Mission and Preface: USP 35NF 30 and Supplements … · United States Pharmacopeial Convention (USP), as well as keted articles. general information about the 35th revision of the

First Supplement to USP 35–NF 30 Mission and Preface 5093

Mission and PrefaceUSP 35–NF 30 and

SupplementsThis section provides background information on the keted in the United States or are contained in legally mar-

United States Pharmacopeial Convention (USP), as well as keted articles.general information about the 35th revision of the United A USP–NF monograph for an official substance or prepara-States Pharmacopeia (USP 35) and the 30th edition of the tion may consist of various components, including the arti-National Formulary (NF 30) and its Supplements. Unless oth- cle’s name; definition; packaging, storage, and other re-erwise noted, the text in USP 35–NF 30 is official May 1, quirements; and a specification. The specification consists of2012, the text in the First Supplement to USP 35–NF 30 is a series of universal tests (description, identity/identification,official August 1, 2012, and the text in the Second Supple- impurities, assay) and specific tests, one or more analyticalment to USP 35–NF 30 is official December 1, 2012. procedures for each test, and acceptance criteria. Ingredi-

ents are defined as either drug substances or excipients. Anexcipient is any component, other than the active sub-MISSION STATEMENT stance(s), intentionally added to the formulation of a dosageform. Excipients are not necessarily inert. Drug substances

USP–NF is published in continuing pursuit of the mission and excipients may be synthetic, semi-synthetic, drawn fromof USP: To improve the health of people around the world nature (natural source), or manufactured using recombinantthrough public standards and related programs that help en- technology. Drugs that consist of larger molecules and mix-sure the quality, safety, and benefit of medicines and foods. tures requiring a potency test are usually referred to as bio-

logicals or biotechnological articles.General chapters provide frequently cited procedures,HISTORY sometimes with acceptance criteria, in order to compile into

one location repetitive information that appears in manyOn January 1, 1820, 11 physicians met in the Senate monographs. New and revised monographs and general

Chamber of the U.S. Capitol building to establish a pharma- chapters and obsolete matter deleted from this edition arecopeia for the United States. These practitioners sought to indicated in the Admissions section.create a compendium of the best and most fully established USP–NF Organization—USP–NF is printed as a three-vol-medicines, give them useful names, and provide recipes for ume set. Volume 1 includes front matter (Mission and Pref-their preparation. Nearly a year later, on December 15, ace, People, Governance pages and websites, and Admis-1820, the first edition of The Pharmacopoeia of the United sions/Annotations). It also includes USP General Notices,States was published. Over time, the nature of the United general chapters, dietary supplement general chapters, Re-States Pharmacopeia (USP) changed from being a compen- agents, Reference Tables, dietary supplement monographs,dium of recipes to a compendium of documentary stan- NF Admissions, Excipients, and NF monographs. Volume 2 in-dards for identity and quality that typically involve reference cludes USP monographs A–I, and Volume 3 includes USPmaterials used as comparison standards in specified tests monographs J–Z. To facilitate convenient use and reference,and assays. The publishing schedule of USP also changed all three volumes include the full index, as well as the USPover time. From 1820 to 1942, USP was published at 10- General Notices and the Guide to General Chapters. Generalyear intervals; from 1942 to 2000, at five-year intervals; and chapters specific to dietary supplements are included in nu-beginning in 2002, annually. merical order with the rest of the general chapters in USP.In 1888, the American Pharmaceutical Association pub- Excipient monographs usually are presented in NF but alsolished the first National Formulary under the title The Na- may appear in USP with suitable cross-referencing whentional Formulary of Unoficinal [sic] Preparations (NF). Both they are also drug substances. The Excipients section (VolumeUSP and NF were recognized in the Federal Food and Drugs 1) presents a tabulation of excipients by functional category.Act of 1906 and again in the Federal Food, Drug, and Cos-

