Drugs and Medication-Final

7/29/2019 Drugs and Medication-Final

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Drugs and Medicines

Krista Lou Dyan M. Bedia



REPUBLIC ACT No. 3720

AN ACT TO ENSURE THE SAFETY AND PURITY OF FOODS,DRUGS, AND COSMETICS BEING MADE AVAILABLE TO THEPUBLIC BY CREATING THE FOOD AND DRUGADMINISTRATION WHICH SHALL ADMINISTER ANDENFORCE THE LAWS PERTAINING THERETO.



Section 1. This Act shall be known as the "Food, Drug, and Cosmetic Act."

CHAPTER II-Declaration of Policy

Section 2. It is hereby declared the policy of the State to insure safe andgood quality supply of food, drug and cosmetic, and to regulate the

production, sale, and traffic of the same to protect the health of the people.

Section 3. In the implementation of the foregoing policy, the Governmentshall in accordance with the provisions of this Act:

(a) Establish standards and quality measures for food, drug, and cosmetic.

(b) Adopt measures to insure pure and safe supply of food, drug, and

cosmetic in the country.CHAPTER III-Creation of the Food and Drug Administration

Section 4. To carry out the provisions of this Act, there is hereby created anoffice to be called the Food and Drug Administration in the Department of Health. Said Administration shall be under the Office of the Secretary andshall have the following functions, powers and duties:

(a) To administer and supervise the implementation of this Act and of therules and regulations issued pursuant to the same.

(b) To provide for the collection of samples of food, drug and cosmetic.

(c) To analyze and inspect food, drug and cosmetic in connection with theimplementation of this Act.



(d) To establish analytical data to serve as basis for the preparation of food,drug and cosmetic standards, and to recommend standards of identity, purity,quality and fill of container.

(e) To issue certificate of compliance with technical requirements to serve asbasis for the issuance of license and spot-check for compliance withregulations regarding operation of food, drug and cosmetic manufacturers andestablishments.

(f) To levy, assess and collect fees for inspection, analysis and testing of products and materials submitted in compliance with the provisions of this Act.

(g) To certify batches of anti-biotic and anti-biotic preparations in compliance

with the provisions of this Act.Section 5. The Food and Drug Administration shall have the followingDivisions:

(a) Inspection and Licensing Division, which shall have charge of the inspectionof food, drug, and cosmetic establishments engaged in their manufacture andsale.

(b) Laboratory Division, which shall conduct all the tests, analyses and trials of products covered by this Act.

Section 6. The Food and Drug Administration shall have a Food and DrugAdministrator who shall be appointed by the Secretary of Health subject to theCivil Service rules and regulations. The compensation of said official shall bedetermined by the Secretary of Health.



CHAPTER VI-Prohibited Acts and Penalties

PROHIBITED ACTS

Section 11. The following acts and the causing thereof are hereby prohibited:

(a) The manufacture, sale, offering for sale or transfer of any food, drug, device or

cosmetic that is adulterated or misbranded.(b) The adulteration or misbranding of any food, drug, device, or cosmetic.

(c) The refusal to permit entry or inspection as authorized by Section twenty-sevenhereof or to allow samples to be collected.

(d) The giving of a guaranty or undertaking referred to in Section twelve (b) hereof

which guaranty or undertaking is false, except by a person who relied upon aguaranty or undertaking to the same effect signed by, and containing the name andaddress of, the person residing in the Philippines from whom he received in good faiththe food, drug, device, or cosmetic or the giving of a guaranty or undertaking referredto in Section twelve (b) which guaranty or undertaking is false.

(e) Forging, counterfeiting, simulating, or falsely representing or without proper

authority using any mark, stamp, tag label, or other identification device authorizedor required by regulations promulgated under the provisions of this Act.

(f) The using by any person to his own advantage, or revealing, other than to theSecretary or officers or employees of the Department or to the courts when relevantin any judicial proceeding under this Act, any information acquired under authority of Section nine, or concerning any method or process which as a trade secret is entitled

to protection.



(g) The alteration, mutilation, destruction, obliteration, or removal of the whole orany part of the labeling of, or the doing of any other act with respect to, a food,drug, device, or cosmetic, if such act is done while such article is held for sale(whether or not the first sale) and results in such article being adulterated ormisbranded.

(h) The use, on the labeling of any drug or in any advertising relating to such drug,of any representation or suggestion that an application with respect to such drug iseffective under Section twenty-one hereof, or that such drug complies with theprovisions of such section.

(i) The use, in labeling, advertising or other sales promotion of any reference to anyreport or analysis furnished in compliance with Section twenty-six hereof.

PENALTIES

Section 12. (a) Any person who violates any of the provisions of Section elevenhereof shall, upon conviction, be subject to imprisonment of not less than sixmonths and one day, but not more than five years, or a fine of not less than onethousand pesos, or both such imprisonment and fine, in the discretion of the Court.(b) No person shall be subject to the penalties of subsection (a) of this section (1)

for having sold, offered for sale or transferred any article and delivered it, if suchdelivery was made in good faith, unless he refuses to furnish on request of theBoard of Food and Drug Inspection or an officer or employee duly designated by theSecretary, the name and address of the person from whom he purchased or receivedsuch article and copies of all documents, if any there be, pertaining to the delivery of the article to him; (2) for having violated Section eleven (a) if he established a

guaranty or undertaking signed by, and containing the name and address of, theperson residing in the Philippines from whom he received in good faith the article,



(3) for having violated Section eleven (a), where the violation exists because the article isadulterated by reason of containing a coal-tar color not permissible under regulationspromulgated by the Secretary under this Act, if such person establishes a guaranty orundertaking signed by, and containing the name and address, of the manufacturer of thecoal-tar color, to the effect that such color is permissible, under applicable regulationspromulgated by the Secretary under this Act.

(c) Any article of food, drug, device, or cosmetic that is adulterated or misbranded whenintroduced into the domestic commerce may be seized and held in custody pendingproceedings pursuant to Section twenty-six (d) hereof, without a hearing or court order,when the Secretary has probable cause to believe from facts found by him or any officeror employee of the Food and Drug Administration that the misbranded article is dangerousto health, or that the labeling of the misbranded articles is fraudulent, or would be in amaterial respect misleading to the injury or damage of the purchaser or consumer.

CHAPTER VII-Definition and Standards for Food

Section 13. Whenever in the judgment of the Secretary such action will promote honestyand fair dealing in the interest of consumers, he shall, upon recommendation of the Foodand Drug Administrator, promulgate regulations fixing and establishing for any food, underits common or usual name so far as practicable, a reasonable definition and standard of identity, a reasonable standard of quality, and/or reasonable standards of fill of container:Provided, That no definition and standard of identity and no standard of quality shall be

established for fresh or dried fruits, fresh or dried vegetables.ADULTERATED FOOD

Section 14. A food shall be deemed to be adulterated: (a) (1) If it bears or contains anypoisonous or deleterious substance which may render it injurious to health; but in casethe substance is not an added substance such food shall not be considered adulteratedunder this clause if the quantity of such substance in such food does not ordinarily renderit injurious to health;



(2) if it bears or contains any added poisonous or added deleterious substance other thenone which is a pesticide chemical in or a raw agricultural commodity for which toleranceshave been established and it conforms to such tolerances;

(3) if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if itis otherwise unfit for food:

(4) if it has been prepared, packed, or held under unsanitary conditions whereby it mayhave become contaminated with filth, or whereby, it may have been rendered injurious tohealth;

(5) if it is, in whole or in part, the product of a diseased animal or of an animal which hasdied otherwise than by slaughter;

(6) if its container is composed, in whole or in part, of any poisonous or deleterioussubstance which may render the contents injurious to health.

(b) (1) If any valuable constituent has been, in whole or in part, omitted or abstractedtherefrom and same has not been substituted by any healthful equivalent of suchconstituent;

(2) if any substance injurious to health has been added or substituted;

(3) if damage or inferiority has been concealed in any manner; and

(4) if any substance has been added thereto or mixed or packed therewith so as to

increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is.

(c) If it bears or contains a coal-tar color other than one which is permissible underexisting regulations;

(d) If it is confectionery, and it bears or contains any alcohol or non-nutritive article orsubstance except harmless coloring, harmless flavoring, harmless resinous glass lesscoloring, harmless flavoring, harmless resinous glass not in excess of four-tenths of oneper centum, natural gum and pectin.



(e) If it is oleomargarine or margarine or butter and any of the raw material usedtherein consists in whole or in part of any filthy, putrid or decomposed substance, orsuch oleomargarine, margarine or butter is otherwise unfit for food.

MISBRANDED FOOD

Section 15. A food shall be deemed to be misbranded

Emergency Permit Control

Section 16. (a) Whenever the Secretary finds after investigation that the sale ordistribution in domestic commerce of any class of food may be injurious to health, andthat such injurious nature cannot be adequately determined after such articles haveentered domestic commerce, he shall promulgate regulations also in accordance withthe recommendations of the Food and Drug Administrator providing for the issuance, tomanufacturers, processors, or packers of such class of food in such locality, of permitsto which shall be attached such conditions governing the manufacture, processing, orpacking of such class of food, for such temporary period of time, as may be necessaryto protect the public health; and after the effective date of such regulations, and duringsuch temporary period, no person shall manufacture, sell or offer for sale or transfer

any such food manufactured, processed, or packed by any such manufacturer,processor, or packer unless such manufacturer, processor or packer holds a permitissued by the Secretary as provided by such regulations.

