule III through V controlled sub-stances in any of the secure storageareas required by 21 CFR 1301.72(b),provided that permission for such stor-age of non-controlled items is obtainedin advance, in writing, from the Spe-cial Agent in Charge of DEA for thearea in which such storage area is situ-ated. Any such permission tenderedmust be upon the Special Agent inCharge’s written determination thatsuch non-segregated storage does notdiminish security effectiveness forSchedules III through V controlled sub-stances.

(c) Multiple storage areas. Where sev-eral types or classes of controlled sub-stances are handled separately by theregistrant or applicant for differentpurposes (e.g., returned goods, or goodsin process), the controlled substancesmay be stored separately, providedthat each storage area complies withthe requirements set forth in this sec-tion.

(d) Accessibility to storage areas. Thecontrolled substances storage areasshall be accessible only to an absoluteminimum number of specifically au-

thorized employees. When it is nec-essary for employee maintenance per-sonnel, nonemployee maintenance per-sonnel, business guests, or visitors tobe present in or pass through con-trolled substances storage areas, theregistrant shall provide for adequateobservation of the area by an employeespecifically authorized in writing.

[36 FR 18730, Sept. 21, 1971, as amended at 37FR 15919, Aug. 8, 1972. Redesignated at 38 FR26609, Sept. 24, l973]

EDITORIAL NOTE: For FEDERAL REGISTER ci-tations affecting § 1301.72, see the List of CFRSections Affected, which appears in theFinding Aids section of the printed volumeand on GPO Access.

§ 1301.73 Physical security controls fornon-practitioners; compounders fornarcotic treatment programs; man-ufacturing and compounding areas.

All manufacturing activities (includ-ing processing, packaging and labeling)involving controlled substances listedin any schedule and all activities ofcompounders shall be conducted in ac-cordance with the following:

(a) All in-process substances shall bereturned to the controlled substancesstorage area at the termination of theprocess. If the process is not termi-nated at the end of a workday (exceptwhere a continuous process or othernormal manufacturing operationshould not be interrupted), the proc-essing area or tanks, vessels, bins orbulk containers containing such sub-stances shall be securely locked, withadequate security for the area or build-ing. If such security requires an alarm,such alarm, upon unauthorized entry,shall transmit a signal directly to acentral station protection company, orlocal or state police agency which hasa legal duty to respond, or a 24-hourcontrol station operated by the reg-istrant.

(b) Manufacturing activities withcontrolled substances shall be con-ducted in an area or areas of clearly de-fined limited access which is under sur-veillance by an employee or employeesdesignated in writing as responsible forthe area. ‘‘Limited access’’ may be pro-vided, in the absence of physical divid-ers such as walls or partitions, by traf-fic control lines or restricted space des-ignation. The employee designated as


38

21 CFR Ch. II (4–1–01 Edition)§ 1301.74

responsible for the area may be en-gaged in the particular manufacturingoperation being conducted: Provided,That he is able to provide continuoussurveillance of the area in order thatunauthorized persons may not enter orleave the area without his knowledge.

(c) During the production of con-trolled substances, the manufacturingareas shall be accessible to only thoseemployees required for efficient oper-ation. When it is necessary for em-ployee maintenance personnel, non-employee maintenance personnel, busi-ness guests, or visitors to be present inor pass through manufacturing areasduring production of controlled sub-stances, the registrant shall provide foradequate observation of the area by anemployee specifically authorized inwriting.

[36 FR 18731, Sept. 21, 1971. Redesignated at38 FR 26609, Sept. 24, l973 and amended at 39FR 37984, Oct. 25, 1974]

§ 1301.74 Other security controls fornon-practitioners; narcotic treat-ment programs and compoundersfor narcotic treatment programs.

(a) Before distributing a controlledsubstance to any person who the reg-istrant does not know to be registeredto possess the controlled substance, theregistrant shall make a good faith in-quiry either with the Administrationor with the appropriate State con-trolled substances registration agency,if any, to determine that the person isregistered to possess the controlledsubstance.

(b) The registrant shall design andoperate a system to disclose to the reg-istrant suspicious orders of controlledsubstances. The registrant shall informthe Field Division Office of the Admin-istration in his area of suspicious or-ders when discovered by the registrant.Suspicious orders include orders of un-usual size, orders deviating substan-tially from a normal pattern, and or-ders of unusual frequency.

(c) The registrant shall notify theField Division Office of the Adminis-tration in his area of any theft or sig-nificant loss of any controlled sub-stances upon discovery of such theft orloss. The supplier shall be responsiblefor reporting in-transit losses of con-trolled substances by the common or

contract carrier selected pursuant to§ 1301.74(e), upon discovery of such theftor loss. The registrant shall also com-plete DEA Form 106 regarding suchtheft or loss. Thefts must be reportedwhether or not the controlled sub-stances are subsequently recoveredand/or the responsible parties are iden-tified and action taken against them.

(d) The registrant shall not dis-tribute any controlled substance listedin Schedules II through V as a com-plimentary sample to any potential orcurrent customer (1) without the priorwritten request of the customer, (2) tobe used only for satisfying the legiti-mate medical needs of patients of thecustomer, and (3) only in reasonablequantities. Such request must containthe name, address, and registrationnumber of the customer and the nameand quantity of the specific controlledsubstance desired. The request shall bepreserved by the registrant with otherrecords of distribution of controlledsubstances. In addition, the require-ments of part 1305 of the chapter shallbe complied with for any distributionof a controlled substance listed inSchedule II. For purposes of this para-graph, the term ‘‘customer’’ includes aperson to whom a complimentary sam-ple of a substance is given in order toencourage the prescribing or recom-mending of the substance by the per-son.

(e) When shipping controlled sub-stances, a registrant is responsible forselecting common or contract carrierswhich provide adequate security toguard against in-transit losses. Whenstoring controlled substances in a pub-lic warehouse, a registrant is respon-sible for selecting a warehousemanwhich will provide adequate security toguard against storage losses; whereverpossible, the registrant shall store con-trolled substances in a public ware-house which complies with the require-ments set forth in § 1301.72. In addition,the registrant shall employ pre-cautions (e.g., assuring that shippingcontainers do not indicate that con-tents are controlled substances) toguard against storage or in-transitlosses.

(f) When distributing controlled sub-stances through agents (e.g.,detailmen), a registrant is responsible


39


for providing and requiring adequatesecurity to guard against theft and di-version while the substances are beingstored or handled by the agent oragents.

(g) Before the initial distribution ofcarfentanil etorphine hydrochlorideand/or diprenorphine to any person, theregistrant must verify that the personis authorized to handle the sub-stances(s) by contacting the Drug En-forcement Administration.

(h) The acceptance of delivery of nar-cotic substances by a narcotic treat-ment program shall be made only by alicensed practitioner employed at thefacility or other authorized individualsdesignated in writing. At the time ofdelivery, the licensed practitioner orother authorized individual designatedin writing (excluding persons currentlyor previously dependent on narcoticdrugs), shall sign for the narcotics andplace his specific title (if any) on anyinvoice. Copies of these signed invoicesshall be kept by the distributor.

(i) Narcotics dispensed or adminis-tered at a narcotic treatment programwill be dispensed or administered di-rectly to the patient by either (1) thelicensed practitioner, (2) a registerednurse under the direction of the li-censed practitioner, (3) a licensed prac-tical nurse under the direction of thelicensed practitioner, or (4) a phar-macist under the direction of the li-censed practitioner.

(j) Persons enrolled in a narcotictreatment program will be required towait in an area physically separatedfrom the narcotic storage and dis-pensing area. This requirement will beenforced by the program physician andemployees.

(k) All narcotic treatment programsmust comply with standards estab-lished by the Secretary of Health andHuman Services (after consultationwith the Administration) respectingthe quantities of narcotic drugs whichmay be provided to persons enrolled ina narcotic treatment program for unsu-pervised use.

(l) DEA may exercise discretion re-garding the degree of security requiredin narcotic treatment programs basedon such factors as the location of a pro-gram, the number of patients enrolledin a program and the number of physi-

cians, staff members and securityguards. Similarly, such factors will betaken into consideration when evalu-ating existing security or requiringnew security at a narcotic treatmentprogram.

[36 FR 7778, Apr. 24, 1971; 36 FR 13386, July 21,1971, as amended at 36 FR 18731, Sept. 21,1971. Redesignated at 38 FR 26609, Sept. 24,l973]


§ 1301.75 Physical security controls forpractitioners.

(a) Controlled substances listed inSchedule I shall be stored in a securelylocked, substantially constructed cabi-net.

(b) Controlled substances listed inSchedules II, III, IV, and V shall bestored in a securely locked, substan-tially constructed cabinet. However,pharmacies and institutional practi-tioners may disperse such substancesthroughout the stock of noncontrolledsubstances in such a manner as to ob-struct the theft or diversion of the con-trolled substances.

(c) This section shall also apply tononpractitioners authorized to conductresearch or chemical analysis underanother registration.

(d) Carfentanil etorphine hydro-chloride and diprenorphine shall bestored in a safe or steel cabinet equiva-lent to a U.S. Government Class V se-curity container.

[39 FR 3674, Jan. 29, 1974, as amended at 39FR 17838, May 21, 1974; 54 FR 33674, Aug. 16,1989; 62 FR 13957, Mar. 24, 1997]

§ 1301.76 Other security controls forpractitioners.

(a) The registrant shall not employ,as an agent or employee who has accessto controlled substances, any personwho has been convicted of a felony of-fense relating to controlled substancesor who, at any time, had an applicationfor registration with the DEA denied,had a DEA registration revoked or hassurrendered a DEA registration forcause. For purposes of this subsection,the term ‘‘for cause’’ means a sur-render in lieu of, or as a consequence


40

21 CFR Ch. II (4–1–01 Edition)§ 1301.77

of, any federal or state administrative,civil or criminal action resulting froman investigation of the individual’shandling of controlled substances.

(b) The registrant shall notify theField Division Office of the Adminis-tration in his area of the theft or sig-nificant loss of any controlled sub-stances upon discovery of such loss ortheft. The registrant shall also com-plete DEA (or BND) Form 106 regardingsuch loss or theft.

(c) Whenever the registrant distrib-utes a controlled substance (withoutbeing registered as a distributor, aspermitted in § 1301.13(e)(1) and/or§§ 1307.11–1307.12) he/she shall complywith the requirements imposed on non-practitioners in § 1301.74 (a), (b), and (e).

[36 FR 7778, Apr. 24, 1971, as amended at 36FR 18731, Sept. 21, 1971; 37 FR 15919, Aug. 8,1972. Redesignated at 38 FR 26609, Sept. 24,l973; 47 FR 41735, Sept. 22, 1982; 56 FR 36728,Aug. 1, 1991; 62 FR 13957, Mar. 24, 1997]

§ 1301.77 Security controls for freightforwarding facilities.

(a) All Schedule II–V controlled sub-stances that will be temporarily storedat the freight forwarding facility mustbe either:

(1) stored in a segregated area underconstant observation by designated re-sponsible individual(s); or

(2) stored in a secured area thatmeets the requirements of Section1301.72(b) of this Part. For purposes ofthis requirement, a facility that maybe locked down (i.e., secured againstphysical entry in a manner consistentwith requirements of Section1301.72(b)(3)(ii) of this part) and has amonitored alarm system or is subjectto continuous monitoring by securitypersonnel will be deemed to meet therequirements of Section 1301.72(b)(3) ofthis Part.

(b) Access to controlled substancesmust be kept to an absolute minimumnumber of specifically authorized indi-viduals. Non-authorized individualsmay not be present in or pass throughcontrolled substances storage areaswithout adequate observation providedby an individual authorized in writingby the registrant.

(c) Controlled substances being trans-ferred through a freight forwarding fa-

cility must be packed in sealed, un-marked shipping containers.

[65 FR 44678, July 19, 2000; 65 FR 45829, July25, 2000]

EMPLOYEE SCREENING—NON-PRACTITIONERS

§ 1301.90 Employee screening proce-dures.

It is the position of DEA that the ob-taining of certain information by non-practitioners is vital to fairly assessthe likelihood of an employee commit-ting a drug security breach. The needto know this information is a matter ofbusiness necessity, essential to overallcontrolled substances security. In thisregard, it is believed that conviction ofcrimes and unauthorized use of con-trolled substances are activities thatare proper subjects for inquiry. It is,therefore, assumed that the followingquestions will become a part of an em-ployer’s comprehensive employeescreening program:

Question. Within the past five years, haveyou been convicted of a felony, or within thepast two years, of any misdemeanor or areyou presently formally charged with com-mitting a criminal offense? (Do not includeany traffic violations, juvenile offenses ormilitary convictions, except by generalcourt-martial.) If the answer is yes, furnishdetails of conviction, offense, location, dateand sentence.

Question. In the past three years, have youever knowingly used any narcotics, amphet-amines or barbiturates, other than those pre-scribed to you by a physician? If the answeris yes, furnish details.

Advice. An authorization, in writing, thatallows inquiries to be made of courts and lawenforcement agencies for possible pendingcharges or convictions must be executed by aperson who is allowed to work in an areawhere access to controlled substances clear-ly exists. A person must be advised that anyfalse information or omission of informationwill jeopardize his or her position with re-spect to employment. The application foremployment should inform a person that in-formation furnished or recovered as a resultof any inquiry will not necessarily precludeemployment, but will be considered as partof an overall evaluation of the person’squalifications. The maintaining of fair em-ployment practices, the protection of theperson’s right of privacy, and the assurancethat the results of such inquiries will be


41


treated by the employer in confidence will beexplained to the employee.

[40 FR 17143, Apr. 17, 1975]

§ 1301.91 Employee responsibility toreport drug diversion.

Reports of drug diversion by fellowemployees is not only a necessary partof an overall employee security pro-gram but also serves the public inter-est at large. It is, therefore, the posi-tion of DEA that an employee who hasknowledge of drug diversion from hisemployer by a fellow employee has anobligation to report such informationto a responsible security official of theemployer. The employer shall treatsuch information as confidential andshall take all reasonable steps to pro-tect the confidentiality of the informa-tion and the identity of the employeefurnishing information. A failure to re-port information of drug diversion willbe considered in determining the feasi-bility of continuing to allow an em-ployee to work in a drug security area.The employer shall inform all employ-ees concerning this policy.

[40 FR 17143, Apr. 17, 1975]

§ 1301.92 Illicit activities by employ-ees.

It is the position of DEA that em-ployees who possess, sell, use or divertcontrolled substances will subjectthemselves not only to State or Fed-eral prosecution for any illicit activ-ity, but shall also immediately becomethe subject of independent action re-garding their continued employment.The employer will assess the serious-ness of the employee’s violation, theposition of responsibility held by theemployee, past record of employment,etc., in determining whether to sus-pend, transfer, terminate or take otheraction against the employee.

[40 FR 17143, Apr. 17, 1975]

§ 1301.93 Sources of information foremployee checks.

DEA recommends that inquiries con-cerning employees’ criminal records bemade as follows:

Local inquiries. Inquiries should be made byname, date and place of birth, and otheridentifying information, to local courts andlaw enforcement agencies for records of

pending charges and convictions. Local prac-tice may require such inquiries to be made inperson, rather than by mail, and a copy of anauthorization from the employee may be re-quired by certain law enforcement agencies.

DEA inquiries. Inquiries supplying identi-fying information should also be furnished toDEA Field Division Offices along with writ-ten consent from the concerned individualfor a check of DEA files for records of con-victions. The Regional check will result in anational check being made by the Field Divi-sion Office.

[40 FR 17143, Apr. 17, 1975, as amended at 47FR 41735, Sept. 22, 1982]

PART 1302—LABELING AND PACK-AGING REQUIREMENTS FORCONTROLLED SUBSTANCES

Sec.1302.01 Scope of part 1302.1302.02 Definitions.1302.03 Symbol required; exceptions.1302.04 Location and size of symbol on label

and labeling.1302.05 Effective dates of labeling require-

ments.1302.06 Sealing of controlled substances.1302.07 Labeling and packaging require-

ments for imported and exported sub-stances.

AUTHORITY: 21 U.S.C. 821, 825, 871(b), 958(e).


§ 1302.01 Scope of part 1302.Requirements governing the labeling

and packaging of controlled substancespursuant to sections 1305 and 1008(d) ofthe Act (21 U.S.C. 825 and 958(d)) are setforth generally by those sections andspecifically by the sections of this part.

[36 FR 13386, July 21, 1971. Redesignated at 38FR 26609, Sept. 24, l973]

§ 1302.02 Definitions.Any term contained in this part shall

have the definition set forth in section102 of the Act (21 U.S.C. 802) or part1300 of this chapter.

[62 FR 13958, Mar. 24, 1997]

§ 1302.03 Symbol required; exceptions.(a) Each commercial container of a

controlled substance (except for a con-trolled substance excepted by the Ad-ministrator pursuant to § 1308.31 of thischapter) shall have printed on the label


42

21 CFR Ch. II (4–1–01 Edition)§ 1302.04

the symbol designating the schedule inwhich such controlled substance is list-ed. Each such commercial container, ifit otherwise has no label, must bear alabel complying with the requirementof this part.

(b) Each manufacturer shall printupon the labeling of each controlledsubstance distributed by him the sym-bol designating the schedule in whichsuch controlled substance is listed.

(c) The following symbols shall des-ignate the schedule correspondingthereto:

Schedule

Schedule I ............................................ CI or C–I.Schedule II ........................................... CII or C–II.Schedule III .......................................... CIII or C–III.Schedule IV ......................................... CIV or C–IV.Schedule V .......................................... CV or C–V.

The word ‘‘schedule’’ need not be used.No distinction need be made betweennarcotic and nonnarcotic substances.

(d) The symbol is not required on acarton or wrapper in which a commer-cial container is held if the symbol iseasily legible through such carton orwrapper.

(e) The symbol is not required on acommercial container too small or oth-erwise unable to accommodate a label,if the symbol is printed on the box orpackage from which the commercialcontainer is removed upon dispensingto an ultimate user.

(f) The symbol is not required on acommercial container containing, oron the labeling of, a controlled sub-stance being utilized in clinical re-search involving blind and double blindstudies.

[36 FR 7785, Apr. 24, 1971, as amended at 36FR 18731, Sept. 21, 1971. Redesignated at 38FR 26609, Sept. 24, 1973]

§ 1302.04 Location and size of symbolon label and labeling.

The symbol shall be prominently lo-cated on the label or the labeling of thecommercial container and/or the panelof the commercial container normallydisplayed to dispensers of any con-trolled substance. The symbol on labelsshall be clear and large enough to af-ford easy identification of the scheduleof the controlled substance upon in-spection without removal from the dis-penser’s shelf. The symbol on all other

labeling shall be clear and largeenough to afford prompt identificationof the controlled substance upon in-spection of the labeling.

[62 FR 13958, Mar. 24, 1997]

§ 1302.05 Effective dates of labeling re-quirements.

All labels on commercial containersof, and all labeling of, a controlled sub-stance which either is transferred toanother schedule or is added to anyschedule shall comply with the require-ments of § 1302.03, on or before the ef-fective date established in the finalorder for the transfer or addition.

[62 FR 13958, Mar. 24, 1997]

§ 1302.06 Sealing of controlled sub-stances.

On each bottle, multiple dose vial, orother commercial container of anycontrolled substance, there shall be se-curely affixed to the stopper, cap, lid,covering, or wrapper or such containera seal to disclose upon inspection anytampering or opening of the container.

[62 FR 13958, Mar. 24, 1997]

§ 1302.07 Labeling and packaging re-quirements for imported and ex-ported substances.

(a) The symbol requirements of§§ 1302.03–1302.05 apply to every com-mercial container containing, and toall labeling of, controlled substancesimported into the jurisdiction of and/orthe customs territory of the UnitedStates.

(b) The symbol requirements of§§ 1302.03–1302.05 do not apply to anycommercial containers containing, orany labeling of, a controlled substanceintended for export from the jurisdic-tion of the United States.

(c) The sealing requirements of§ 1302.06 apply to every bottle, multipledose vial, or other commercial con-tainer of any controlled substance list-ed in schedule I or II, or any narcoticcontrolled substance listed in scheduleIII or IV, imported into, exported from,or intended for export from, the juris-diction of and/or the customs territoryof the United States.

[62 FR 13958, Mar. 24, 1997]


43


PART 1303—QUOTAS

GENERAL INFORMATION

Sec.1303.01 Scope of part 1303.1303.02 Definitions.

AGGREGATE PRODUCTION AND PROCUREMENTQUOTAS

1303.11 Aggregate production quotas.1303.12 Procurement quotas.1303.13 Adjustments of aggregate produc-

tion quotas.

INDIVIDUAL MANUFACTURING QUOTAS

1303.21 Individual manufacturing quotas.1303.22 Procedure for applying for individual

manufacturing quotas.1303.23 Procedure for fixing individual man-

ufacturing quotas.1303.24 Inventory allowance.1303.25 Increase in individual manufac-

turing quotas.1303.26 Reduction in individual manufac-

turing quotas.1303.27 Abandonment of quota.

HEARINGS

1303.31 Hearings generally.1303.32 Purpose of hearing.1303.33 Waiver or modification of rules.1303.34 Request for hearing or appearance;

waiver.1303.35 Burden of proof.1303.36 Time and place of hearing.1303.37 Final order.

AUTHORITY: 21 U.S.C. 821, 826, 871(b).

GENERAL INFORMATION

§ 1303.01 Scope of part 1303.

Procedures governing the establish-ment of production and manufacturingquotas on basic classes of controlledsubstances listed in schedules I and IIpursuant to section 306 of the Act (21U.S.C. 826) are governed generally bythat section and specifically by thesections of this part.

[36 FR 7786, Apr. 24, 1971. Redesignated at 38FR 26609, Sept. 24, 1973]

§ 1303.02 Definitions.

Any term contained in this part shallhave the definition set forth in section102 of the Act (21 U.S.C. 802) or part1300 of this chapter.

[62 FR 13958, Mar. 24, 1997]

AGGREGATE PRODUCTION ANDPROCUREMENT QUOTAS

§ 1303.11 Aggregate production quotas.(a) The Administrator shall deter-

mine the total quantity of each basicclass of controlled substance listed inSchedule I or II necessary to be manu-factured during the following calendaryear to provide for the estimated med-ical, scientific, research and industrialneeds of the United States, for lawfulexport requirements, and for the estab-lishment and maintenance of reservestocks.

(b) In making his determinations, theAdministrator shall consider the fol-lowing factors:

(1) Total net disposal of the class byall manufacturers during the currentand 2 preceding years;

(2) Trends in the national rate of netdisposal of the class;

(3) Total actual (or estimated) inven-tories of the class and of all substancesmanufactured from the class, andtrends in inventory accumulation;

(4) Projected demand for such classas indicated by procurement quotas re-quested pursuant to § 1303.12; and

(5) Other factors affecting medical,scientific, research, and industrialneeds in the United States and lawfulexport requirements, as the Adminis-trator finds relevant, includingchanges in the currently accepted med-ical use in treatment with the class orthe substances which are manufacturedfrom it, the economic and physicalavailability of raw materials for use inmanufacturing and for inventory pur-poses, yield and stability problems, po-tential disruptions to production (in-cluding possible labor strikes), and re-cent unforeseen emergencies such asfloods and fires.

(c) The Administrator shall, on or be-fore May 1 of each year, publish in theFEDERAL REGISTER, general notice ofan aggregate production quota for anybasic class determined by him underthis section. A copy of said notice shallbe mailed simultaneously to each per-son registered as a bulk manufacturerof the basic class. The Administratorshall permit any interested person tofile written comments on or objectionsto the proposal and shall designate inthe notice the time during which such


44

21 CFR Ch. II (4–1–01 Edition)§ 1303.12

filings may be made. The Adminis-trator may, but shall not be requiredto, hold a public hearing on one ormore issues raised by the commentsand objections filed with him. In theevent the Administrator decides tohold such a hearing, he shall publishnotice of the hearing in the FEDERALREGISTER, which notice shall summa-rize the issues to be heard and shall setthe time for the hearing which shallnnt be less than 30 days after the dateof publication of the notice. After con-sideration of any comments or objec-tions, or after a hearing if one is or-dered by the Administrator, the Ad-ministrator shall issue and publish inthe FEDERAL REGISTER his final orderdetermining the aggregate productionquota for the basic class of controlledsubstance. The order shall include thefindings of fact and conclusions of lawupon which the order is based. Theorder shall specify the date on which itshall take effect. A copy of said ordershall be mailed simultaneously to eachperson registered as a bulk manufac-turer of the basic class.

[36 FR 7786, Apr. 24, 1971, as amended at 37FR 15919, Aug. 8, 1972. Redesignated at 38 FR26609, Sept. 24, 1973]

§ 1303.12 Procurement quotas.(a) In order to determine the esti-

mated needs for, and to insure an ade-quate and uninterrupted supply of,basic classes of controlled substanceslisted in Schedules I and II (except rawopium being imported by the registrantpursuant to an import permit) the Ad-ministrator shall issue procurementquotas authorizing persons to procureand use quantities of each basic classof such substances for the purpose ofmanufacturing such class into dosageforms or into other substances.

(b) Any person who is registered tomanufacture controlled substanceslisted in any schedule and who desiresto use during the next calendar yearany basic class of controlled substanceslisted in Schedule I or II (except rawopium being imported by the registrantpursuant to an import permit) for pur-poses of manufacturing, shall apply onDEA Form 250 for a procurement quotafor such basic class. A separate applica-tion must be made for each basic classdesired to be procured or used. The ap-

plicant shall state whether he intendsto manufacture the basic class himselfor purchase it from another manufac-turer. The applicant shall state sepa-rately each purpose for which the basicclass is desired, the quantity desiredfor that purpose during the next cal-endar year, and the quantities used andestimated to be used, if any, for thatpurpose during the current and pre-ceding 2 calendar years. If the purposeis to manufacture the basic class intodosage form, the applicant shall statethe official name, common or usualname, chemical name, or brand nameof that form. If the purpose is to manu-facture another substance, the appli-cant shall state the official name, com-mon or usual name, chemical name, orbrand name of the substance, and, if acontrolled substance listed in anyschedule, the schedule number and Ad-ministration Controlled SubstancesCode Number, as set forth in part 1308of this chapter, of the substance. If thepurpose is to manufacture anotherbasic class of controlled substance list-ed in Schedule I or II, the applicantshall also state the quantity of theother basic class which the applicanthas applied to manufacture pursuant to§ 1303.22 and the quantity of the firstbasic class necessary to manufacture aspecified unit of the second basic class.DEA Form 250 shall be filed on or be-fore April 1 of the year preceding thecalendar year for which the procure-ment quota is being applied. Copies ofDEA Form 250 may be obtained from,and shall be filed with, the Drug &Chemical Evaluation Section, Drug En-forcement Administration, Departmentof Justice, Washington, DC 20537.

(c) The Administrator shall, on or be-fore July 1 of the year preceding thecalendar year during which the quotashall be effective, issue to each quali-fied applicant a procurement quota au-thorizing him to procure and use:

(1) All quantities of such class nec-essary to manufacture all quantities ofother basic classes of controlled sub-stances listed in Schedules I and IIwhich the applicant is authorized tomanufacture pursuant to § 1303.23; and

(2) Such other quantities of suchclass as the applicant has applied toprocure and use and are consistentwith his past use, his estimated needs,


45


and the total quantity of such classthat will be produced.

(d) Any person to whom a procure-ment quota has been issued may at anytime request an adjustment in thequota by applying to the Adminis-trator with a statement showing theneed for the adjustment. Such applica-tion shall be filed with the Drug &Chemical Evaluation Section, Drug En-forcement Administration, Departmentof Justice, Washington, DC 20537. TheAdministrator shall increase or de-crease the procurement quota of suchperson if and to the extent that hefinds, after considering the factors enu-merated in paragraph (c) of this sectionand any occurrences since the issuanceof the procurement quota, that theneed justifies an adjustment.

(e) The following persons need notobtain a procurement quota:

(1) Any person who is registered tomanufacture a basic class of controlledsubstance listed in Schedule I or II andwho uses all of the quantity he manu-factures in the manufacture of a sub-stance not controlled under the Act;

(2) Any person who is registered orauthorized to conduct chemical anal-ysis with controlled substances (forcontrolled substances to be used insuch analysis only); and

(3) Any person who is registered toconduct research with a basic class ofcontrolled substance listed in ScheduleI or II and who is authorized to manu-facture a quantity of such class pursu-ant to § 1301.13 of this chapter.