Revisions to USP–NF—USP–NF is continuously revised.metic Act of 1938 (FD&C Act). In 1975, USP acquired theRevisions are presented annually as Standard Revisions inNational Formulary (NF), which now contains excipient stan-USP–NF and in twice-yearly Supplements, and as Accelerateddards that also call for reference materials. USP continues toRevisions on USP’s website (Errata, Interim Revision Announce-develop USP and NF, through the work of the Council ofments [IRAs], and Revision Bulletins).Experts, into compendia that provide standards for articles

Standard Revisions—USP’s Standard Revision Process callsbased on advances in analytical and metrological science. Asfor publication of a proposed revision in the Pharmacopeialthese and allied sciences evolve, so do USP and NF.Forum (PF) for a 90-day notice and comment period and,after the revision is approved by the relevant USP Expert

CONTENT OF USP–NF Committee, publication in the next USP–NF or Supplement,as applicable.

USP–NF contains official substance and preparation (prod- Accelerated Revisions—The Accelerated Revision process isuct) monographs. The terms official substance and official used to make revisions to USP–NF official more quickly thanpreparation are defined in the General Notices and Require- through USP’s Standard Revisions process. Accelerated Revi-ments (General Notices). With few exceptions, all articles for sions, which include Errata, IRAs, and Revision Bulletins, arewhich monographs are provided in USP–NF are legally mar- posted on USP’s website, do not always require notice and

comment, and allow for a revision to become official prior

Official from August 1, 2012Copyright (c) 2012 The United States Pharmacopeial Convention. All rights reserved.

Accessed from 128.83.63.20 by nEwp0rt1 on Sat May 19 06:19:03 EDT 2012

5094 Mission and Preface First Supplement to USP 35–NF 30

to the next USP–NF or Supplement. See the USP Guideline on that are simultaneously official, lots deleted from official sta-Use of Accelerated Processes for Revisions to the USP–NF, tus, and a preview of items eventually to be adopted.which is posted on USP’s website. Purchase order information is included, and the names of

distributors who can facilitate international availability ofErrata—An Erratum/Errata is content erroneously pub-these items are suggested. This program benefits from thelished in a USP publication that does not accurately reflectwidespread voluntary contribution of suitable materials andthe intended official or effective requirements as approvedtest data from pharmaceutical manufacturers. USP advancesby the Council of Experts. These typically are changes thatthis material via careful characterization studies and collabo-do not have a broad impact on the standards. Errata are notrative testing, followed by review and approval of the com-subject to public comment and become official whenpendial use of the reference material by Expert Committeesposted to the USP website. Errata are incorporated into theof the Council of Experts.next available USP–NF or Supplement.

Symbols—Symbols identify the beginning and end ofInterim Revision Announcements (IRAs)—An IRA appears ineach revision, or nonharmonized text. The following tablePF first as a Proposed Interim Revision Announcement with asummarizes the types of symbols and the associated sub-90-day comment period. If there are no significant com-scripts used in USP publications:ments, the IRA becomes official in the “New Official Text”

section of USP’s website, with the official date indicated.IRAs are incorporated into the next available USP–NF or Sup- Revision Type Symbol Subscriptplement. Interim Revision •new text•(IRA1-Jul-2012) (IRA 1-Jul-2012)*

Revision Bulletins—If circumstances require rapid publica- Announcementtion of official text, a revision or postponement may be Revision Bulletin •new text• (RB 1-Jan-2012) (RB 1-Jan-2012)*published through a Revision Bulletin. Revision Bulletins are ••(IRA 1-Jul-2012) or (IRA 1-Jul-2012)*Text deletionposted on USP’s website with the official date indicated. Re-

■■1S (USP35) or 1S (USP35)*vision Bulletins are incorporated into the next available

▲▲(USP35) USP35**USP–NF or Supplement.