(b) The Secretary is authorized to suspend immediately upon notice any permit issuedunder authority of this section if it is found that any of the conditions of the permithave been violated.



(c) Any officer or employee duly designated by the Secretary shall have access toany factory or establishment, the operator of which holds a permit from theSecretary, for the purpose of ascertaining whether or not the conditions of thepermit are being complied with, and denial of access for such inspection shall beground for suspension of the permit until such access is freely given by the operator.

Tolerances for Poisonous Ingredients in Food

COAL-TAR COLOR FOR FOOD

Section 17. (a) Any poisonous or deleterious substance added to any food, shall bedeemed to be unsafe except when such substance is required or cannot be avoidedin its production or manufacture. In such case the Secretary shall promulgate, upon

recommendation of the Food and Drug Administrator, regulations limiting thequantity therein to such extent as he finds necessary for the protection of publichealth, and any quantity exceeding the limits so fixed shall also be deemed to beunsafe. In determining the quantity of such added substance to be tolerated indifferent articles of food the Secretary shall take into account the extent to whichthe use of such article is required or cannot be avoided in the production ormanufacture of such article and the other ways in which the consumer may be

affected by the same or other poisonous or deleterious substances.

(b) The Secretary shall, upon recommendation of the Food and Drug Administrator,promulgate regulations providing for the listing of coal-tar colors which are harmlessand suitable for use in food.



CHAPTER VIII-Drug and Devices

ADULTERATED DRUGS AND DEVICES

Section 18. A drug or device shall be deemed to be adulterated: (a) (1) If itconsists in whole or in part of any filthy, putrid, decomposed substance; or (2)

if it has been prepared, packed, or held under insanitary conditionscontaminated with filth or whereby it may have been rendered injurious tohealth; or (3) if it is a drug and its container is composed, in whole or in part,of any poisonous or deleterious substance which may render the contentsinjurious to health; or (4) if it is a drug and it bears or contains, for purposes of coloring only, a coal-tar color other than a permissible one.

(b) If it purports to be or is represented as a drug the name of which isrecognized in an official compendium, and its strength differs from, or itsquality or purity falls below, the standard set forth in such compendium, exceptthat whenever tests or methods of assay as are prescribed are, in the judgmentof the Secretary, insufficient for the making of such determination theSecretary, shall promulgate, upon recommendation of the Food and Drug

Administrator, regulations prescribing appropriate tests or methods of assay inaccordance with which such determination as to strength, quality or purity shallbe made. No drug defined in an official compendium shall be deemed to beadulterated under this paragraph because it differs from the standard of strength, quality or purity in strength, quality, or purity from such standards isplainly stated on its label.



(c) If it is not subject to the provisions of paragraph (b) of this section and its strengthdiffers from, or its purity of quality falls below, that which it purports or its represented topossess.

(d) If it is a drug and any substance has been (1) mixed or packed therewith so as toreduce its quality or strength or (2) substituted wholly or in part therefor.

MISBRANDED DRUGS AND DEVICES

Section 19. A drug or device shall be deemed to be misbranded

EXEMPTION IN CASE OF DRUGS AND DEVICES

Section 20. (a) The Secretary is hereby directed to promulgate regulations exemptingfrom any labeling or packaging requirement of this Act drugs and devices which are, inaccordance with the practice of the trade, to be processed, labeled, or repacked insubstantial quantities at establishments other than those where originally processed orpacked, on condition that such drugs and devices are not adulterated or misbranded,under the provisions of this Act upon removal from such processing, labeling, or repackingestablishment.

(b) (1) Drugs intended for use by man which:

(A) are habit-forming(B) because of its toxicity or other potentiality for harmful effect, or the method of its useis not safe for use except under the supervision of a practitioner licensed by law toadminister such drug;

C) are new drugs whose application are limited to investigational use shall be dispensedonly (1) upon a written prescription of a practitioner licensed by law to administer such

drug, or (2) upon an oral prescription of such practitioner which is reduced promptly towriting and filed by the pharmacist



(3) by refilling any such written or oral prescription if such refilling is authorized bythe prescriber either in the original prescription or by oral order which is reducedpromptly to writing and filed by the pharmacist. The act of dispensing a drugcontrary to the provisions of this paragraph shall be deemed to be an act whichresults in the drug being misbranded while held for sale.

(2) Any drug dispensed by filling or refilling a written prescription of a practitionerlicensed by law to administer such drug shall be exempt from the requirements of Section nineteen, except paragraphs (a), (1), (2) and (3), and the packagingrequirements of paragraphs (g) and (h), if the drug bears a label containing thename and address of the dispenser, the serial number and date of the prescription orof its filling, the name of prescriber, and, if stated in the prescription the name of thepatient, and the directions of use and cautionary statements, if any, contained insuch prescription.

(3) The Secretary may by regulation remove drugs subject to Section nineteen (d)and Section twenty-one from the requirements of Subsection (b) (1) of this Section,when such requirements are not necessary for the protection of the public health.

(4) A drug which is subject to subsection (b) (1) of this section shall be deemed tobe misbranded if at any time prior to dispensing, its label fails to bear the statement"Caution: Food, Drug and Cosmetics Law prohibits dispensing without prescription."

A drug to which subsection (b) (1) of this Section does not apply shall be deemed tobe misbranded if at any time prior to dispensing, its label bears the cautionstatement quoted in the preceding sentence.

NEW DRUGS

Section 21. (a) No person shall manufacture, sell, offer for the sale or transfer anynew drug, unless an application filed pursuant to subsection (b) is effective with

respect to such drug.



(b) Any person may file with the Secretary, thru the Food and DrugAdministration, an application with respect to any drug subject to theprovisions of subsection (a). Such persons shall permit to the Secretarythru the Food and Drug Administration as a part of the application (1) full

reports of investigations which have been made to show whether or notsuch drug is safe for use; (2) a full list of the articles used as componentsof such drug; (3) a full statement of the composition of such drug; (4) afull description of the methods used in and the facilities and controls usedfor the manufacture, processing, and packing of such drug; (5) suchsamples of such drug and of the articles used as components hereof as the

Secretary may require; and (6) specimens of the labeling proposed to beused for such drug.

(c) Within one hundred and eighty days after the filing of an applicationunder this subsection, or such additional period as may be agreed upon bythe Secretary and the applicant, the Secretary shall either (1) approve theapplication if he then finds that none of the grounds for denying approvalspecified in subsection (d) applies, or (2) give the applicant notice of anopportunity for a hearing before the Secretary under subsection (d) on thequestion whether such application is approvable.



(d) If the Secretary finds, after due notice to the applicant and giving him anopportunity for a hearing, that (1) the investigation, reports of which arerequired to be submitted to the Secretary pursuant to subsection (b), do notinclude adequate tests by all methods reasonably applicable to show whetheror not such drug is safe for use under the conditions prescribed, recommended,

or suggested in the proposed labeling thereof; (2) the results of such testsshow that such drug is unsafe for use under such conditions or do not showthat such drug is safe for use under such conditions; (3) the methods used in,and the facilities and controls used for the manufacture, processing, andpacking of such drug are inadequate to preserve its identity, strength, quality,and purity; or (4) upon the basis of the information submitted to him as part of the application, or upon the basis of any other information before him with

respect to such drug, he has insufficient information to determine whether suchdrug is safe for use under such conditions; or (5) evaluated on the basis of theinformation submitted to him as part of the application, and any otherinformation before him with respect to such drug, there is a lack of substantialevidence that the drug will have the effect it purports or is represented to haveunder the conditions of use prescribed, recommended, or suggested in theproposed labeling thereof; or (6) based on a fair evaluation of all material facts,

such labeling is false or misleading in any particular; he shall issue an orderrefusing to approve the application.

(e) The effectiveness of an application with respect to any drug shall, after duenotice and opportunity for hearing to the applicant, by order of the Secretarybe suspended if the Secretary finds (1) that clinical experience, tests by newmethods, or tests by methods not deemed reasonably applicable when such

application became effective show that such drug is unsafe for use under theconditions of use upon the basis of which the application became effective,



(2) that the application contains any untrue statement of a material fact. Theorder shall state the findings upon which it is based.

(f) An order refusing to permit an application with respect to any drug tobecome effective shall be revoked whenever the Secretary finds that the factsso require.

(g) The Secretary shall promulgate regulations for exempting from theoperation of this section drugs intended solely for investigational use by expertsqualified by scientific training and experience to investigate the safety andeffectiveness of drugs.

CHAPTER IX-Certification of Drugs containing Penicillin, Streptomycin,Chlortetracycline, Chloramphenicol or Bacitracin.