(f) Any person to whom a procure-ment quota has been issued, author-izing that person to procure and use aquantity of a basic class of controlledsubstances listed in Schedules I or IIduring the current calendar year, shall,at or before the time of giving an orderto another manufacturer requiring thedistribution of a quantity of such basicclass, certify in writing to such othermanufacturer that the quantity of suchbasic class ordered does not exceed theperson’s unused and available procure-ment quota of such basic class for thecurrent calendar year. The written cer-tification shall be executed by thesame individual who signed the DEAForm 222 transmitting the order. Man-ufacturers shall not fill an order frompersons required to apply for a procure-

ment quota under paragraph (b) of thissection unless the order is accompaniedby a certification as required underthis section. The certification requiredby this section shall contain the fol-lowing: The date of the certification;the name and address of the bulk man-ufacturer to whom the certification isdirected; a reference to the number ofthe DEA Form 222 to which the certifi-cation applies; the name of the persongiving the order to which the certifi-cation applies; the name of the basicclass specified in the DEA Form 222 towhich the certification applies; the ap-propriate schedule within which is list-ed the basic class specified in the DEAForm 222 to which the certification ap-plies; a statement that the quantity(expressed in grams) of the basic classspecified in the DEA Form 222 to whichthe certification applies does not ex-ceed the unused and available procure-ment quota of such basic class, issuedto the person giving the order, for thecurrent calendar year; and the signa-ture of the individual who signed theDEA Form 222 to which the certifi-cation applies.

[36 FR 7786, Apr. 24, 1971, as amended at 36FR 13386, July 21, 1971; 36 FR 18731, Sept. 21,1971; 37 FR 15919, Aug. 8, 1972. Redesignatedat 38 FR 26609, Sept. 24, 1973]


§ 1303.13 Adjustments of aggregateproduction quotas.

(a) The Administrator may at anytime increase or reduce the aggregateproduction quota for a basic class ofcontrolled substance listed in ScheduleI or II which he has previously fixedpursuant to § 1303.11.

(b) In determining to adjust the ag-gregate production quota, the Adminis-trator shall consider the following fac-tors:

(1) Changes in the demand for thatclass, changes in the national rate ofnet disposal of the class, and changesin the rate of net disposal of the classby registrants holding individual man-ufacturing quotas for that class;


46

21 CFR Ch. II (4–1–01 Edition)§ 1303.21

(2) Whether any increased demand forthat class, the national and/or indi-vidual rates of net disposal of thatclass are temporary, short term, orlong term;

(3) Whether any increased demand forthat class can be met through existinginventories, increased individual man-ufacturing quotas, or increased impor-tation, without increasing the aggre-gate production quota, taking into ac-count production delays and the prob-ability that other individual manufac-turing quotas may be suspended pursu-ant to § 1303.24(b);

(4) Whether any decreased demandfor that class will result in excessiveinventory accumulation by all personsregistered to handle that class (includ-ing manufacturers, distributors, practi-tioners, importers, and exporters), not-withstanding the possibility that indi-vidual manufacturing quotas may besuspended pursuant to § 1303.24(b) orabandoned pursuant to § 1303.27;

(5) Other factors affecting medical,scientific, research, and industrialneeds in the United States and lawfulexport requirements, as the Adminis-trator finds relevant, includingchanges in the currently accepted med-ical use in treatment with the class orthe substances which are manufacturedfrom it, the economic and physicalavailability of raw materials for use inmanufacturing and for inventory pur-poses, yield and stability problems, po-tential disruptions to production (in-cluding possible labor strikes), and re-cent unforeseen emergencies such asfloods and fires.

(c) The Administrator in the event hedetermines to increase or reduce theaggregate production quota for a basicclass of controlled substance, shallpublish in the FEDERAL REGISTER gen-eral notice of an adjustment in the ag-gregate production quota for that classdetermined by him under this section.A copy of said notice shall be mailedsimultaneously to each person reg-istered as a bulk manufacturer of thebasic class. The Administrator shallpermit any interested person to filewritten comments on or objections tothe proposal and shall designate in thenotice the time during which such fil-ings may be made. The Administratormay, but shall not be required to, hold

a public hearing on one or more issuesraised by the comments and objectionsfiled with him. In the event the Admin-istrator decides to hold such a hearing,he shall publish notice of the hearingin the FEDERAL REGISTER, which noticeshall summarize the issues to be heardand shall set the time for the hearing,which shall not be less than 10 daysafter the date of publication of the no-tice. After consideration of any com-ments or objections, or after a hearingif one is ordered by the Administrator,the Administrator shall issue and pub-lish in the FEDERAL REGISTER his finalorder determining the aggregate pro-duction for the basic class of controlledsubstance. The order shall include thefindings of fact and conclusions of lawupon which the order is based. Theorder shall specify the date on which itshall take effect. A copy of said ordershall be mailed simultaneously to eachperson registered as a bulk manufac-turer of the basic class.

[37 FR 15919, Aug. 8, 1972. Redesignated at 38FR 26609, Sept. 24, 1973]

INDIVIDUAL MANUFACTURING QUOTAS

§ 1303.21 Individual manufacturingquotas.

(a) The Administrator shall, on or be-fore July 1 of each year, fix for andissue to each person who is registeredto manufacture a basic class of con-trolled substance listed in Schedule Ior II, and who applies for a manufac-turing quota, an individual manufac-turing quota authorizing that person tomanufacture during the next calendaryear a quantity of that basic class. Anymanufacturing quota fixed and issuedby the Administrator shall be subjectto his authority to reduce or limit it ata later date pursuant to § 1303.26 and tohis authority to revoke or suspend it atany time pursuant to §§ 1301.36 of thischapter.

(b) No individual manufacturingquota shall be required for registrantslisted in § 1303.12(e).

[36 FR 7786, Apr. 24, 1971. Redesignated at 38FR 26609, Sept. 24, 1973, as amended at 62 FR13958, Mar. 24, 1997]


47


§ 1303.22 Procedure for applying forindividual manufacturing quotas.

Any person who is registered to man-ufacture any basic class of controlledsubstance listed in Schedule I or II andwho desires to manufacture a quantityof such class shall apply on DEA Form189 for a manufacturing quota for suchquantity of such class. Copies of DEAForm 189 may be obtained from, andshall be filed (on or before May 1 of theyear preceding the calendar year forwhich the manufacturing quota isbeing applied) with, the Drug & Chem-ical Evaluation Section, Drug Enforce-ment Administration, Department ofJustice, Washington, D.C. 20537. A sep-arate application must be made foreach basic class desired to be manufac-tured. The applicant shall state:

(a) The name and AdministrationControlled Substances Code Number, asset forth in part 1308 of this chapter, ofthe basic class.

(b) For the basic class in each of thecurrent and preceding 2 calendar years,

(1) The authorized individual manu-facturing quota, if any;

(2) The actual or estimated quantitymanufactured;

(3) The actual or estimated net dis-posal;

(4) The actual or estimated inventoryallowance pursuant to § 1303.24; and

(5) The actual or estimated inventoryas of December 31;

(c) For the basic class in the next cal-endar year,

(1) The desired individual manufac-turing quota; and

(2) Any additional factors which theapplicant finds relevant to the fixing ofhis individual manufacturing quota, in-cluding the trend of (and recentchanges in) his and the national ratesof net disposal, his production cycleand current inventory position, theeconolic and physical availability ofraw materials for use in manufacturingand for inventory purposes, yield andstability problems, potential disrup-tions to production (including possible

labor strikes) and recent unforeseenemergencies such as floods and fires.

[36 FR 7786, Apr. 24, 1971, as amended at 36FR 13386, July 21, 1971; 37 FR 15920, Aug. 8,1972. Redesignated at 38 FR 26609, Sept. 24,1973, and amended at 46 FR 28841, May 29,1981; 51 FR 5319, Feb. 13, 1986; 62 FR 13958,Mar. 24, 1997]

§ 1303.23 Procedure for fixing indi-vidual manufacturing quotas.

(a) In fixing individual manufac-turing quotas for a basic class of con-trolled substance listed in Schedule Ior II, the Administrator shall allocateto each applicant who is currentlymanufacturing such class a quota equalto 100 percent of the estimated net dis-posal of that applicant for the next cal-endar year, adjusted—

(1) By the amount necessary to in-crease or reduce the estimated inven-tory of the applicant on December 31 ofthe current year to his estimated in-ventory allowance for the next cal-endar year, pursuant to § 1303.24, and

(2) By any other factors which theAdministrator deems relevant to thefixing of the individual manufacturingquota of the applicant, including thetrend of (and recent changes in) his andthe national rates of net disposal, hisproduction cycle and current inventoryposition, the economic and physicalavailability of raw materials for use inmanufacturing and for inventory pur-poses, yield and stability problems, po-tential disruptions to production (in-cluding possible labor strikes), and re-cent unforeseen emergencies such asfloods and fires.

(b) In fixing individual manufac-turing quotas for a basic class of con-trolled substance listed in Schedule Ior II, the Administrator shall allocateto each applicant who is not currentlymanufacturing such class a quota equalto 100 percent of the reasonably esti-mated net disposal of that applicantfor the next calendar year, as deter-mined by the Administrator, ad-justed—


48

21 CFR Ch. II (4–1–01 Edition)§ 1303.24

(1) By the amount necessary to pro-vide the applicant his estimated inven-tory allowance for the next calendaryear, pursuant to § 1303.24, and

(2) By any other factors which theAdministrator deems relevant to thefixing of the individual manufacturingquota of the applicant, including thetrend of (and recent changes in) the na-tional rate of net disposal, his produc-tion cycle and current inventory posi-tion, the economic and physical avail-ability of raw materials for use in man-ufacturing and for inventory purposes,yield and stability problems, potentialdisruptions to production (includingpossible labor strikes), and recent un-foreseen emergencies such as floodsand fires.

(c) The Administrator shall, on or be-fore March 1 of each year, adjust theindividual manufacturing quota allo-cated for that year to each applicant inparagraph (a) of this section by theamount necessary to increase or reducethe actual inventory of the applicantto December 31 of the preceding year tohis estimated inventory allowance forthe current calendar year, pursuant to§ 1303.24.


§ 1303.24 Inventory allowance.(a) For the purpose of determining

individual manufacturing quotas pur-suant to § 1303.23, each registered man-ufacturer shall be allowed as a part ofsuch quota an amount sufficient tomaintain an inventory equal to,

(1) For current manufacturers, 50 per-cent of his average estimated net dis-posal for the current calendar year andthe last preceding calendar year; or

(2) For new manufacturers, 50 percentof his reasonably estimated net dis-posal for the next calendar year as de-termined by the Administrator.

(b) During each calendar year eachregistered manufacturer shall be al-lowed to maintain an inventory of abasic class not exceeding 65 percent ofhis estimated net disposal of that classfor that year, as determined at thetime his quota for that year was deter-mined. At any time the inventory of abasic class held by a manufacturer ex-ceeds 65 percent of his estimated net

disposal, his quota for that class isautomatically suspended and shall re-main suspended until his inventory isless than 60 percent of his estimatednet disposal. The Administrator may,upon application and for good causeshown, permit a manufacturer whosequota is, or is likely to be, suspendedpursuant to this paragraph to continuemanufacturing and to accumulate aninventory in excess of 65 percent of hisestimated net disposal, upon such con-ditions and within such limitations asthe Administrator may find necessaryor desirable.

(c) If, during a calendar year, a reg-istrant has manufactured the entirequantity of a basic class allocated tohim under an individual manufacturingquota, and his inventory of that classis less than 40 percent of his estimatednet disposal of that class for that year,the Administrator may, upon applica-tion pursuant to § 1303.25, increase thequota of such registrant sufficiently toallow restoration of the inventory to 50percent of the estimated net disposalfor that year.

[36 FR 7786, Apr. 24, 1971, as amended at 36FR 13386, July 21, 1971. Redesignated at 38 FR26609, Sept. 24, 1973]

§ 1303.25 Increase in individual manu-facturing quotas.

(a) Any registrant who holds an indi-vidual manufacturing quota for a basicclass of controlled substance listed inSchedule I or II may file with the Ad-ministrator an application on Adminis-tration Form 189 for an increase insuch quota in order for him to meet hisestimated net disposal, inventory andother requirements during the remain-der of such calendar year.

(b) The Administrator, in passingupon a registrant’s application for anincrease in his individual manufac-turing quota, shall take into consider-ation any occurrences since the filingof such registrant’s initial quota appli-cation that may require an increasedmanufacturing rate by such registrantduring the balance of the calendaryear. In passing upon such applicationthe Administrator may also take intoconsideration the amount, if any, bywhich his determination of the totalquantity for the basic class of con-trolled substance to be manufactured


49


under § 1303.11 exceeds the aggregate ofall the individual manufacturingquotas for the basic class of controlledsubstance, and the equitable distribu-tion of such excess among other reg-istrants.


§ 1303.26 Reduction in individual man-ufacturing quotas.

The Administrator may at any timereduce an individual manufacturingquota for a basic class of controlledsubstance listed in Schedule I or IIwhich he has previously fixed in orderto prevent the aggregate of the indi-vidual manufacturing quotas and im-port permits outstanding or to begranted from exceeding the aggregateproduction quota which has been estab-lished for that class pursuant of§ 1303.11, as adjusted pursuant to§ 1303.13. If a quota assigned to a newmanufacturer pursuant to § 1303.23(b),or if a quota assigned to any manufac-turer is increased pursuant to§ 1303.24(c), or if an import permitissued to an importer pursuant to part1312 of this chapter, causes the totalquantity of a basic class to be manu-factured and imported during the yearto exceed the aggregate productionquota which has been established forthat class pursuant to § 1303.11, as ad-justed pursuant to § 1303.13, the Admin-istrator may proportionately reducethe individual manufacturing quotasand import permits of all other reg-istrants to keep the aggregate produc-tion quota within the limits originallyestablished, or, alternatively, the Ad-ministrator may reduce the individualmanufacturing quota of any registrantwhose quota is suspended pursuant to§ 1303.24(b) or § 1301.36 of this chapter, oris abandoned pursuant to § 1303.27.

[36 FR 7786, Apr. 24, 1971, as amended at 37FR 15920, Aug. 8, 1972. Redesignated at 38 FR26609, Sept. 24, 1973, as amended at 62 FR13958, Mar. 24, 1997]

§ 1303.27 Abandonment of quota.Any manufacturer assigned an indi-

vidual manufacturing quota for anybasic class pursuant to § 1303.23 may atany time abandon his right to manu-facture all or any part of such quota by

filing with the Drug & Chemical Eval-uation Section a written notice of suchabandonment, stating the name andAdministration Controlled SubstancesCode Number, as set forth in part 1308of this chapter, of the substance andthe amount which he has chosen not tomanufacture. The Administrator may,in his discretion, allocate such amountamong the other manufacturers in pro-portion to their respective quotas.

[36 FR 7786, Apr. 24, 1971, as amended at 36FR 13386, July 21, 1971. Redesignated at 38 FR26609, Sept. 24, 1973, and amended at 46 FR28841, May 29, 1981; 51 FR 5319, Feb. 13, 1986;62 FR 13958, Mar. 24, 1997]

HEARINGS

§ 1303.31 Hearings generally.

(a) In any case where the Adminis-trator shall hold a hearing regardingthe determination of an aggregate pro-duction quota pursuant to § 1303.11(c),or regarding the adjustment of an ag-gregate production quota pursuant to§ 1303.13(c), the procedures for suchhearing shall be governed generally bythe rule making procedures set forth inthe Administrative Procedure Act (5U.S.C. 551–559) and specifically by sec-tion 306 of the Act (21 U.S.C. 826), by§§ 1303.32–1303.37, and by the proceduresfor administrative hearings under theAct set forth in §§ 1316.41–1316.67 of thischapter.

(b) In any case where the Adminis-trator shall hold a hearing regardingthe issuance, adjustment, suspension,or denial of a procurement quota pur-suant to § 1303.12, or the issuance, ad-justment, suspension, or denial of anindividual manufacturing quota pursu-ant to §§ 1303.21–1303.27, the proceduresfor such hearing shall be governed gen-erally by the adjudication proceduresset forth in the Administrative Proce-dures Act (5 U.S.C. 551–559) and specifi-cally by section 306 of the Act (21U.S.C. 826), by §§ 1303.32–1303.37, and bythe procedures for administrative hear-ings under the Act set forth in§§ 1316.41–1316.67 of this chapter.



50

21 CFR Ch. II (4–1–01 Edition)§ 1303.32

§ 1303.32 Purpose of hearing.(a) The Administrator may, in his

sole discretion, hold a hearing for thepurpose of receiving factual evidenceregarding any one or more issues (to bespecified by him) involved in the deter-mination or adjustment of any aggre-gate production quota.

(b) If requested by a person applyingfor or holding a procurement quota oran individual manufacturing quota, theAdministrator shall hold a hearing forthe purpose of receiving factual evi-dence regarding the issues involved inthe issuance, adjustment, suspension,or denial of such quota to such person,but the Administrator need not hold ahearing on the suspension of a quotapursuant to § 1301.36 of this chapter sep-arate from a hearing on the suspensionof registration pursuant to those sec-tions.

(c) Extensive argument should not beoffered into evidence but rather pre-sented in opening or closing state-ments of counsel or in memoranda orproposed findings of fact and conclu-sions of law.


§ 1303.33 Waiver or modification ofrules.

The Administrator or the presidingofficer (with respect to matters pend-ing before him) may modify or waiveany rule in this part by notice in ad-vance of the hearing, if he determinesthat no party in the hearing will be un-duly prejudiced and the ends of justicewill thereby be served. Such notice ofmodification or waiver shall be made apart of the record of the hearing.

[36 FR 7786, Apr. 24,1971. Redesignated at 38FR 26609, Sept. 24, 1973]


(a) Any applicant or registrant whodesires a hearing on the issuance, ad-justment, suspension, or denial of hisprocurement and/or individual manu-facturing quota shall, within 30 daysafter the date of receipt of theissuance, adjustment, suspension, ordenial of such quota, file with the Ad-

ministrator a written request for ahearing in the form prescribed in§ 1316.47 of this chapter. Any interestedperson who desires a hearing on the de-termination of an aggregate productionquota shall, within the time prescribedin § 1303.11(c), file with the Adminis-trator a written request for a hearingin the form prescribed in § 1316.47 ofthis chapter, including in the request astatement of the grounds for a hearing.

(b) Any interested person who desiresto participate in a hearing on the de-termination or adjustment of an aggre-gate production quota, which hearingis ordered by the Administrator pursu-ant to § 1303.11(c) or § 1303.13(c) may doso by filing with the Administrator,within 30 days of the date of publica-tion of notice of the hearing in theFEDERAL REGISTER, a written notice ofhis intention to participate in suchhearing in the form prescribed in§ 1316.48 of this chapter.

(c) Any person entitled to a hearingor to participate in a hearing pursuantto paragraph (b) of this section, may,within the period permitted for filing arequest for a hearing of notice of ap-pearance, file with the Administrator awaiver of an opportunity for a hearingor to participate in a hearing, togetherwith a written statement regarding hisposition on the matters of fact and lawinvolved in such hearing. Such state-ment, if admissible, shall be made apart of the record and shall be consid-ered in light of the lack of opportunityfor cross-examination in determiningthe weight to be attached to matters offact asserted therein.

(d) If any person entitled to a hearingor to participate in a hearing pursuantto paragraph (b) of this section, fails tofile a request for a hearing or notice ofappearance, or if he so files and fails toappear at the hearing, he shall bedeemed to have waived his opportunityfor the hearing or to participate in thehearing, unless he shows good cause forsuch failure.

(e) If all persons entitled to a hearingor to participate in a hearing waive orare deemed to waive their opportunityfor the hearing or to participate in thehearing, the Administrator may cancelthe hearing, if scheduled, and issue his


51

Drug Enforcement Administration, Justice Pt. 1304

final order pursuant to § 1303.37 withouta hearing.

[36 FR 7786, Apr. 24, 1971, as amended at 36FR 18731, Sept. 21, 1971; 37 FR 15920, Aug. 8,1972. Redesignated at 38 FR 26609, Sept. 24,1973]

§ 1303.35 Burden of proof.(a) At any hearing regarding the de-

termination or adjustment of an aggre-gate production quota, each interestedperson participating in the hearingshall have the burden of proving anypropositions of fact or law asserted byhim in the hearing.

(b) At any hearing regarding theissuance, adjustment, suspension, ordenial of a procurement or individualmanufacturing quota, the Administra-tion shall have the burden of provingthat the requirements of this part forsuch issuance, adjustment, suspension,or denial are satisfied.


§ 1303.36 Time and place of hearing.(a) If any applicant or registrant re-

quests a hearing on the issuance, ad-justment, suspension, or denial of hisprocurement and/or individual manu-facturing quota pursuant to § 1303.34,the Administrator shall hold suchhearing. Notice of the hearing shall begiven to the applicant or registrant ofthe time and place at least 30 daysprior to the hearing, unless the appli-cant or registrant waives such noticeand requests the hearing be held at anearlier time, in which case the Admin-istrator shall fix a date for such hear-ing as early as reasonably possible.

(b) The hearing will commence at theplace and time designated in the noticegiven pursuant to paragraph (a) of thissection or in the notice of hearing pub-lished in the FEDERAL REGISTER pursu-ant to § 1303.11(c) or § 1303.13 (c), butthereafter it may be moved to a dif-ferent place and may be continuedfrom day to day or recessed to a laterday without notice other than an-nouncement thereof by the presidingofficer at the hearing.


§ 1303.37 Final order.

As soon as practicable after the pre-siding officer has certified the recordto the Administrator, the Adminis-trator shall issue his order on the de-termination or adjustment of the ag-gregate production quota or on theissuance, adjustment, suspension, ordenial of the procurement quota or in-dividual manufacturing quota, as casemay be. The order shall include thefindings of fact and conclusions of lawupon which the order is based. Theorder shall specify the date on which itshall take effect. The Administratorshall serve one copy of his order uponeach party in the hearing.


PART 1304—RECORDS ANDREPORTS OF REGISTRANTS

GENERAL INFORMATION

Sec.1304.01 Scope of part 1304.1304.02 Definitions.1304.03 Persons required to keep records and

file reports.1304.04 Maintenance of records and inven-

tories.

INVENTORY REQUIREMENTS

1304.11 Inventory requirements.

CONTINUING RECORDS

1304.21 General requirements for continuingrecords.

1304.22 Records for manufacturers, distribu-tors, dispensers, researchers, importers,and exporters.

1304.23 Records for chemical analysts.1304.24 Records for maintenance treatment

programs and detoxification treatmentprograms.

1304.25 Records for treatment programswhich compound narcotics for treatmentprograms and other locations.

REPORTS

1304.31 Reports from manufacturers import-ing narcotic raw material.

1304.32 Reports of manufacturers importingcoca leaves.

1304.33 Reports to ARCOS.

AUTHORITY: 21 U.S.C. 821, 827, 871(b), 958(e),965, unless otherwise noted.


52

21 CFR Ch. II (4–1–01 Edition)§ 1304.01

GENERAL INFORMATION

§ 1304.01 Scope of part 1304.Inventory and other records and re-

ports required under section 307 or sec-tion 1008(d) of the Act (21 U.S.C. 827 and958(d)) shall be in accordance with, andcontain the information required by,those sections and by the sections ofthis part.

[36 FR 7789, Apr. 24, 1971. Redesignated at 38FR 26609, Sept. 24, 1973]



[62 FR 13958, Mar. 24, 1997]

§ 1304.03 Persons required to keeprecords and file reports.

(a) Each registrant shall maintainthe records and inventories and shallfile the reports required by this part,except as exempted by this section.Any registrant who is authorized toconduct other activities without beingregistered to conduct those activities,either pursuant to § 1301.22(b) of thischapter or pursuant to §§ 1307.11–1307.15of this chapter, shall maintain therecords and inventories and shall filethe reports required by this part forpersons registered to conduct such ac-tivities. This latter requirement shouldnot be construed as requiring stocks ofcontrolled substances being used invarious activities under one registra-tion to be stored separately, nor thatseparate records are required for eachactivity. The intent of the Administra-tion is to permit the registrant to keepone set of records which are adapted bythe registrant to account for controlledsubstances used in any activity. Also,the Administration does not wish toacquire separate stocks of the samesubstance to be purchased and storedfor separate activities. Otherwise,there is no advantage gained by per-mitting several activities under oneregistration. Thus, when a researchermanufactures a controlled item, hemust keep a record of the quantitymanufactured; when he distributes aquantity of the item, he must use andkeep invoices or order forms to docu-

ment the transfer; when he imports asubstance, he keeps as part of hisrecords the documentation required ofan importer; and when substances areused in chemical analysis, he need notkeep a record of this because such arecord would not be required of himunder a registration to do chemicalanalysis. All of these records may bemaintained in one consolidated recordsystem. Similarly, the researcher maystore all of his controlled items in oneplace, and every two years take inven-tory of all items on hand, regardless ofwhether the substances were manufac-tured by him, imported by him, or pur-chased domestically by him, of whetherthe substances will be administered tosubjects, distributed to other research-ers, or destroyed during chemical anal-ysis.

(b) A registered individual practi-tioner is required to keep records, asdescribed in § 1304.04, of controlled sub-stances in Schedules II, III, IV, and Vwhich are dispensed, other than by pre-scribing or administering in the lawfulcourse of professional practice.

(c) A registered individual practi-tioner is not required to keep recordsof controlled substances in SchedulesII, III, IV, and V which are prescribedin the lawful course of professionalpractice, unless such substances areprescribed in the course of mainte-nance or detoxification treatment of anindividual.

(d) A registered individual practi-tioner is not required to keep recordsof controlled substances listed inSchedules II, III, IV and V which areadministered in the lawful course ofprofessional practice unless the practi-tioner regularly engages in the dis-pensing or administering of controlledsubstances and charges patients, eitherseparately or together with charges forother professional services, for sub-stances so dispensed or administered.Records are required to be kept forcontrolled substances administered inthe course of maintenance or detoxi-fication treatment of an individual.

(e) Each registered mid-level practi-tioner shall maintain in a readily re-trievable manner those documents re-quired by the state in which he/shepractices which describe the conditionsand extent of his/her authorization to


53


dispense controlled substances andshall make such documents availablefor inspection and copying by author-ized employees of the Administration.Examples of such documentation in-clude protocols, practice guidelines orpractice agreements.

(f) Registered persons using any con-trolled substances while conductingpreclinical research, in teaching at aregistered establishment which main-tains records with respect to such sub-stances or conducting research in con-formity with an exemption grantedunder section 505(i) or 512(j) of the Fed-eral Food, Drug, and Cosmetic Act (21U.S.C. 355(i) or 360b(j)) at a registeredestablishment which maintains recordsin accordance with either of those sec-tions, are not required to keep recordsif he/she notifies the Administration ofthe name, address, and registrationnumber of the establishment maintain-ing such records. This notificationshall be given at the time the personapplies for registration or reregistra-tion and shall be made in the form ofan attachment to the application,which shall be filed with the applica-tion.

(g) A distributing registrant who uti-lizes a freight forwarding facility shallmaintain records to reflect transfer ofcontrolled substances through the fa-cility. These records must contain thedate, time of transfer, number of car-tons, crates, drums or other packagesin which commercial containers of con-trolled substances are shipped and au-thorized signatures for each transfer. Adistributing registrant may, as part ofthe initial request to operate a freightforwarding facility, request permissionto store records at a central location.Approval of the request to maintaincentral records would be implicit inthe approval of the request to operatethe facility. Otherwise, a request tomaintain records at a central locationmust be submitted in accordance with§ 1304.04 of this part. These records

must be maintained for a period of twoyears.

[36 FR 7790, Apr. 24, 1971, as amended at 36FR 18731, Sept. 21, 1971; 37 FR 15920, Aug. 8,1972. Redesignated at 38 FR 26609, Sept. 24,1973, and amended at 50 FR 40523, Oct. 4, 1985;51 FR 5320, Feb. 13, 1986; 51 FR 26154, July 21,1986; 58 FR 31175, June 1, 1993; 62 FR 13958,Mar. 24, 1997; 65 FR 44679, July 19, 2000]

§ 1304.04 Maintenance of records andinventories.

(a) Every inventory and other recordsrequired to be kept under this partshall be kept by the registrant and beavailable, for at least 2 years from thedate of such inventory or records, forinspection and copying by authorizedemployees of the Administration, ex-cept that financial and shippingrecords (such as invoices and packingslips but not executed order forms sub-ject to § 1305.13 of this chapter) may bekept at a central location, rather thanat the registered location, if the reg-istrant has notified the Administrationof his intention to keep centralrecords. Written notification must besubmitted by registered or certifiedmail, return receipt requested, in trip-licate, to the Special Agent in Chargeof the Administration in the area inwhich the registrant is located. Unlessthe registrant is informed by the Spe-cial Agent in Charge that permissionto keep central records is denied, theregistrant may maintain centralrecords commencing 14 days after re-ceipt of his notification by the SpecialAgent in Charge.

All notifications must include:(1) The nature of the records to be

kept centrally.(2) The exact location where the

records will be kept.(3) The name, address, DEA registra-

tion number and type of DEA registra-tion of the registrant whose records arebeing maintained centrally.

(4) Whether central records will bemaintained in a manual, or computerreadable form.


54

21 CFR Ch. II (4–1–01 Edition)§ 1304.04

(b) All registrants that are author-ized to maintain a central record-keeping system shall be subject to thefollowing conditions:

(1) The records to be maintained atthe central record location shall notinclude executed order forms, prescrip-tions and/or inventories which shall bemaintained at each registered location.