Adopted in ■new text■1S (USP35) 1 or 2S (USP annualPharmacopeial Forum (PF)—The PF is USP’s official publi-Supplement edition)*cation for public notice and comment. Proposals for revi-

Adopted in ▲new text▲(USP35) USP annual edi-sion are presented in the In-Process Revision or the ProposedUSP–NF tion**Interim Revision Announcement (see above) sections and rep-

resent draft revisions that are expected to advance to official Harmonization ✦ indicates residualstatus pending final review and approval by the relevant national text orExpert Committee. nonharmonized text

On January 3, 2011, PF transitioned to an online-only * A subscript number or date indicates the IRA, Revision Bulletin, or Sup-publication that is available free of charge. The print ver- plement in which the revision first appeared. sion is no longer available. The new online-only PF includes ** An example of a revision that was officially adopted in the USP–NFproposed changes and additions to the USP–NF, including would be ▲(USP35). Stage 4 Harmonization, and Stimuli articles for which USP isseeking public comments. All proposals, including IRAs, will The following table shows symbols and official dates forhave a 90-day comment period. Other information that was IRAs and Supplements to USP 35–NF 30.contained in PF, including official text (final IRAs) is nowpublished solely on USP’s website or moved into other USP

IRAs and Supplements to USP 35–NF 30publications.Official Dates and SymbolsThis change to make PF freely available will help facilitate

open and public participation when revisions are proposed Proposedto the USP–NF. Supplement IRA Official Date Symbols

38(1) July 1, 2012 •and•(IRA 1-Jul-2012)Supplements—Supplements to USP–NF follow a standardschedule each year: the First Supplement is published in Feb- 1 Aug. 1, 2012 ■and■1S (USP35)

ruary and becomes official August 1. The Second Supplement 38(2) Sept. 1, 2012 •and•(IRA 1-Sep-2012)is published in June and becomes official December 1. Users 38(3) Nov. 1, 2012 •and•(IRA 1-Nov-2012)of USP print products must retain Supplements and check

2 Dec. 1, 2012 ■and■2S (USP35)the “New Official Text” section of USP’s website in order to38(4) Jan. 1, 2013 •and•(IRA 1-Jan-2013)have up-to-date official text. The USP–NF online version is38(5) Mar. 1, 2013 •and•(IRA 1-Mar-2013)updated with each Supplement or annual revision. Each time

a new edition or Supplement is released during the subscrip- 38(6) May 1, 2013 •and•(IRA 1-May-2013)

tion period, a new electronic version is issued. The Index ineach Supplement is cumulative and includes citations to the Commentary—In accordance with USP’s Rules and Proce-annual revision and, for the Second Supplement, citations to dures of the Council of Experts, USP publishes all proposedthe First Supplement. The contents of the two Supplements revisions to USP–NF for public review and comment in theare integrated into the annual edition of the following year, PF, USP’s bimonthly journal for public notice and comment.along with new official revisions that have been adopted After comments are considered and incorporated as the Ex-since the Second Supplement to the previous compendia. pert Committee deems appropriate, the proposal may ad-

vance to official status or be republished in PF for furtherUSP–NF Spanish Edition—In 2006, USP began providingnotice and comment, in accordance with the Rules and Pro-a Spanish edition of USP–NF. Maintenance of this editioncedures. In cases when proposals advance to official statusfollows the same revision approaches as the English edition.without republication in PF, a summary of comments re-USP Reference Standards—When approved for use as aceived and the appropriate Expert Committee’s responsescomparison standard as a component of a USP monographare published in the Commentary section of the USP websiteor other compendial procedure, use of USP–NF Referenceat the time the revision is published.Standards promotes uniform quality of drugs and supports

The Commentary is not part of the official text and is notreliability and consistency by those performing complianceintended to be enforceable by regulatory authorities.testing and other users of USP–NF, including manufacturers,Rather, it explains the basis of the Expert Committee’s re-buyers, and regulatory authorities. The USP Catalog, whichsponse to public comments. If there is a difference betweenlists the collection of USP–NF Reference Standards, can bethe contents of the Commentary and the official text, theaccessed on the USP’s website at www.usp.org. The listingofficial text prevails. In case of a dispute or question ofidentifies new items, replacement lots, lots of a single item




interpretation, the language of the official text, alone and content of USP’s official and authorized publications (seeindependent of the Commentary, shall prevail. Figure 1). The Executive Committee of the Council of Ex-

perts includes all Expert Committee Chairs and providesChemical Names and CAS Registry Numbers—Chemi-overall direction, is an appeals body, and performs othercal subtitles given in the monographs are index names usedfunctions that support the Council of Experts’ operations.by the Chemical Abstracts Service (CAS) of the American