Section 22. (a) The Secretary, pursuant to regulations promulgated by himshall provide for the certification of batches of drugs composed wholly or partlyof any kind of penicillin, streptomycin, chlortetracycline, chloramphenicol,bacitracin, or any anti-biotic drug, or any derivative thereof. A batch of suchdrug shall be certified if such drug has such characteristics of identity, strength,quality and purity, as the Secretary prescribes in such regulations as necessaryto adequately insure safety and efficacy of use, but shall not otherwise becertified. Prior to the effective date of such regulations the Secretary, in lieu of

certification, shall issue a release for any batch which, in his judgment, may bereleased without risk as to the safety and efficacy of its use. Such release shallprescribe the date of its expiration and other conditions under which it shallcease to be effective as to such batch and as to portions thereof. For purposesof this section and of Section nineteen (k), the term "anti-biotic drug" meansany drug intended for use by man containing any quantity of any chemicalsubstance which is produced by micro-organism and which has the capacity toinhibit or destroy micro-organism in dilute solution (including the chemically

synthesized equivalent of any such substance).

(b) Wh i th j d t f th S t th i t f thi



(b) Whenever in the judgment of the Secretary, the requirements of thissection and of Section nineteen (k) with respect to any drug or class of drugsare not necessary to insure safety and efficacy of use, the Secretary shallpromulgate regulations exempting such drug or class of drugs from suchrequirements.

(c) The Secretary shall promulgate regulations exempting from the requirement

of this section and of Section nineteen (k), (1) drugs which are to be stored,processed labeled, or repacked at establishments other than those wheremanufactured, on condition that such drugs comply with all such requirementsupon removal from such establishments; (2) drugs which conform to applicablestandards of identity, strength, quality, and purity prescribed by theseregulations and are intended for use in manufacturing other drugs; and (3)drugs which are intended for investigational use by experts qualified byscientific training and experience to investigate the safety and efficacy of drugs.

CHAPTER X-Cosmetics

ADULTERATED COSMETICS

Section 23. A cosmetic shall be deemed to be adulterated

MISBRANDED COSMETIC

Section 24. A cosmetic shall be deemed to be misbranded

REGULATIONS MAKING EXEMPTIONS

Section 25. The Secretary shall promulgate regulations exempting from anylabeling requirements of this Act cosmetic which are, in accordance with thepractice of the trade, to be processed, labeled, or repacked in substantialquantities at establishments other than those where originally processed orpacked, on condition that such cosmetics are not adulterated or misbranded

under the provisions of this Act upon removal from such processing, labeling,repacking establishment.



CHAPTER XI-General Administration Provisions, Regulations,Hearings and Institution of Criminal Action

Section 26. (a) Except as otherwise provided in this section, the Secretary

of Health shall, upon recommendation of the Food and Drug Administrator,issue rules and regulations as may be necessary to enforce effectively theprovisions of this Act.

(b) The Commissioner of Customs, the Commissioner of Internal Revenueand the Secretary of Health shall jointly prescribe regulations for theefficient enforcement of the provisions of Section thirty, except as otherwise

provided therein. Such regulations shall be promulgated upon therecommendation of the Food and Drug Administrator and shall take effectat such time, after due notice, as the Secretary of Health shall determine.

(c) Hearings authorized or required by this Act shall be conducted by theBoard of Food and Drug Inspection which shall submit its recommendationto the Food and Drug Administrator.

(d) When it appears to the Food and Drug Administrator from the report of the Food and Drug Laboratory that any article of food or any drug, orcosmetic secured pursuant to Section twenty-eight of this Act is adulteratedor misbranded, he shall cause notice thereof to be given to the person orpersons concerned and such person or persons shall be given anopportunity to be heard before the Board of Food and Drug Inspection and

to submit evidence impeaching the correctness of the finding or charge inquestion.



(e) When a violation of any provisions of this Act comes to the knowledge of the Food andDrug Administrator of such character that a criminal prosecution ought to be institutedagainst the offender, he shall certify the facts to the Secretary of Justice through theSecretary of Health, together with the chemist's report, the findings of the Board of Foodand Drug Inspection, or other documentary evidence on which the charge is based.

(f) Nothing in this Act shall be construed as requiring the Food and Drug Administrator to

certify for prosecution pursuant to sub-paragraph (e) hereof, minor violations of this Actwhenever he believes that public interest will be adequately served by a suitable writtennotice or warning.

FACTORY INSPECTION

Section 27. (a) For purposes of enforcement of this Act, officers or employees dulydesignated by the Secretary, upon presenting appropriate credentials to the owner,

operator, or agent in charge, are authorized (1) to enter, at reasonable hours, any factory,warehouse, or establishment in which food, drugs, devices or cosmetics are manufactured,processed, packed or held, for introduction into domestic commerce or are held after suchintroduction, or to enter any vehicle being used to transport or hold such food, drugs,devices, or cosmetics, in domestic commerce; and (2) to inspect, in a reasonable manner,such factory, warehouse, establishment, or vehicle and all pertinent equipment, finishedand unfinished materials, containers, and labeling therein.

Section 28. (a) If the officer or employee making any such inspection of a factory,warehouse or other establishment has obtained any sample in the course of the inspection,upon completion of the inspection and prior to leaving the premises he shall give to theowner, operator, or agent in charge a receipt describing the samples obtained.

(b) Whenever in the course of any such inspection of a factory or other establishmentwhere food is manufactured, processed, or packed, the officer or employee making theinspection obtains a sample of any such food, and an analysis is made of such sample forthe purpose of ascertaining whether such food consists in whole or in part of any filthy,

putrid or decomposed substance, or is otherwise unfit for food, a copy of the results of such analysis shall be furnished promptly to the owner, operator, or agent in charge.



PUBLICITY

Section 29. (a) The Secretary may cause to be disseminated informationregarding food, drugs, devices, or cosmetics in situations involving, in theopinion of the Secretary, imminent danger to health, or gross deception of theconsumer. Nothing in this Section shall be construed to prohibit the Secretaryfrom collecting, reporting, and illustrating the results of the investigations of theDepartment.

CHAPTER XII-Imports and Exports

Section 30. (a) The Commissioner of Customs shall cause to be delivered tothe Food and Drug Administration samples taken at random from everyincoming shipment of food, drugs, devices, and cosmetics which are beingimported or offered for import into the Philippines giving notice thereof to the

owner or consignee. The quantity of such samples shall be fixed by regulationissued by the Secretary. If it appears from the examination of such samples orotherwise that (1) such article has been manufactured, processed, or packedunder insanitary conditions, or (2) such article is forbidden or restricted fromsale in the country in which it was produced or from which it was produced orfrom which it was exported, or (3) such article is adulterated, misbranded, or inviolation of Section twenty-one, then the Food and Drug Administrator shall soinform the Commissioner of Customs and such article shall be refused

admission, except as provided in subsection (b) of this section. TheCommissioner of Customs shall then cause the destruction of any such articlerefused admission unless such article is exported, under regulations prescribedby the Commissioner of Customs, within ninety days of the date of notice of such refusal or within such additional time as may be permitted pursuant tosuch regulations. If the food, drugs, devices, and cosmetics being imported oroffered for import into the Philippines arrives at a port of entry other thanManila, the collection of such samples shall be the responsibility of the RegionalHealth Director having jurisdiction over the port of entry and such samples shallbe forwarded to the Food and Drug Administration.

(b) P di d i i t th d i i f ti l b i i t d ff d f i t



(b) Pending decision as to the admission of an article being imported or offered for import,the Commissioner of Customs may authorize delivery of such article to the owner orconsignee upon execution by him of a good and sufficient bond providing for the paymentof such liquidated damages in the event of default as may be required pursuant toregulations of the Commissioner of Customs. If it appears to the Secretary that an articleincluded within the provisions of clause

(3) of subsection (a) of this section can, by relabeling or other action, be brought intocompliance with the Act or rendered other than a food, drug, device, or cosmetic, finaldetermination as to admission of such article may be deferred, and upon filing to timelywritten application by the owner or consignee, and the execution by him of a bond asprovided in the preceding provisions of this subsection, the Secretary may, in accordancewith regulations, authorize the applicant to perform such relabeling or other actionsspecified in such authorization with regulations (including destruction or export of rejectedarticles or portions thereof, as may be specified in the Secretary's authorization).

(c) All expenses (including travel, per diem or subsistence, and salaries) of officers oremployees of the Philippines in connection with the destruction provided for in subsection(a) of this section and the supervision of the relabeling or other action authorized underthe provisions of subsection (b) of this section, the amount of such expenses to bedetermined in accordance with regulations, and all expenses in connection with thestorage, cargo, or labor with respect to any article refused admission under subsection (a)of this section, shall be paid by the owner or consignee, and in default of such payment,

shall constitute a lien against any future importations made by such owner or consignee.(d) A food, drug, device, or cosmetic intended for export shall not be deemed to beadulterated or misbranded under this Act if it (1) conforms with the specifications of theforeign purchaser, (2) is not conflict with laws of the country to which it is intended forexport, and (3) is labelled on the outside of the shipping package to show that it isintended for export. But if such article is sold or offered for sale in domestic commerce,this subsection shall not exempt it from any of the provisions of this Act.




AN ACT REGULATING THE PRACTICE OF PHARMACYAND SETTING STANDARDS OF PHARMACEUTICALEDUCATION IN THE PHILIPPINES AND FOR OTHER PURPOSES.



ARTICLE 1-Objectives and Implementation

Section 1. Objectives. This Act provides for and shall govern (a) thestandardization and regulation of pharmaceutical education; (b) the

examination for registration of graduates of schools of pharmacy and (c)the supervision, control and regulation of the practice of pharmacy in thePhilippines.

Section 2. Enforcement. For the purposes of implementing the provisionsof this Act, the Council of Pharmaceutical Education and the Board of Pharmacy are hereby created.