(2) If the records are kept on micro-film, computer media or in any formrequiring special equipment to renderthe records easily readable, the reg-istrant shall provide access to suchequipment with the records. If anycode system is used (other than pricinginformation), a key to the code shall beprovided to make the records under-standable.

(3) The registrant agrees to deliverall or any part of such records to theregistered location within two businessdays upon receipt of a written requestfrom the Administration for suchrecords, and if the Administrationchooses to do so in lieu of requiring de-livery of such records to the registeredlocation, to allow authorized employ-ees of the Administration to inspectsuch records at the central locationupon request by such employees with-out a warrant of any kind.

(4) In the event that a registrant failsto comply with these conditions, theSpecial Agent in Charge may cancelsuch central recordkeeping authoriza-tion, and all other central record-keeping authorizations held by the reg-istrant without a hearing or other pro-cedures. In the event of a cancellationof central recordkeeping authoriza-tions under this paragraph the reg-istrant shall, within the time specifiedby the Special Agent in Charge, complywith the requirements of this sectionthat all records be kept at the reg-istered location.

(c) Registrants need not notify theSpecial Agent in Charge or obtain cen-tral recordkeeping approval in order tomaintain records on an in-house com-puter system.

(d) ARCOS participants who desireauthorization to report from otherthan their registered locations mustobtain a separate central reportingidentifier. Request for central report-ing identifiers will be submitted to:

ARCOS Unit, P.O. Box 28293, CentralStation, Washington, DC 20005.

(e) All central recordkeeping permitspreviously issued by the Administra-tion expired September 30, 1980.

(f) Each registered manufacturer, dis-tributor, importer, exporter, narcotictreatment program and compounderfor narcotic treatment program shallmaintain inventories and records ofcontrolled substances as follows:

(1) Inventories and records of con-trolled substances listed in Schedules Iand II shall be maintained separatelyfrom all of the records of the reg-istrant; and

(2) Inventories and records of con-trolled substances listed in SchedulesIII, IV, and V shall be maintained ei-ther separately from all other recordsof the registrant or in such form thatthe information required is readily re-trievable from the ordinary businessrecords of the registrant.

(g) Each registered individual practi-tioner required to keep records and in-stitutional practitioner shall maintaininventories and records of controlledsubstances in the manner prescribed inparagraph (f) of this section.

(h) Each registered pharmacy shallmaintain the inventories and records ofcontrolled substances as follows:

(1) Inventories and records of all con-trolled substances listed in Schedules Iand II shall be maintained separatelyfrom all other records of the pharmacy,and prescriptions for such substancesshall be maintained in a separate pre-scription file; and

(2) Inventories and records of con-trolled substances listed in SchedulesIII, IV, and V shall be maintained ei-ther separately from all other recordsof the pharmacy or in such form thatthe information required is readily re-trievable from ordinary businessrecords of the pharmacy, and prescrip-tions for such substances shall bemaintained either in a separate pre-scription file for controlled substanceslisted in Schedules III, IV, and V onlyor in such form that they are readilyretrievable from the other prescriptionrecords of the pharmacy. Prescriptionswill be deemed readily retrievable if, atthe time they are initially filed, theface of the prescription is stamped inred ink in the lower right corner with


55


the letter ‘‘C’’ no less than 1 inch highand filed either in the prescription filefor controlled substances listed inSchedules I and II or in the usual con-secutively numbered prescription filefor non-controlled substances. How-ever, if a pharmacy employs an ADPsystem or other electronic record-keeping system for prescriptions whichpermits identification by prescriptionnumber and retrieval of original docu-ments by prescriber’s name, patient’sname, drug dispensed, and date filled,then the requirement to mark the hardcopy prescription with a red ‘‘C’’ iswaived.

(Authority: 21 U.S.C. 821 and 871(b); 28 CFR0.100)

[36 FR 7790, Apr. 24, 1971, as amended at 36FR 13386, July 21, 1971. Redesignated at 38 FR26609, Sept. 24, l973, and amended at 39 FR37985, Oct. 25, 1974; 45 FR 44266, July 1, 1980;47 FR 41735, Sept. 22, 1982; 51 FR 5320, Feb. 13,1986; 62 FR 13959, Mar. 24, 1997]

INVENTORY REQUIREMENTS

§ 1304.11 Inventory requirements.(a) General requirements. Each inven-

tory shall contain a complete and accu-rate record of all controlled substanceson hand on the date the inventory istaken, and shall be maintained in writ-ten, typewritten, or printed form atthe registered location. An inventorytaken by use of an oral recording de-vice must be promptly transcribed.Controlled substances shall be deemedto be ‘‘on hand’’ if they are in the pos-session of or under the control of theregistrant, including substances re-turned by a customer, ordered by a cus-tomer but not yet invoiced, stored in awarehouse on behalf of the registrant,and substances in the possession of em-ployees of the registrant and intendedfor distribution as complimentary sam-ples. A separate inventory shall bemade for each registered location andeach independent activity registered,except as provided in paragraph (e)(4)of this section. In the event controlledsubstances in the possession or underthe control of the registrant are storedat a location for which he/she is notregistered, the substances shall be in-cluded in the inventory of the reg-istered location to which they are sub-ject to control or to which the person

possessing the substance is responsible.The inventory may be taken either asof opening of business or as of the closeof business on the inventory date andit shall be indicated on the inventory.

(b) Initial inventory date. Every personrequired to keep records shall take aninventory of all stocks of controlledsubstances on hand on the date he/shefirst engages in the manufacture, dis-tribution, or dispensing of controlledsubstances, in accordance with para-graph (e) of this section as applicable.In the event a person commences busi-ness with no controlled substances onhand, he/she shall record this fact asthe initial inventory.

(c) Biennial inventory date. After theinitial inventory is taken, the reg-istrant shall take a new inventory ofall stocks of controlled substances onhand at least every two years. The bi-ennial inventory may be taken on anydate which is within two years of theprevious biennial inventory date.

(d) Inventory date for newly controlledsubstances. On the effective date of arule by the Administrator pursuant to§§ 1308.45, 1308.46, or 1308.47 of this chap-ter adding a substance to any scheduleof controlled substances, which sub-stance was, immediately prior to thatdate, not listed on any such schedule,every registrant required to keeprecords who possesses that substanceshall take an inventory of all stocks ofthe substance on hand. Thereafter,such substance shall be included ineach inventory made by the registrantpursuant to paragraph (c) of this sec-tion.

(e) Inventories of manufacturers, dis-tributors, dispensers, researchers, import-ers, exporters and chemical analysts.Each person registered or authorized(by § 1301.13 or §§ 1307.11–1307.13 of thischapter) to manufacture, distribute,dispense, import, export, conduct re-search or chemical analysis with con-trolled substances and required to keeprecords pursuant to § 1304.03 shall in-clude in the inventory the informationlisted below.

(1) Inventories of manufacturers. Eachperson registered or authorized to man-ufacture controlled substances shall in-clude the following information in theinventory:


56

21 CFR Ch. II (4–1–01 Edition)§ 1304.11

(i) For each controlled substance inbulk form to be used in (or capable ofuse in) the manufacture of the same orother controlled or non-controlled sub-stances in finished form, the inventoryshall include:

(A) The name of the substance and(B) The total quantity of the sub-

stance to the nearest metric unitweight consistent with unit size.

(ii) For each controlled substance inthe process of manufacture on the in-ventory date, the inventory shall in-clude:

(A) The name of the substance;(B) The quantity of the substance in

each batch and/or stage of manufac-ture, identified by the batch number orother appropriate identifying number;and

(C) The physical form which the sub-stance is to take upon completion ofthe manufacturing process (e.g., granu-lations, tablets, capsules, or solutions),identified by the batch number orother appropriate identifying number,and if possible the finished form of thesubstance (e.g., 10-milligram tablet or10-milligram concentration per fluidounce or milliliter) and the number orvolume thereof.

(iii) For each controlled substance infinished form the inventory shall in-clude:

(A) The name of the substance;(B) Each finished form of the sub-

stance (e.g., 10-milligram tablet or 10-milligram concentration per fluidounce or milliliter);

(C) The number of units or volume ofeach finished form in each commercialcontainer (e.g., 100-tablet bottle or 3-milliliter vial); and

(D) The number of commercial con-tainers of each such finished form (e.g.four 100-tablet bottles or six 3-milli-liter vials).

(iv) For each controlled substancenot included in paragraphs (e)(1) (i), (ii)or (iii) of this section (e.g., damaged,defective or impure substances await-ing disposal, substances held for qual-ity control purposes, or substancesmaintained for extemporaneouscompoundings) the inventories shallinclude:

(A) The name of the substance;(B) The total quantity of the sub-

stance to the nearest metric unit

weight or the total number of units offinished form; and

(C) The reason for the substancebeing maintained by the registrant andwhether such substance is capable ofuse in the manufacture of any con-trolled substance in finished form.

(2) Inventories of distributors. Eachperson registered or authorized to dis-tribute controlled substances shall in-clude in the inventory the same infor-mation required of manufacturers pur-suant to paragraphs (e)(1) (iii) and (iv)of this section.

(3) Inventories of dispensers and re-searchers. Each person registered or au-thorized to dispense or conduct re-search with controlled substances shallinclude in the inventory the same in-formation required of manufacturerspursuant to paragraphs (e)(1) (iii) and(iv) of this section. In determining thenumber of units of each finished formof a controlled substance in a commer-cial container which has been opened,the dispenser shall do as follows:

(i) If the substance is listed in Sched-ule I or II, make an exact count ormeasure of the contents, or

(ii) If the substance is listed inSchedule III, IV or V, make an esti-mated count or measure of the con-tents, unless the container holds morethan 1,000 tablets or capsules in whichcase he/she must make an exact countof the contents.

(4) Inventories of importers and export-ers. Each person registered or author-ized to import or export controlled sub-stances shall include in the inventorythe same information required of man-ufacturers pursuant to paragraphs(e)(1) (iii) and (iv) of this section. Eachsuch person who is also registered as amanufacturer or as a distributor shallinclude in his/her inventory as an im-porter or exporter only those stocks ofcontrolled substances that are actuallyseparated from his stocks as a manu-facturer or as a distributor (e.g., intransit or in storage for shipment).

(5) Inventories of chemical analysts.Each person registered or authorized toconduct chemical analysis with con-trolled substances shall include in hisinventory the same information re-quired of manufacturers pursuant toparagraphs (e)(1) (iii) and (iv) of thissection as to substances which have


57


been manufactured, imported, or re-ceived by such person. If less than 1kilogram of any controlled substance(other than a hallucinogenic controlledsubstance listed in Schedule I), or lessthan 20 grams of a hallucinogenic sub-stance listed in Schedule I (other thanlysergic acid diethylamide), or lessthan 0.5 gram of lysergic aciddiethylamide, is on hand at the time ofinventory, that substance need not beincluded in the inventory. Laboratoriesof the Administration may possess upto 150 grams of any hallucinogenic sub-stance in Schedule I without regard toa need for an inventory of those sub-stances. No inventory is required ofknown or suspected controlled sub-stances received as evidentiary mate-rials for analysis.

[62 FR 13959, Mar. 24, 1997]

CONTINUING RECORDS

§ 1304.21 General requirements forcontinuing records.

(a) Every registrant required to keeprecords pursuant to § 1304.03 shall main-tain on a current basis a complete andaccurate record of each such substancemanufactured, imported, received,sold, delivered, exported, or otherwisedisposed of by him/her, except that noregistrant shall be required to main-tain a perpetual inventory.

(b) Separate records shall be main-tained by a registrant for each reg-istered location except as provided in§ 1304.04 (a). In the event controlledsubstances are in the possession orunder the control of a registrant at alocation for which he is not registered,the substances shall be included in therecords of the registered location towhich they are subject to control or towhich the person possessing the sub-stance is responsible.

(c) Separate records shall be main-tained by a registrant for each inde-pendent activity for which he/she isregistered, except as provided in§ 1304.22(d).

(d) In recording dates of receipt, im-portation, distribution, exportation, orother transfers, the date on which thecontrolled substances are actually re-ceived, imported, distributed, exported,or otherwise transferred shall be usedas the date of receipt or distribution of

any documents of transfer (e.g., in-voices or packing slips).

[36 FR 7792, Apr. 24, 1971, as amended at 36FR 13386, July 21, 1971. Redesignated at 38 FR26609, Sept. 24, 1973, as amended at 62 FR13960, Mar. 24, 1997]

§ 1304.22 Records for manufacturers,distributors, dispensers, research-ers, importers and exporters.

Each person registered or authorized(by § 1301.13(e) or §§ 1307.11–1307.13 ofthis chapter) to manufacture, dis-tribute, dispense, import, export orconduct research with controlled sub-stances shall maintain records with theinformation listed below.

(a) Records for manufacturers. Eachperson registered or authorized to man-ufacture controlled substances shallmaintain records with the following in-formation:

(1) For each controlled substance inbulk form to be used in, or capable ofuse in, or being used in, the manufac-ture of the same or other controlled ornoncontrolled substances in finishedform,

(i) The name of the substance;(ii) The quantity manufactured in

bulk form by the registrant, includingthe date, quantity and batch or otheridentifying number of each batch man-ufactured;

(iii) The quantity received fromother persons, including the date andquantity of each receipt and the name,address, and registration number of theother person from whom the substancewas received;

(iv) The quantity imported directlyby the registrant (under a registrationas an importer) for use in manufactureby him/her, including the date, quan-tity, and import permit or declarationnumber for each importation;

(v) The quantity used to manufacturethe same substance in finished form,including:

(A) The date and batch or other iden-tifying number of each manufacture;

(B) The quantity used in the manu-facture;

(C) The finished form (e.g., 10-milli-gram tablets or 10-milligram con-centration per fluid ounce or milli-liter);

(D) The number of units of finishedform manufactured;


58

21 CFR Ch. II (4–1–01 Edition)§ 1304.22

(E) The quantity used in quality con-trol;

(F) The quantity lost during manu-facturing and the causes therefore, ifknown;

(G) The total quantity of the sub-stance contained in the finished form;

(H) The theoretical and actual yields;and

(I) Such other information as is nec-essary to account for all controlledsubstances used in the manufacturingprocess;

(vi) The quantity used to manufac-ture other controlled and noncon-trolled substances, including the nameof each substance manufactured andthe information required in paragraph(a)(1)(v) of this section;

(vii) The quantity distributed in bulkform to other persons, including thedate and quantity of each distributionand the name, address, and registrationnumber of each person to whom a dis-tribution was made;

(viii) The quantity exported directlyby the registrant (under a registrationas an exporter), including the date,quantity, and export permit or declara-tion number of each exportation;

(ix) The quantity distributed or dis-posed of in any other manner by theregistrant (e.g., by distribution of com-plimentary samples or by destruction),including the date and manner of dis-tribution or disposal, the name, ad-dress, and registration number of theperson to whom distributed, and thequantity distributed or disposed; and

(x) The originals of all written cer-tifications of available procurementquotas submitted by other persons (asrequired by § 1303.12(f) of this chapter)relating to each order requiring thedistribution of a basic class of con-trolled substance listed in Schedule Ior II.

(2) For each controlled substance infinished form,

(i) The name of the substance;(ii) Each finished form (e.g., 10-milli-

gram tablet or 10-milligram concentra-tion per fluid ounce or milliliter) andthe number of units or volume of fin-ished form in each commercial con-tainer (e.g., 100-tablet bottle or 3-milli-liter vial);

(iii) The number of containers ofeach such commercial finished form

manufactured from bulk form by theregistrant, including the informationrequired pursuant to paragraph(a)(1)(v) of this section;

(iv) The number of units of finishedforms and/or commercial containersacquired from other persons, includingthe date of and number of units and/orcommercial containers in each acquisi-tion to inventory and the name, ad-dress, and registration number of theperson from whom the units were ac-quired;

(v) The number of units of finishedforms and/or commercial containersimported directly by the person (undera registration or authorization to im-port), including the date of, the num-ber of units and/or commercial con-tainers in, and the import permit ordeclaration number for, each importa-tion;

(vi) The number of units and/or com-mercial containers manufactured bythe registrant from units in finishedform received from others or imported,including:

(A) The date and batch or other iden-tifying number of each manufacture;

(B) The operation performed (e.g., re-packaging or relabeling);

(C) The number of units of finishedform used in the manufacture, thenumber manufactured and the numberlost during manufacture, with thecauses for such losses, if known; and

(D) Such other information as is nec-essary to account for all controlledsubstances used in the manufacturingprocess;

(vii) The number of commercial con-tainers distributed to other persons, in-cluding the date of and number of con-tainers in each reduction from inven-tory, and the name, address, and reg-istration number of the person towhom the containers were distributed;(viii) The number of commercial con-tainers exported directly by the reg-istrant (under a registration as an ex-porter), including the date, number ofcontainers and export permit or dec-laration number for each exportation;and

(ix) The number of units of finishedforms and/or commercial containersdistributed or disposed of in any othermanner by the registrant (e.g., by dis-tribution of complimentary samples or


59


by destruction), including the date andmanner of distribution or disposal, thename, address, and registration num-ber of the person to whom distributed,and the quantity in finished form dis-tributed or disposed.

(b) Records for distributors. Each per-son registered or authorized to dis-tribute controlled substances shallmaintain records with the same infor-mation required of manufacturers pur-suant to paragraphs (a)(2) (i), (ii), (iv),(v), (vii), (viii) and (ix) of this section.

(c) Records for dispensers and research-ers. Each person registered or author-ized to dispense or conduct researchwith controlled substances shall main-tain records with the same informationrequired of manufacturers pursuant toparagraph (a)(2) (i), (ii), (iv), (vii), and(ix) of this section. In addition, recordsshall be maintained of the number ofunits or volume of such finished formdispensed, including the name and ad-dress of the person to whom it was dis-pensed, the date of dispensing, thenumber of units or volume dispensed,and the written or typewritten name orinitials of the individual who dispensedor administered the substance on be-half of the dispenser.

(d) Records for importers and exporters.Each person registered or authorized toimport or export controlled substancesshall maintain records with the sameinformation required of manufacturerspursuant to paragraphs (a)(2) (i), (iv),(v) and (vii) of this section. In addition,the quantity disposed of in any othermanner by the registrant (except quan-tities used in manufacturing by an im-porter under a registration as a manu-facturer), which quantities are to be re-corded pursuant to paragraphs (a)(1)(iv) and (v) of this section; and thequantity (or number of units or volumein finished form) exported, includingthe date, quantity (or number of unitsor volume), and the export permit ordeclaration number for each expor-tation, but excluding all quantities(and number of units and volumes)manufactured by an exporter under aregistration as a manufacturer, whichquantities (and numbers of units andvolumes) are to be recorded pursuantto paragraphs (a)(1)(xiii) or (a)(2)(xiii)of this section.

[62 FR 13960, Mar. 24, 1997]

§ 1304.23 Records for chemical ana-lysts.

(a) Each person registered or author-ized (by § 1301.22(b) of this chapter) toconduct chemical analysis with con-trolled substances shall maintainrecords with the following information(to the extent known and reasonablyascertainable by him) for each con-trolled substance:

(1) The name of the substance;(2) The form or forms in which the

substance is received, imported, ormanufactured by the registrant (e.g.,powder, granulation, tablet, capsule, orsolution) and the concentration of thesubstance in such form (e.g., C.P.,U.S.P., N.F., 10-milligram tablet or 10-milligram concentration per milli-liter);

(3) The total number of the forms re-ceived, imported or manufactured (e.g.,100 tablets, thirty 1-milliliter vials, or10 grams of powder), including the dateand quantity of each receipt, importa-tion, or manufacture and the name, ad-dress, and registration number, if any,of the person from whom the substancewas received;

(4) The quantity distributed, ex-ported, or destroyed in any manner bythe registrant (except quantities usedin chemical analysis or other labora-tory work), including the date andmanner of distribution, exportation, ordestruction, and the name, address,and registration number, if any, ofeach person to whom the substance wasdistributed or exported.

(b) Records of controlled substancesused in chemical analysis or other lab-oratory work are not required.

(c) Records relating to known or sus-pected controlled substances receivedas evidentiary material for analysis arenot required under paragraph (a) ofthis section.

[36 FR 7793, Apr. 24, 1971, as amended at 36FR 13386, July 21, 1971; 36 FR 18732, Sept. 21,1971. Redesignated at 38 FR 26609, Sept. 24,1973, and further redesignated at 62 FR 13961,Mar. 24, 1997]

§ 1304.24 Records for maintenancetreatment programs and detoxifica-tion treatment programs.

(a) Each person registered or author-ized (by § 1301.22 of this chapter) tomaintain and/or detoxify controlled


60

21 CFR Ch. II (4–1–01 Edition)§ 1304.25

substance users in a narcotic treat-ment program shall maintain recordswith the following information for eachnarcotic controlled substance:

(1) Name of substance;(2) Strength of substance;(3) Dosage form;(4) Date dispensed;(5) Adequate identification of patient

(consumer);(6) Amount consumed;(7) Amount and dosage form taken

home by patient; and(8) Dispenser’s initials.(b) The records required by paragraph

(a) of this section will be maintained ina dispensing log at the narcotic treat-ment program site and will be main-tained in compliance with § 1304.22without reference to § 1304.03.

(c) All sites which compound a bulknarcotic solution from bulk narcoticpowder to liquid for on-site use mustkeep a separate batch record of thecompounding.

(d) Records of identity, diagnosis,prognosis, or treatment of any patientswhich are maintained in connectionwith the performance of a narcotictreatment program shall be confiden-tial, except that such records may bedisclosed for purposes and under thecircumstances authorized by part 310and 42 CFR part 2.

[39 FR 37985, Oct. 25, 1974. Redesignated andamended at 62 FR 13961, Mar. 24, 1997]

§ 1304.25 Records for treatment pro-grams which compound narcoticsfor treatment programs and otherlocations.

Each person registered or authorizedby § 1301.22 of this chapter to compoundnarcotic drugs for off-site use in a nar-cotic treatment program shall main-tain records which include the fol-lowing information for each narcoticdrug:

(a) For each narcotic controlled sub-stance in bulk form to be used in, orcapable of use in, or being used in, thecompounding of the same or other non-controlled substances in finished form:

(1) The name of the substance;(2) The quantity compounded in bulk

form by the registrant, including thedate, quantity and batch or other iden-tifying number of each batch com-pounded;

(3) The quantity received from otherpersons, including the date and quan-tity of each receipt and the name, ad-dress and registration number of theother person from whom the substancewas received;

(4) The quantity imported directly bythe registrant (under a registration asan importer) for use in compounding byhim, including the date, quantity andimport permit or declaration numberof each importation;

(5) The quantity used to compoundthe same substance in finished form,including:

(i) The date and batch or other iden-tifying number of each compounding;

(ii) The quantity used in the com-pound;

(iii) The finished form (e.g., 10-milli-gram tablets or 10-milligram con-centration per fluid ounce or milliliter;

(iv) The number of units of finishedform compounded;

(v) The quantity used in quality con-trol;

(vi) The quantity lost duringcompounding and the causes therefore,if known;

(vii) The total quantity of the sub-stance contained in the finished form;

(viii) The theoretical and actualyields; and

(ix) Such other information as is nec-essary to account for all controlledsubstances used in the compoundingprocess;

(6) The quantity used to manufactureother controlled and non-controlledsubstances; including the name of eachsubstance manufactured and the infor-mation required in paragraph (a)(5) ofthis section;

(7) The quantity distributed in bulkform to other programs, including thedate and quantity of each distributionand the name, address and registrationnumber of each program to whom a dis-tribution was made;

(8) The quantity exported directly bythe registrant (under a registration asan exporter), including the date, quan-tity, and export permit or declarationnumber of each exploration; and

(9) The quantity disposed of by de-struction, including the reason, dateand manner of destruction. All otherdestruction of narcotic controlled sub-stances will comply with § 1307.22.


61


(b) For each narcotic controlled sub-stance in finished form:

(1) The name of the substance;(2) Each finished form (e.g., 10-milli-

gram tablet or 10 milligram concentra-tion per fluid ounce or milliliter) andthe number of units or volume or fin-ished form in each commercial con-tainer (e.g., 100-tablet bottle or 3-milli-liter vial);

(3) The number of containers of eachsuch commercial finished form com-pounded from bulk form by the reg-istrant, including the information re-quired pursuant to paragraph (a)(5) ofthis section;

(4) The number of units of finishedforms and/or commercial containers re-ceived from other persons, includingthe date of and number of units and/orcommercial containers in each receiptand the name, address and registrationnumber of the person from whom theunits were received;

(5) The number of units of finishedforms and/or commercial containersimported directly by the person (undera registration or authorization to im-port), including the date of, the num-ber of units and/or commercial con-tainers in, and the import permit ordeclaration number for, each importa-tion;

(6) The number of units and/or com-mercial containers compounded by theregistrant from units in finished formreceived from others or imported, in-cluding:

(i) The date and batch or other iden-tifying number of each compounding;

(ii) The operation performed (e.g., re-packaging or relabeling);

(iii) The number of units of finishedform used in the compound, the num-ber compounded and the number lostduring compounding, with the causesfor such losses, if known; and

(iv) Such other information as is nec-essary to account for all controlledsubstances used in the compoundingprocess;

(7) The number of containers distrib-uted to other programs, including thedate, the number of containers in eachdistribution, and the name, address andregistration number of the program towhom the containers were distributed;

(8) The number of commercial con-tainers exported directly by the reg-

istrant (under a registration as an ex-porter), including the date, number ofcontainers and export permit or dec-laration number for each exportation;and

(9) The number of units of finishedforms and/or commercial containersdestroyed in any manner by the reg-istrant, including the reason, the dateand manner of destruction. All otherdestruction of narcotic controlled sub-stances will comply with § 1307.22.

[39 FR 37985, Oct. 25, 1974. Redesignated at 62FR 13961, Mar. 24, 1997]

REPORTS

§ 1304.31 Reports from manufacturersimporting narcotic raw material.

(a) Every manufacturer which im-ports or manufactures from narcoticraw material (opium, poppy straw, andconcentrate of poppy straw) shall sub-mit information which accounts for theimportation and for all manufacturingoperations performed between importa-tion and the production in bulk or fin-ished marketable products, standard-ized in accordance with the U.S. Phar-macopeia, National Formulary or otherrecognized medical standards. Reportsshall be signed by the authorized offi-cial and submitted quarterly on com-pany letterhead to the Drug Enforce-ment Administration, Drug and Chem-ical Evaluation Section, Washington,D.C. 20537, on or before the 15th day ofthe month immediately following theperiod for which it is submitted.

(b) The following information shallbe submitted for each type of narcoticraw material (quantities are expressedas grams of anhydrous morphine alka-loid):

(1) Beginning inventory;(2) Gains on reweighing;(3) Imports;(4) Other receipts;(5) Quantity put into process;(6) Losses on reweighing;(7) Other dispositions and(8) Ending inventory.(c) The following information shall

be submitted for each narcotic raw ma-terial derivative including morphine,codeine, thebaine, oxycodone,hydrocodone, medicinal opium, manu-facturing opium, crude alkaloids and


62

21 CFR Ch. II (4–1–01 Edition)§ 1304.32

other derivatives (quantities are ex-pressed as grams of anhydrous base oranhydrous morphine alkaloid for man-ufacturing opium and medicinalopium):

(1) Beginning inventory;(2) Gains on reweighing;(3) Quantity extracted from narcotic

raw material;(4) Quantity produced/manufactured/

synthesized;(5) Quantity sold;(6) Quantity returned to conversion

processes for reworking;(7) Quantity used for conversion;(8) Quantity placed in process;(9) Other dispositions;(10) Losses on reweighing and(11) Ending inventory.(d) The following information shall

be submitted for importation of eachnarcotic raw material:

(1) Import permit number;(2) Date shipment arrived at the

United States port of entry;(3) Actual quantity shipped;(4) Assay (percent) of morphine, co-

deine and thebaine and(5) Quantity shipped, expressed as an-

hydrous morphine alkaloid.(e) Upon importation of crude opium,

samples will be selected and assaysmade by the importing manufacturerin the manner and according to themethod specified in the U.S. Pharma-copoeia. Where final assay data is notdetermined at the time of rendering re-port, the report shall be made on thebasis of the best data available, subjectto adjustment, and the necessary ad-justing entries shall be made on thenext report.

(f) Where factory procedure is suchthat partial withdrawals of opium aremade from individual containers, thereshall be attached to each container astock record card on which shall bekept a complete record of all with-drawals therefrom.

(g) All in-process inventories shouldbe expressed in terms of end-productsand not precursors. Once precursor ma-terial has been changed or placed intoprocess for the manufacture of a speci-fied end-product, it must no longer beaccounted for as precursor stocksavailable for conversion or use, but

rather as end-product in-process inven-tories.

[62 FR 13961, Mar. 24, 1997]

§ 1304.32 Reports of manufacturers im-porting coca leaves.