Chemical Society. They are provided only in monographs in Expert Panels to the Council of Experts—The Chair ofwhich the titles specify substances that are definable chemi- the Council of Experts may appoint Expert Panels to assistcal entities. The first subtitle is the inverted form of the sys- the Council of Experts by providing advisory recommenda-tematic chemical name developed by CAS for the purpose tions to particular Expert Committees in response to a spe-of the Collective Index (CI). The second subtitle, given in cific charge consistent with the Expert Committee’s Workuninverted form, is a preferred IUPAC name (PIN) sanc- Plan. Expert Panels are continuously formed; their topicstioned and used by the International Union of Pure and Ap- and membership appear in the People section.plied Chemistry (IUPAC). Preferred IUPAC names are also Stakeholder Forums and Project Teams—USP hasused by the World Health Organization (WHO). Occasionally formed several domestic and international Stakeholder Fo-a third subtitle is supplied for historical reasons or when the rums and Project Teams to exchange information on USP’ssynonym uses an alternative, but equivalent, naming con- standards-setting activities. Stakeholder Forums may formvention. Monographs with chemical subtitles also generally Project Teams to work on selected topics. The following listscarry CAS registry numbers. These bracketed numbers func- the current USP Stakeholder Forums.tion independently of nomenclature as invariant numerical North American Stakeholder Forums (United States anddesignators of unique, unambiguous chemical substances in Canada)the CAS registry and thus are convenient and widely used. • Prescription/Nonprescription

Print and Electronic Presentations—All USP–NF publica- • Dietary Supplementstions are available in print form (with the exception of the • Food IngredientsPharmacopeial Forum and Accelerated Revisions, discussed International Stakeholder Forumsabove, which are posted on USP’s website until incorpora- • Indiation into the next USP–NF or Supplement). In addition, • MexicoUSP–NF and its two annual Supplements are available in USB • Brazilflash drive and online versions. The USB flash drive version • Othersmakes USP–NF accessible to users on their computer hard USP also conducts Scientific and Standards Symposia (for-drives. The online format allows individual registered users merly Annual Scientific Meetings) in the United States, India,to access the online format through the Internet. Both elec- China, Latin America, Middle East/North Africa, and othertronic formats provide access to official USP–NF content, regions of the world.along with extensive search options. The electronic formats

Staff—USP maintains a staff of over 700 scientists, pro-are cumulatively updated to integrate the content of Supple-fessionals, and administrative personnel at its Rockville, Ma-ments. A searchable electronic version of the USP Dictionaryryland, headquarters and throughout the world, includingalso is available.an account management office in Basel, Switzerland, andlaboratory facilities in Hyderabad, India; Shanghai, China;

USP GOVERNING, STANDARDS-SETTING, AND and Sao Paulo, Brazil.ADVISORY BODIES

RULES AND PROCEDURESUSP’s governing, standards-setting, and advisory bodies

include the USP Convention, the Board of Trustees, theGoverning Documents—USP–NF standards are recog-Council of Experts and its Expert Committees, Expert Panels

nized widely because they are authoritative and science-(formerly known as Advisory Panels), and staff. Additionalbased and are established by a transparent and crediblevolunteer bodies include Stakeholder Forums, Project Teams,process. See the Articles of Incorporation section in this book;and Advisory Groups, which act in an advisory capacity tothe Bylaws and the Rules and Procedures of the Council ofprovide input to USP’s governing, standards-setting, andExperts are available on USP’s website (www.usp.org). Col-management bodies.lectively, these documents serve USP volunteers and staff asUSP Convention—The composition of the USP Conven-the governing principles for USP’s standards-setting activi-tion membership is designed to ensure a global representa-ties.tion from all sectors of health care, with an emphasis on