ARTICLE II-The Council of Pharmaceutical Education

Section 3. The Council of Pharmaceutical Education and its composition.

Section 5. Meetings and traveling expenses.

ARTICLE III-The Board of Pharmacy and Examination and

Registration of Pharmacists

Section 6. The Board of Pharmacy and its Composition.

Section 7. Qualification of Board members. To be appointed a member of the Board of Pharmacy, a person shall be:



(a) A natural born citizen of the Philippines;

(b) A duly registered pharmacist and has been in the practice of pharmacyfor at least ten years;

(c) Of good moral character and of recognized standing in the

pharmaceutical profession;(d) At the time of appointment, not a member of the faculty of any school,college or university offering courses in pharmacy; nor have any direct orindirect pecuniary interests in such school or college of pharmacy; and

(e) A member of good standing of any bona fide national pharmaceuticalassociation of the Philippines.

Section 8. Tenure of office and fees of board members.

Section 9. Removal of the Board members.

Section 10. Executive Officer of the Board.

Section 11. Powers and duties of the Board.

(a) To examine applicants for the practice of pharmacy;

(b) To issue certificates of registration or pharmacists.

(c) To reprimand any pharmacist or to suspend or revoke his certificate of registration on the grounds as provided for in Section thirteen hereof, aftera formal administrative investigation has been conducted by it.



(d) To promulgate from time to time the necessary rules and regulations forthe effective enforcement of this Act, subject to the approval of thePresident upon advice of the Commissioner of Civil Service;

(e) To study the conditions affecting the practice of pharmacy in thePhilippines;

(f) To check the employment of qualified personnel in drug stores, hospitalpharmacies, drug or pharmaceutical laboratories, cosmetic laboratories andsimilar establishments for which the Board may designate inspectors fromthe Board of Pharmacy; and

(g) To encourage the development of botanical gardens and their inspectionparticularly the propagation of Philippine medicinal plants with thecooperation of the Department of Agriculture and Natural Resources.

Section 12. Detail men, requirements, qualifications and fees.

Section 13. Grounds for reprimand, suspension or revocation of registrantcertificate.

(a) Conviction by a court of competent jurisdiction of any violation aspenalized in sections forty and forty-one hereof;

(b) I l di h bl d t hi h i l d i ti b



(b) Immoral or dishonorable conduct which includes conviction by acompetent court of any criminal offense involving moral turpitude;

(c) Fraud or deceit in the acquisition of the certificate of registration;

(d) Gross negligence, ignorance or incompetence in the practice of his

profession resulting in the injury damage or death of another;(e) Malpractice, including aiding or abetting the commission of criminalabortion or sex crimes through illegal compounding, dispensing or sale of abortive or sex drugs as the case may be;

(f) Acting as a dummy of an alien or of a person who is not qualified to

establish and operate a retail drugstore;

(g) Addiction to alcoholic beverage or to any habit-forming drug renderinghim incompetent to practice his profession;

(h) Insanity;

(i) False or extravagant or unethical advertisements wherein other thingsthan his name, profession, limitation of practice, office and home addressand the like are mentioned; and

(j) Violations of any provision of the Code of Ethics which may be adoptedas part of the Rules and Regulations of the Board.

Section 14 Administrative Investigation



Section 14. Administrative Investigation.

Section 15. Procedure and rules.

Section 16. Right of respondent.

Section 17. Appeal from judgment.

Section 18. Candidate for board examination. A candidate for the boardexamination in Pharmacy shall have the following qualifications:

(a) He shall be a natural-born citizen of the Philippines;

(b) He shall be of good moral character;

(c) He shall have completed an Internship Program which shall consist of at

least nine hundred sixty hours, one-half of which shall be spent equallydistributed in a prescription pharmacy, a pharmaceutical manufacturinglaboratory and a hospital pharmacy duly accredited by the Council of Pharmacyand the rest of the hours of internship shall be spent in any or all of the saidestablishments at the choice of the candidate.

(d) He shall have graduated with a degree of Bachelor of Science in Pharmacy

or with an equivalent degree from a school, college or university duly accreditedby the Council of Pharmaceutical Education after satisfactorily completing astandard pharmacy course of not less than five academic years.

Section 19. Scope of Examination. The pharmacist examination shall consistof both theoretical and practical examinations. The theoretical examination shallinclude subjects in Chemistry, Biological Sciences and Pharmacy.



Republic Act No. 6675

AN ACT TO PROMOTE, REQUIRE AND ENSURE THEPRODUCTION OF AN ADEQUATE SUPPLY, DISTRIBUTION,USE AND ACCEPTANCE OF DRUGS AND MEDICINESIDENTIFIED BY THEIR GENERIC NAMES



Section 1. Title – This Act shall be known as the "Generics Act of 1988."

Section 2. Statement of Policy To promote, encourage and require the use of generic terminology in theimportation, manufacture, distribution, marketing, advertising andpromotion, prescription and dispensing of drugs;

To ensure the adequate supply of drugs with generic names at the lowest

possible cost and endeavor to make them available for free to indigentpatients;

To encourage the extensive use of drugs with generic names through arational system of procurement and distribution;

To emphasize the scientific basis for the use of drugs, in order that health

professionals may become more aware and cognizant of their therapeuticeffectiveness; and

To promote drug safety by minimizing duplication in medications and/or useof drugs with potentially adverse drug interactions.



Section 4. The Use of Generic Terminology for Essential Drugs and Promotional Incentives.

Section 5. Posting and Publication

Section 6. Who Shall Use Generic Terminology - (a) All government healthagencies and their personnel as well as other government agencies shalluse generic terminology or generic names in all transactions related topurchasing, prescribing, dispensing and administering of drugs andmedicines.

(b) All medical, dental and veterinary practitioners, including privatepractitioners, shall write prescriptions using the generic name. The brandname may be included if so desired.

(c) Any organization or company involved in the manufacture, importation,repacking, marketing and/or distribution of drugs and medicines shallindicate prominently the generic name of the product. In the case of brandname products, the generic name shall appear prominently andimmediately above the brand name in all product labels as well as inadvertising and other promotional materials.



(d) Drug outlets, including drugstores, hospital and non-hospitalpharmacies and non-traditional outlets such as supermarkets and stores,shall inform any buyer about any and all other drug products having thesame generic name, together with their corresponding prices so that thebuyer may adequately exercise, his option.

Section 7. Provision on Quality, Manufacturer’s Identity and Responsibility

Section 8. Required Production

Section 9. Rules and Regulations – The implementation of the provisions of this Act shall be in accordance with the rules and regulations to be

promulgated by the Department of Health. Rules and regulations with penalsanctions shall be promulgated within one hundred eighty (180) days afterapproval of this Act and shall take effect fifteen (15) days after publicationin the Official Gazette or in two (2) newspapers of general circulation.

Section 10. Authority to Import

Section 11. Education Drive

Section 12. Penalty

(a) for the first conviction, he shall suffer the penalty of reprimand whichshall be officially recorded in the appropriate books of the ProfessionalRegulation Commission.



(b) for the second conviction, the penalty of fine in the amount of not lessthan two thousand pesos (P2,000.00) but not exceeding five thousandpesos (5,000.00) at the discretion of the court.

c) for the third conviction, the penalty of fine in the amount of not less than

five thousand pesos (P5,000.00) but not exceeding then thousand pesos(P10,000.00) and suspension of his license to practice his profession forthirty (30) days at the discretion of the court.

(d) for the fourth and subsequent convictions, the penalty of fine of not lessthan ten thousand pesos (P10,000.00) and suspension of his license to

practice his profession for one year or longer at the discretion of the court.Section 13. Separability Clause – If any provision of this Act is declaredinvalid, the remainder or any provision hereof not affected thereby shallremain in force and effect.

Section 14. Repealing Clause – The provisions of any law, executive order,

presidential decree or other issuances inconsistent with this Act are herebyrepealed or modified accordingly.

Section 15. Effectivity – This Act shall take effect fifteen (15) days after itscomplete publication in the Official Gazette or two (2) newspapers of general circulation.




AN ACT PRESCRIBING SPECIAL MEASURES TO LOWER THE COST OFMEDICINES, AND FOR OTHER PURPOSES

SECTION 1: Declaration of Policy. It is hereby declared the



y ypolicy of the State:To promote, encourage, and require the use of generic terminology in the importation,manufacture, distribution, marketing, advertising and promotion, prescription, anddispensing of drugs and other drug preparations;

To emphasize the moral obligation of medical and para-medical practitioners relative totheir drug prescription or advise;

To ensure the adequate supply of drugs with generic names at the lowest possible cost andthe availability of over-the-counter drugs in establishments other than accredited drugoutlets:

To promote drug safety and efficacy simultaneous with the full implementation of theGeneric Law;

To set the patent for pharmaceutical products at twenty (20) years from application,regardless of the place of application; and to amend the policy on granting distributorshipto allow parallel imports.