(a) Every manufacturer importing ormanufacturing from raw coca leavesshall submit information accountingfor the importation and for all manu-facturing operations performed be-tween the importation and the manu-facture of bulk or finished productsstandardized in accordance with U.S.Pharmacopoeia, National Formulary,or other recognized standards. The re-ports shall be submitted quarterly oncompany letterhead to the Drug En-forcement Administration, Drug andChemical Evaluation Section, Wash-ington, DC 20537, on or before the 15thday of the month immediately fol-lowing the period for which it is sub-mitted.

(b) The following information shallbe submitted for raw coca leaf, ecgo-nine, ecgonine for conversion or fur-ther manufacture, benzoylecgonine,manufacturing coca extracts (list fortinctures and extracts; and others sep-arately), other crude alkaloids andother derivatives (quantities should bereported as grams of actual quantityinvolved and the cocaine alkaloid con-tent or equivalency):

(1) Beginning inventory;(2) Imports;(3) Gains on reweighing;(4) Quantity purchased;(5) Quantity produced;(6) Other receipts;(7) Quantity returned to processes for

reworking;(8) Material used in purification for

sale;(9) Material used for manufacture or

production;(10) Losses on reweighing;(11) Material used for conversion;(12) Other dispositions and(13) Ending inventory.(c) The following information shall

be submitted for importation of cocaleaves:

(1) Import permit number;(2) Date the shipment arrived at the

United States port of entry;(3) Actual quantity shipped;


63


(4) Assay (percent) of cocaine alka-loid and

(5) Total cocaine alkaloid content.(d) Upon importation of coca leaves,

samples will be selected and assaysmade by the importing manufacturerin accordance with recognized chem-ical procedures. These assays shallform the basis of accounting for suchcoca leaves, which shall be accountedfor in terms of their cocaine alkaloidcontent or equivalency or their totalanhydrous coca alkaloid content.Where final assay data is not deter-mined at the time of submission, thereport shall be made on the basis of thebest data available, subject to adjust-ment, and the necessary adjusting en-tries shall be made on the next report.

(e) Where factory procedure is suchthat partial withdrawals of medicinalcoca leaves are made from individualcontainers, there shall be attached tothe container a stock record card onwhich shall be kept a complete recordof withdrawals therefrom.

(f) All in-process inventories shouldbe expressed in terms of end-productsand not precursors. Once precursor ma-terial has been changed or placed intoprocess for the manufacture of a speci-fied end-product, it must no longer beaccounted for as precursor stocksavailable for conversion or use, butrather as end-product in-process inven-tories.

[62 FR 13962, Mar. 24, 1997]

§ 1304.33 Reports to ARCOS.(a) Reports generally. All reports re-

quired by this section shall be filedwith the ARCOS Unit, PO 28293, Cen-tral Station, Washington, DC 20005 onDEA Form 333, or on media which con-tains the data required by DEA Form333 and which is acceptable to theARCOS Unit.

(b) Frequency of reports. Acquisition/Distribution transaction reports shallbe filed every quarter not later thanthe 15th day of the month succeedingthe quarter for which it is submitted;except that a registrant may be givenpermission to file more frequently (butnot more frequently than monthly), de-pending on the number of transactionsbeing reported each time by that reg-istrant. Inventories shall provide dataon the stocks of each reported con-

trolled substance on hand as of theclose of business on December 31 ofeach year, indicating whether the sub-stance is in storage or in process ofmanufacturing. These reports shall befiled not later than January 15 of thefollowing year. Manufacturing trans-action reports shall be filed annuallyfor each calendar year not later thanJanuary 15 of the following year, ex-cept that a registrant may be givenpermission to file more frequently (butnot more frequently than quarterly).

(c) Persons reporting. For controlledsubstances in Schedules I, II or nar-cotic controlled substances in ScheduleIII, each person who is registered tomanufacture in bulk or dosage form, orto package, repackage, label or relabel,and each person who is registered todistribute shall report acquisition/dis-tribution transactions. In addition toreporting acquisition/distributiontransactions, each person who is reg-istered to manufacture controlled sub-stances in bulk or dosage form shall re-port manufacturing transactions oncontrolled substances in Schedules Iand II, each narcotic controlled sub-stance listed in Schedules III, IV, andV, and on each psychotropic controlledsubstance listed in Schedules III and IVas identified in paragraph (d) of thissection.

(d) Substances covered. (1) Manufac-turing and acquisition/distributiontransaction reports shall include dataon each controlled substance listed inSchedules I and II and on each narcoticcontrolled substance listed in ScheduleIII (but not on any material, com-pound, mixture or preparation con-taining a quantity of a substance hav-ing a stimulant effect on the centralnervous system, which material, com-pound, mixture or preparation is listedin Schedule III or on any narcotic con-trolled substance listed in Schedule V).Additionally, reports on manufacturingtransactions shall include the fol-lowing psychotropic controlled sub-stances listed in Schedules III and IV:

(i) Schedule III(A) Benzphetamine;(B) Cyclobarbital;(C) Methyprylon; and(D) Phendimetrazine.(ii) Schedule IV(A) Barbital;


64


(B) Diethylpropion (Amfepramone);(C) Ethchlorvynol;(D) Ethinamate;(E) Lefetamine (SPA);(F) Mazindol;(G) Meprobamate;(H) Methylphenobarbital;(I) Phenobarbital;(J) Phentermine; and(K) Pipradrol.(2) Data shall be presented in such a

manner as to identify the particularform, strength, and trade name, if any,of the product containing the con-trolled substance for which the reportis being made. For this purpose, per-sons filing reports shall utilize the Na-tional Drug Code Number assigned tothe product under the National DrugCode System of the Food and Drug Ad-ministration.

(e) Transactions reported. Acquisition/distribution transaction reports shallprovide data on each acquisition to in-ventory (identifying whether it is, e.g.,by purchase or transfer, return from acustomer, or supply by the FederalGovernment) and each reduction frominventory (identifying whether it is,e.g., by sale or transfer, theft, destruc-tion or seizure by Government agen-cies). Manufacturing reports shall pro-vide data on material manufactured,manufacture from other material, usein manufacturing other material anduse in producing dosage forms.

(f) Exceptions. A registered institu-tional practitioner who repackages orrelabels exclusively for distribution orwho distributes exclusively to (for dis-pensing by) agents, employees, or af-filiated institutional practitioners ofthe registrant may be exempted fromfiling reports under this section by ap-plying to the ARCOS Unit of the Ad-ministration.

(Approved by the Office of Management andBudget under control number 1117–0003)

[62 FR 13962, Mar. 24, 1997]

PART 1305—ORDER FORMS

Sec.1305.01 Scope of part 1305.1305.02 Definitions.1305.03 Distributions requiring order forms.1305.04 Persons entitled to obtain and exe-

cute order forms.1305.05 Procedure for obtaining order forms.

1305.06 Procedure for executing order forms.1305.07 Power of attorney.1305.08 Persons entitled to fill order forms.1305.09 Procedure for filling order forms.1305.10 Procedure for endorsing order forms.1305.11 Unaccepted and defective order

forms.1305.12 Lost and stolen order forms.1305.13 Preservation of order forms.1305.14 Return of unused order forms.1305.15 Cancellation and voiding of order

forms.1305.16 Special procedure for filling certain

order forms.

AUTHORITY: 21 U.S.C. 821, 828, 871(b), unlessotherwise noted.


§ 1305.01 Scope of part 1305.Procedures governing the issuance,

use, and preservation of order formspursuant to section 1308 of the Act (21U.S.C. 828) are set forth generally bythat section and specifically by thesections of this part.



[62 FR 13963, Mar. 24, 1997]

§ 1305.03 Distributions requiring orderforms.

An order form (DEA Form 222) is re-quired for each distribution of a Sched-ule I or II controlled substance exceptto persons exempted from registrationunder part 1301 of this chapter; whichare exported from the United States inconformity with the Act; or for deliv-ery to a registered analytical labora-tory, or its agent approved by DEA.

[62 FR 13963, Mar. 24, 1997]

§ 1305.04 Persons entitled to obtainand execute order forms.

(a) Order forms may be obtained onlyby persons who are registered undersection 303 of the Act (21 U.S.C. 823) tohandle controlled substances listed inSchedules I and II, and by persons whoare registered under section 1008 of theAct (21 U.S.C. 958) to export such sub-stances. Persons not registered to han-dle controlled substances listed in


65


Schedule I or II and persons registeredonly to import controlled substanceslisted in any schedule are not entitledto obtain order forms.

(b) An order form may be executedonly on behalf of the registrant namedthereon and only if his/her registrationas to the substances being purchasedhas not expired or been revoked or sus-pended.


§ 1305.05 Procedure for obtainingorder forms.

(a) Order Forms are issued in mailingenvelopes containing either seven orfourteen forms, each form containingan original duplicate and triplicatecopy (respectively, Copy 1, Copy 2, andCopy 3). A limit, which is based on thebusiness activity of the registrant, willbe imposed on the number of orderforms which will be furnished on anyrequisition unless additional forms arespecifically requested and a reasonableneed for such additional forms isshown.

(b) Any person applying for a reg-istration which would entitle him/herto obtain order forms may requisitionsuch forms by so indicating on the ap-plication form; order forms will be sup-plied upon the registration of the appli-cant. Any person holding a registrationentitling him/her to obtain order formsmay requisition such forms for thefirst time by contacting any DivisionOffice or the Registration Unit of theAdministration. Any person alreadyholding order forms may requisitionadditional forms on DEA Form 222awhich is mailed to a registrant ap-proximately 30 days after each ship-ment of order forms to that registrantor by contacting any Division Office orthe Registration Unit of the Adminis-tration. All requisition forms (DEAForm 222a) shall be submitted to theRegistration Unit, Drug EnforcementAdministration, Department of Jus-tice, Post Office Box 28083, Central Sta-tion, Washington, DC 20005.

(c) Each requisition shall show thename, address, and registration num-ber of the registrant and the number ofbooks of order forms desired. Each req-uisition shall be signed and dated by

the same person who signed the mostrecent application for registration orfor reregistration, or by any person au-thorized to obtain and execute orderforms by a power of attorney pursuantto § 1305.07.

(d) Order forms will be serially num-bered and issued with the name, ad-dress and registration number of theregistrant, the authorized activity andschedules of the registrant. This infor-mation cannot be altered or changedby the registrant; any errors must becorrected by the Registration Unit ofthe Administration by returning theforms with notification of the error.

[36 FR 7796, Apr. 24, 1971, as amended at 36FR 18732, Sept. 21, 1971. Redesignated at 38FR 26609, Sept. 24, 1973, and amended at 51FR 5319, Feb. 13, 1986; 53 FR 4963, Feb. 19,1988; 62 FR 13964, Mar. 24, 1997]

§ 1305.06 Procedure for executingorder forms.

(a) Order forms shall be prepared andexecuted by the purchaser simulta-neously in triplicate by means ofinterleaved carbon sheets which arepart of the DEA Form 222. Order formsshall be prepared by use of a type-writer, pen, or indelible pencil.

(b) Only one item shall be entered oneach numbered line. An item shall con-sist of one or more commercial or bulkcontainers of the same finished or bulkform and quantity of the same sub-stance. The number of lines completedshall be noted on that form at the bot-tom of the form, in the space provided.Order forms for carfentanil, etorphinehydrochloride, and diprenorphine shallcontain only these substances.

(c) The name and address of the sup-plier from whom the controlled sub-stances are being ordered shall be en-tered on the form. Only one suppliermay be listed on any form.

(d) Each order form shall be signedand dated by a person authorized tosign an application for registration.The name of the purchaser, if differentfrom the individual signing the orderform, shall also be inserted in the sig-nature space. Unexecuted order formsmay be kept and may be executed at alocation other than the registered loca-tion printed on the form, provided thatall unexecuted forms are deliveredpromptly to the registered location


66

21 CFR Ch. II (4–1–01 Edition)§ 1305.07

upon an inspection of such location byany officer authorized to make inspec-tions, or to enforce, any Federal, State,or local law regarding controlled sub-stances.

[62 FR 13963, Mar. 24, 1997]

§ 1305.07 Power of attorney.Any purchaser may authorize one or

more individuals, whether or not lo-cated at the registered location of thepurchaser, to obtain and execute orderforms on his/her behalf by executing apower of attorney for each such indi-vidual. The power of attorney shall besigned by the same person who signedthe most recent application for reg-istration or reregistration and by theindividual being authorized to obtainand execute order forms. The power ofattorney shall be filed with the exe-cuted order forms of the purchaser, andshall be retained for the same period asany order form bearing the signature ofthe attorney. The power of attorneyshall be available for inspection to-gether with other order form records.Any power of attorney may be revokedat any time by executing a notice ofrevocation, signed by the person whosigned (or was authorized to sign) thepower of attorney or by a successor,whoever signed the most recent appli-cation for registration or reregistra-tion, and filing it with the power of at-torney being revoked. The form for thepower of attorney and notice of revoca-tion shall be similar to the following:

Power of Attorney for DEA Order Forms

lllll (Name of registrant)lllll (Address of registrant)lllll (DEA registration number)

I, lllll (name of person grantingpower), the undersigned, who is authorizedto sign the current application for registra-tion of the above-named registrant under theControlled Substances Act or ControlledSubstances Import and Export Act, havemade, constituted, and appointed, and bythese presents, do make, constitute, and ap-point lllll (name of attorney-in-fact),my true and lawful attorney for me in myname, place, and stead, to execute applica-tions for books of official order forms and tosign such order forms in requisition forSchedule I and II controlled substances, inaccordance with section 308 of the ControlledSubstances Act (21 U.S.C. 828) and part 1305of Title 21 of the Code of Federal Regula-tions. I hereby ratify and confirm all that

said attorney shall lawfully do or cause to bedone by virtue hereof.


(Signature of person granting power)

I, lllll (name of attorney-in-fact),hereby affirm that I am the person namedherein as attorney-in-fact and that the sig-nature affixed hereto is my signature.


(Signature of attorney-in-fact)

Witnesses:1. lllll.2. lllll.Signed and dated on the lll day of

lllll, (year), at lllll.

Notice of Revocation

The foregoing power of attorney is herebyrevoked by the undersigned, who is author-ized to sign the current application for reg-istration of the above-named registrantunder the Controlled Substances Act of theControlled Substances Import and ExportAct. Written notice of this revocation hasbeen given to the attorney-in-fact lllll

this same day.


(Signature of person revoking power)Witnesses:1. lllll.2. lllll.Signed and dated on the lll day of

lllll, (year), at lllll.

[62 FR 13963, Mar. 24, 1997]

§ 1305.08 Persons entitled to fill orderforms.

An order form may be filled only bya person registered as a manufactureror distributor of controlled substanceslisted in Schedule I or II under section303 of the Act (21 U.S.C. 823) or as animporter of such substances under sec-tion 1008 of the Act (21 U.S.C. 958), ex-cept for the following:

(a) A person registered to dispensesuch substances under section 303 ofthe Act, or to export such substancesunder section 1008 of the Act, if he/sheis discontinuing business or if his/herregistration is expiring without rereg-istration, may dispose of any con-trolled substances listed in Schedule Ior II in his/her possession pursuant toorder forms in accordance with § 1307.14of this chapter;

(b) A person who has obtained anycontrolled substance in Schedule I or II


67


by order form may return such sub-stance, or portion thereof, to the per-son from whom he obtained the sub-stance or the manufacturer of the sub-stance pursuant to the order form ofthe latter person;

(c) A person registered to dispensesuch substances may distribute suchsubstances to another dispenser pursu-ant to, and only in the circumstancesdescribed in, § 1307.11 of this chapter;and

(d) A person registered or authorizedto conduct chemical analysis or re-search with controlled substances maydistribute a controlled substance listedin Schedule I or II to another personregistered or authorized to conductchemical analysis, instructional activi-ties, or research with such substancespursuant to the order form of the lat-ter person, if such distribution is forthe purpose of furthering such chem-ical analysis, instructional activities,or research.

(e) A person registered as acompounder of narcotic substances foruse at off-site locations in conjunctionwith a narcotic treatment program atthe compounding location, who is au-thorized to handle Schedule II nar-cotics, is authorized to fill order formsfor distribution of narcotic drugs tooff-site narcotic treatment programsonly.

[36 FR 7796, Apr. 24, 1971, as amended at 36FR 13386, July 21, 1971; 36 FR 18732, Sept. 21,1971; 37 FR 15921, Aug. 8, 1972. Redesignatedat 38 FR 26609, Sept. 24, 1973]


§ 1305.09 Procedure for filling orderforms.

(a) The purchaser shall submit Copy 1and Copy 2 of the order form to thesupplier, and retain Copy 3 in his ownfiles.

(b) The supplier shall fill the order, ifpossible and if he/she desires to do so,and record on Copies 1 and 2 the num-ber of commercial or bulk containersfurnished on each item and the date onwhich such containers are shipped tothe purchaser. If an order cannot befilled in its entirety, it may be filled in

part and the balance supplied by addi-tional shipments within 60 days fol-lowing the date of the order form. Noorder form shall be valid more than 60days after its execution by the pur-chaser, except as specified in paragraph(f) of this section.

(c) The controlled substances shallonly be shipped to the purchaser and atthe location printed by the Adminis-tration on the order form, except asspecified in paragraph (f) of this sec-tion.

(d) The supplier shall retain Copy 1 ofthe order form for his/her own files andforward Copy 2 to the Special Agent inCharge of the Drug Enforcement Ad-ministration in the area in which thesupplier is located. Copy 2 shall be for-warded at the close of the month dur-ing which the order is filled; if an orderis filled by partial shipments, Copy 2shall be forwarded at the close of themonth during which the final shipmentis made or during which the 60-day va-lidity period expires.

(e) The purchaser shall record onCopy 3 of the order form the number ofcommercial or bulk containers fur-nished on each item and the dates onwhich such containers are received bythe purchaser.

(f) Order forms submitted by reg-istered procurement officers of the De-fense Personnel Support Center of De-fense Supply Agency for delivery toarmed services establishments withinthe United States may be shipped to lo-cations other than the location printedon the order form, and in partial ship-ments at different times not to exceedsix months from the date of the order,as designated by the procurement offi-cer when submitting the order.

[36 FR 7796, Apr. 24, 1971, as amended at 36FR 18732, Sept. 21, 1971. Redesignated at 38FR 26609, Sept. 24, 1973, and amended at 47FR 41735, Sept. 22, 1982; 62 FR 13964, Mar. 24,1997]

§ 1305.10 Procedure for endorsingorder forms.

(a) An order form made out to anysupplier who cannot fill all or a part ofthe order within the time limitationset forth in § 1305.09 may be endorsed toanother supplier for filling. The en-dorsement shall be made only by thesupplier to whom the order form was


68

21 CFR Ch. II (4–1–01 Edition)§ 1305.11

first made, shall state (in the spacesprovided on the reverse sides of Copies1 and 2 of the order form) the name andaddress of the second supplier, andshall be signed by a person authorizedto obtain and execute order forms onbehalf of the first supplier. The firstsupplier may not fill any part of anorder on an endorsed form. The secondsupplier shall fill the order, if possibleand if he/she desires to do so, in accord-ance with § 1305.09 (b), (c), and (d), in-cluding shipping all substances di-rectly to the purchaser.

(b) Distributions made on endorsedorder forms shall be reported by thesecond supplier in the same manner asall other distributions except thatwhere the name of the supplier is re-quested on the reporting form, the sec-ond supplier shall record the name, ad-dress and registration number of thefirst supplier.


§ 1305.11 Unaccepted and defectiveorder forms.

(a) No order form shall be filled if it:(1) Is not complete, legible, or prop-

erly prepared, executed, or endorsed; or(2) Shows any alteration, erasure, or

change of any description.(b) If an order form cannot be filled

for any reason under this section, thesupplier shall return Copies 1 and 2 tothe purchaser with a statement as tothe reason (e.g., illegible or altered). Asupplier may for any reason refuse toaccept any order and if a supplier re-fuses to accept the order, a statementthat the order is not accepted shall besufficient for purposes of this para-graph.

(c) When received by the purchaser,Copies 1 and 2 of the order form and thestatement shall be attached to Copy 3and retained in the files of the pur-chaser in accordance with § 1305.13. Adefective order form may not be cor-rected; it must be replaced by a neworder form in order for the order to befilled.

§ 1305.12 Lost and stolen order forms.(a) If a purchaser ascertains that an

unfilled order form has been lost, heshall execute another in triplicate and

a statement containing the serial num-ber and date of the lost form, and stat-ing that the goods covered by the firstorder form were not received throughloss of that order form. Copy 3 of thesecond form and a copy of the state-ment shall be retained with Copy 3 ofthe order form first executed. A copy ofthe statement shall be attached to Cop-ies 1 and 2 of the second order formsent to the supplier. If the first orderform is subsequently received by thesupplier to whom it was directed, thesupplier shall mark upon the facethereof ‘‘Not accepted’’ and return Cop-ies 1 and 2 to the purchaser, who shallattach it to Copy 3 and the statement.

(b) Whenever any used or unusedorder forms are stolen or lost (other-wise than in the course of trans-mission) by any purchaser or supplier,he/she shall immediately upon dis-covery of such theft or loss, report thesame to the Special Agent in Charge ofthe Drug Enforcement Administrationin the Divisional Office responsible forthe area in which the registrant is lo-cated, stating the serial number ofeach form stolen or lost. If the theft orloss includes any original order formsreceived from purchasers and the sup-plier is unable to state the serial num-bers of such order forms, he/she shallreport the date or approximate date ofreceipt thereof and the names and ad-dresses of the purchasers. If an entirebook of order forms is lost or stolen,and the purchaser is unable to statethe serial numbers of the order formscontained therein, he/she shall report,in lieu of the numbers of the forms con-tained in such book, the date or ap-proximate date of issuance thereof. Ifany unused order form reported stolenor lost is subsequently recovered orfound, the Special Agent in Charge ofthe Drug Enforcement Administrationin the Divisional Office responsible forthe area in which the registrant is lo-cated shall immediately be notified.

[36 FR 7796, Apr. 24, 1971, as amended at 36FR 13386, July 21, 1971. Redesignated at 38 FR26609, Sept. 24, 1973, and amended at 51 FR5319, Feb. 13, 1986; 62 FR 13964, Mar. 24, 1997]

§ 1305.13 Preservation of order forms.(a) The purchaser shall retain Copy 3

of each order form which has beenfilled. He/She shall also retain in his


69

Drug Enforcement Administration, Justice Pt. 1306

files all copies of each unaccepted ordefective order form and each state-ment attached thereto.

(b) The supplier shall retain Copy 1 ofeach order form which he/she has filled.

(c) Order forms must be maintainedseparately from all other records of theregistrant. Order forms are required tobe kept available for inspection for aperiod of 2 years. If a purchaser hasseveral registered locations, he/shemust retain Copy 3 of the executedorder forms and any attached state-ments or other related documents (notincluding unexecuted order formswhich may be kept elsewhere pursuantto § 1305.06(d)) at the registered loca-tion printed on the order form.

(d) The supplier of carfentaniletorphine hydrochloride anddiprenorphine shall maintain orderforms for these substances separatelyfrom all other order forms and recordsrequired to be maintained by the reg-istrant.

[36 FR 7796, Apr. 24, 1971. Redesignated at 38FR 26609, Sept. 24, 1973, and amended at 39FR 17839, May 21, 1974; 54 FR 33674, Aug. 16,1989; 62 FR 13964, Mar. 24, 1997]

§ 1305.14 Return of unused orderforms.

If the registration of any purchaserterminates (because the purchaser dies,ceases legal existence, discontinuesbusiness or professional practice, orchanges his name or address as shownon his registration) or is suspended orrevoked pursuant to § 1301.36 of thischapter as to all controlled substanceslisted in Schedules I and II for whichhe/she is registered, he/she shall returnall unused order forms for such sub-stance to the nearest office of the Ad-ministration.

[36 FR 7796, Apr. 24, 1971, as amended at 36FR 18732, Sept. 21, 1971. Redesignated at 38FR 26609, Sept. 24, 1973, as amended at 62 FR13964, Mar. 24, 1997]

§ 1305.15 Cancellation and voiding oforder forms.

(a) A purchaser may cancel part orall of an order on an order form by no-tifying the supplier in writing of suchcancellation. The supplier shall indi-cate the cancellation on Copies 1 and 2of the order form by drawing a linethrough the canceled items and print-

ing ‘‘canceled’’ in the space providedfor number of items shipped.

(b) A supplier may void part or all ofan order on an order form by notifyingthe purchaser in writing of such void-ing. The supplier shall indicate thevoiding in the manner prescribed forcancellation in paragraph (a) of thissection.

(c) No cancellation or voiding per-mitted by this section shall affect inany way contract rights of either thepurchaser or the supplier.


§ 1305.16 Special procedure for fillingcertain order forms.

(a) The purchaser of carfentaniletorphine hydrochloride ordiprenorphine shall submit copy 1 and 2of the order form to the supplier andretain copy 3 in his own files.

(b) The supplier, if he/she determinesthat the purchaser is a veterinarian en-gaged in zoo and exotic animal prac-tice, wildlife management programsand/or research and authorized by theAdministrator to handle these sub-stances shall fill the order in accord-ance with the procedures set forth in§ 1305.09 except that:

(1) Order forms for carfentaniletorphine hydrochloride anddiprenorphine shall only contain thesesubstances in reasonable quantitiesand

(2) The substances shall only beshipped to the purchaser at the loca-tion printed by the Administrationupon the order form under secure con-ditions using substantial packagingmaterial with no markings on the out-side which would indicate the content.

[39 FR 17839, May 21, 1974, as amended at 54FR 33674, Aug. 16, 1989; 62 FR 13964, Mar. 24,1997]

PART 1306—PRESCRIPTIONS

GENERAL INFORMATION

Sec.1306.01 Scope of part 1306.1306.02 Definitions.1306.03 Persons entitled to issue prescrip-

tions.1306.04 Purpose of issue of prescription.1306.05 Manner of issuance of prescriptions.


70

21 CFR Ch. II (4–1–01 Edition)§ 1306.01

1306.06 Persons entitled to fill prescriptions.1306.07 Administering or dispensing of nar-

cotic drugs.

CONTROLLED SUBSTANCES LISTED IN SCHEDULEII

1306.11 Requirement of prescription.1306.12 Refilling prescriptions.1306.13 Partial filling of prescriptions.1306.14 Labeling of substances and filling of

prescriptions.

CONTROLLED SUBSTANCES LISTED INSCHEDULES III, IV, AND V

1306.21 Requirement of prescription.1306.22 Refilling of prescriptions.1306.23 Partial filling of prescriptions.1306.24 Labeling of substances and filling of

prescriptions.1306.25 Transfer between pharmacies of

presription information for Schedules III,IV, and V controlled substances for refillpurposes.

1306.26 Dispensing without prescription.


SOURCE: 36 FR 7799, Apr. 24, 1971; 36 FR13386, July 21, 1971, unless otherwise noted.Redesignated at 38 FR 26609, Sept. 24, 1973.

GENERAL INFORMATION

§ 1306.01 Scope of part 1306.Rules governing the issuance, filling

and filing of prescriptions pursuant tosection 309 of the Act (21 U.S.C. 829) areset forth generally in that section andspecifically by the sections of this part.



[62 FR 13964, Mar. 24, 1997]

§ 1306.03 Persons entitled to issue pre-scriptions.

(a) A prescription for a controlledsubstance may be issued only by an in-dividual practitioner who is:

(1) authorized to prescribe controlledsubstances by the jurisdiction in whichhe is licensed to practice his professionand

(2) either registered or exemptedfrom registration pursuant to§§ 1301.22(c) and 1301.23 of this chapter.

(b) A prescription issued by an indi-vidual practitioner may be commu-nicated to a pharmacist by an em-

ployee or agent of the individual prac-titioner.

[36 FR 7799, Apr. 24, 1971, as amended at 36FR 18732, Sept. 21, 1971. Redesignated at 38FR 26609, Sept. 24, 1973, as amended at 62 FR13966, Mar. 24, 1997]

§ 1306.04 Purpose of issue of prescrip-tion.

(a) A prescription for a controlledsubstance to be effective must beissued for a legitimate medical purposeby an individual practitioner acting inthe usual course of his professionalpractice. The responsibility for theproper prescribing and dispensing ofcontrolled substances is upon the pre-scribing practitioner, but a cor-responding responsibility rests withthe pharmacist who fills the prescrip-tion. An order purporting to be a pre-scription issued not in the usual courseof professional treatment or in legiti-mate and authorized research is not aprescription within the meaning andintent of section 309 of the Act (21U.S.C. 829) and the person knowinglyfilling such a purported prescription, aswell as the person issuing it, shall besubject to the penalties provided forviolations of the provisions of law re-lating to controlled substances.

(b) A prescription may not be issuedin order for an individual practitionerto obtain controlled substances for sup-plying the individual practitioner forthe purpose of general dispensing to pa-tients.

(c) A prescription may not be issuedfor the dispensing of narcotic drugslisted in any schedule for ‘‘detoxifica-tion treatment’’ or ‘‘maintenancetreatment’’ as defined in Section 102 ofthe Act (21 U.S.C. 802).