Conflicts of Interest—USP’s Conflict of Interest provi-practitioners, given USP’s practitioner heritage (see the His-sions require all members of the Council of Experts, its Ex-tory section). Voting Delegates of Convention member orga-pert Committees, Expert Panels, Board of Trustees, and keynizations elect USP’s President, Treasurer, other members ofstaff to disclose financial or other interests that may interferethe Board of Trustees, and the Council of Experts. They alsowith their duties as USP volunteers. Members of the Boardadopt resolutions to guide USP’s strategic direction andof Trustees, Council of Experts, and its Expert Committeesamend USP’s Bylaws. The 2010 meeting of the USP Con-are not allowed to take part in the final discussion or votevention occurred in April 2010 in Washington, DC. A listingon any matter in which they have a conflict of interest orof all current Voting Delegates of the USP Convention isthe appearance of a conflict of interest. Members of Expertincluded in the People section.Panels may participate and vote, so long as any conflictsBoard of Trustees—USP’s Board of Trustees is responsi-have been adequately and promptly disclosed and are com-ble for the management of the business affairs, finances,municated to the relevant Expert Committee along with anyand property of USP. During its 5-year term, the Board de-Expert Panel recommendations.fines USP’s strategic direction through its key policy and op-

Confidentiality and Document Disclosure— Memberserational decisions. A listing of the members of theof the Council of Experts, Expert Committees, and Expert2010–2015 Board of Trustees is included in the People sec-Panels sign confidentiality agreements, in keeping withtion.USP’s Confidentiality Policy and the confidentiality provisionsCouncil of Experts—The Council of Experts is the stan-of the Rules and Procedures of the Council of Experts. The USPdards-setting body of USP. For the 2010–2015 cycle it isDocument Disclosure Policy, available on USP’s website,composed of 21 members, elected to 5-year terms by USP’scontributes to the transparency of the standards-setting pro-Convention, each of whom chairs an Expert Committee.cess by making information available to the public, yet pro-These Chairs in turn elect the members of their Expert Com-

mittees. The Expert Committees are responsible for the




Figure 1. 2010–2015 USP Council of Experts.

vides protection to manufacturers and others who submit mittees vote to make them official text in USP–NF. Thus, theconfidential information to USP. USP standards-setting process gives those who manufacture,

regulate, and use therapeutic products the opportunity toAuthority for Publication—USP–NF is published in accor-comment on the development and revision of USP–NF stan-dance with Article II, Purposes, of the USP Bylaws, whichdards. Figure 2 shows the public review and comment pro-states, “The purposes for which the Convention is formedcess and its relationship to standards development. are as set forth in the Articles of Incorporation and include

developing and disseminating public standards for Working with the Food and Drug Administrationmedicines and other articles, and engaging in related public (FDA)—As specified in U.S. law, USP works with the Secre-health programs.” tary of the Department of Health and Human Services in

many ways. The principal agency in the Department for thiswork is the Food and Drug Administration. The FDA LiaisonUSP–NF REVISION PROCESS Program allows FDA representatives to participate in ExpertCommittee and Expert Panel meetings, enabling interactionsbetween FDA scientific staff and Expert Committees. Staff inPublic Participation—Although USP’s Council of Expertsthe FDA Centers who are responsible for review of com-is the ultimate decision-making body for USP–NF standards,pendial activities provide specific links and opportunities forthese standards are developed by an exceptional process ofexchange of comments. Dr. Paul Seo in the Center for Drugpublic involvement and substantial interaction between USPEvaluation and Research provides a primary compendialand its stakeholders, both domestically and internationally.point of contact between FDA and USP.Participation in the revision process results from the support

of many individuals and groups and also from scientific,technical, and trade organizations. LEGAL RECOGNITIONRequests for Revision of the USP–NF, whether new mono-graphs or general chapters or those needing updating, con-tain information submitted voluntarily by manufacturers and Recognition of USP–NF—USP–NF is recognized by lawother interested parties. At times USP staff and Expert Com- and custom in many countries throughout the world. In themittees may develop information to support a Request for United States, the FD&C Act defines the term “official com-Revision. USP has prepared a document titled Guideline for pendium” as the official USP, the official NF, the official Ho-Submitting Requests for Revision to USP–NF (available at meopathic Pharmacopeia of the United States, or any supple-www.usp.org; search on “Submission Guidelines”). Via PF, ment to them. As noted below (and in General NoticesUSP solicits and encourages public comment on these revi- section 2.30), USP–NF standards play a role in the adultera-sion proposals. Comments received are considered by the tion and misbranding provisions of the FD&C Act (whichExpert Committees, who determine whether changes should apply as well to biologics, a subset of drugs, under the Pub-be made to the proposed revisions based on such com- lic Health Service Act). USP has no role in enforcement ofments. Proposed standards are finalized when Expert Com- these or other provisions that recognize USP–NF standards,