SEC. 2. Strengthening the Generic Law. - Section 12 of the GenericAct of 1998 is hereby amended to read as follows: “Sec.12. Penalty. - A) any person who shall violate Section 6(a) or 6(b) of this act shallsuffer penalty graduated hereunder, viz: a) For the fist conviction, he shall suffer thepenalty of reprimand, which shall be officially recorded in the appropriate books of theProfessional Regulation Commission;(b) For the second conviction, the penalty of fine inthe amount of not less than [two thousand pesos] TWENTY FIVE THOUSAND PESOS, at thediscretion of the courts;

c) For the third conviction, the penalty of fine in the amount of not less than [five



c) o t e t d co ct o , t e pe a ty o e t e a ou t o ot ess t a [ ethousand pesos] TWENTY FIVE THOUSAND PESOS and suspension of his licenseto practice his profession for [thirty] SIXTY days at the discretion of the courts;

d) For the fourth and subsequent convictions, the penalty of fine of not less than[ten thousand pesos] ONE HUNDRED THOUSAND PESOS ,suspension of his

license to practice his profession for one year longer at the discretion of thecourt.

SEC. 3. Amending the Pharmacy Law. Section 2 of P.D. 1363 is hereby amendedto read as follows:

“Sec. 25. Sale of medicines, pharmaceuticals, drugs and devices. No medicine,pharmaceutical or drug, except for those which are non-prescription or over-the-

counter, of whatever nature and kind, or device shall be compounded, dispensed,sold or resold, or otherwise be made available to the consuming public exceptthrough a prescription drugstore or hospital pharmacy, duly established inaccordance with the provision of this Act. NON-PRESCRIPTION OR OVER-THE-COUNTER DRUGS MAY BE SOLD IN THEIR ORIGINAL PACKAGES BOTTLESCONTAINERS OR IN SMALL QUANTITIES NOT IN THEIR ORIGINAL CONTAINERS

TO THE CONSUMING PUBLIC THROUGH SUPERMARKETS AND OTHERESTABLISHMENT.

SEC. 4. Drug Price Selling Index

SEC. 5. Distributorship - parallel importation shall be allowed by allowing morethan one ( I ) Philippine importer to enter into foreign Agency Agreement with aforeign supplier



SEC. 6. Patents for Pharmaceutical Products.

Sec. 7. False claims to promote food supplements. -Any law to the contrarynot with standing, any product approve by BFAD as food supplement shallcarry the words as “AS FOOD SJPPLEMENTS ONLY” printed in parenthesis

below the BFAD Registration

SEC. 8. Congressional Oversight on Implementation of Generics LawandNational Drug Policy.

SEC. 9. Implementing Agency. - The Department of Health (DOH)shall bethe main agency tasked to enforce the provision of this Act. It shall,likewise

promulgate the rules and regulation necessary to effectively implement theprovision of this Act.

SEC. I O . Separability Clause. - If any provision of this Act is declaredinvalid the remainder or any provision hereof not affected thereby shallremain in full force and effect.

SEC. 11. - Repealing Clause. - The provision of any law, Executive Orders,Presidential Decrees, and other issuance inconsistent with this Act arehereby repealed on modified accordingly.

SEC. 12. -This Act shall take effect fifteen (15) days after its completepublication in the Official Gazette or in at least two national newspapers.of

general circulation, which ever comes first.




AN ACT CREATING THE PHILIPPINE INSTITUTE OF

TRADITIONAL AND ALTERNATIVE HEALTH CARE (PITAHC)TO ACCELERATE THE DEVELOPMENT OF TRADITIONAL ANDALTERNATIVE HEALTH CARE IN THE PHILIPPINES,PROVIDING FOR A TRADITIONAL AND ALTERNATIVEHEALTH CARE DEVELOPMENT FUND AND FOR OTHERPURPOSES

Section 1 Short Title - This Act shall be known as the "Traditional and



Section 1. Short Title. - This Act shall be known as the Traditional and Alternative Medicine Act (TAMA) of 1997 ."

ARTICLE I-GUIDING PRINCIPLES

Section 2. Declaration of Policy .

Section 3. Objectives. - The objectives of this Act are as follows:(a) To encourage scientific research on and develop traditional and alternativehealth care systems that have direct impact on public health care;

(b) To promote and advocate the use of traditional, alternative, preventive andcurative health care modalities that have been proven safe, effective, costeffective and consistent with government standards on medical practice;

(c) To develop and coordinate skills training courses for various forms of traditional and alternative health care modalities;

(d) To formulate standards, guidelines and codes of ethical practice appropriatefor the practice of traditional and alternative health care as well as in themanufacture, quality control and marketing of different traditional andalternative health care materials, natural and organic products, for approval and

adoption by the appropriate government agencies;

(e) To formulate policies for the protection of indigenous and natural healthresources and technology from unwarranted exploitation, for approval andadoption by the appropriate government agencies;

(f) To formulate policies to strengthen the role of traditional and alternativehealth care delivery system; and

(g) To promote traditional and alternative health care in international and



(g) To promote traditional and alternative health care in international andnational conventions, seminars and meetings in coordination with theDepartment of Tourism, Duty Free Philippines, Incorporated, PhilippineConvention and Visitors Corporation and other tourism-related agencies as wellas non-government organizations and local government units.

Section 7. Board of Trustees.

Secretary of Health - ex-officio chairman

Permanent representatives of the following government offices:

Department of Science and Technology; Department of Environment and NaturalResources; Department of Agriculture; Department of Education, Culture andSports; and Commission on Higher Education.

Representatives of the following industries/sectors:One (1) physician who is engaged in the practice of traditional and alternativehealth care;

One (1) member from a duly recognized academe/research institution engagedin traditional and alternative health care research;

One (1) traditional and alternative health care practitioner who is not a

physician;One (1) biomedical/allopathietwestem medical practitioner preferably from thePhilippine Medical Association;

One (1) member from the natural food industry and/or organic food industry;and

One (1) member from an environmental sector organization,

Section 8 Powers and Functions of the Board



Section 8. Powers and Functions of the Board .

(a) To define and approve the programs, plans, policies, procedures andguidelines for the Institute in accordance with its purposes and objectives, andto control the management, operation and administration of the Institute;

(b) To approve the Institute's organizational structure, staffing pattern,

operating and capital expenditure, and financial budgets prepared in accordancewith the corporate plan of the Institute;

(c) To approve salary ranges, benefits and privileges, bonuses and other termsand conditions of service for all officers and employees of the Institute, uponrecommendation of the Director General and consistent with the salarystandardization and other laws;

(d) To appoint, transfer, promote, suspend, remove or otherwise discipline anysubordinate officer or employee of the Institute, upon recommendation of theDirector General;

(e) To create such committee or committees and appoint the members thereof,as may be necessary or proper for the management of the Institute or theattainment of its purposes and objectives;

(f) To determine the research priorities of the Institute consistent with theframework of its purposes and objectives and in coordination with othergovernment agencies; and

(g) To exercise such other powers and functions and perform such other acts asmay be necessary or proper for the attainment of the purposes and objectivesof the Institute, or as may be delegated by the Secretary of Health.

Section 9. Director General and Other Officers.



Section 10. Powers, Functions and Duties of the Director General .

(a) To exercise overall supervision and direction over the implementation of allresearch and development programs of the Institute, and to supervise anddirect the management, operation and administration of the Institute;

(b) To execute contracts, including the deeds that may incur obligations, acquireand dispose of assets and deliver documents on behalf of the Institute, withinthe limits of authority delegated to him by the Board;

(c) To implement and enforce policies, decisions, orders, rules and regulationsadopted by the Board;

(d) To submit to the Board an annual report of the Institute;

(e) To submit to the Board an annual budget and such supplemental budget asmay be necessary for its consideration and approval; and

(f) To exercise such other powers and functions and perform such other dutiesas may be authorized by the Board.

Section 11. Government Agency Support and Coordination.

ARTICLE IV-PROMOTION OF TRADITIONAL AND ALTERNATIVE HEALTH

CARE Section 12. Traditional and Alternative Health Care Advocacy and ResearchProgram.

Section 13. Standards for the Manufacture, Marketing and Quality Control of Traditional Medicine.

Section 14. Incentives for the Manufacturers of Traditional and Alternative

Health Care Products.

Section 15. Traditional and Alternative Health Care Development Fund .



ARTICLE V-TRANSITORY PROVISIONS

Section 16. Appointment of Board Members. Section 17. Transfer of Functions of the Traditional Medivine Unit.

ARTICLE VI-MISCELLANEOUS PROVISIONS

Section 18. Oversight Function.

Section 19. Implementing Rules and Regulations. - Within thirty (30) daysfrom the completion of their appointments, the Board shall convene and, incollaboration with the Department of Health - Traditional Medicine Unit,formulate the rules and regulations necessary for the implementation of

this Act.Section 20. Repealing Clause. - All laws, decrees, executive orders, andother laws including their implementing rules and regulations inconsistentwith the provisions of this Act are hereby amended, repealed or modifiedaccordingly.

Section 21. Separability Clause. - If any provision of this Act is declaredunconstitutional or invalid, other provisions thereof which are not affectedthereby shall continue in full force and effect.

Section 22. Effectivity. - This Act shall take effect fifteen (15) daysfollowing its publication in the Official Gazette or in at least two (2)newspapers of general circulation.



REPUBLIC ACT NO. 9165

AN ACT INSTITUTING THE COMPREHENSIVE DANGEROUSDRUGS ACT OF 2002, REPEALING REPUBLIC ACT NO. 6425,OTHERWISE KNOWN AS THE DANGEROUS DRUGS ACT OF1972, AS AMENDED, PROVIDING FUNDS THEREFOR, ANDFOR OTHER PURPOSES



Section 1. Short Title. – This Act shall be known and cited as the"Comprehensive Dangerous Drugs Act of 2002".