[36 FR 7799, Apr. 24, 1971. Redesignated at 38FR 26609, Sept. 24, 1973, and amended at 39FR 37986, Oct. 25, 1974]

§ 1306.05 Manner of issuance of pre-scriptions.

(a) All prescriptions for controlledsubstances shall be dated as of, andsigned on, the day when issued andshall bear the full name and address ofthe patient, the drug name, strength,dosage form, quantity prescribed, di-rections for use and the name, address


71


and registration number of the practi-tioner. A practitioner may sign a pre-scription in the same manner as hewould sign a check or legal document(e.g., J.H. Smith or John H. Smith).Where an oral order is not permitted,prescriptions shall be written with inkor indelible pencil or typewriter andshall be manually signed by the practi-tioner. The prescriptions may be pre-pared by the secretary or agent for thesignature of a practitioner, but the pre-scribing practitioner is responsible incase the prescription does not conformin all essential respects to the law andregulations. A corresponding liabilityrests upon the pharmacist who fills aprescription not prepared in the formprescribed by these regulations.

(b) An individual practitioner ex-empted from registration under§ 1301.22(c) of this chapter shall includeon all prescriptions issued by him orher the registration number of the hos-pital or other institution and the spe-cial internal code number assigned tohim or her by the hospital or other in-stitution as provided in § 1301.22(c) ofthis chapter, in lieu of the registrationnumber of the practitioner required bythis section. Each written prescriptionshall have the name of the physicianstamped, typed, or handprinted on it,as well as the signature of the physi-cian.

(c) An official exempted from reg-istration under § 1301.22(c) shall includeon all prescriptions issued by him hisbranch of service or agency (e.g., ‘‘U.S.Army’’ or ‘‘Public Health Service’’) andhis service identification number, inlieu of the registration number of thepractitioner required by this section.The service identification number for aPublic Health Service employee is hisSocial Security identification number.Each prescription shall have the nameof the officer stamped, typed, orhandprinted on it, as well as the signa-ture of the officer.

[36 FR 7799, Apr. 24, 1971, as amended at 36FR 18733, Sept. 21, 1971. Redesignated at 38FR 26609, Sept. 24, 1973, and amended at 56FR 25026, June 3, 1991; 60 FR 36641, July 18,1995; 62 FR 13966, Mar. 24, 1997]

§ 1306.06 Persons entitled to fill pre-scriptions.

A prescription for controlled sub-stances may only be filled by a phar-macist acting in the usual course of hisprofessional practice and either reg-istered individually or employed in aregistered pharmacy or registered in-stitutional practitioner.

§ 1306.07 Administering or dispensingof narcotic drugs.

(a) The administering or dispensingdirectly (but not prescribing) of nar-cotic drugs listed in any schedule to anarcotic drug dependent person for‘‘detoxification treatment’’ or ‘‘main-tenance treatment’’ as defined in sec-tion 102 of the Act (21 U.S.C. 802) shallbe deemed to be within the meaning ofthe term ‘‘in the course of his profes-sional practice or research’’ in section308(e) and section 102(20) of the Act (21U.S.C. 828 (e)): Provided, That the prac-titioner is separately registered withthe Attorney General as required bysection 303(g) of the Act (21 U.S.C.823(g)) and then thereafter complieswith the regulatory standards imposedrelative to treatment qualification, se-curity, records and unsupervised use ofdrugs pursuant to such Act.

(b) Nothing in this section shall pro-hibit a physician who is not specifi-cally registered to conduct a narcotictreatment program from administering(but not prescribing) narcotic drugs toa person for the purpose of relievingacute withdrawal symptoms when nec-essary while arrangements are beingmade for referral for treatment. Notmore than one day’s medication maybe administered to the person or forthe person’s use at one time. Suchemergency treatment may be carriedout for not more than three days andmay not be renewed or extended.

(c) This section is not intended to im-pose any limitations on a physician orauthorized hospital staff to administeror dispense narcotic drugs in a hospitalto maintain or detoxify a person as anincidental adjunct to medical or sur-gical treatment of conditions otherthan addiction, or to administer or dis-pense narcotic drugs to persons withintractable pain in which no relief or


72

21 CFR Ch. II (4–1–01 Edition)§ 1306.11

cure is possible or none has been foundafter reasonable efforts.

[39 FR 37986, Oct. 25, 1974]

CONTROLLED SUBSTANCES LISTED INSCHEDULE II

§ 1306.11 Requirement of prescription.(a) A pharmacist may dispense di-

rectly a controlled substance listed inSchedule II, which is a prescriptiondrug as determined under the FederalFood, Drug, and Cosmetic Act, onlypursuant to a written prescriptionsigned by the practitioner, except asprovided in paragraph (d) of this sec-tion. A prescription for a Schedule IIcontrolled substance may be trans-mitted by the practitioner or the prac-titioner’s agent to a pharmacy via fac-simile equipment, provided that theoriginal written, signed prescription ispresented to the pharmacist for reviewprior to the actual dispensing of thecontrolled substance, except as notedin paragraph (e), (f), or (g) of this sec-tion. The original prescription shall bemaintained in accordance with§ 1304.04(h) of this chapter.

(b) An individual practitioner mayadminister or dispense directly a con-trolled substance listed in Schedule IIin the course of his professional prac-tice without a prescription, subject to§ 1306.07.

(c) An institutional practitioner mayadminister or dispense directly (butnot prescribe) a controlled substancelisted in Schedule II only pursuant to awritten prescription signed by the pre-scribing individual practitioner or toan order for medication made by an in-dividual practitioner which is dis-pensed for immediate administrationto the ultimate user.

(d) In the case of an emergency situa-tion, as defined by the Secretary in§ 290.10 of this title, a pharmacist maydispense a controlled substance listedin Schedule II upon receiving oral au-thorization of a prescribing individualpractitioner, provided that:

(1) The quantity prescribed and dis-pensed is limited to the amount ade-quate to treat the patient during theemergency period (dispensing beyondthe emergency period must be pursuantto a written prescription signed by theprescribing individual practitioner);

(2) The prescription shall be imme-diately reduced to writing by the phar-macist and shall contain all informa-tion required in § 1306.05, except for thesignature of the prescribing individualpractitioner;

(3) If the prescribing individual prac-titioner is not known to the phar-macist, he must make a reasonable ef-fort to determine that the oral author-ization came from a registered indi-vidual practitioner, which may includea callback to the prescribing individualpractitioner using his phone number aslisted in the telephone directory and/orother good faith efforts to insure hisidentity; and

(4) Within 7 days after authorizing anemergency oral prescription, the pre-scribing individual practitioner shallcause a written prescription for theemergency quantity prescribed to bedelivered to the dispensing pharmacist.In addition to conforming to the re-quirements of § 1306.05, the prescriptionshall have written on its face ‘‘Author-ization for Emergency Dispensing,’’and the date of the oral order. Thewritten prescription may be deliveredto the pharmacist in person or by mail,but if delivered by mail it must bepostmarked within the 7 day period.Upon receipt, the dispensing phar-macist shall attach this prescription tothe oral emergency prescription whichhad earlier been reduced to writing.The pharmacist shall notify the near-est office of the Administration if theprescribing individual practitionerfails to deliver a written prescriptionto him; failure of the pharmacist to doso shall void the authority conferredby this paragraph to dispense withouta written prescription of a prescribingindividual practitioner.

(e) A prescription prepared in accord-ance with § 1306.05 written for a Sched-ule II narcotic substance to be com-pounded for the direct administrationto a patient by parenteral, intra-venous, intramuscular, subcutaneousor intraspinal infusion may be trans-mitted by the practitioner or the prac-titioner’s agent to the pharmacy byfacsimile. The facsimile serves as theoriginal written prescription for pur-poses of this paragraph (e) and it shallbe maintained in accordance with§ 1304.04(h) of this chapter.


73


(f) A prescription prepared in accord-ance with § 1306.05 written for ScheduleII substance for a resident of a LongTerm Care Facility may be trans-mitted by the practitioner or the prac-titioner’s agent to the dispensing phar-macy by facsimile. The facsimileserves as the original written prescrip-tion for purposes of this paragraph (f)and it shall be maintained in accord-ance with § 1304.04(h).

(g) A prescription prepared in accord-ance with § 1306.05 written for a Sched-ule II narcotic substance for a patientenrolled in a hospice care program cer-tified and/or paid for by Medicare underTitle XVIII or a hospice program whichis licensed by the state may be trans-mitted by the practitioner or the prac-titioner’s agent to the dispensing phar-macy by facsimile. The practitioner orthe practitioner’s agent will note onthe prescription that the patient is ahospice patient. The facsimile serves asthe original written prescription forpurposes of this paragraph (g) and itshall be maintained in accordance with§ 1304.04(h).

[36 FR 7799, Apr. 24, 1971, as amended at 36FR 18733, Sept. 21, 1971. Redesignated at 38FR 26609, Sept. 24, 1973 and amended at 53 FR4964, Feb. 19, 1988; 59 FR 26111, May 19, 1994;59 FR 30832, June 15, 1994; 62 FR 13964, Mar.24, 1997; 65 FR 45713, July 25, 2000]

§ 1306.12 Refilling prescriptions.The refilling of a prescription for a

controlled substance listed in ScheduleII is prohibited.

§ 1306.13 Partial filling of prescrip-tions.

(a) The partial filling of a prescrip-tion for a controlled substance listed inSchedule II is permissible, if the phar-macist is unable to supply the fullquantity called for in a written oremergency oral prescription and hemakes a notation of the quantity sup-plied on the face of the written pre-scription (or written record of theemergency oral prescription). The re-maining portion of the prescriptionmay be filled within 72 hours of thefirst partial filling; however, if the re-maining portion is not or cannot befilled within the 72-hour period, thepharmacist shall so notify the pre-scribing individual practitioner. No

further quantity may be supplied be-yond 72 hours without a new prescrip-tion.

(b) A prescription for a Schedule IIcontrolled substance written for a pa-tient in a Long Term Care Facility(LTCF) or for a patient with a medicaldiagnosis documenting a terminal ill-ness may be filled in partial quantitiesto include individual dosage units. Ifthere is any question whether a patientmay be classified as having a terminalillness, the pharmacist must contactthe practitioner prior to partially fill-ing the prescription. Both the phar-macist and the prescribing practitionerhave a corresponding responsibility toassure that the controlled substance isfor a terminally ill patient. The phar-macist must record on the prescriptionwhether the patient is ‘‘terminally ill’’or an ‘‘LTCF patient.’’ A prescriptionthat is partially filled and does notcontain the notation ‘‘terminally ill’’or ‘‘LTCF patient’’ shall be deemed tohave been filled in violation of the Act.For each partial filling, the dispensingpharmacist shall record on the back ofthe prescription (or on another appro-priate record, uniformly maintained,and readily retrievable) the date of thepartial filling, quantity dispensed, re-maining quantity authorized to be dis-pensed, and the identification of thedispensing pharmacist. The total quan-tity of Schedule II controlled sub-stances dispensed in all partial fillingsmust not exceed the total quantity pre-scribed. Schedule II prescriptions forpatients in a LTCF or patients with amedical diagnosis documenting a ter-minal illness shall be valid for a periodnot to exceed 60 days from the issuedate unless sooner terminated by thediscontinuance of medication.

(c) Information pertaining to currentSchedule II prescriptions for patientsin a LTCF or for patients with a med-ical diagnosis documenting a terminalillness may be maintained in a comput-erized system if this system has the ca-pability to permit:

(1) Output (display or printout) of theoriginal prescription number, date ofissue, identification of prescribing indi-vidual practitioner, identification ofpatient, address of the LTCF or address


74

21 CFR Ch. II (4–1–01 Edition)§ 1306.14

of the hospital or residence of the pa-tient, identification of medication au-thorized (to include dosage, form,strength and quantity), listing of thepartial fillings that have been dis-pensed under each prescription and theinformation required in § 1306.13(b).

(2) Immediate (real time) updating ofthe prescription record each time apartial filling of the prescription isconducted.

(3) Retrieval of partially filled Sched-ule II prescription information is thesame as required by § 1306.22(b) (4) and(5) for Schedule III and IV prescriptionrefill information.

(Authority: 21 U.S.C. 801, et seq.)

[36 FR 7799, Apr. 24, 1971. Redesignated at 38FR 26609, Sept. 24, 1973, and amended at 45FR 54330, July 15, 1980; 56 FR 25027, June 3,1991; 62 FR 13965, Mar. 24, 1997]

§ 1306.14 Labeling of substances andfilling of prescriptions.

(a) The pharmacist filling a writtenor emergency oral prescription for acontrolled substance listed in ScheduleII shall affix to the package a labelshowing date of filling, the pharmacyname and address, the serial number ofthe prescription, the name of the pa-tient, the name of the prescribing prac-titioner, and directions for use andcautionary statements, if any, con-tained in such prescription or requiredby law.

(b) The requirements of paragraph (a)of this section do not apply when acontrolled substance listed in ScheduleII is prescribed for administration toan ultimate user who is institutional-ized: Provided, That:

(1) Not more than 7-day supply of thecontrolled substance listed in ScheduleII is dispensed at one time;

(2) The controlled substance listed inSchedule II is not in the possession ofthe ultimate user prior to the adminis-tration;

(3) The institution maintains appro-priate safeguards and records regardingthe proper administration, control, dis-pensing, and storage of the controlledsubstance listed in Schedule II; and

(4) The system employed by the phar-macist in filling a prescription is ade-quate to identify the supplier, theproduct, and the patient, and to set

forth the directions for use and cau-tionary statements, if any, containedin the prescription or required by law.

(c) All written prescriptions andwritten records of emergency oral pre-scriptions shall be kept in accordancewith requirements of § 1304.04(h) of thischapter.

[36 FR 13368, July 21, 1971, as amended at 37FR 15921, Aug. 8, 1972. Redesignated at 38 FR26609, Sept. 24, 1973, as amended at 62 FR13965, Mar. 24, 1997]

CONTROLLED SUBSTANCES LISTED INSCHEDULES III, IV, AND V

§ 1306.21 Requirement of prescription.

(a) A pharmacist may dispense di-rectly a controlled substance listed inSchedule III, IV, or V which is a pre-scription drug as determined under theFederal Food, Drug, and Cosmetic Act,only pursuant to either a written pre-scription signed by a practitioner or afacsimile of a written, signed prescrip-tion transmitted by the practitioner orthe practitioner’s agent to the phar-macy or pursuant to an oral prescrip-tion made by an individual practitionerand promptly reduced to writing by thepharmacist containing all informationrequired in § 1306.05, except for the sig-nature of the practitioner.

(b) An individual practitioner mayadminister or dispense directly a con-trolled substance listed in Schedule III,IV, or V in the course of his/her profes-sional practice without a prescription,subject to § 1306.07.

(c) An institutional practitioner mayadminister or dispense directly (butnot prescribe) a controlled substancelisted in Schedule III, IV, or V onlypursuant to a written prescriptionsigned by an individual practitioner, orpursuant to a facsimile of a writtenprescription or order for medicationtransmitted by the practitioner or thepractitioner’s agent to the institu-tional practitioner-pharmacist, or pur-suant to an oral prescription made byan individual practitioner and prompt-ly reduced to writing by the phar-macist (containing all information re-quired in Section 1306.05 except for thesignature of the individual practi-tioner), or pursuant to an order formedication made by an individual


75


practitioner which is dispensed for im-mediate administration to the ulti-mate user, subject to § 1306.07.

[62 FR 13965, Mar. 24, 1997]

§ 1306.22 Refilling of prescriptions.(a) No prescription for a controlled

substance listed in Schedule III or IVshall be filled or refilled more than sixmonths after the date on which suchprescription was issued and no suchprescription authorized to be refilledmay be refilled more than five times.Each refilling of a prescription shall beentered on the back of the prescriptionor on another appropriate document. Ifentered on another document, such asa medication record, the documentmust be uniformly maintained andreadily retrievable. The following in-formation must be retrievable by theprescription number consisting of thename and dosage form of the controlledsubstance, the date filled or refilled,the quantity dispensed, initials of thedispensing pharmacist for each refill,and the total number of refills for thatprescription. If the pharmacist merelyinitials and dates the back of the pre-scription it shall be deemed that thefull face amount of the prescription hasbeen dispensed. The prescribing practi-tioner may authorize additional refillsof Schedule III or IV controlled sub-stances on the original prescriptionthrough an oral refill authorizationtransmitted to the pharmacist pro-vided the following conditions are met:

(1) The total quantity authorized, in-cluding the amount of the original pre-scription, does not exceed five refillsnor extend beyond six months from thedate of issue of the original prescrip-tion.

(2) The pharmacist obtaining the oralauthorization records on the reverse ofthe original prescription the date,quantity of refill, number of additionalrefills authorized, and initials the pre-scription showing who received the au-thorization from the prescribing prac-titioner who issued the original pre-scription.

(3) The quantity of each additionalrefill authorized is equal to or less thanthe quantity authorized for the initialfilling of the original prescription.

(4) The prescribing practitioner mustexecute a new and separate prescrip-

tion for any additional quantities be-yond the five refill, six-month limita-tion.

(b) As an alternative to the proce-dures provided by subsection (a), anautomated data processing system maybe used for the storage and retrieval ofrefill information for prescription or-ders for controlled substances inSchedule III and IV, subject to the fol-lowing conditions:

(1) Any such proposed computerizedsystem must provide on-line retrieval(via CRT display or hard-copy print-out) of original prescription order in-formation for those prescription orderswhich are currently authorized for re-filling. This shall include, but is notlimited to, data such as the originalprescription number, date of issuanceof the original prescription order bythe practitioner, full name and addressof the patient, name, address, and DEAregistration number of the practi-tioner, and the name, strength, dosageform, quantity of the controlled sub-stance prescribed (and quantity dis-pensed if different from the quantityprescribed), and the total number of re-fills authorized by the prescribing prac-titioner.

(2) Any such proposed computerizedsystem must also provide on-line re-trieval (via CRT display or hard-copyprintout) of the current refill historyfor Schedule III or IV controlled sub-stance prescription orders (those au-thorized for refill during the past sixmonths.) This refill history shall in-clude, but is not limited to, the nameof the controlled substance, the date ofrefill, the quantity dispensed, the iden-tification code, or name or initials ofthe dispensing pharmacist for each re-fill and the total number of refills dis-pensed to date for that prescriptionorder.

(3) Documentation of the fact thatthe refill information entered into thecomputer each time a pharmacist re-fills an original prescription order for aSchedule III or IV controlled substanceis correct must be provided by the indi-vidual pharmacist who makes use ofsuch a system. If such a system pro-vides a hard-copy printout of eachday’s controlled substance prescriptionorder refill data, that printout shall be


76

21 CFR Ch. II (4–1–01 Edition)§ 1306.23

verified, dated, and signed by the indi-vidual pharmacist who refilled such aprescription order. The individualpharmacist must verify that the dataindicated is correct and then sign thisdocument in the same manner as hewould sign a check or legal document(e.g., J. H. Smith, or John H. Smith).This document shall be maintained in aseparate file at that pharmacy for a pe-riod of two years from the dispensingdate. This printout of the day’s con-trolled substance prescription order re-fill data must be provided to each phar-macy using such a computerized sys-tem within 72 hours of the date onwhich the refill was dispensed. It mustbe verified and signed by each phar-macist who is involved with such dis-pensing. In lieu of such a printout, thepharmacy shall maintain a bound logbook, or separate file, in which each in-dividual pharmacist involved in suchdispensing shall sign a statement (inthe manner previously described) eachday, attesting to the fact that the refillinformation entered into the computerthat day has been reviewed by him andis correct as shown. Such a book or filemust be maintained at the pharmacyemploying such a system for a periodof two years after the date of dis-pensing the appropriately authorizedrefill.

(4) Any such computerized systemshall have the capability of producing aprintout of any refill data which theuser pharmacy is responsible for main-taining under the Act and its imple-menting regulations. For example, thiswould include a refill-by-refill audittrail for any specified strength and dos-age form of any controlled substance(by either brand or generic name orboth). Such a printout must includename of the prescribing practitioner,name and address of the patient, quan-tity dispensed on each refill, date ofdispensing for each refill, name oridentification code of the dispensingpharmacist, and the number of theoriginal prescription order. In anycomputerized system employed by auser pharmacy the central record-keeping location must be capable ofsending the printout to the pharmacywithin 48 hours, and if a DEA SpecialAgent or Diversion Investigator re-quests a copy of such printout from the

user pharmacy, it must, if requested todo so by the Agent or Investigator,verify the printout transmittal capa-bility of its system by documentation(e.g., postmark).

(5) In the event that a pharmacywhich employs such a computerizedsystem experiences system down-time,the pharmacy must have an auxiliaryprocedure which will be used for docu-mentation of refills os Schedule III andIV controlled substance prescriptionorders. This auxiliary procedure mustinsure that refills are authorized bythe original prescription order, thatthe maximum number of refills has notbeen exceeded, and that all of the ap-propriate data is retained for on-linedata entry as soon as the computer sys-tem is available for use again.

(c) When filing refill information fororiginal prescription orders for Sched-ule III or IV controlled substances, apharmacy may use only one of the twosystems described in paragraphs (a) or(b) of this section.

[36 FR 7799, Apr. 24, 1971; 36 FR 13386, July 21,1971. Redesignated at 38 FR 26609, Sept. 24,1973, and amended at 42 FR 28878, June 6,1977; 45 FR 44266, July 1, 1980; 52 FR 3605, Feb.5, 1987; 62 FR 13966, Mar. 24, 1997]

§ 1306.23 Partial filling of prescrip-tions.

The partial filling of a prescriptionfor a controlled substance listed inSchedule III, IV, or V is permissible,provided that:

(a) Each partial filling is recorded inthe same manner as a refilling,

(b) The total quantity dispensed inall partial fillings does not exceed thetotal quantity prescribed, and

(c) No dispensing occurs after 6months after the date on which theprescription was issued.

[36 FR 18733, Sept. 21, 1971. Redesignated at38 FR 26609, Sept. 24, 1973, and amended at 51FR 5320, Feb. 13, 1986; 62 FR 13965, Mar. 24,1997]

§ 1306.24 Labeling of substances andfiling of prescriptions.

(a) The pharmacist filling a prescrip-tion for a controlled substance listed inSchedule III, IV, or V shall affix to thepackage a label showing the pharmacyname and address, the serial numberand date of initial filling, the name of


77


the patient, the name of the practi-tioner issuing the prescription, and di-rections for use and cautionary state-ments, if any, contained in such pre-scription as required by law.

(b) The requirements of paragraph (a)of this section do not apply when acontrolled substance listed in ScheduleIII, IV, or V is prescribed for adminis-tration to an ultimate user who is in-stitutionalized: Provided, That:

(1) Not more than a 34-day supply or100 dosage units, whichever is less, ofthe controlled substance listed inSchedule III, IV, or V is dispensed atone time;

(2) The controlled substance listed inSchedule III, IV, or V is not in the pos-session of the ultimate user prior toadministration;

(3) The institution maintains appro-priate safeguards and records the prop-er administration, control, dispensing,and storage of the controlled substancelisted in Schedule III, IV, or V; and

(4) The system employed by the phar-macist in filling a prescription is ade-quate to identify the supplier, theproduct and the patient, and to setforth the directions for use and cau-tionary statements, if any, containedin the prescription or required by law.

(c) All prescriptions for controlledsubstances listed in Schedules III, IV,and V shall be kept in accordance with§ 1304.04(h) of this chapter.

[62 FR 13965, Mar. 24, 1997]

§ 1306.25 Transfer between pharmaciesof prescription information forSchedules III, IV, and V controlledsubstances for refill purposes.

(a) The transfer of original prescrip-tion information for a controlled sub-stance listed in Schedules III, IV or Vfor the purpose of refill dispensing ispermissible between pharmacies on aone time basis only. However, phar-macies electronically sharing a real-time, on-line database may transfer upto the maximum refills permitted bylaw and the prescriber’s authorization.Transfers are subject to the followingrequirements:

(1) The transfer is communicated di-rectly between two licensed phar-macists and the transferring phar-macist records the following informa-tion:

(i) Write the word ‘‘VOID’’ on theface of the invalidated prescription.

(ii) Record on the reverse of the in-validated prescription the name, ad-dress and DEA registration number ofthe pharmacy to which it was trans-ferred and the name of the pharmacistreceiving the prescription information.

(iii) Record the date of the transferand the name of the pharmacist trans-ferring the information.

(b) The pharmacist receiving thetransferred prescription informationshall reduce to writing the following:

(1) Write the word ‘‘transfer’’ on theface of the transferred prescription.

(2) Provide all information requiredto be on a prescription pursuant to 21CFR 1306.05 and include:

(i) Date of issuance of original pre-scription;

(ii) Original number of refills author-ized on original prescription;

(iii) Date of original dispensing;(iv) Number of valid refills remaining

and date(s) and locations of previousrefill(s);

(v) Pharmacy’s name, address, DEAregistration number and prescriptionnumber from which the prescription in-formation was transferred;

(vi) Name of pharmacist who trans-ferred the prescription.

(vii) Pharmacy’s name, address, DEAregistration number and prescriptionnumber from which the prescriptionwas originally filled;

(3) The original and transferred pre-scription(s) must be maintained for aperiod of two years from the date oflast refill.

(c) Pharmacies electronically access-ing the same prescription record mustsatisfy all information requirements ofa manual mode for prescriptiontransferral.

(d) The procedure allowing the trans-fer of prescription information for re-fill purposes is permissible only if al-lowable under existing state or otherapplicable law.

[46 FR 48919, Oct. 5, 1981. Redesignated andamended at 62 FR 13966, Mar. 24, 1997]

§ 1306.26 Dispensing without prescrip-tion.

A controlled substance listed inSchedules II, III, IV, or V which is nota prescription drug as determined


78


under the Federal Food, Drug, and Cos-metic Act, may be dispensed by a phar-macist without a prescription to a pur-chaser at retail, provided that:

(a) Such dispensing is made only by apharmacist (as defined in part 1300 ofthis chapter), and not by a nonphar-macist employee even if under the su-pervision of a pharmacist (althoughafter the pharmacist has fulfilled hisprofessional and legal responsibilitiesset forth in this section, the actualcash, credit transaction, or delivery,may be completed by a nonphar-macist);

(b) Not more than 240 cc. (8 ounces) ofany such controlled substance con-taining opium, nor more than 120 cc. (4ounces) of any other such controlledsubstance nor more than 48 dosageunits of any such controlled substancecontaining opium, nor more than 24dosage units of any other such con-trolled substance may be dispensed atretail to the same purchaser in anygiven 48-hour period;

(c) The purchaser is at least 18 yearsof age;

(d) The pharmacist requires everypurchaser of a controlled substanceunder this section not known to him tofurnish suitable identification (includ-ing proof of age where appropriate);

(e) A bound record book for dis-pensing of controlled substances underthis section is maintained by the phar-macist, which book shall contain thename and address of the purchaser, thename and quantity of controlled sub-stance purchased, the date of each pur-chase, and the name or initials of thepharmacist who dispensed the sub-stance to the purchaser (the book shallbe maintained in accordance with therecordkeeping requirement of § 1304.04of this chapter); and

(f) A prescription is not required fordistribution or dispensing of the sub-stance pursuant to any other Federal,State or local law.

[36 FR 7799, Apr. 24, 1971, as amended at 36FR 18733, Sept. 21, 1971. Redesignated at 38FR 26609, Sept. 24, 1973, and furtherredesigated and amended at 62 FR 13966, Mar.24, 1997]

PART 1307—MISCELLANEOUS

GENERAL INFORMATION

Sec.1307.01 Definitions.1307.02 Application of State law and other

Federal law.1307.03 Exceptions to regulations.

SPECIAL EXCEPTIONS FOR MANUFACTURE ANDDISTRIBUTION OF CONTROLLED SUBSTANCES

1307.11 Distribution by dispenser to anotherpractitioner.

1307.12 Distribution to supplier.1307.13 Incidental manufacture of controlled

substances.

DISPOSAL OF CONTROLLED SUBSTANCES

1307.21 Procedure for disposing of controlledsubstances.

1307.22 Disposal of controlled substances bythe Administration.

SPECIAL EXEMPT PERSONS

1307.31 Native American Church.

AUTHORITY: 21 U.S.C. 821, 822(d), 871(b), un-less otherwise noted.


GENERAL INFORMATION


Any term contained in this part shallhave the definition set forth in section102 of the Act (21 U.S.C. 802) or part1300 of this chapter.

[62 FR 13966, Mar. 24, 1997]

§ 1307.02 Application of State law andother Federal law.

Nothing in this chapter shall be con-strued as authorizing or permittingany person to do any act which suchperson is not authorized or permittedto do under other Federal laws or obli-gations under international treaties,conventions or protocols, or under thelaw of the State in which he/she desiresto do such act nor shall compliancewith such parts be construed as compli-ance with other Federal or State lawsunless expressly provided in such otherlaws.