Figure 2. USP’s standards-setting public review and comment process.

which is the responsibility of FDA and other government requirements. This is equally so for biologics approvedauthorities in the United States and elsewhere. under the longstanding PHS Act “351(a)” pathway, as well

Under the relevant FD&C Act provisions, a drug will be as the new “351(k)” pathway for biosimilars added by thedeemed misbranded unless its label bears to the exclusion 2010 healthcare reform legislation.of any other nonproprietary name the “established” name, Medical Devices—Section 201(h) of the FD&C Act de-which ordinarily is the compendial name (see discussion of fines a device as an instrument, apparatus, similar article, orNomenclature, below). A drug with a name recognized in component thereof recognized in USP–NF. Section 502(e) ofUSP–NF must comply with the identity/identification require- the FD&C Act defines the established name of a device inments of its monograph, or be deemed adulterated, mis- the absence of an FDA designation of the official name asbranded, or both. Drugs also must comply with compendial the official title in an official compendium. Despite thesestandards for strength, quality, and purity (tests for assay statutory provisions, there is no comparable recognition ofand impurities), unless labeled to show all respects in which USP’s role in establishing compendial standards for medicalthe drugs differ. FDA requires that names for articles that devices as exists for drugs and biologics. Under authorityare not official must be clearly distinguished and differenti- granted by the Food and Drug Administration Moderniza-ated from any name recognized in an official compendium. tion Act of 1997, the Center for Devices and RadiologicalDrugs with a name recognized in USP–NF also will be con- Health recognizes national and international standards, in-sidered misbranded unless they meet compendial standards cluding some USP tests and assays, for medical devices.for packaging and labeling. Dietary Supplements—The Dietary Supplement Health

Drugs—USP’s goal is to have substance and preparation and Education Act of 1994 amendments to the FD&C Act(product) monographs in USP–NF for all FDA-approved name USP and NF as official compendia for dietary supple-drugs, including biologics, and their ingredients. USP also ments. The amendments also provide that a dietary supple-develops monographs for therapeutic products not ap- ment may be deemed misbranded if it is covered by a mon-proved by FDA, e.g., pre-1938 drugs, dietary supplements, ograph in an official compendium, is represented asand compounded preparations. Although submission of in- conforming to this monograph, but fails to so conform. Theformation needed to develop a monograph by the Council dietary supplement must be represented as conforming to aof Experts is voluntary, compliance with a USP–NF mono- USP–NF dietary supplement monograph for the compendialgraph, if available, is mandatory. standards to apply. This contrasts with pharmaceutical prod-

Biologics—In the United States, all biologics are consid- ucts, wherein conformance to the monograph is mandatory,ered a subset of drugs, whether they are approved by FDA whether or not the product claims to conform.under the FD&C Act (and receive a new drug application Compounded Preparations—Compounding means the[NDA]) or under the Public Health Service Act (PHS Act, preparation, mixing, assembling, altering, packaging, andwhere they receive a biologics license application [BLA]). As labeling of a drug or device or other article, as the result ofa result, all PHS Act biologics are subject to the drug regula- a practitioner’s order or in anticipation of such an ordertory requirements of the FD&C Act, which means they are based on routine, regularly observed prescribing patterns.required to comply with the adulteration and misbranding USP provides both general chapters and monographs forprovisions of the FD&C Act, including USP–NF compendial compounded preparations. Compounded preparation