Section 2. Declaration of Policy. – It is the policy of the State to safeguard theintegrity of its territory and the well-being of its citizenry particularly the youth,

from the harmful effects of dangerous drugs on their physical and mental well-being, and to defend the same against acts or omissions detrimental to theirdevelopment and preservation. In view of the foregoing, the State needs toenhance further the efficacy of the law against dangerous drugs, it being one of today's more serious social ills.

ARTICLE II-Unlawful Acts and Penalties

Section 4. Importation of Dangerous Drugs and/or Controlled Precursors andEssential Chemicals.-derived therefrom even for floral, decorative and culinarypurposes.

Section 5. Sale, Trading, Administration, Dispensation, Delivery, Distributionand Transportation of Dangerous Drugs and/or Controlled Precursors andEssential Chemicals.

Section 6. Maintenance of a Den, Dive or Resort.

Section 7. Employees and Visitors of a Den, Dive or Resort. Section8. Manufacture of Dangerous Drugs and/or Controlled Precursors and EssentialChemicals.

Section 9. Illegal Chemical Diversion of Controlled Precursors and EssentialChemicals.

Section 10. Manufacture or Delivery of Equipment, Instrument, Apparatus, and



y q p , , pp ,Other Paraphernalia for Dangerous Drugs and/or Controlled Precursors andEssential Chemicals.

Section 11. Possession of Dangerous Drugs. - The penalty of life imprisonmentto death and a fine ranging from Five hundred thousand pesos (P500,000.00) toTen million pesos (P10,000,000.00) shall be imposed upon any person, who,unless authorized by law, shall possess any dangerous drug in the followingquantities, regardless of the degree of purity thereof:

Otherwise, if the quantity involved is less than the foregoing quantities, thepenalties shall be graduated as follows:

(1) Life imprisonment and a fine ranging from Four hundred thousand pesos

(P400,000.00) to Five hundred thousand pesos (P500,000.00), if the quantity of methamphetamine hydrochloride or "shabu" is ten (10) grams or more but lessthan fifty (50) grams; (1) 10 grams or more of opium;(2) 10 grams or more of morphine;(3) 10 grams or more of heroin;(4) 10 grams or more of cocaine orcocaine hydrochloride;(5) 50 grams or more of methamphetamine hydrochlorideor "shabu";(6) 10 grams or more of marijuana resin or marijuana resin oil;(7)500 grams or more of marijuana; and(8) 10 grams or more of other dangerous

drugs such as, but not limited to, methylenedioxymethamphetamine (MDA) or"ecstasy", paramethoxyamphetamine (PMA), trimethoxyamphetamine (TMA),lysergic acid diethylamine (LSD), gamma hydroxyamphetamine (GHB), andthose similarly designed or newly introduced drugs and their derivatives,without having any therapeutic value or if the quantity possessed is far beyondtherapeutic requirements, as determined and promulgated by the Board inaccordance to Section 93, Article XI of this Act.



(2) Imprisonment of twenty (20) years and one (1) day to life imprisonmentand a fine ranging from Four hundred thousand pesos (P400,000.00) to Fivehundred thousand pesos (P500,000.00), if the quantities of dangerous drugs arefive (5) grams or more but less than ten (10) grams of opium, morphine,

heroin, cocaine or cocaine hydrochloride, marijuana resin or marijuana resin oil,methamphetamine hydrochloride or "shabu", or other dangerous drugs such as,but not limited to, MDMA or "ecstasy", PMA, TMA, LSD, GHB, and those similarlydesigned or newly introduced drugs and their derivatives, without having anytherapeutic value or if the quantity possessed is far beyond therapeuticrequirements; or three hundred (300) grams or more but less than five(hundred) 500) grams of marijuana;

(3) Imprisonment of twelve (12) years and one (1) day to twenty (20) yearsand a fine ranging from Three hundred thousand pesos (P300,000.00) to Fourhundred thousand pesos (P400,000.00), if the quantities of dangerous drugs areless than five (5) grams of opium, morphine, heroin, cocaine or cocainehydrochloride, marijuana resin or marijuana resin oil, methamphetaminehydrochloride or "shabu", or other dangerous drugs such as, but not limited to,MDMA or "ecstasy", PMA, TMA, LSD, GHB, and those similarly designed or newlyintroduced drugs and their derivatives, without having any therapeutic value or

if the quantity possessed is far beyond therapeutic requirements; or less thanthree hundred (300) grams of marijuana.

Section 12. Possession of Equipment, Instrument, Apparatus and OtherParaphernalia for Dangerous Drugs.

Section 13. Possession of Dangerous Drugs During Parties, Social Gatherings orMeetings.

Section 14. Possession of Equipment, Instrument, Apparatus and Other Paraphernalia



for Dangerous Drugs During Parties, Social Gatherings or Meetings.

Section 15. Use of Dangerous Drugs.

Section 16. Cultivation or Culture of Plants Classified as Dangerous Drugs or areSources Thereof.

Section 17. Maintenance and Keeping of Original Records of Transactions onDangerous Drugs and/or Controlled Precursors and Essential Chemicals. Section18. Unnecessary Prescription of Dangerous Drugs

Section 19. Unlawful Prescription of Dangerous Drugs.

Section 20. Confiscation and Forfeiture of the Proceeds or Instruments of the Unlawful

Act, Including the Properties or Proceeds Derived from the Illegal Trafficking of Dangerous Drugs and/or Precursors and Essential Chemicals.

Section 21. Custody and Disposition of Confiscated, Seized, and/or Surrendered Dangerous Drugs, Plant Sources of Dangerous Drugs, Controlled Precursors and Essential Chemicals, Instruments/Paraphernalia and/or Laboratory Equipment .

Section 22. Grant of Compensation, Reward and Award .

Section 23. Plea-Bargaining Provision.

Section 24. Non-Applicability of the Probation Law for Drug Traffickers and Pushers.

Section 25. Qualifying Aggravating Circumstances in the Commission of a Crime by anOffender Under the Influence of Dangerous Drugs.

Section 26. Attempt or Conspiracy. (a) Importation of any dangerous drug and/or

controlled precursor and essential chemical;

(b) Sale trading administration dispensation delivery distribution and



(b) Sale, trading, administration, dispensation, delivery, distribution andtransportation of any dangerous drug and/or controlled precursor and essentialchemical;

(c) Maintenance of a den, dive or resort where any dangerous drug is used inany form;

(d) Manufacture of any dangerous drug and/or controlled precursor andessential chemical; and

(e) Cultivation or culture of plants which are sources of dangerous drugs

Section 27. Criminal Liability of a Public Officer or Employee for Misappropriation, Misapplication or Failure to Account for the Confiscated,

Seized and/or Surrendered Dangerous Drugs, Plant Sources of DangerousDrugs, Controlled Precursors and Essential Chemicals,Instruments/Paraphernalia and/or Laboratory Equipment Including the Proceedsor Properties Obtained from the Unlawful Act Committed.

Section 28. Criminal Liability of Government Officials and Employees.

Section 29. Criminal Liability for Planting of Evidence.

Section 30. Criminal Liability of Officers of Partnerships, Corporations, Associations or Other Juridical Entities.

Section 31. Additional Penalty if Offender is an Alien.

Section 32. Liability to a Person Violating Any Regulation Issued by the Board.

Section 33. Immunity from Prosecution and Punishment .



Section 34. Termination of the Grant of Immunity.

Section 35. Accessory Penalties. – A person convicted under this Act shall be disqualifiedto exercise his/her civil rights such as but not limited to, the rights of parental authority orguardianship, either as to the person or property of any ward, the rights to dispose of suchproperty by any act or any conveyance inter vivos, and political rights such as but notlimited to, the right to vote and be voted for.

ARTICLE III-Dangerous Drugs Test and Record Requirements

Section 36. Authorized Drug Testing.

(a) Applicants for driver's license.

(b) Applicants for firearm's license and for permit to carry firearms outside of residence.

(c) Students of secondary and tertiary schools.

(d) Officers and employees of public and private offices (e) Officers and members of themilitary, police and other law enforcement agencies. (f) All persons charged before theprosecutor's office with a criminal offense having an imposable penalty of imprisonment of not less than six (6) years and one (1) day shall have to undergo a mandatory drug test;and

(g) All candidates for public office whether appointed or elected both in the national orlocal government shall undergo a mandatory drug test.

Section 37. Issuance of False or Fraudulent Drug Test Results.

Section 38. Laboratory Examination or Test on Apprehended/Arrested Offenders.

Section 39. Accreditation of Drug Testing Centers and Physicians.

Section 40. Records Required for Transactions on Dangerous Drug and P d E ti l Ch i l



Precursors and Essential Chemicals.

ARTICLE IV-Participation of the Family, Students, Teachers andSchool Authorities in the Enforcement of this Act

Section 41. Involvement of the Family .

Section 42. Student Councils and Campus Organizations.

Section 43. School Curricula.

Section 44. Heads, Supervisors, and Teachers of Schools.

Section 45. Publication and Distribution of Materials on Dangerous Drugs.