[62 FR 13966, Mar. 24, 1997]


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§ 1307.03 Exceptions to regulations.Any person may apply for an excep-

tion to the application of any provisionof this chapter by filing a written re-quest stating the reasons for such ex-ception. Requests shall be filed withthe Administrator, Drug EnforcementAdministration, Department of Jus-tice, Washington, DC 20537. The Admin-istrator may grant an exception in hisdiscretion, but in no case shall he/shebe required to grant an exception toany person which is otherwise requiredby law or the regulations cited in thissection.

[62 FR 13966, Mar. 24, 1997]

SPECIAL EXCEPTIONS FOR MANUFACTUREAND DISTRIBUTION OF CONTROLLEDSUBSTANCES

§ 1307.11 Distribution by dispenser toanother practitioner.

(a) A practitioner who is registeredto dispense a controlled substance maydistribute (without being registered todistribute) a quantity of such sub-stance to another practitioner for thepurpose of general dispensing by thepractitioner to his or its patients: Pro-vided, That:

(1) The practitioner to whom the con-trolled substance is to be distributed isregistered under the Act to dispensethat controlled substance;

(2) The distribution is recorded bythe distributing practitioner in accord-ance with § 1304.22(c) of this chapterand by the receiving practitioner in ac-cordance with § 1304.22(c) of this chap-ter;

(3) If the substance is listed in Sched-ule I or II, an order form is used as re-quired in part 1305 of this chapter;

(4) The total number of dosage unitsof all controlled substances distributedby the practitioner pursuant to thissection and § 1301.25 of this chapter dur-ing each calendar year in which thepractitioner is registered to dispensedoes not exceed 5 percent of the totalnumber of dosage units of all con-trolled substances distributed and dis-pensed by the practitioner during thesame calendar year.

(b) If, during any calendar year inwhich the practitioner is registered todispense, the practitioner has reason tobelieve that the total number of dosage

units of all controlled substanceswhich will be distributed by him pursu-ant to this section and § 1301.25 of thischapter will exceed 5 percent of thetotal number of dosage units of all con-trolled substances distributed and dis-pensed by him during that calendaryear, the practitioner shall obtain aregistration to distribute controlledsubstances.

[36 FR 18733, Sept. 21, 1971. Redesignated at38 FR 26609, Sept. 24, 1973, and amended at 50FR 31590, Aug. 5, 1985; 62 FR 13967, Mar. 24,1997]

§ 1307.12 Distribution to supplier.

(a) Any person lawfully in possessionof a controlled substance listed in anyschedule may distribute (without beingregistered to distribute) that substanceto the person from whom he obtained itor to the manufacturer of the sub-stance, provided that a written recordis maintained which indicates the dateof the transaction, the name, form, andquantity of the substance, the name,address, and registration number, ifany, of the person making the distribu-tion, and the name, address, and reg-istration number, if known, of the sup-plier or manufacturer. In the case ofreturning a controlled substance inSchedule I or II, an order form shall beused in the manner prescribed in part1305 of this chapter and be maintainedas the written record of the trans-action. Any person not required to reg-ister pursuant to sections 302(c) or1007(b)(1) of the Act (21 U.S.C. 822(c) or957(b)(1)) shall be exempt from main-taining the records required by thissection.

(b) Distributions referred to in para-graph (a) may be made through afreight forwarding facility operated bythe person to whom the controlled sub-stance is being returned provided thatprior arrangement has been made forthe return and the person making thedistribution delivers the controlledsubstance directly to an agent or em-ployee of the person to whom the con-trolled substance is being returned.

[65 FR 44679, July 19, 2000; 65 FR 45829, July25, 2000]


80

21 CFR Ch. II (4–1–01 Edition)§ 1307.13

§ 1307.13 Incidental manufacture ofcontrolled substances.

Any registered manufacturer who, in-cidentally but necessarily, manufac-tures a controlled substance as a resultof the manufacture of a controlled sub-stance or basic class of controlled sub-stance for which he is registered andhas been issued an individual manufac-turing quota pursuant to part 1303 ofthis chapter (if such substance or classis listed in Schedule I or II) shall be ex-empt from the requirement of registra-tion pursuant to part 1301 of this chapter and, if such incidentally manu-factured substance is listed in ScheduleI or II, shall be exempt from the re-quirement of an individual manufac-turing quota pursuant to part 1303 ofthis chapter, if such substances are dis-posed of in accordance with § 1307.21.

[36 FR 7801, Apr. 24, 1971. Redesignated at 38FR 26609, Sept. 24, 1973, and further redesig-nated at 62 FR 13967, Mar. 24, 1997]

DISPOSAL OF CONTROLLED SUBSTANCES

§ 1307.21 Procedure for disposing ofcontrolled substances.

(a) Any person in possession of anycontrolled substance and desiring or re-quired to dispose of such substancemay request assistance from the Spe-cial Agent in Charge of the Adminis-tration in the area in which the personis located for authority and instruc-tions to dispose of such substance. Therequest should be made as follows:

(1) If the person is a registrant, he/she shall list the controlled substanceor substances which he/she desires todispose of on DEA Form 41, and submitthree copies of that form to the SpecialAgent in Charge in his/her area; or

(2) If the person is not a registrant,he/she shall submit to the SpecialAgent in Charge a letter stating:

(i) The name and address of the per-son;

(ii) The name and quantity of eachcontrolled substance to be disposed of;

(iii) How the applicant obtained thesubstance, if known; and

(iv) The name, address, and registra-tion number, if known, of the personwho possessed the controlled sub-stances prior to the applicant, ifknown.

(b) The Special Agent in Charge shallauthorize and instruct the applicant todispose of the controlled substance inone of the following manners:

(1) By transfer to person registeredunder the Act and authorized to pos-sess the substance;

(2) By delivery to an agent of the Ad-ministration or to the nearest office ofthe Administration;

(3) By destruction in the presence ofan agent of the Administration orother authorized person; or

(4) By such other means as the Spe-cial Agent in Charge may determine toassure that the substance does not be-come available to unauthorized per-sons.

(c) In the event that a registrant isrequired regularly to dispose of con-trolled substances, the Special Agentin Charge may authorize the registrantto dispose of such substances, in ac-cordance with paragraph (b) of this sec-tion, without prior approval of the Ad-ministration in each instance, on thecondition that the registrant keeprecords of such disposals and file peri-odic reports with the Special Agent inCharge summarizing the disposalsmade by the registrant. In grantingsuch authority, the Special Agent inCharge may place such conditions as hedeems proper on the disposal of con-trolled substances, including the meth-od of disposal and the frequency anddetail of reports.

(d) This section shall not be con-strued as affecting or altering in anyway the disposal of controlled sub-stances through procedures provided inlaws and regulations adopted by anyState.

[36 FR 7801, Apr. 24, 1971, as amended at 37FR 15922, Aug. 8, 1972. Redesignated at 38 FR26609, Sept. 24, 1973, and amended at 47 FR41735, Sept. 22, 1982; 62 FR 13967, Mar. 24, 1997]

§ 1307.22 Disposal of controlled sub-stances by the Administration.

Any controlled substance deliveredto the Administration under § 1307.21 orforfeited pursuant to section 511 of theAct (21 U.S.C. 881) may be delivered toany department, bureau, or other agen-cy of the United States or of any Stateupon proper application addressed tothe Administrator, Drug Enforcement


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Administration, Department of Jus-tice, Washington, DC 20537 The applica-tion shall show the name, address, andofficial title of the person or agency towhom the controlled drugs are to bedelivered, including the name andquantity of the substances desired andthe purpose for which intended. The de-livery of such controlled drugs shall beordered by the Administrator, if, in hisopinion, there exists a medical or sci-entific need therefor.


SPECIAL EXEMPT PERSONS

§ 1307.31 Native American Church.

The listing of peyote as a controlledsubstance in Schedule I does not applyto the nondrug use of peyote in bonafide religious ceremonies of the NativeAmerican Church, and members of theNative American Church so using pe-yote are exempt from registration. Anyperson who manufactures peyote for ordistributes peyote to the Native Amer-ican Church, however, is required toobtain registration annually and tocomply with all other requirements oflaw.

PART 1308—SCHEDULES OFCONTROLLED SUBSTANCES

GENERAL INFORMATION

Sec.1308.01 Scope of part 1308.1308.02 Definitions.1308.03 Administration Controlled Sub-

stances Code Number.

SCHEDULES

1308.11 Schedule I.1308.12 Schedule II.1308.13 Schedule III.1308.14 Schedule IV.1308.15 Schedule V.

EXCLUDED NONNARCOTIC SUBSTANCES

1308.21 Application for exclusion of a non-narcotic substance.

1308.22 Excluded substances.

EXEMPT CHEMICAL PREPARATIONS

1308.23 Exemption of certain chemical prep-arations; application.

1308.24 Exemption chemical preparations.

EXCLUDED VETERINARY ANABOLIC STEROIDIMPLANT PRODUCTS

1308.25 Exclusion of a veterinary anabolicsteroid implant product; application.

1308.26 Excluded veterinary anabolic steroidimplant products.

EXEMPTED PRESCRIPTION PRODUCTS

1308.31 Application for exemption of a non-narcotic prescription product.

1308.32 Exempted prescription products.

EXEMPT ANABOLIC STEROID PRODUCTS

1308.33 Exemption of certain anabolic ster-oid products; application.

1308.34 Exempt anabolic steroid products.

HEARINGS

1308.41 Hearings generally.1308.42 Purpose of hearing.1308.43 Initiation of proceedings for rule-

making.1308.44 Request for hearing or appearance;

waiver.1308.45 Final order.1308.46 Control required under international

treaty.1308.47 Control of immediate precursors.1308.49 Emergency scheduling.


SOURCE: 38 FR 8254, Mar. 30, 1973, unlessotherwise noted. Redesignated at 38 FR 26609,Sept. 24, 1973.

GENERAL INFORMATION

§ 1308.01 Scope of part 1308.Schedules of controlled substances

established by section 202 of the Act (21U.S.C. 812), as they are changed, up-dated, and republished from time totime, are set forth in this part.



[62 FR 13967, Mar. 24, 1997]

§ 1308.03 Administration ControlledSubstances Code Number.

(a) Each controlled substance, orbasic class thereof, has been assignedan ‘‘Administration Controlled Sub-stances Code Number’’ for purposes ofidentification of the substances orclass on certain Certificates of Reg-istration issued by the Administrationpursuant to §§ 1301.35 of this chapter


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21 CFR Ch. II (4–1–01 Edition)§ 1308.11

and on certain order forms issued bythe Administration pursuant to§ 1305.05(d) of this chapter. Applicantsfor procurement and/or individual man-ufacturing quotas must include the ap-propriate code number on the applica-tion as required in §§ 1303.12(b) and1303.22(a) of this chapter. Applicantsfor import and export permits must in-clude the appropriate code number onthe application as required in§§ 1312.12(a) and 1312.22(a) of this chap-ter. Authorized registrants who desireto import or export a controlled sub-stance for which an import or exportpermit is not required must include theappropriate Administration ControlledSubstances Code Number beneath orbeside the name of each controlled sub-stance listed on the DEA Form 236(Controlled Substance Import/ExportDeclaration) which is executed for suchimportation or exportation as requiredin §§ 1312.18(c) and 1312.27(b) of thischapter.

(b) Except as stated in paragraph (a)of this section, no applicant or reg-istrant is required to use the Adminis-tration Controlled Substances CodeNumber for any purpose.

[38 FR 8254, Mar. 30, 1973. Redesignated at 38FR 26609, Sept. 24, 1973 and amended at 51 FR15318, Apr. 23, 1986; 62 FR 13968, Mar. 24, 1997]

SCHEDULES

§ 1308.11 Schedule I.(a) Schedule I shall consist of the

drugs and other substances, by what-ever official name, common or usualname, chemical name, or brand namedesignated, listed in this section. Eachdrug or substance has been assignedthe DEA Controlled Substances CodeNumber set forth opposite it.

(b) Opiates. Unless specifically ex-cepted or unless listed in anotherschedule, any of the following opiates,including their isomers, esters, ethers,salts, and salts of isomers, esters andethers, whenever the existence of suchisomers, esters, ethers and salts is pos-sible within the specific chemical des-ignation (for purposes of paragraph(b)(34) only, the term isomer includesthe optical and geometric isomers):(1) Acetyl-alpha-methylfentanyl (N-[1-(1-methyl-2-

phenethyl)-4-piperidinyl]-N-phenylacetamide) ............ 9815(2) Acetylmethadol ......................................................... 9601(3) Allylprodine ............................................................... 9602

(4) Alphacetylmethadol (except levo-alphacetylmethadol also known as levo-alpha-acetylmethadol, levomethadyl acetate, or LAAM) ..... 9603

(5) Alphameprodine ....................................................... 9604(6) Alphamethadol ......................................................... 9605(7) Alpha-methylfentanyl (N-[1-(alpha-methyl-beta-

phenyl)ethyl-4-piperidyl] propionanilide; 1-(1-methyl-2-phenylethyl)-4-(N-propanilido) piperidine) ............... 9814

(8) Alpha-methylthiofentanyl (N-[1-methyl-2-(2-thienyl)ethyl-4-piperidinyl]-N-phenylpropanamide) ..... 9832

(9) Benzethidine ............................................................. 9606(10) Betacetylmethadol .................................................. 9607(11) Beta-hydroxyfentanyl (N-[1-(2-hydroxy-2-

phenethyl)-4-piperidinyl]-N-phenylpropanamide) ....... 9830(12) Beta-hydroxy-3-methylfentanyl (other name: N-[1-

(2-hydroxy-2-phenethyl)-3-methyl-4-piperidinyl]-N-phenylpropanamide .................................................... 9831

(13) Betameprodine ....................................................... 9608(14) Betamethadol ......................................................... 9609(15) Betaprodine ............................................................ 9611(16) Clonitazene ............................................................ 9612(17) Dextromoramide ..................................................... 9613(18) Diampromide .......................................................... 9615(19) Diethylthiambutene ................................................. 9616(20) Difenoxin ................................................................ 9168(21) Dimenoxadol .......................................................... 9617(22) Dimepheptanol ....................................................... 9618(23) Dimethylthiambutene .............................................. 9619(24) Dioxaphetyl butyrate .............................................. 9621(25) Dipipanone ............................................................. 9622(26) Ethylmethylthiambutene ......................................... 9623(27) Etonitazene ............................................................ 9624(28) Etoxeridine ............................................................. 9625(29) Furethidine ............................................................. 9626(30) Hydroxypethidine .................................................... 9627(31) Ketobemidone ........................................................ 9628(32) Levomoramide ........................................................ 9629(33) Levophenacylmorphan ........................................... 9631(34) 3-Methylfentanyl (N-[3-methyl-1-(2-phenylethyl)-4-

piperidyl]-N-phenylpropanamide) ............................... 9813(35) 3-methylthiofentanyl (N-[(3-methyl-1-(2-

thienyl)ethyl-4-piperidinyl]-N-phenylpropanamide) ..... 9833(36) Morpheridine .......................................................... 9632(37) MPPP (1-methyl-4-phenyl-4-propionoxypiperidine) 9661(38) Noracymethadol ..................................................... 9633(39) Norlevorphanol ....................................................... 9634(40) Normethadone ........................................................ 9635(41) Norpipanone ........................................................... 9636(42) Para-fluorofentanyl (N-(4-fluorophenyl)-N-[1-(2-

phenethyl)-4-piperidinyl] propanamide ....................... 9812(43) PEPAP (1-(-2-phenethyl)-4-phenyl-4-

acetoxypiperidine ....................................................... 9663(44) Phenadoxone ......................................................... 9637(45) Phenampromide ..................................................... 9638(46) Phenomorphan ....................................................... 9647(47) Phenoperidine ........................................................ 9641(48) Piritramide .............................................................. 9642(49) Proheptazine .......................................................... 9643(50) Properidine ............................................................. 9644(51) Propiram ................................................................. 9649(52) Racemoramide ....................................................... 9645(53) Thiofentanyl (N-phenyl-N-[1-(2-thienyl)ethyl-4-

piperidinyl]-propanamide ............................................ 9835(54) Tilidine .................................................................... 9750(55) Trimeperidine ......................................................... 9646

(c) Opium derivatives. Unless specifi-cally excepted or unless listed in an-other schedule, any of the followingopium derivatives, its salts, isomers,and salts of isomers whenever the ex-istence of such salts, isomers, and saltsof isomers is possible within the spe-cific chemical designation:


83


(1) Acetorphine .............................................................. 9319(2) Acetyldihydrocodeine ............................................... 9051(3) Benzylmorphine ........................................................ 9052(4) Codeine methylbromide ........................................... 9070(5) Codeine-N-Oxide ...................................................... 9053(6) Cyprenorphine .......................................................... 9054(7) Desomorphine .......................................................... 9055(8) Dihydromorphine ...................................................... 9145(9) Drotebanol ................................................................ 9335(10) Etorphine (except hydrochloride salt) .................... 9056(11) Heroin ..................................................................... 9200(12) Hydromorphinol ...................................................... 9301(13) Methyldesorphine ................................................... 9302(14) Methyldihydromorphine .......................................... 9304(15) Morphine methylbromide ........................................ 9305(16) Morphine methylsulfonate ...................................... 9306(17) Morphine-N-Oxide .................................................. 9307(18) Myrophine ............................................................... 9308(19) Nicocodeine ............................................................ 9309(20) Nicomorphine ......................................................... 9312(21) Normorphine ........................................................... 9313(22) Pholcodine .............................................................. 9314(23) Thebacon ............................................................... 9315

(d) Hallucinogenic substances. Unlessspecifically excepted or unless listed inanother schedule, any material, com-pound, mixture, or preparation, whichcontains any quantity of the followinghallucinogenic substances, or whichcontains any of its salts, isomers, andsalts of isomers whenever the existenceof such salts, isomers, and salts of iso-mers is possible within the specificchemical designation (for purposes ofthis paragraph only, the term ‘‘isomer’’includes the optical, position and geo-metric isomers):(1) Alpha-ethyltryptamine ............................................... 7249

Some trade or other names: etryptamine; Monase;α-ethyl-1H-indole-3-ethanamine; 3-(2-aminobutyl)indole; α-ET; and AET.

(2) 4-bromo-2,5-dimethoxy-amphetamine ..................... 7391Some trade or other names: 4-bromo-2,5-

dimethoxy-α-methylphenethylamine; 4-bromo-2,5-DMA

(3) 4-Bromo-2,5-dimethoxyphenethylamine .................. 7392Some trade or other names: 2-(4-bromo-2,5-

dimethoxyphenyl)-1-aminoethane; alpha-desmethyl DOB; 2C-B, Nexus.

(4) 2,5-dimethoxyamphetamine ..................................... 7396Some trade or other names: 2,5-dimethoxy-α-

methylphenethylamine; 2,5-DMA(5) 2,5-dimethoxy-4-ethylamphet-amine ........................ 7399

Some trade or other names: DOET(6) 4-methoxyamphetamine ........................................... 7411

Some trade or other names: 4-methoxy-α-methylphenethylamine;paramethoxyamphetamine, PMA

(7) 5-methoxy-3,4-mdthylenedioxy-amphetamine ......... 7401(8) 4-methyl-2,5-dimethoxy-amphetamine ..................... 7395

Some trade and other names: 4-methyl-2,5-dimethoxy-α-methylphenethylamine; ‘‘DOM’’; and‘‘STP’’

(9) 3,4-methylenedioxy amphetamine ........................... 7400(10) 3,4-methylenedioxymethamphetamine (MDMA) .... 7405(11) 3,4-methylenedioxy-N-ethylamphetamine (also

known as N-ethyl-alpha-methyl-3,4(methylenedioxy)phenethylamine, N-ethyl MDA,MDE, MDEA ............................................................... 7404

(12) N-hydroxy-3,4-methylenedioxyamphetamine (alsoknown as N-hydroxy-alpha-methyl-3,4(methylenedioxy)phenethylamine, and N-hydroxyMDA ........................................................................... 7402

(13) 3,4,5-trimethoxy amphetamine ............................... 7390(14) Bufotenine .............................................................. 7433

Some trade and other names: 3-(β-Dimethylaminoethyl)-5-hydroxyindole; 3-(2-dimethylaminoethyl)-5-indolol; N, N-dimethylserotonin; 5-hydroxy-N,N-dimethyltryptamine; mappine

(15) Diethyltryptamine .................................................... 7434Some trade and other names: N,N-

Diethyltryptamine; DET(16) Dimethyltryptamine ................................................. 7435

Some trade or other names: DMT(17) Ibogaine .................................................................. 7260

Some trade and other names: 7-Ethyl-6,6β,7,8,9,10,12,13-octahydro-2-methoxy-6,9-methano-5H-pyrido [1′, 2′:1,2] azepino [5,4-b]indole; Tabernanthe iboga

(18) Lysergic acid diethylamide ..................................... 7315(19) Marihuana .............................................................. 7360(20) Mescaline ............................................................... 7381(21) Parahexyl—7374; some trade or other names: 3-

Hexyl-1-hydroxy-7,8,9,10-tetrahydro-6,6,9-trimethyl-6H-dibenzo[b,d]pyran; Synhexyl.

(22) Peyote .................................................................... 7415Meaning all parts of the plant presently classified

botanically as Lophophora williamsii Lemaire,whether growing or not, the seeds thereof, anyextract from any part of such plant, and everycompound, manufacture, salts, derivative, mixture,or preparation of such plant, its seeds or extracts

(Interprets 21 USC 812(c), Schedule I(c) (12))(23) N-ethyl-3-piperidyl benzilate ................................... 7482(24) N-methyl-3-piperidyl benzilate ................................ 7484(25) Psilocybin ............................................................... 7437(26) Psilocyn .................................................................. 7438(27) Tetrahydrocannabinols ........................................... 7370

Synthetic equivalents of the substances contained inthe plant, or in the resinous extractives of Can-nabis, sp. and/or synthetic substances, deriva-tives, and their isomers with similar chemicalstructure and pharmacological activity such as thefollowing:

∆1 cis or trans tetrahydrocannabinol, and their opti-cal isomers

∆6 cis or trans tetrahydrocannabinol, and their opti-cal isomers

∆3,4 cis or trans tetrahydrocannabinol, and its opti-cal isomers

(Since nomenclature of these substances is notinternationally standardized, compounds of thesestructures, regardless of numerical designation ofatomic positions covered.)

(28) Ethylamine analog of phencyclidine ...................... 7455Some trade or other names: N-ethyl-1-

phenylcyclohexylamine, (1-phenylcyclohexyl)ethylamine, N-(1-phenylcyclohexyl)ethylamine, cyclohexamine, PCE

(29) Pyrrolidine analog of phencyclidine ....................... 7458Some trade or other names: 1-(1-phenylcyclohexyl)-

pyrrolidine, PCPy, PHP(30) Thiophene analog of phencyclidine ....................... 7470

Some trade or other names: 1-[1-(2-thienyl)-cyclohexyl]-piperidine, 2-thienylanalog ofphencyclidine, TPCP, TCP

(31) 1-[1-(2-thienyl)cyclohexyl]pyrrolidine ...................... 7473Some other names: TCPy

(e) Depressants. Unless specificallyexcepted or unless listed in anotherschedule, any material, compound,mixture, or preparation which contains


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21 CFR Ch. II (4–1–01 Edition)§ 1308.12

any quantity of the following sub-stances having a depressant effect onthe central nervous system, includingits salts, isomers, and salts of isomerswhenever the existence of such salts,isomers, and salts of isomers is possiblewithin the specific chemical designa-tion:(1) gamma-hydroxybutyric acid (some other names in-

clude GHB; gamma-hydroxybutyrate; 4-hydroxybutyrate; 4-hydroxybutanoic acid; sodiumoxybate; sodium oxybutyrate) .................................... 2010

(2) Mecloqualone ........................................................... 2572(3) Methaqualone ........................................................... 2565

(f) Stimulants. Unless specifically ex-cepted or unless listed in anotherschedule, any material, compound,mixture, or preparation which containsany quantity of the following sub-stances having a stimulant effect onthe central nervous system, includingits salts, isomers, and salts of isomers:(1) Aminorex (Some other names: aminoxaphen; 2-

amino-5-phenyl-2-oxazoline; or 4,5-dihydro-5-phenly-2-oxazolamine) ............................................... 1585

(2) Cathinone ................................................................. 1235Some trade or other names: 2-amino-1-phenyl-1-

propanone, alpha-aminopropiophenone, 2-aminopropiophenone, and norephedrone

(3) Fenethylline .............................................................. 1503(4) Methcathinone (Some other names: 2-

(methylamino)-propiophenone; alpha-(methylamino)propiophenone; 2-(methylamino)-1-phenylpropan-1-one; alpha-N-methylaminopropiophenone; monomethylpropion;ephedrone; N-methylcathinone; methylcathinone;AL–464; AL–422; AL–463 and UR1432), its salts,optical isomers and salts of optical isomers .............. 1237

(5) (±)cis-4-methylaminorex ((±)cis-4,5-dihydro-4-meth-yl-5-phenyl-2-oxazolamine) ........................................ 1590

(6) N-ethylamphetamine ................................................ 1475(7) N,N-dimethylamphetamine (also known as N,N-

alpha-trimethyl-benzeneethanamine; N,N-alpha-trimethylphenethylamine) ........................................... 1480

(g) Temporary listing of substances sub-ject to emergency scheduling. Any mate-rial, compound, mixture or preparationwhich contains any quantity of the fol-lowing substances:(1) N-[1-benzyl-4-piperidyl]-N-phenylpropanamide

(benzylfentanyl), its optical isomers, salts and saltsof isomers ................................................................... 9818

(2) N-[1-(2-thienyl)methyl-4-piperidyl]-N-phenylpropanamide (thenylfentanyl), its opticalisolers, salts and salts of isomers .............................. 9834

[39 FR 22141, June 20, 1974]


§ 1308.12 Schedule II.(a) Schedule II shall consist of the

drugs and other substances, by what-ever official name, common or usualname, chemical name, or brand namedesignated, listed in this section. Eachdrug or substance has been assignedthe Controlled Substances Code Num-ber set forth opposite it.

(b) Substances, vegetable origin orchemical synthesis. Unless specificallyexcepted or unless listed in anotherschedule, any of the following sub-stances whether produced directly orindirectly by extraction from sub-stances of vegetable origin, or inde-pendently by means of chemical syn-thesis, or by a combination of extrac-tion and chemical synthesis:

(1) Opium and opiate, and any salt,compound, derivative, or preparationof opium or opiate excludingapomorphine, thebaine-derivedbutorphanol, dextrorphan, nalbuphine,nalmefene, naloxone, and naltrexone,and their respective salts, but includ-ing the following:(1) Raw opium ............................................................... 9600(2) Opium extracts ......................................................... 9610(3) Opium fluid ............................................................... 9620(4) Powdered opium ...................................................... 9639(5) Granulated opium ..................................................... 9640(6) Tincture of opium ..................................................... 9630(7) Codeine .................................................................... 9050(8) Dihydroetorphine ...................................................... 9334(9) Ethylmorphine .......................................................... 9190(10) Etorphine hydrochloride ......................................... 9059(11) Hydrocodone .......................................................... 9193(12) Hydromorphone ...................................................... 9150(13) Metopon ................................................................. 9260(14) Morphine ................................................................ 9300(15) Oxycodone ............................................................. 9143(16) Oxymorphone ......................................................... 9652(17) Thebaine ................................................................ 9333

(2) Any salt, compound, derivative, orpreparation thereof which is chemi-cally equivalent or identical with anyof the substances referred to in para-graph (b) (1) of this section, except thatthese substances shall not include theisoquinoline alkaloids of opium.

(3) Opium poppy and poppy straw.(4) Coca leaves (9040) and any salt,

compound, derivative or preparation ofcoca leaves (including cocaine (9041)and ecgonine (9180) and their salts, iso-mers, derivatives and salts of isomersand derivatives), and any salt, com-pound, derivative, or preparationthereof which is chemically equivalentor identical with any of these sub-stances, except that the substances


85


shall not include decocainized cocaleaves or extraction of coca leaves,whhch extractions do not contain co-caine or ecgonine.

(5) Concentrate of poppy straw (thecrude extract of poppy straw in eitherliquid, solid or powder form which con-tains the phenanthrene alkaloids of theopium poppy), 9670.