monographs include formulas (ingredients and quantities), formation chapter ⟨1196⟩, Pharmacopeial Harmonization,specific directions to correctly compound the particular provides (1) the PDG Policy Statement, (2) the PDG Work-preparation, packaging and storage information, labeling in- ing Procedures and a definition of each stage of harmoniza-formation, pH, beyond-use dates based on stability studies, tion, (3) a discussion, (4) a status report, and (5) a glossary.and detailed assays (majority of monographs). Standards in More information regarding PDG is available on USP’sUSP–NF for compounded preparations may be enforced by website.both the states (as pharmacy practice/compounding is tradi-tionally regulated by state boards of pharmacy), and FDA OTHER USP PUBLICATIONS(as compounded preparations subject to FDA regulation asdrugs remain subject to the adulteration and misbrandingprovisions of the FD&C Act, which require conformance to Chromatographic Columns—This comprehensive refer-USP–NF standards). ence, previously titled Chromatographic Reagents, provides

detailed information needed to conduct chromatographicNomenclature—In the United States, FDA generally de-procedures found in USP–NF. Chromatographic Columns listsfers to USP to create established (nonproprietary) names forthe brand names of the column reagents cited in every pro-drug products, including “proper” names for biologics. USP,posal for new or revised gas- or liquid-chromatographic ana-as a member of the United States Adopted Names (USAN)lytical procedures that have been published in PF sinceCouncil, works to determine names for drug and biological1980. Chromatographic Columns also helps to track whichsubstances. USP’s authority to develop official nonproprie-column reagents were used to validate analytical procedurestary names is identified in section 502(e) of the FD&C Act.that have become official. The branded column reagents listFDA’s policy on established names is set forth in 21 CFRis updated bimonthly and maintained on USP’s website.299.4. FDA-approved nonproprietary names are considered

by FDA and the courts to be interim names that exist only USP Dictionary—The USP Dictionary of USAN and Interna-unless and until USP designates a name. In contrast to tional Drug Names provides in a single volume the most up-USP’s role in designating nonproprietary names, the desig- to-date United States Adopted Names of drugs; officialnation of proprietary names is solely the responsibility of USP–NF names; nonproprietary, brand, and chemical names;FDA, working with applicants. graphic formulas; molecular formulas and weights; CAS reg-

The USP Nomenclature Expert Committee, the predeces- istry numbers and code designations; drug manufacturers;sor to the 2010–2015 Nomenclature, Safety, and Labeling and pharmacologic and therapeutic categories. The Diction-Expert Committee, was formed in 1986 to create appropri- ary helps to ensure the accuracy of the following: productate established names for dosage forms and combination labeling; reports, articles, and correspondence; FDA regula-drug products, and to develop naming policies. Today, the tory filings; and pharmaceutical package inserts. It is pub-Nomenclature, Safety, and Labeling Expert Committee coor- lished annually and is recognized by FDA as the officialdinates its work with the USAN Council, and it establishes source for established drug names. (See Nomenclature.)the Pronunciation Guide, which is used by USAN. USP Dietary Supplements Compendium—The Dietary Sup-

The USAN Council began in 1961 by providing ingredient plements Compendium combines, in a single volume, USP–NFnames for drugs prior to their marketing. USP participates in standards for dietary supplements, standards and informa-this activity, together with the American Medical Associa- tion from the Food Chemicals Codex, regulatory and industrytion, the American Pharmacists Association, and FDA. The documents, and other tools and resources. It is publishedCouncil’s output is incorporated, along with other names for every 2 years, as a hardcover print edition.drugs (including generic, proprietary, and chemical names Food Chemicals Codex—The Food Chemicals Codex (FCC)and code designations), into the USP Dictionary of USAN and is a compendium of internationally recognized monographInternational Drug Names (the Dictionary). Since 1988, the standards and tests for the purity and quality of food ingre-current compendial name (which in most cases is consistent dients, e.g., preservatives, flavorings, colorings, and nutri-with the USAN name) has been recognized by federal regu- ents. FCC is published every 2 years with supplements everylation as the source of established names for drug sub- 6 months, and is available in print and electronic formats.stances in the United States.