Section 46. Special Drug Education Center .

ARTICLE V-Promotion of a National Drug-Free Workplace Program With theParticipation of Private and Labor Sectors and the Department of Labor andEmployment

Section 47. Drug-Free Workplace.

Section 48. Guidelines for the National Drug-Free Workplace Program.

ARTICLE VI-Participation of the Private and Labor Sectors in theEnforcement of this Act

Section 49. Labor Organizations and the Private Sector.

Section 63. Prescription of the Offense Charged Against a Drug Dependent Under



Section 63. Prescription of the Offense Charged Against a Drug Dependent Underthe Compulsory Submission Program.

Section 64. Confidentiality of Records Under the Compulsory Submission Program.

Section 65. Duty of the Prosecutor in the Proceedings.

Section 66. Suspension of Sentence of a First-Time Minor Offender .

Section 67. Discharge After Compliance with Conditions of Suspended Sentence of aFirst-Time Minor Offender .

Section 68. Privilege of Suspended Sentence to be Availed of Only Once by a First-Time Minor Offender

Section 69. Promulgation of Sentence for First-Time Minor Offender

Section 70. Probation or Community Service for a First-Time Minor Offender in Lieuof Imprisonment .

Section 71. Records to be kept by the Department of Justice

Section 72. Liability of a Person Who Violates the Confidentiality of Records.

Section 73. Liability of a Parent, Spouse or Guardian Who Refuses to Cooperate withthe Board or any Concerned Agency.

Section 74. Cost-Sharing in the Treatment and Rehabilitation of a Drug Dependent.

Section 75. Treatment and Rehabilitation Centers

Section 76. The Duties and Responsibilities of the Department of health (DOH)Under this Act.

Section 50. Government Assistance.



ARTICLE VII-Participation of Local Government Units

Section 51. Local Government Units' Assistance.

Section 52. Abatement of Drug Related Public Nuisances.

Section 53. Effect of Board Declaration.

ARTICLE VIII-Program for Treatment and Rehabilitation of Drug Dependents

Section 54. Voluntary Submission of a Drug Dependent to Confinement, Treatment andRehabilitation.

Section 55. Exemption from the Criminal Liability Under the Voluntary Submission Program.

Section 56. Temporary Release From the Center; After-Care and Follow-Up Treatment Under theVoluntary Submission Program.

Section 57. Probation and Community Service Under the Voluntary Submission Program.

Section 58. Filing of Charges Against a Drug Dependent Who is Not Rehabilitated Under theVoluntary Submission Program.

Section 59. Escape and Recommitment for Confinement and Rehabilitation Under the Voluntary

Submission Program.Section 60. Confidentiality of Records Under the Voluntary Submission Program.

Section 61. Compulsory Confinement of a Drug Dependent Who Refuses to Apply Under theVoluntary Submission Program.

Section 62. Compulsory Submission of a Drug Dependent Charged with an Offense to Treatmentand Rehabilitation.

ARTICLE IX-Dangerous Drugs Board and Philippine Drug Enforcement Agency



Section 77. The Dangerous Drugs Board

Section 78. Composition of the Board. – The Board shall be composed of seventeen (17)members wherein three (3) of which are permanent members, the other twelve (12)members shall be in an ex officio capacity and the two (2) shall be regular members.

The other twelve (12) members who shall be ex officio members of the Board are thefollowing:

(1) Secretary of the Department of Justice or his/her representative;

(2) Secretary of the Department of Health or his/her representative;

(3) Secretary of the Department of National Defense or his/her representative;

(4) Secretary of the Department of Finance or his/her representative;(5) Secretary of the Department of Labor and Employment or his/her representative;

(6) Secretary of the Department of the Interior and Local Government or his/herrepresentative;

(7) Secretary of the Department of Social Welfare and Development or his/herrepresentative;

(8) Secretary of the Department of Foreign Affairs or his/her representative; (9) Secretaryof the Department of Education or his/her representative;

(10) Chairman of the Commission on Higher Education or his/her representative;

(11) Chairman of the National Youth Commission;

(12) Director General of the Philippine Drug Enforcement Agency.



Cabinet secretaries who are members of the Board may designate their dulyauthorized and permanent representatives whose ranks shall in no case belower than undersecretary.

The two (2) regular members shall be as follows:

(a) The president of the Integrated Bar of the Philippines; and

(b) The chairman or president of a non-government organization involved indangerous drug campaign to be appointed by the President of the Philippines.

Section 79. Meetings of the Board .

Section 80. Secretariat of the Board.

Section 81. Powers and Duties of the Board

Section 82. Creation of the Philippine Drug Enforcement Agency (PDEA).

Section 83. Organization of the PDEA. – The present Secretariat of the NationalDrug Law Enforcement and Prevention Coordinating Center as created byExecutive Order No. 61 shall be accordingly modified and absorbed by the

PDEA.Section 84. Powers and Duties of the PDEA. – The PDEA shall:

(a)Implement or cause the efficient and effective implementation of the nationaldrug control strategy formulated by the Board thereby carrying out anational drug campaign program which shall include drug law enforcement,control and prevention campaign with the assistance of concerned

government agencies;

(b) Undertake the enforcement of the provisions of Article II of this Act relative to theunlawful acts and penalties involving any dangerous drug and/or controlled precursor and



unlawful acts and penalties involving any dangerous drug and/or controlled precursor andessential chemical and investigate all violators and other matters involved in the commissionof any crime relative to the use, abuse or trafficking of any dangerous drug and/or controlledprecursor and essential chemical as provided for in this Act and the provisions of PresidentialDecree No. 1619;

(c) Administer oath, issue subpoena and subpoena duces tecum relative to the conduct of investigation involving the violations of this Act;

(d) Arrest and apprehend as well as search all violators and seize or confiscate, the effectsor proceeds of the crimes as provided by law and take custody thereof, for this purpose theprosecutors and enforcement agents are authorized to possess firearms, in accordance withexisting laws;

(e) Take charge and have custody of all dangerous drugs and/or controlled precursors and

essential chemicals seized, confiscated or surrendered to any national, provincial or local lawenforcement agency, if no longer needed for purposes of evidence in court;

(f) Establish forensic laboratories in each PNP office in every province and city in order tofacilitate action on seize or confiscated drugs, thereby hastening its destruction withoutdelay;

(g) Recommend to the DOJ the forfeiture of properties and other assets of persons and/orcorporations found to be violating the provisions of this Act and in accordance with the

pertinent provisions of the Anti-Money-Laundering Act of 2001;

(h) Prepare for prosecution or cause the filing of appropriate criminal and civil cases forviolation of all laws on dangerous drugs, controlled precursors and essential chemicals, andother similar controlled substances, and assist, support and coordinate with othergovernment agencies for the proper and effective prosecution of the same;



(i) Monitor and if warranted by circumstances, in coordination with the PhilippinePostal Office and the Bureau of Customs, inspect all air cargo packages, parcels andmails in the central post office, which appear from the package and address itself to

be a possible importation of dangerous drugs and/or controlled precursors andessential chemicals, through on-line or cyber shops via the internet or cyberspace;

(j) Conduct eradication programs to destroy wild or illegal growth of plants fromwhich dangerous drugs may be extracted;

(k) Initiate and undertake the formation of a nationwide organization which shallcoordinate and supervise all activities against drug abuse in every province, city,

municipality and barangay with the active and direct participation of all such localgovernment units and nongovernmental organizations, including the citizenry,subject to the provisions of previously formulated programs of action againstdangerous drugs;

(l) Submit an annual and periodic reports to the Board as may be required fromtime to time, and perform such other functions as may be authorized or requiredunder existing laws and as directed by the President himself/herself or asrecommended by the congressional committees concerned.

Section 85. The PDEA Academy .



ARTICLE X-Appropriations, Management of Funds and Annual Report

Section 87. Appropriations. – The amount necessary for the operation of theBoard and the PDEA shall be charged against the current year's

appropriations of the Board, the National Drug Law Enforcement andPrevention Coordinating Center, the Narcotics Group of the PNP, the NarcoticsDivision of the NBI and other drug abuse units of the different lawenforcement agencies integrated into the PDEA in order to carry out theprovisions of this Act. Section 88. Management of Funds Under this Act;

Annual Report by the Board and the PDEA.

Section 89. Auditing the Accounts and Expenses of the Board and the PDEA.

ARTICLE XI-Jurisdiction Over Dangerous Drugs Cases

Section 90. Jurisdiction

Section 91. Responsibility and Liability of Law Enforcement Agencies and

other Government Officials and Employees in Testifying as ProsecutionWitnesses in Dangerous Drugs Cases out by his/her immediate superiorand/or appropriate body.

Section 92. Delay and Bungling in the Prosecution of Drug Cases.

Section 93. Reclassification, Addition or Removal of Any Drug from the List of Dangerous Drugs



of Dangerous Drugs.

ARTICLE XII-Implementing Rules and Regulations

Section 94. Implementing Rules and Regulations. – The present Board inconsultation with the DOH, DILG, DOJ, DepEd, DSWD, DOLE, PNP, NBI,

PAGCOR and the PCSO and all other concerned government agencies shallpromulgate within sixty (60) days the Implementing Rules and Regulationsthat shall be necessary to implement the provisions of this Act.

ARTICLE XIII-Final Provisions

Section 95. Congressional Oversight Committee.