(c) Opiates. Unless specifically ex-cepted or unless in another scheduleany of the following opiates, includingits isomers, esters, ethers, salts andsalts of isomers, esters and etherswhenever the existence of such iso-mers, esters, ethers, and salts is pos-sible within the specific chemical des-ignation, dextrorphan andlevopropoxyphene excepted:(1) Alfentanil ................................................................... 9737(2) Alphaprodine ............................................................ 9010(3) Anileridine ................................................................. 9020(4) Bezitramide .............................................................. 9800(5) Bulk dextropropoxyphene (non-dosage forms) ........ 9273(6) Carfentanil ................................................................ 9743(7) Dihydrocodeine ........................................................ 9120(8) Diphenoxylate ........................................................... 9170(9) Fentanyl .................................................................... 9801(10) Isomethadone ......................................................... 9226(11) Levo-alphacetylmethadol ....................................... 9648

[Some other names: levo-alpha-acetylmethadol,levomethadyl acetate, LAAM]

(12) Levomethorphan .................................................... 9210(13) Levorphanol ............................................................ 9220(14) Metazocine ............................................................. 9240(15) Methadone ............................................................. 9250(16) Methadone-Intermediate, 4-cyano-2-

dimethylamino-4,4-diphenyl butane ........................... 9254(17) Moramide-Intermediate, 2-methyl-3-morpholino-1,

1-diphenylpropane-carboxylic acid ............................. 9802(18) Pethidine (meperidine) ........................................... 9230(19) Pethidine-Intermediate-A, 4-cyano-1-methyl-4-

phenylpiperidine ......................................................... 9232(20) Pethidine-Intermediate-B, ethyl-4-

phenylpiperidine-4-carboxylate .................................. 9233(21) Pethidine-Intermediate-C, 1-methyl-4-

phenylpiperidine-4-carboxylic acid ............................. 9234(22) Phenazocine ........................................................... 9715(23) Piminodine .............................................................. 9730(24) Racemethorphan .................................................... 9732(25) Racemorphan ......................................................... 9733(26) Remifentanil ........................................................... 9739(27) Sufentanil ............................................................... 9740

(d) Stimulants. Unless specifically ex-cepted or unless listed in anotherschedule, any material, compound,mixture, or preparation which containsany quantity of the following sub-stances having a stimulant effect onthe central nervous system:(1) Amphetamine, its salts, optical isomers, and salts

of its optical isomers .................................................. 1100(2) Methamphetamine, its salts, isomers, and salts of

its isomers .................................................................. 1105(3) Phenmetrazine and its salts ..................................... 1631(4) Methylphenidate ....................................................... 1724

(e) Depressants. Unless specificallyexcepted or unless listed in anotherschedule, any material, compound,mixture, or preparation which containsany quantity of the following sub-stances having a depressant effect onthe central nervous system, includingits salts, isomers, and salts of isomerswhenever the existence of such salts,isomers, and salts of isomers is possiblewithin the specific chemical designa-tion:(1) Amobarbital .............................................................. 2125(2) Glutethimide ............................................................. 2550(3) Pentobarbital ............................................................ 2270(4) Phencyclidine ........................................................... 7471(5) Secobarbital ............................................................. 2315

(f) Hallucinogenic substances.(1) Nabilone ................................................................... 7379

[Another name for nabilone: (±)-trans-3-(1,1-dimethylheptyl)-6,6a,7,8,10,10a-hexahydro-1-hy-droxy-6,6-dimethyl-9H-dibenzo[b,d]pyran-9-one]

(g) Immediate precursors. Unless spe-cifically excepted or unless listed inanother schedule, any material, com-pound, mixture, or preparation whichcontains any quantity of the followingsubstances:

(1) Immediate precursor to amphet-amine and methamphetamine:(i) Phenylacetone ........................................................... 8501

Some trade or other names: phenyl-2-propanone;P2P; benzyl methyl ketone; methyl benzyl ke-tone;

(2) Immediate precursors tophencyclidine (PCP):(i) 1-phenylcyclohexylamine .......................................... 7460(ii) 1-piperidinocyclohexanecarbonitrile (PCC) .............. 8603

[39 FR 22142, June 20, 1974]


§ 1308.13 Schedule III.(a) Schedule III shall consist of the


(b) Stimulants. Unless specifically ex-cepted or unless listed in anotherschedule, any material, compound,mixture, or preparation which containsany quantity of the following sub-stances having a stimulant effect on


86

21 CFR Ch. II (4–1–01 Edition)§ 1308.13

the central nervous sxstem, includingits salts, isomers (whether optical, po-sition, or geometric), and salts of suchisomers whenever the existence of suchsalts, isomers, and salts of isomers ispossible within the specific chemicaldesignation:(1) Those compounds, mixtures, or preparations in

dosage unit form containing any stimulant sub-stances listed in schedule II which compounds, mix-tures, or preparations were listed on August 25,1971, as excepted compounds under § 1308.32, andany other drug of the quantitative compositionshown in that list for those drugs or which is thesame except that it contains a lesser quantity ofcontrolled substances ................................................ 1405

(2) Benzphetamine ........................................................ 1228(3) Chlorphentermine ..................................................... 1645(4) Clortermine ............................................................... 1647(5) Phendimetrazine ...................................................... 1615

(c) Depressants. Unless specificallyexcepted or unless listed in anotherschedule, any material, compound,mixture, or preparation which containsany quantity of the following sub-stances having a depressant effect onthe central nervous system:(1) Any compound, mixture or preparation containing:

(i) Amobarbital ................................................. 2126(ii) Secobarbital ............................................... 2316(iii) Pentobarbital ............................................. 2271

or any salt thereof and one or more other activemedicinal ingredients which are not listed in anyschedule.

(2) Any suppository dosage form containing:(i) Amobarbital ................................................. 2126(ii) Secobarbital ............................................... 2316(iii) Pentobarbital ............................................. 2271

or any salt of any of these drugs and approved bythe Food and Drug Administration for marketingonly as a suppository.

(3) Any substance which contains any quantity of aderivative of barbituric acid or any salt thereof ......... 2100

(4) Chlorhexadol ............................................................ 2510(5) Any drug product containing gamma hydroxybutyric

acid, including its salts, isomers, and salts of iso-mers, for which an application is approved undersection 505 of the Federal Food, Drug, and Cos-metic Act .................................................................... 2012

(6) Ketamine, its salts, isomers, and salts of isomers .. 7285[Some other names for ketamine: (±)-2-(2-

chlorophenyl)-2-(methylamino)-cyclohexanone](7) Lysergic acid ............................................................ 7300(8) Lysergic acid amide ................................................. 7310(9) Methyprylon .............................................................. 2575(10) Sulfondiethylmethane ............................................. 2600(11) Sulfonethylmethane ................................................ 2605(12) Sulfonmethane ....................................................... 2610(13) Tiletamine and zolazepam or any salt thereof ...... 7295

Some trade or other names for a tiletamine-zolazepam combination product:

Telazol..Some trade or other names for tiletamine:

2-(ethylamino)-2-(2-thienyl)-cyclohexanone..Some trade or other names for zolazepam:

4-(2-fluorophenyl)-6,8-dihydro-1,3,8-trimethylpyrazolo-[3,4-e] [1,4]-diazepin-7(1H)-one, flupyrazapon..

(d) Nalorphine 9400.

(e) Narcotic Drugs. Unless specificallyexcepted or unless listed in anotherschedule, any material, compound,mixture, or preparation containing anyof the following narcotic drugs, ortheir salts calculated as the free anhy-drous base or alkaloid, in limited quan-tities as set forth below:(1) Not more than 1.8 grams of codeine per 100 milli-

liters or not more than 90 milligrams per dosageunit, with an equal or greater quantity of anisoquinoline alkaloid of opium .................................... 9803

(2) Not more than 1.8 grams of codeine per 100 milli-liters or not more than 90 milligrams per dosageunit, with one or more active, nonnarcotic ingredi-ents in recognized therapeutic amounts .................... 9804

(3) Not more than 300 milligrams of dihydrocodeinone(hydrocodone) per 100 milliliters or not more than15 milligrams per dosage unit, with a fourfold orgreater quantity of an isoquinoline alkaloid of opium 9805

(4) Not more than 300 milligrams of dihydrocodeinone(hydrocodone) per 100 milliliters or not more than15 milligrams per dosage unit, with one or more ac-tive nonnarcotic ingredients in recognized thera-peutic amounts ........................................................... 9806

(5) Not more than 1.8 grams of dihydrocodeine per100 milliliters or not more than 90 milligrams perdosage unit, with one or more active nonnarcotic in-gredients in recognized therapeutic amounts ............ 9807

(6) Not more than 300 milligrams of ethylmorphine per100 milliliters or not more than 15 milligrams perdosage unit, with one or more active, nonnarcotic in-gredients in recognized therapeutic amounts ............ 9808

(7) Not more than 500 milligrams of opium per 100milliliters or per 100 grams or not more than 25 milli-grams per dosage unit, with one or more active,nonnarcotic ingredients in recognized therapeuticamounts ...................................................................... 9809

(8) Not more than 50 milligrams of morphine per 100milliliters or per 100 grams, with one or more active,nonnarcotic ingredients in recognized therapeuticamounts ...................................................................... 9810

(f) Anabolic steroids. Unless specifi-cally excepted or unless listed in an-other schedule, any material, com-pound, mixture, or preparation con-taining any quantity of the followingsubstances, including its salts, isomers,and salts of isomers whenever the ex-istence of such salts of isomers is pos-sible within the specific chemical des-ignation:

(1) Anabolic Steroids ................................4000

(g) Hallucinogenic substances.

(1) Dronabinol (synthetic) in sesame oiland encapsulated in a soft gelatin capsule ina U.S. Food and Drug Administration ap-proved product—7369.

[Some other names for dronabinol: (6aR-trans)-6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3-pentyl-6H-dibenzo [b,d]pyran-1-ol] or (-)-delta-9-(trans)-tetrahydrocannabinol]


87


(2) [Reserved]

[39 FR 22142, June 20, 1974, as amended at 41FR 43401, Oct. 1, 1976; 43 FR 3359, Jan. 25, 1978;44 FR 40888, July 13, l979; 46 FR 52334, Oct. 27,1981; 51 FR 5320, Feb. 13, 1986; 52 FR 2222, Jan.21, 1987; 52 FR 5952, Feb. 27, 1987; 56 FR 5754,Feb. 13, 1991; 56 FR 11932, Mar. 21, 1991; 62 FR13968, Mar. 24, 1997; 64 FR 35930, July 2, 1999;64 FR 37675, July 13, 1999; 65 FR 13238, Mar.13, 2000; 65 FR 17440, Apr. 3, 2000]

§ 1308.14 Schedule IV.(a) Schedule IV shall consist of the


(b) Narcotic drugs. Unless specificallyexcepted or unless listed in anotherschedule, any material, compound,mixture, or preparation containing anyof the following narcotic drugs, ortheir salts calculated as the free anhy-drous base or alkaloid, in limited quan-tities as set forth below:(1) Not more than 1 milligram of difenoxin and not less

than 25 micrograms of atropine sulfate per dosageunit .............................................................................. 9167

(2) Dextropropoxyphene (alpha-(∂)-4-dimethylamino-1,2-diphenyl-3-methyl-2-propionoxybutane) ............... 9278

(c) Depressants. Unless specificallyexcepted or unless listed in anotherschedule, any material, compound,mixture, or preparation which containsany quantity of the following sub-stances, including its salts, isomers,and salts of isomers whenever the ex-istence of such salts, isomers, and saltsof isomers is possible within the spe-cific chemical designation:(1) Alprazolam ........................................................... 2882(2) Barbital ................................................................. 2145(3) Bromazepam ........................................................ 2748(4) Camazepam ......................................................... 2749(5) Chloral betaine ..................................................... 2460(6) Chloral hydrate .................................................... 2465(7) Chlordiazepoxide ................................................. 2744(8) Clobazam ............................................................. 2751(9) Clonazepam ......................................................... 2737(10) Clorazepate ......................................................... 2768(11) Clotiazepam ......................................................... 2752(12) Cloxazolam .......................................................... 2753(13) Delorazepam ....................................................... 2754(14) Diazepam ............................................................ 2765(15) Estazolam ............................................................ 2756(16) Ethchlorvynol ....................................................... 2540(17) Ethinamate .......................................................... 2545(18) Ethyl loflazepate .................................................. 2758(19) Fludiazepam ........................................................ 2759(20) Flunitrazepam ...................................................... 2763(21) Flurazepam .......................................................... 2767(22) Halazepam .......................................................... 2762

(23) Haloxazolam ........................................................ 2771(24) Ketazolam ............................................................ 2772(25) Loprazolam .......................................................... 2773(26) Lorazepam ........................................................... 2885(27) Lormetazepam ..................................................... 2774(28) Mebutamate ......................................................... 2800(29) Medazepam ......................................................... 2836(30) Meprobamate ...................................................... 2820(31) Methohexital ........................................................ 2264(32) Methylphenobarbital (mephobarbital) .................. 2250(33) Midazolam ........................................................... 2884(34) Nimetazepam ...................................................... 2837(35) Nitrazepam .......................................................... 2834(36) Nordiazepam ....................................................... 2838(37) Oxazepam ........................................................... 2835(38) Oxazolam ............................................................ 2839(39) Paraldehyde ........................................................ 2585(40) Petrichloral ........................................................... 2591(41) Phenobarbital ...................................................... 2285(42) Pinazepam ........................................................... 2883(43) Prazepam ............................................................ 2764(44) Quazepam ........................................................... 2881(45) Temazepam ......................................................... 2925(46) Tetrazepam ......................................................... 2886(47) Triazolam ............................................................. 2887(48) Zaleplon .............................................................. 2781(49) Zolpidem .............................................................. 2783

(d) Fenfluramine. Any material, com-pound, mixture, or preparation whichcontains any quantity of the followingsubstances, including its salts, isomers(whether optical, position, or geo-metric), and salts of such isomers,whenever the existence of such salts,isomers, and salts of isomers is pos-sible:(1) Fenfluramine ............................................................ 1670

(e) Stimulants. Unless specifically ex-cepted or unless listed in anotherschedule, any material, compound,mixture, or preparation which containsany quantity of the following sub-stances having a stimulant effect onthe central nervous system, includingits salts, isomers and salts of isomers:(1) Cathine ((∂)-norpseudoephedrine) ......................... 1230(2) Diethylpropion .......................................................... 1610(3) Fencamfamin ............................................................ 1760(4) Fenproporex ............................................................. 1575(5) Mazindol ................................................................... 1605(6) Mefenorex ................................................................ 1580(7)Modafinil .................................................................... 1680(8) Pemoline (including organometallic complexes and

chelates thereof) ........................................................ 1530(9) Phentermine ............................................................. 1640(10) Pipradrol ................................................................. 1750(11) Sibutramine ............................................................ 1675(12) SPA ((-)-1-dimethylamino- 1,2-diphenylethane) .... 1635

(f) Other substances. Unless specifi-cally excepted or unless listed in an-other schedule, any material, com-pound, mixture or preparation whichcontains any quantity of the followingsubstances, including its salts:(1) Pentazocine .............................................................. 9709(2) Butorphanol (including its optical isomers) .............. 9720

[39 FR 22143, June 20, 1974]


88

21 CFR Ch. II (4–1–01 Edition)§ 1308.15


§ 1308.15 Schedule V.(a) Schedule V shall consist of the

drugs and other substances, by what-ever official name, common or usualname, chemical name, or brand namedesignated, listed in this section.

(b) Narcotic drugs. Unless specificallyexcepted or unless listed in anotherschedule, any material, compound,mixture, or preparation containing anyof the following narcotic drugs andtheir salts, as set forth below:(1) Buprenorphine .......................................................... 9064

(c) Narcotic drugs containing non-nar-cotic active medicinal ingredients. Anycompound, mixture, or preparationcontaining any of the following nar-cotic drugs, or their salts calculated asthe free anhydrous base or alkaloid, inlimited quantities as set forth below,which shall include one or more non-narcotic active medicinal ingredientsin sufficient proportion to confer uponthe compound, mixture, or preparationvaluable medicinal qualities other thanthose possessed by narcotic drugsalone:

(1) Not more than 200 milligrams ofcodeine per 100 milliliters or per 100grams.

(2) Not more than 100 milligrams ofdihydrocodeine per 100 milliliters orper 100 grams.

(3) Not more than 100 milligrams ofethylmorphine per 100 milliliters or per100 grams.

(4) Not more than 2.5 milligrams ofdiphenoxylate and not less than 25micrograms of atropine sulfate per dos-age unit.

(5) Not more than 100 milligrams ofopium per 100 milliliters or per 100grams.

(6) Not more than 0.5 milligram ofdifenoxin and not less than 25micrograms of atropine sulfate per dos-age unit.

(d) Stimulants. Unless specifically ex-empted or excluded or unless listed inanother schedule, any material, com-pound, mixture, or preparation whichcontains any quantity of the followingsubstances having a stimulant effect

on the central nervous system, includ-ing its salts, isomers and salts of iso-mers:

(1) Pyrovalerone ......................................1485.(2) [Reserved]

[39 FR 22143, June 20, 1974, as amended at 43FR 38383, Aug. 28, 1978; 44 FR 40888, July 13,1979; 47 FR 49841, Nov. 3, 1982; 50 FR 8108, Feb.28, 1985; 52 FR 5952, Feb. 27, 1987; 53 FR 10870,Apr. 4, 1988; 56 FR 61372, Dec. 3, 1991]

EXCLUDED NONNARCOTIC SUBSTANCES

§ 1308.21 Application for exclusion of anonnarcotic substance.

(a) Any person seeking to have anynonnarcotic substance which may,under the Federal Food, Drug, and Cos-metic Act (21 U.S.C. 301), be lawfullysold over the counter without a pre-scription, excluded from any schedule,pursuant to section 201(g) (1) of the Act(21 U.S.C. 811 (g) (1)), may apply to theAdministrator, Drug Enforcement Ad-ministration, Department of Justice,Washington, DC 20537.

(b) An application for an exclusionunder this section shall contain the fol-lowing information:

(1) The name and address of the ap-plicant;

(2) The name of the substance forwhich exclusion is sought; and

(3) The complete quantitative com-position of the substance.

(c) Within a reasonable period oftime after the receipt of an applicationfor an exclusion under this section, theAdministrator shall notify the appli-cant of his acceptance or nonaccept-ance of his application, and if not ac-cepted, the reason therefore. The Ad-ministrator need not accept an applica-tion for filing if any of the require-ments prescribed in paragraph (b) ofthis section is lacking or is not setforth as to be readily understood. If theapplicant desires, he may amend theapplication to meet the requirementsof paragraph (b) of this section. If theapplication is accepted for filing, theAdministrator shall issue and publishin the FEDERAL REGISTER his order onthe application, which shall include areference to the legal authority underwhich the order is issued and the find-ings of fact and conclusions of lawupon which the order is based. Thisorder shall specify the date on which it


89


shall take effect. The Administratorshall permit any interested person tofile written comments on or objectionsto the order within 60 days of the dateof publication of his order in the FED-ERAL REGISTER. If any such commentsor objections raise significant issuesregarding any finding of fact or conclu-sion of law upon which the order isbased, the Administrator shall imme-diately suspend the effectiveness of theorder until he may reconsider the ap-plication in light of the comments andobjections filed. Thereafter, the Ad-ministrator shall reinstate, revoke, oramend his original order as he deter-mines appropriate.

(d) The Administrator may at anytime revoke any exclusion granted pur-suant to section 201(g) of the Act (21U.S.C. 811(g)) by following the proce-dures set forth in paragraph (c) of thissection for handling an application foran exclusion which has been acceptedfor filing.

§ 1308.22 Excluded substances.The following nonnarcotic substances

which may, under the Federal Food,Drug, and Cosmetic Act (21 U.S.C. 301),be lawfully sold over the counter with-out a prescription, are excluded fromall schedules pursuant to section 201(g)(1) of the Act (21 U.S.C. 811(g) (1)):

EXCLUDED NONNARCOTIC PRODUCTS

Company Trade name NDC code Form Controlled substance (mg or mg/ml)

Bioline Laboratories ........... Theophed .......................... 00719–1945 TB Phenobarbital .................... 8.00Goldline Laboratories ........ Guiaphed Elixir ................. 00182–1377 EL Phenobarbital .................... 4.00Goldline Laboratories ........ Tedrigen Tablets ............... 00182–0134 TB Phenobarbital .................... 8.00Hawthorne Products Inc .... Choate’s Leg Freeze ........ ........................ LQ Chloral hydrate ................. 246.67Parke-Davis & Co .............. Tedral ................................ 00071–0230 TB Phenobarbital .................... 8.00Parke-Davis & Co .............. Tedral Elixir ....................... 00071–0242 EX Phenobarbital .................... 40.00Parke-Davis & Co .............. Tedral S.A. ........................ 00071–0231 TB Phenobarbital .................... 8.00Parke-Davis & Co .............. Tedral Suspension ............ 00071–0237 SU Phenobarbital .................... 80.00Parmed Pharmacy ............. Asma-Ese ......................... 00349–2018 TB Phenobarbital .................... 8.10Rondex Labs ..................... Azma-Aids ........................ 00367–3153 TB Phenobarbital .................... 8.00Smith Kline Consumer ....... Benzedrex ......................... 49692–0928 IN Propylhexedrine ................ 250.00Sterling Drug, Inc ............... Bronkolixir ......................... 00057–1004 EL Phenobarbital .................... 0.80Sterling Drug, Inc ............... Bronkotabs ........................ 00057–1005 TB Phenobarbital .................... 8.00Vicks Chemical Co ............ Vicks Inhaler ..................... 23900–0010 IN I-Desoxyephedrine ............ 113.00White Hall Labs ................. Primatene (P-tablets) ........ 00573–2940 TB Phenobarbital .................... 8.00

[38 FR 8255, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, l973, and amended at 41 FR16553, Apr. 20, 1976; 41 FR 53477, Dec. 7, 1976; 46 FR 51603, Oct. 21, 1981; 47 FR 45867, Oct. 14,1982; 54 FR 2100, Jan. 19, 1989; 55 FR 12162, Mar. 30, 1990; 62 FR 13968, Mar. 24, 1997]

EXEMPT CHEMICAL PREPARATIONS

§ 1308.23 Exemption of certain chem-ical preparations; application.

(a) The Administrator may, by regu-lation, exempt from the application ofall or any part of the Act any chemicalpreparation or mixture containing oneor more controlled substances listed inany schedule, which preparation ormixture is intended for laboratory, in-dustrial, educational, or special re-search purposes and not for general ad-ministration to a human being or otheranimal, if the preparation or mixtureeither:

(1) Contains no narcotic controlledsubstance and is packaged in such aform or concentration that the pack-aged quantity does not present any sig-

nificant potential for abuse (the type ofpackaging and the history of abuse ofthe same or similar preparations maybe considered in determining the po-tential for abuse of the preparation ormixture); or

(2) Contains either a narcotic or non-narcotic controlled substance and oneor more adulterating or denaturingagents in such a manner, combination,quantity, proportion, or concentration,that the preparation or mixture doesnot present any potential for abuse. Ifthe preparation or mixture contains anarcotic controlled substance, thepreparation or mixture must be formu-lated in such a manner that it incor-porates methods of denaturing or othermeans so that the preparation or mix-ture is not liable to be abused or have


90

21 CFR Ch. II (4–1–01 Edition)§ 1308.23

ill effects, if abused, and so that thenarcotic substance cannot in practicebe removed.

(b) Any person seeking to have anypreparation or mixture containing acontrolled substance and one or morenoncontrolled substances exemptedfrom the application of all or any partof the Act, pursuant to paragraph (a) ofthis section, may apply to the Admin-istrator, Drug Enforcement Adminis-tration, Department of Justice, Wash-ington, DC 20537.

(c) An application for an exemptionunder this section shall contain the fol-lowing information:

(1) The name, address, and registra-tion number, if any, of the applicant;

(2) The name, address, and registra-tion number, if any, of the manufac-turer or importer of the preparation ormixture, if not the applicant;

(3) The exact trade name or otherdesignation of the preparation or mix-ture;

(4) The complete qualitative andquantitative composition of the prepa-ration or mixture (including all activeand inactive ingredients and all con-trolled and noncontrolled substances);

(5) The form of the immediate con-tainer in which the preparation or mix-ture will be distributed with sufficientdescriptive detail to identify the prepa-ration or mixture (e.g., bottle, packet,vial, soft plastic pillow, agar gel plate,etc.);

(6) The dimensions or capacity of theimmediate container of the prepara-tion or mixture;

(7) The label and labeling, as definedin part 1300 of this chapter, of the im-mediate container and the commercialcontainers, if any, of the preparationor mixture;

(8) A brief statement of the factswhich the applicant believes justify thegranting of an exemption under thisparagraph, including information onthe use to which the preparation ormixture will be put;

(9) The date of the application; and(10) Which of the information sub-

mitted on the application, if any, isdeemed by the applicant to be a tradesecret or otherwise confidential and en-titled to protection under subsection402(a)(8) of the Act (21 U.S.C. 842(a) (8))

or any other law restricting public dis-closure of information.

(d) The Administrator may requirethe applicant to submit such docu-ments or written statements of factrelevant to the application as he deemsnecessary to determine whether the ap-plication should be granted.

(e) Within a reasonable period oftime after the receipt of an applicationfor an exemption under this section,the Administrator shall notify the ap-plicant of his acceptance or nonaccept-ance of his application, and if not ac-cepted, the reason therefor. The Ad-ministrator need not accept an applica-tion for filing if any of the require-ments prescribed in paragraph (c) or re-quested pursuant to paragraph (d) islacking or is not set forth as to bereadily understood. If the applicant de-sires, he may amend the application tomeet the requirements of paragraphs(c) and (d) of this section. If the appli-cation is accepted for filing, the Ad-ministrator shall issue and publish inthe FEDERAL REGISTER his order on theapplication, which shall include a ref-erence to the legal authority underwhich the order is based. This ordershall specify the date on which it shalltake effect. The Administrator shallpermit any interested person to filewritten comments on or objections tothe order within 60 days of the date ofpublication of his order in the FEDERALREGISTER. If any such comments or ob-jections raise significant issues regard-ing any finding of fact or conclusion oflaw upon which the order is based, theAdministrator shall immediately sus-pend the effectiveness of the orderuntil he may reconsider the applicationin light of the comments and objec-tions filed. Thereafter, the Adminis-trator shall reinstate, revoke, oramend his original order as he deter-mines appropriate.

(f) The Administrator may at anytime revoke or modify any exemptiongranted pursuant to this section by fol-lowing the procedures set forth in para-graph (e) of this section for handling anapplication for an exemption which hasbeen accepted for filing. The Adminis-trator may also modify or revoke thecriteria by which exemptions aregranted (and thereby modify or revokeall preparations and mixtures granted


91


under the old criteria) and modify thescope of exemptions at any time.

[38 FR 8254, Mar. 30, 1973. Redesignated at 38FR 26609, Sept. 24, 1973, and amended at 46FR 28841, May 29, 1981; 62 FR 13968, Mar. 24,1997]

§ 1308.24 Exempt chemical prepara-tions.

(a) The chemical preparations andmixtures approved pursuant to § 1308.23are exempt from application of sec-tions 302, 303, 305, 306, 307, 308, 309, 1002,1003 and 1004 of the Act (21 U.S.C. 822–823, 825–829, 952–954) and § 1301.74 of thischapter, to the extent described inparagraphs (b) to (h) of this section.Substances set forth in paragraph (j) ofthis section shall be exempt from theapplication of sections 305, 306, 307, 308,309, 1002, 1003 and 1004 of the Act (21U.S.C. 825–829, 952–954) and §§ 1301.71—1301.73 and 1301.74 (a), (b), (d), (e) and (f)of this chapter to the extent as herein-after may be provided.

(b) Registration and security: Anyperson who manufactures an exemptchemical preparation or mixture mustbe registered under the Act and complywith all relevant security requirementsregarding controlled substances beingused in the manufacturing processuntil the preparation or mixture is inthe form described in paragraph (i) ofthis section. Any other person whohandles an exempt chemical prepara-tion after it is in the form described inparagraph (i) of this section is not re-quired to be registered under the Actto handle that preparation, and thepreparation is not required to be storedin accordance with security require-ments regarding controlled substances.

(c) Labeling: In lieu of the require-ments set forth in part 1302 of thischapter, the label and the labeling ofan exempt chemical preparation mustbe prominently marked with its fulltrade name or other description andthe name of the manufacturer or sup-plier as set forth in paragraph (i) ofthis section, in such a way that theproduct can be readily identified as anexempt chemical preparation. Thelabel and labeling must also include ina prominent manner the statement‘‘For industrial use only’’ or ‘‘Forchemical use only’’ or ‘‘For in vitro useonly—not for human or animal use’’ or

‘‘Diagnostic reagent—for professionaluse only’’ or a comparable statementwarning the person reading it thathuman or animal use is not intended.The symbol designating the schedule ofthe controlled substance is not re-quired on either the label or the label-ing of the exempt chemical prepara-tion, nor is it necessary to list all in-gredients of the preparation.

(d) Records and reports: Any personwho manufactures an exempt chemicalpreparation or mixture must keep com-plete and accurate records and file allreports required under part 1304 of thischapter regarding all controlled sub-stances being used in the manufac-turing process until the preparation ormixture is in the form described inparagraph (i) of this section. In lieu ofrecords and reports required under part1304 of this chapter regarding exemptchemical preparations, the manufac-turer need only record the name, ad-dress, and registration number, if any,of each person to whom the manufac-turer distributes any exempt chemicalpreparation. Each importer or exporterof an exempt narcotic chemical prepa-ration must submit a semiannual re-port of the total quantity of each sub-stance imported or exported in eachcalendar half-year within 30 days of theclose of the period to the Drug andChemical Evaluation Section, Drug En-forcement Administration, Departmentof Justice, Washington, DC 20537. Anyother person who handles an exemptchemical preparation after it is in theform described in paragraph (i) of thissection is not required to maintainrecords or file reports.