USP Medicines Compendium—The USP Medicines Compen-dium (MC) is an online compendium that includesHARMONIZATION ACTIVITIES monographs, general chapters, and reference materials forsuitable chemical and biological medicines and their ingredi-ents approved by national regulatory authorities. The pur-Pharmacopeial Discussion Group—USP harmonizespose of the MC is to help ensure that these medicines are ofpharmacopeial excipient monographs and general chaptersgood quality by providing up-to-date, relevant public stan-through the Pharmacopeial Discussion Group (PDG), whichdards and reference materials. MC standards are availableincludes representatives from the European, Japanese, andto manufacturers, purchasers, national regulatory authorities,United States pharmacopeias, and WHO (as an observer).and others to ensure conformity of a medicine to MC stan-According to the PDG definition, “a pharmacopeial generaldards through testing. The MC does not include standardschapter or other pharmacopeial document is harmonizedfor foods or for traditional medicines/dietary supplements.when a pharmaceutical substance or product tested by theThe MC is available at www.usp-mc.org.document’s harmonized procedure yields the same results,

and the same accept/reject decision is reached.” General in-



First Supplement to USP 35–NF 30 People / Committees 5099

People2010–2015 Revision Cycle

Officers of the USP Convention, Board of Trustees,and the Council of Experts, Expert Committees,

Expert Panels, and Advisory Groups

Gail Wilensky, Ph.D.Officers (2010–2015) Trustee At-LargeTimothy R. Franson, B.S. Pharm., M.D. Bethesda, MDPresident Roger L. Williams, M.D.Washington, DC Chief Executive OfficerRene H. Bravo, M.D., F.A.A.P. (ex-officio)Past President Rockville, MDSan Luis Obispo, CAJohn E. Courtney, Ph.D.Treasurer Council of Experts (2010–2015)Bethesda, MD Roger L. Williams, M.D.Susan S. de Mars, J.D. Chair, Council of ExpertsSecretary Rockville, MDRockville, MD James E. Akers, Ph.D.

Chair, General Chapters—MicrobiologyLeawood, KSBoard of Trustees (2010–2015) Gregory E. Amidon, Ph.D.

Duane M. Kirking, Pharm.D., Ph.D. Chair, General Chapters—Physical AnalysisChair Ann Arbor, MITrustee Representing the Pharmaceutical Sciences Lawrence H. Block, Ph.D.Ann Arbor, MI Chair, Monographs—ExcipientsCarolyn H. Asbury, Ph.D., Sc.M.P.H. Pittsburgh, PATrustee Representing the Public Matthew W. Borer, Ph.D.New York, NY Chair, Reference StandardsRobert L. Buchanan, Ph.D. Indianapolis, INTrustee At-Large Michael A. Cutrera, M.Sc.College Park, MD Chair, Monographs—Small Molecules 4Michael Maves, M.D., M.B.A. Langhorne, PATrustee Representing the Medical Sciences Gigi S. Davidson, B.S.Pharm., DICVPMillwood, VA Chair, CompoundingThomas Menighan, B.S. Pharm., M.B.A., Sc.D., Raleigh, NCF.A.Ph.A. James E. DeMuth, Ph.D.Trustee At-Large Chair, General Chapters—Dosage FormsWashington, DC Madison, WIRobert M. Russell, M.D. Andrew G. Ebert, Ph.D.,Trustee Representing the Medical Sciences Chair, Monographs—Food IngredientsArlington, MA Sandy Springs, GAMarilyn K. Speedie, Ph.D. Mary G. Foster, Pharm.D., BFATrustee Representing the Pharmaceutical Sciences Chair, General Chapters—Packaging, Storage, andMinneapolis, MN DistributionJeffrey L. Sturchio, Ph.D. Philadelphia, PATrustee At-Large Antony Raj Gomas, Ph.D.New York, NY Chair, USP Medicines CompendiumThomas R. Temple, R.Ph., M.S. Hyderabad, IndiaTrustee At-Large Dennis K.J. Gorecki, B.S.P., Ph.D.Des Moines, IA Chair, Monographs—Dietary Supplements

Saskatoon, SK, Canada