Section 96. Powers and Functions of the Oversight Committee.

(a) To set the guidelines and overall framework to monitor and ensure theproper implementation of this Act;

(b) To ensure transparency and require the submission of reports fromgovernment agencies concerned on the conduct of programs, projects and

policies relating to the implementation of this act;(c) To approve the budget for the programs of the Oversight Committee onDangerous Drugs and all disbursements therefrom, including compensationof all personnel;

(d) To submit periodic reports to the President of the Philippines andCongress on the implementation of the provisions of this Act;

(e) To determine inherent weaknesses in the law and recommend the



(e) To determine inherent weaknesses in the law and recommend thenecessary remedial legislation or executive measures; and

(f) To perform such other duties, functions and responsibilities as may benecessary to effectively attain the objectives of this Act.

Section 97. Adoption of Committee Rules and Regulations, and Funding. –

Section 98. Limited Applicability of the Revised Penal Code.

Section 99. Separability Clause. – If for any reason any section or provisionof this Act, or any portion thereof, or the application of such section,

provision or portion thereof to any person, group or circumstance is declaredinvalid or unconstitutional, the remainder of this Act shall not be affected bysuch declaration and shall remain in force and effect.

Section 100. Repealing Clause. – Republic Act No. 6425, as amended, ishereby repealed and all other laws, administrative orders, rules andregulations, or parts thereof inconsistent with the provisions of this Act, are

hereby repealed or modified accordingly.

Section 101. Amending Clause. – Republic Act No. 7659 is hereby amendedaccordingly.

Section 102. Effectivity . – This Act shall take effect fifteen (15) days uponits publication in at least two (2) national newspapers of general circulation.




Amending RA8293, RA6675, RA5921

AN ACT PROVIDING FOR CHEAPER AND QUALITYMEDICINES, AMENDING FOR THE PURPOSE REPUBLIC ACTNO. 8293 OR THE INTELLECTUAL PROPERTY CODE,REPUBLIC ACT NO. 6675 OR THE GENERICS ACT OF 1988,AND REPUBLIC ACT NO. 5921 OR THE PHARMACY LAW,AND FOR OTHER PURPOSES

Section 1. Short Title. - This Act shall be known as the "Universally Accessible

http://www.lawphil.net/statutes/repacts/ra1997/ra_8293_1997.html








Cheaper and Quality Medicines Act of 2008".

SEC. 2. Declaration of Policy . - It is the policy of the State to protect public healthand, when the public interest or circumstances of extreme urgency so require, itshall adopt appropriate measures to promote and ensure access to affordable

quality drugs and medicines for all.

CHAPTER 2- Amendments To Republic Act No. 8293, Otherwise Known AsThe Intellectual Property Code Of The Philippines

Chapter 3-Drugs And Medicines Price Regulation

SEC. 17. Drugs and Medicines Price Regulation Authority of the President of the

Philippines.

SEC. 18. Drugs and Medicines Price Monitoring and Regulation Authority of theSecretary of the Department of Health.

SEC. 19. Functions and Responsibilities of the Secretary of the Department of Health.

SEC. 20. Procedures for Inquiries, Studies, Hearings, Investigations, and Proceedings.

SEC. 21. Effectivity of the Decisions or Orders of the Secretary of the Department of Health.

SEC. 22. Review of the Decisions or Orders of the Secretary of the Department of

Health

SEC. 23. List of Drugs and Medicines that are Subject to Price Regulation. (a)All drugs and medicines indicated for treatment of chronic illnesses and life threatening





g gconditions, such as, but not limited to, endocrine disorders, e.g., diabetes mellitus;gastrointestinal disorders, e.g., peptic ulcer; urologic disorders, e.g., benign prostatichyperplasia (BPH); cardiovascular diseases, e.g., hypertension; pulmonary diseases,e.g., pulmonary tuberculosis (PTB), asthma; auto-immune diseases, e.g., systemic

lupus erythematosus (SLE); skin diseases, e.g., psoriasis; neuro-psychiatric disorders;other infectious diseases, e.g., human immunodeficiency virus-acquired immunedeficiency syndrome (HIV-AIDS); and other conditions such as organ transplants andneoplasm;

(b) Drugs and medicines indicated for prevention of diseases, e.g., vaccines,immunoglobulin, anti-sera;

(c) Drugs and medicines indicated for prevention of pregnancy, e.g., oralcontraceptives;

(d) Anesthetic agents;

(e) Intravenous fluids;

(f) Drugs and medicines that are included in the Philippine National Drug Formulary

(PNDF) Essential Drug List; and

(g) All other drugs and medicines which, from time to time, the Secretary of theDepartment of Health determines to be in need of price regulation.

SEC. 24. Illegal Acts of Price Manipulation.

SEC. 25. Penalty for Illegal Acts of Price Manipulation. - Any person or entity who



y g p y p ycommits any act of illegal price manipulation of any drug and medicine subject to priceregulation shall suffer the penalty of imprisonment for a period of not less than five (5)years nor more than fifteen (15) years or shall be imposed a fine of not less than Onehundred thousand pesos (Php100,000.00) nor more than Ten million pesos

(Php10,000,000.00), at the discretion of the court. The court may also order thesuspension or revocation of its license to operate (LTO), professional or businesslicense.

SEC. 26. Display of Maximum Retail Price Fixed and Approved by Order of thePresident of the Philippines for Drugs and Medicines Subject to Price Regulation.

SEC. 27. Reports from Local Government Units (LGUs) and the Department of Trade

and Industry (DTI). -

SEC. 28. Role of the Department of Health (DOH) and the Department of Trade and Industry (DTI).

SEC. 29. Rules and Regulations. - The Secretary of the Department of Health, inconsultation with the Department of Trade and Industry, the Congressional Oversight

Committee and other appropriate government agencies, shall, within one hundredtwenty (120) days from the effectivity of this Act, promulgate the rules and regulationsnecessary to effectively implement the provisions of this Chapter.

SEC. 30. Reportorial and Public Notice Requirements.

CHAPTER 4-STRENGTHENING OF THE BUREAU OF FOOD AND DRUGS

SEC 31 Strengthening of the Bureau of Food and Drugs (BFAD)



SEC. 31. Strengthening of the Bureau of Food and Drugs (BFAD).

SEC. 32. Quality Assurance of Drugs.

CHAPTER 5-NON-DISCRIMINATORY CLAUSE

SEC. 33. Non-Discriminatory Clause. - It shall be unlawful for any retail drugoutlet to refuse to carry either by sale or by consignment, or offer for saledrugs and medicines brought into the country, as allowed under Section 7 of this Act which amends Section 72.1 of the Intellectual Property Code of thePhilippines or Republic Act No. 8293, by the government or authorized thirdparty which have been previously approved for distribution or sale by theBureau of Food and Drugs. For this purpose, the said products shall be

displayed with equal prominence as all other products sold in theestablishment.

SEC. 34. Refusal to Sell Drugs and Medicines.

SEC. 35. Penalties. - Any person or entity who shall refuse to carry or selldrugs and medicines pursuant to the provisions of this Chapter shall be

punished with a fine of not less than One hundred thousand pesos(Php100,000.00) but not more than Five hundred thousand pesos(Php500,000.00), at the discretion of the court. For the succeeding offense,the penalties shall not be less than Five hundred thousand pesos(Php500,000.00) but not more than One million pesos (Php1,000,000.00), atthe discretion of the court, and suspension or revocation of its license tooperate (LTO), business or professional license, as the case may be.

SEC. 36. Implementing Rules and Regulations on the Non-Discriminatory Clause. - Within onehundred twenty (120) days from the effectivity of this Act, the Department of Health, in

lt ti ith th D t t f T d d I d t h ll l t th l d l ti



consultation with the Department of Trade and Industry, shall promulgate the rules and regulationsnecessary to effectively implement the provisions of this Chapter.

Chapter 6- Amendments To Republic Act No. 6675, Otherwise Known As The Generics ActOf 1988

Chapter 7- Amendments To Republic Act No. 5921, As Amended, Otherwise Known AsThe Pharmacy Law

CHAPTER 8-MISCELLANEOUS PROVISIONS

SEC. 45. Congressional Oversight Committee.

SEC. 46. Appropriations. - For the initial implementation of this Act, the amount of Twenty-fivemillion pesos (Php25,000,000.00), in addition to the budget of the Department of Health, shall be

provided for the operations of the Office of the Secretary of the Department of Health. The QualityAffordable Medicines Oversight Committee shall be provided an initial budget of Five million pesos(Php5,000,000.00) to perform its functions as mandated under this Act. Thereafter, such sum asmay be necessary for its continued implementation shall be included in the annual GeneralAppropriations Act.

SEC. 47. Separability Clause. - Any portion or provision of this Act that may be declaredunconstitutional or invalid shall not have the effect of nullifying other portions and provisions hereof

as long as such remaining portion or provision can still subsist and be given effect in their entirety.

SEC. 48. Repealing Clause. - All laws, decrees, executive orders, proclamations and administrativeregulations or parts thereof inconsistent herewith are hereby repealed or modified accordingly.

SEC. 49. Effectivity Clause. - This Act shall take effect fifteen (15) days after its publication in atleast two (2) national papers of general circulation.






Documents

Drugs and Medication-Final