(e) Quotas, order forms, prescrip-tions, import, export, and trans-shipment requirements: Once an ex-empt chemical preparation is in theform described in paragraph (i) of thissection, the requirements regardingquotas, order forms, prescriptions, im-port permits and declarations, exportpermit and declarations, and trans-shipment and intransit permits anddeclarations do not apply. These re-quirements do apply, however, to anycontrolled substances used in manufac-turing the exempt chemical prepara-tion before it is in the form describedin paragraph (i) of this section.


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21 CFR Ch. II (4–1–01 Edition)§ 1308.25

(f) Criminal penalties: No exemptiongranted pursuant to § 1308.23 affects thecriminal liability for illegal manufac-ture, distribution, or possession of con-trolled substances contained in the ex-empt chemical preparation. Distribu-tion, possession, and use of an exemptchemical preparation are lawful forregistrants and nonregistrants only aslong as such distribution, possession,or use is intended for laboratory, in-dustrial, or educational purposes andnot for immediate or subsequent ad-ministration to a human being or otheranimal.

(g) Bulk materials: For materials ex-empted in bulk quantities, the Admin-istrator may prescribe requirementsother than those set forth in para-graphs (b) through (e) of this section ona case-by-case basis.

(h) Changes in chemical preparations:Any change in the quantitative orqualitative composition of the prepara-tion or mixture after the date of appli-cation, or change in the trade name orother designation of the preparation ormixture, set forth in paragraph (i) ofthis section, requires a new applicationfor exemption.

(i) A listing of exempt chemical prep-arations may be obtained by submit-ting a written request to the Drug andChemical Evaluation Section, Drug En-forcement Administration, Wash-ington, DC 20537.

(j) The following substances are des-ignated as exempt chemical prepara-tions for the purposes set forth in thissection.

(1) Chloral. When packaged in asealed, oxygen-free environment, undernitrogen pressure, safeguarded againstexposure to the air.

(2) EmitR Phenobarbital Enzyme Rea-gent B. In one liter quantities eachwith a 5 ml. retention sample for re-packaging as an exempt chemical prep-aration only.

[38 FR 8255, Mar. 30, 1973]

EDITORIAL NOTE: For FEDERAL REGISTER ci-tations affecting § 1308.24, see the List of CFRSections Affected, which appears in theFinding Aids section of th e printed volumeand on GPO Access.

EXCLUDED VETERINARY ANABOLIC

STEROID IMPLANT PRODUCTS

§ 1308.25 Exclusion of a veterinary an-abolic steroid implant product; ap-plication.

(a) Any person seeking to have anyanabolic steroid product, which is ex-pressly intended for administrationthrough implants to cattle or othernonhuman species and which has beenapproved by the Secretary of Healthand Human Services for such adminis-tration, identified as being excludedfrom any schedule, pursuant to section102(41)(B)(i) of the Act (21 U.S.C.802(41)(B)(i)), may apply to the Admin-istrator, Drug Enforcement Adminis-tration, Department of Justice, Wash-ington, DC 20537.

(b) An application for any exclusionunder this section shall be submittedin triplicate and contain the followinginformation:


(2) The name of the product;(3) The chemical structural formula

or description for any anabolic steroidcontained in the product;

(4) A complete description of dosageand quantitative composition of thedosage form;.

(5) The conditions of use includingwhether or not Federal law restrictsthis product to use by or on the orderof a licensed veterinarian;

(6) A description of the delivery sys-tem in which the dosage form will bedistributed with sufficient detail toidentify the product (e.g. 20 cartridgebrown plastic belt);

(7) The label and labeling of the im-mediate container and the commercialcontainers, if any, of the product;.

(8) The name and address of the man-ufacturer of the dosage form if dif-ferent from that of the applicant; and

(9) Evidence that the product hasbeen approved by the Secretary ofHealth and Human Services for admin-istration through implant to cattle orother nonhuman species.

(c) Within a reasonable period oftime after the receipt of an applicationfor an exclusion under this section, the


93


Administrator shall notify the appli-cant of his acceptance or nonaccept-ance of the application, and if not ac-cepted, the reason therefore. The Ad-ministrator need not accept an applica-tion for filing if any of the require-ments prescribed in paragraph (b) ofthis section is lacking or is not setforth as to be readily understood. Theapplicant may amend the applicationto meet the requirements of paragraph(b) of this section. If the application isaccepted for filing, the Administratorshall issue and have published in theFEDERAL REGISTER his order on the ap-plication, which shall include a ref-erence to the legal authority underwhich the order is issued and the find-ings of fact and conclusions of lawupon which the order is based. Thisorder shall specify the date on which itwill take effect. The Administratorshall permit any interested person tofile written comments on or objectionsto the order within 60 days of the dateof publication in the FEDERAL REG-ISTER. If any such comments or objec-tions raise significant issues regardingany finding of fact or conclusion of lawupon which the order is based, the Ad-ministrator shall immediately suspendthe effectiveness of the order until hemay reconsider the application in lightof the comments and objections filed.Thereafter, the Administrator shall re-instate, revoke, or amend his originalorder as he determines appropriate.

(d) The Administrator may at anytime revoke or modify any designationof excluded status granted pursuant tothis section by following the proce-dures set forth in paragraph (c) of thissection for handling an application foran exclusion which has been acceptedfor filing.

[56 FR 42936, Aug. 30, 1991]

§ 1308.26 Excluded veterinary anabolicsteroid implant products.

(a) Products containing an anabolicsteroid, that are expressly intended foradministration through implants tocattle or other nonhuman species andwhich have been approved by the Sec-retary of Health and Human Servicesfor such administration are excludedfrom all schedules pursuant to section102(41)(B)(I) of the Act (21 U.S.C.802(41)(B)(I)). A listing of the excluded

products may be obtained by submit-ting a written request to the Drug andChemical Evaluation Section, Drug En-forcement Administration, WashingtonDC 20537.

(b) In accordance with section102(41)(B)(ii) of the Act (21 U.S.C.802(41)(B)(ii)) if any person prescribes,dispenses, or distributes a product list-ed in paragraph (a) of this section forhuman use, such person shall be con-sidered to have prescribed, dispensed,or distributed an anabolic steroid with-in the meaning of section 102(41)(A) ofthe Act (21 U.S.C. 802(41)(A)).

[56 FR 42936, Aug. 30, 1991, as amended at 57FR 19534, May 7, 1992; 58 FR 15088, Mar. 19,1993; 62 FR 13967, Mar. 24, 1997]

EXEMPTED PRESCRIPTION PRODUCTS

§ 1308.31 Application for exemption ofa nonnarcotic prescription product.

(a) Any person seeking to have anycompound, mixture, or preparationcontaining any nonnarcotic controlledsubstance listed in § 1308.12(e), or in§ 1308.13 (b) or (c), or in § 1308.14, or in§ 1308.15, exempted from application ofall or any part of the Act pursuant tosection 201(g)(3)(A), of the Act (21U.S.C. 811(g)(3)(A). may apply to theAdministrator, Drug Enforcement Ad-ministration, Washington, DC 20537, forsuch exemption.

(b) An application for an exemptionunder this section shall contain the fol-lowing information:

(1) The complete quantitative com-position of the dosage form.

(2) Description of the unit dosageform together with complete labeling.

(3) A summary of the pharmacologyof the product including animal inves-tigations and clinical evaluations andstudies, with emphasis on the psychicand/or physiological dependence liabil-ity (this must be done for each of theactive ingredients separately and forthe combination product).

(4) Details of synergisms and antag-onisms among ingredients.

(5) Deterrent effects of the noncon-trolled ingredients.

(6) Complete copies of all literaturein support of claims.

(7) Reported instances of abuse.(8) Reported and anticipated adverse

effects.


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21 CFR Ch. II (4–1–01 Edition)§ 1308.32

(9) Number of dosage units producedfor the past 2 years.

(c) Within a reasonable period oftime after the receipt of an applicationfor an exemption under this section,the Administrator shall notify the ap-plicant of his acceptance or non-ac-ceptance of the application, and if notaccepted, the reason therefor. The Ad-ministrator need not accept an applica-tion for filing if any of the require-ments prescribed in paragraph (b) ofthis section is lacking or is not setforth so as to be readily understood. Ifthe applicant desires, he may amendthe application to meet the require-ments of paragraph (b) of this section.If accepted for filing, the Adminis-trator shall publish in the FEDERALREGISTER general notice of this pro-posed rulemaking in granting or deny-ing the application. Such notice shallinclude a reference to the legal author-ity under which the rule is proposed, astatement of the proposed rule grant-ing or denying an exemption, and, inthe discretion of the Administrator, asummary of the subjects and issues in-volved. The Administrator shall permitany interested person to file writtencomments on or objections to the pro-posal and shall designate in the noticeof proposed rule making the time dur-ing which such filings may be made.After consideration of the applicationand any comments on or objections tohis proposed rulemaking, the Adminis-trator shall issue and publish in theFEDERAL REGISTER his final order onthe application, which shall set forththe findings of fact and conclusions oflaw upon which the order is based. Thisorder shall specify the date on which itshall take effect, which shall not beless than 30 days from the date of pub-lication in the FEDERAL REGISTER un-less the Administrator finds that con-ditions of public health or safety neces-sitate an earlier effective date, inwhich event the Administrator shallspecify in the order his findings as tosuch conditions.

(d) The Administrator may revokeany exemption granted pursuant tosection 201(g)(3)(A) of the Act (21 U.S.C.811(g)(3)(A)) by following the proce-dures set forth in paragraph (c) of thissection for handling an application for

an exemption which has been acceptedfor filing.

[38 FR 8254, Mar. 30, 1973. Redesignated at 38FR 26609, Sept. 24, 1973, as amended at 44 FR18968, Mar. 30, 1979; 52 FR 9803, Mar. 27, 1987]

§ 1308.32 Exempted prescription prod-ucts.

The compounds, mixtures, or prep-arations that contain a nonnarcoticcontrolled substance listed in§ 1308.12(e) or in § 1308.13 (b) or (c) or in§ 1308.14 or in § 1308.15 listed in theTable of Exempted Prescription Prod-ucts have been exempted by the Ad-ministrator from the application ofsections 302 through 305, 307 through309, 1002 through 1004 of the Act (21U.S.C. 822–825, 827–829, and 952–954) and§§ 1301.13, 1301.22, and §§ 1301.71 through1301.76 of this chapter for administra-tive purposes only. An exception to theabove is that those products containingbutalbital shall not be exempt from therequirement of 21 U.S.C. 952–954 con-cerning importation, exportation,transshipment and in-transit shipmentof controlled substances. Any deviationfrom the quantitative composition ofany of the listed drugs shall require apetition of exemption in order for theproduct to be exempted. A listing ofthe Exempted Prescription Productsmay be obtained by submitting a writ-ten request to the Drug and ChemicalEvaluation Section, Drug EnforcementAdministration, Washington, DC 20537.

[62 FR 13967, Mar. 24, 1997]

EXEMPT ANABOLIC STEROID PRODUCTS

§ 1308.33 Exemption of certain ana-bolic steroid products; application.

(a) The Administrator, upon the rec-ommendation of the Secretary ofHealth and Human Services, may, byregulation, exempt from the applica-tion of all or any part of the Act anycompound, mixture, or preparationcontaining an anabolic steroid as de-fined in part 1300 of this chapter if, be-cause of its concentration, preparation,mixture or delivery system, it has nosignificant potential for abuse (Pub. L.101–647 section 1903(a)).

(b) Any person seeking to have anycompound, mixture, or preparation


95


containing an anabolic steroid as de-fined in part 1300 of this chapter ex-empted from the application of all orany part of the Act, pursuant to para-graph (a) of this section, may apply tothe Administrator, Drug EnforcementAdministration, Department of Jus-tice, Washington, DC 20537.

(c) An application for an exemptionunder this section shall be submittedin triplicate and contain the followinginformation:


(2) The name of the product;(3) The chemical structural formula

or description for any anabolic steroidcontained in the product;

(4) The complete description of dos-age and quantitative composition ofthe dosage form;

(5) A description of the delivery sys-tem, if applicable;

(6) The indications and conditions foruse in which species, including whetheror not this product is a prescriptiondrug;

(7) Information to facilitate identi-fication of the dosage form, such asshape, color, coating, and scoring;

(8) The label and labeling of the im-mediate container and the commercialcontainers, if any, of the product;

(9) The units in which the dosageform is ordinarily available; and

(10) The facts which the applicant be-lieves justify:

(i) A determination that the producthas no significant potential for abuseand

(ii) a granting of an exemption underthis section.

(d) Within a reasonable period oftime after the receipt of the applica-tion for an exemption under this sec-tion, the Administrator shall notifythe applicant of his acceptance or non-acceptance of the application, and ifnot accepted, the reason therefor. TheAdministrator need not accept an ap-plication for filing if any of the re-quirements prescribed in paragraph (c)of this section is lacking or is not setforth so as to be readily understood.The applicant may amend the applica-tion to meet the requirements of para-graph (c) of this section. If accepted forfiling, the Administrator will requestfrom the Secretary for Health and

Human Services his recommendation,as to whether such product which con-tains an anabolic steroid should be con-sidered for exemption from certain por-tions of the Controlled Substances Act.On receipt of the recommendation ofthe Secretary, the Administrator shallmake a determination as to whetherthe evidence submitted or otherwiseavailable sufficiently establishes thatthe product possesses no significant po-tential for abuse. The Administratorshall issue and publish in the FEDERALREGISTER his order on the application,which shall include a reference to thelegal authority under which the orderis issued, and the findings of fact andconclusions of law upon which theorder is based. This order shall specifythe date on which it will take effect.The Administrator shall permit any in-terested person to file written com-ments on or objections to the orderwithin 60 days of the date of publica-tion of his order in the FEDERAL REG-ISTER. If any such comments or objec-tions raise significant issues regardingany finding of fact or conclusion of lawupon which the order is based, the Ad-ministrator shall immediately suspendthe effectiveness of the order until hemay reconsider the application in lightof the comments and objections filed.Thereafter, the Administrator shall re-instate, revoke, or amend his originalorder as he determines appropriate.

(e) The Administrator may revokeany exemption granted pursuant tosection 1903(a) of Public Law 101–647 byfollowing the procedures set forth inparagraph (d) of this section for han-dling an application for an exemptionwhich has been accepted for filing.

[56 FR 42936, Aug. 30, 1991; 57 FR 10815, Mar.31, 1992, as amended at 62 FR 13968, Mar. 24,1997]

§ 1308.34 Exempt anabolic steroidproducts.

The list of compounds, mixtures, orpreparations that contain an anabolicsteroid that have been exempted by theAdministrator from application of sec-tions 302 through 309 and 1002 through1004 of the Act (21 U.S.C. 822–829 and952–954) and §§ 1301.13, 1301.22, and1301.71 through 1301.76 of this chapterfor administrative purposes only may


96

21 CFR Ch. II (4–1–01 Edition)§ 1308.41

be obtained by submitting a written re-quest to the Drug and Chemical Eval-uation Section, Drug Enforcement Ad-ministration, Washington, DC 20537.

[62 FR 13967, Mar. 24, 1997]

HEARINGS

§ 1308.41 Hearings generally.In any case where the Administrator

shall hold a hearing on the issuance,amendment, or repeal of rules pursuantto section 201 of the Act, the proce-dures for such hearing and accom-panying proceedings shall be governedgenerally by the rulemaking proce-dures set forth in the AdministrativeProcedure Act (5 U.S.C. 551–559) andspecifically by section 201 of the Act (21U.S.C. 811), by §§ 1308.42–1308.51, and by§§ 1316.41–1316.67 of this chapter.

§ 1308.42 Purpose of hearing.If requested by any interested person

after proceedings are initiated pursu-ant to § 1308.43, the Administrator shallhold a hearing for the purpose of re-ceiving factual evidence and expertopinion regarding the issues involvedin the issuance, amendment or repealof a rule issuable pursuant to section201(a) of the Act (21 U.S.C. 811(a)). Ex-tensive argument should not be offeredinto evidence but rather presented inopening or closing statements of coun-sel or in memoranda or proposed find-ings of fact and conclusions of law. Ad-ditional information relating to hear-ings to include waivers or modificationof rules, request for hearing, burden ofproof, time and place, and final orderare set forth in part 1316 of this chap-ter.

[62 FR 13968, Mar. 24, 1997]

§ 1308.43 Initiation of proceedings forrulemaking.

(a) Any interested person may sub-mit a petition to initiate proceedingsfor the issuance, amendment, or repealof any rule or regulation issuable pur-suant to the provisions of section 201 ofthe Act.

(b) Petitions shall be submitted inquintuplicate to the Administrator inthe following form:


(Date)

ADMINISTRATOR, DRUG ENFORCEMENTADMINISTRATIONDepartment of Justice,Washington, DC 20537.

DEAR SIR: The undersigned ———————hereby petitions the Administrator to ini-tiate proceedings for the issuance (amend-ment or repeal) of a rule or regulation pursu-ant to section 201 of the Controlled Sub-stances Act.

Attached hereto and constituting a part ofthis petition are the following:

(A) The proposed rule in the form proposedby the petitioner. (If the petitioner seeks theamendment or repeal of an existing rule, theexisting rule, together with a reference tothe section in the Code of Federal Regula-tions where it appears, should be included.)

(B) A statement of the grounds which thepetitioner relies for the issuance (amend-ment or repeal) of the rule. (Such groundsshall include a reasonably concise statementof the facts relied upon by the petitioner, in-cluding a summary of any relevant medicalor scientific evidence known to the peti-tioner.)

All notices to be sent regarding this peti-tion should be addressed to:


(Name)


(Street Address)


(City and State)

Respectfully yours,


(Signature of petitioner)

(c) Within a reasonable period oftime after the receipt of a petition, theAdministrator shall notify the peti-tioner of his acceptance or nonaccept-ance of the petition, and if not accept-ed, the reason therefor. The Adminis-trator need not accept a petition forfiling if any of the requirements pre-scribed in paragraph (b) of this sectionis lacking or is not set forth so as to bereadily understood. If the petitionerdesires, he may amend the petition tomeet the requirements of paragraph (b)of this section. If accepted for filing, apetition may be denied by the Adminis-trator within a reasonable period oftime thereafter if he finds the groundsupon which the petitioner relies arenot sufficient to justify the initiationof proceedings.


97


(d) The Administrator shall, beforeinitiating proceedings for the issuance,amendment, or repeal of any rule ei-ther to control a drug or other sub-stance, or to transfer a drug or othersubstance from one schedule to an-other, or to remove a drug or othersubstance entirely from the schedules,and after gathering the necessary data,request from the Secretary a scientificand medical evaluation and the Sec-retary’s recommendations as to wheth-er such drug or other substance shouldbe so controlled, transferred, or re-moved as a controlled substance. Therecommendations of the Secretary tothe Administrator shall be binding onthe Administrator as to such scientificand medical matters, and if the Sec-retary recommends that a drug orother substance not be controlled, theAdministrator shall not control thatdrug or other substance.

(e) If the Administrator determinesthat the scientific and medical evalua-tion and recommendations of the Sec-retary and all other relevant data con-stitute substantial evidence of poten-tial for abuse such as to warrant con-trol or additional control over the drugor other substance, or substantial evi-dence that the drug or other sub-stances should be subjected to lessercontrol or removed entirely from theschedules, he shall initiate proceedingsfor control, transfer, or removal as thecase may be.

(f) If and when the Administrator de-termines to initiate proceedings, heshall publish in the FEDERAL REGISTERgeneral notice of any proposed rulemaking to issue, amend, or repeal anyrule pursuant to section 201 of the Act.Such published notice shall include astatement of the time, place, and na-ture of any hearings on the proposal inthe event a hearing is requested pursu-ant to § 1308.44. Such hearings may notbe commenced until after the expira-tion of at least 30 days from the datethe general notice is published in theFEDERAL REGISTER. Such published no-tice shall also include a reference tothe legal authority under which therule is proposed, a statement of theproposed rule, and, in the discretion ofthe Administrator, a summary of thesubjects and issues involved.

(g) The Administrator may permitany interested persons to file writtencomments on or objections to the pro-posal and shall designate in the noticeof proposed rule making the time dur-ing which such filings may be made.

[38 FR 8254, Mar. 30, 1973. Redesignated at 38FR 26609, Sept. 24, 1973, and further redesig-nated and amended at 62 FR 13968, Mar. 24,1997]


(a) Any interested person desiring ahearing on a proposed rulemaking,shall, within 30 days after the date ofpublication of notice of the proposedrulemaking in the FEDERAL REGISTER,file with the Administrator a writtenrequest for a hearing in the form pre-scribed in § 1316.47 of this chapter.

(b) Any interested person desiring toparticipate in a hearing pursuant to§ 1308.41 shall, within 30 days after thedate of publication of the notice ofhearing in the FEDERAL REGISTER, filewith the Administrator a written no-tice of his intention to participate insuch hearing in the form prescribed in§ 1316.48 of this chapter. Any person fil-ing a request for a hearing need notalso file a notice of appearance; the re-quest for a hearing shall be deemed tobe a notice of appearance.

(c) Any interested person may, with-in the period permitted for filing a re-quest for a hearing, file with the Ad-ministrator a waiver of an opportunityfor a hearing or to participate in ahearing, together with a written state-ment regarding his position on thematters of fact and law involved insuch hearing. Such statement, if ad-missible, shall be made a part of therecord and shall be considered in lightof the lack of opportunity for cross-ex-amination in determining the weightto be attached to matters of fact as-serted therein.

(d) If any interested person fails tofile a request for a hearing; or if he sofiles and fails to appear at the hearing,he shall be deemed to have waived hisopportunity for the hearing or to par-ticipate in the hearing, unless he showsgood cause for such failure.

(e) If all interested persons waive orare deemed to waive their opportunityfor the hearing or to participate in the


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21 CFR Ch. II (4–1–01 Edition)§ 1308.45

hearing, the Administrator may cancelthe hearing, if scheduled, and issue hisfinal order pursuant to § 1308.45 withouta hearing.

[38 FR 8254, Mar. 30, 1973. Redesignated at 38FR 26609, Sept. 24, 1973, and further redesig-nated and amended at 62 FR 13968, Mar. 24,1997]

§ 1308.45 Final order.

As soon as practicable after the pre-siding officer has certified the recordto the Administrator, the Adminis-trator shall cause to be published inthe FEDERAL REGISTER his order in theproceeding, which shall set forth thefinal rule and the findings of fact andconclusions of law upon which the ruleis based. This order shall specify thedate on which it shall take effect,which shall not be less than 30 daysfrom the date of publication in theFEDERAL REGISTER unless the Adminis-trator finds that conditions of publichealth or safety necessitate an earliereffective date, in which event the Ad-ministrator shall specify in the orderhis findings as to such conditions.

[38 FR 8254, Mar. 30, 1973. Redesignated at 38FR 26609, Sept. 24, 1973, and further redesig-nated at 62 FR 13968, Mar. 24, 1997]

§ 1308.46 Control required under inter-national treaty.

Pursuant to section 201(d) of the Act(21 U.S.C. 811(d) ), where control of asubstance is required by U.S. obliga-tions under international treaties, con-ventions, or protocols in effect on May1, 1971, the Administrator shall issueand publish in the FEDERAL REGISTERan order controlling such substanceunder the schedule he deems most ap-propriate to carry out obligations.Issuance of such an order shall be with-out regard to the findings required bysubsections 201(a) or 202(b) of the Act(21 U.S.C. 811(a) or 812(b)) and withoutregard to the procedures prescribed by§ 1308.41 or subsections 201 (a) and (b) ofthe Act (21 U.S.C. 811 (a) and (b)). Anorder controlling a substance shall be-come effective 30 days from the date ofpublication in the FEDERAL REGISTER,unless the Administrator finds thatconditions of public health or safetynecessitate an earlier effective date, inwhich event the Administrator shall

specify in the order his findings as tosuch conditions.


§ 1308.47 Control of immediate precur-sors.

Pursuant to section 201(e) of the Act(21 U.S.C. 811(e)), the Administratormay, without regard to the findings re-quired by subsection 201(a) or 202 (b) ofthe Act (21 U.S.C. 811(a) or 812(b)) andwithout regard to the procedures pre-scribed by § 1308.41 or subsections 201(a) and (b) of the Act (21 U.S.C. 811(a)and (b)), issue and publish in the FED-ERAL REGISTER an order controlling animmediate precursor. The order shalldesignate the schedule in which the im-mediate precursor is to be placed,which shall be the same schedule inwhich the controlled substance ofwhich it is an immediate precursor isplaced or any other schedule with ahigher numerical designation. An ordercontrolling an immediate precursorshall become effective 30 days from thedate of publication in the FEDERALREGISTER, unless the Administratorfinds that conditions of public healthor safety necessitate an earlier effec-tive date, in which event the Adminis-trator shall specify in the order hisfindings as to such conditions.


§ 1308.49 Emergency scheduling.

Pursuant to 21 U.S.C. 811(h) and with-out regard to the requirements of 21U.S.C. 811(b) relating to the scientificand medical evaluation of the Sec-retary of Health and Human Services,the Administrator may place a sub-stance into Schedule I on a temporarybasis, if he determines that such actionis necessary to avoid an imminent haz-ard to the public safety. An orderissued under this section may not beeffective before the expiration of 30days from:

(a) The date of publication by the Ad-ministrator of a notice in the FEDERALREGISTER of his intention to issue suchorder and the grounds upon which suchorder is to be issued, and


99


(b) The date the Administrator hastransmitted notification to the Sec-retary of Health and Human Servicesof his intention to issue such order. Anorder issued under this section shall bevacated upon the conclusion of a subse-quent rulemaking proceeding initiatedunder section 201(a) (21 U.S.C. 811(a))with respect to such substance or atthe end of one year from the effectivedate of the order scheduling the sub-stance, except that during the pend-ency of proceedings under section201(a) (21 U.S.C. 811(a)) with respect tothe substance, the Administrator mayextend the temporary scheduling for upto six months.

[51 FR 15318, Apr. 23, 1986. Redesignated andamended at 62 FR 13968, Mar. 24, 1997]

PART 1309—REGISTRATION OFMANUFACTURERS, DISTRIBUTORS,IMPORTERS AND EXPORTERS OFLIST I CHEMICALS

GENERAL INFORMATION

Sec.1309.01 Scope of part 1309.1309.02 Definitions.1309.03 Information; special instructions.

FEES FOR REGISTRATION AND REREGISTRATION

1309.11 Fee amounts.1309.12 Time and method of payment; re-

fund.

REQUIREMENTS FOR REGISTRATION

1309.21 Persons required to register.1309.22 Separate registration for inde-

pendent activities.1309.23 Separate registration for separate

locations.1309.24 Exemption of agents and employees.1309.25 Exemption of certain controlled sub-

stance registrants.1309.26 Exemption of law enforcement offi-

cials.1309.27 Exemption of certain manufacturers.1309.28 Exemption of distributors of regu-

lated prescription drug products.1309.29 Exemption of retail distributors of

regulated drug products.

APPLICATION FOR REGISTRATION

1309.31 Time for application for registra-tion; expiration date.

1309.32 Application forms; contents, signa-ture.

1309.33 Filing of application; joint filings.1309.34 Acceptance for filing; defective ap-

plications.

1309.35 Additional information.1309.36 Amendments to and withdrawals of

applications.

ACTION ON APPLICATIONS FOR REGISTRATION:REVOCATION OR SUSPENSION OF REGISTRATION

1309.41 Administrative review generally.1309.42 Certificate of registration; denial of

registration.1309.43 Suspension or revocation of registra-

tion.1309.44 Suspension of registration pending

final order.1309.45 Extension of registration pending

final order.1309.46 Order to show cause.

HEARINGS

1309.51 Hearings generally.1309.52 Purpose of hearing.1309.53 Request for hearing or appearance;

waiver.1309.54 Burden of proof.1309.55 Time and place of hearing.

MODIFICATION, TRANSFER AND TERMINATIONOF REGISTRATION

1309.61 Modification in registration.1309.62 Termination of registration.1309.63 Transfer of registration.


1309.71 General security requirements.1309.72 Felony conviction; employer respon-

sibilities.1309.73 Employee responsibility to report di-

version.

AUTHORITY: 21 U.S.C. 821, 822, 823, 824, 830,871(b), 875, 877, 958.

SOURCE: 60 FR 32454, June 22, 1995, unlessotherwise noted.

GENERAL INFORMATION

§ 1309.01 Scope of part 1309.

Procedures governing the registra-tion of manufacturers, distributors,importers and exporters of List Ichemicals pursuant to Sections 102, 302,303, 1007 and 1008 of the Act (21 U.S.C.802, 822, 823, 957 and 958) are set forthgenerally by those sections and specifi-cally by the sections of this part.


Any term used in this part shall havethe definition set forth in section 102 ofthe Act (21 U.S.C. 802) or part 1300 ofthis chapter.

[62 FR 13968, Mar. 24, 1997]


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