mission and preface usp 35nf 30 and supplements · 2012-06-12 · united states pharmacopeial...

Second Supplement to USP 35–NF 30 Mission and Preface 5563

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

Accessed from 128.83.63.20 by nEwp0rt1 on Tue Jun 12 02:09:22 EDT 2012

5564 Mission and Preface Second Supplement to USP 35–NF 30

to the next USP–NF or Supplement. See the USP Guideline on identifies new items, replacement lots, lots of a single itemUse of Accelerated Processes for Revisions to the USP–NF, that are simultaneously official, lots deleted from official sta-which is posted on USP’s website. tus, and a preview of items eventually to be adopted.

Purchase order information is included, and the names ofErrata—An Erratum/Errata is content erroneously pub-distributors who can facilitate international availability oflished in a USP publication that does not accurately reflectthese items are suggested. This program benefits from thethe intended official or effective requirements as approvedwidespread voluntary contribution of suitable materials andby the Council of Experts. These typically are changes thattest data from pharmaceutical manufacturers. USP advancesdo not have a broad impact on the standards. Errata are notthis material via careful characterization studies and collabo-subject to public comment and become official on the firstrative testing, followed by review and approval of the com-day of the month following their posting to the USP web-pendial use of the reference material by Expert Committeessite. Errata are incorporated into the next available USP–NFof the Council of Experts.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 listing




official text prevails. In case of a dispute or question of mittees. The Expert Committees are responsible for theinterpretation, 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 • Veterinary Drugsabove, which are posted on USP’s website until incorpora- International Stakeholder Forumstion into the next USP–NF or Supplement). In addition, • IndiaUSP–NF and its two annual Supplements are available in USB • Mexicoflash drive and online versions. The USB flash drive version • Brazilmakes USP–NF accessible to users on their computer hard • Othersdrives. The online format allows individual registered users USP also conducts Scientific and Standards Symposia (for-to access the online format through the Internet. Both elec- merly Annual Scientific Meetings) in the United States, India,tronic formats provide access to official USP–NF content, China, Latin America, Middle East/North Africa, and otheralong with extensive search options. The electronic formats regions of the world.are cumulatively updated to integrate the content of Supple-

Staff—USP maintains a staff of over 700 scientists, pro-ments. A searchable electronic version of the USP Dictionaryfessionals, and administrative personnel at its Rockville, Ma-also is available.ryland, headquarters and throughout the world, includingan account management office in Basel, Switzerland, and

USP GOVERNING, STANDARDS-SETTING, AND laboratory facilities in Hyderabad, India; Shanghai, China;ADVISORY BODIES and Sao Paulo, Brazil.

USP’s governing, standards-setting, and advisory bodies RULES AND PROCEDURESinclude the USP Convention, the Board of Trustees, theCouncil of Experts and its Expert Committees, Expert Panels

Governing Documents—USP–NF standards are recog-(formerly known as Advisory Panels), and staff. Additionalnized widely because they are authoritative and science-volunteer bodies include Stakeholder Forums, Project Teams,based and are established by a transparent and credibleand Advisory Groups, which act in an advisory capacity toprocess. See the Articles of Incorporation section in this book;provide input to USP’s governing, standards-setting, andthe Bylaws and the Rules and Procedures of the Council ofmanagement bodies.Experts are available on USP’s website (www.usp.org). Col-USP Convention—The composition of the USP Conven-lectively, these documents serve USP volunteers and staff astion membership is designed to ensure a global representa-the governing principles for USP’s standards-setting activi-tion from all sectors of health care, with an emphasis onties.practitioners, given USP’s practitioner heritage (see the His-

Conflicts of Interest—USP’s Conflict of Interest provi-tory section). Voting Delegates of Convention member orga-sions require all members of the Council of Experts, its Ex-nizations elect USP’s President, Treasurer, other members ofpert Committees, Expert Panels, Board of Trustees, and keythe Board of Trustees, and the Council of Experts. They alsostaff to disclose financial or other interests that may interfereadopt resolutions to guide USP’s strategic direction andwith their duties as USP volunteers. Members of the Boardamend USP’s Bylaws. The 2010 meeting of the USP Con-of Trustees, Council of Experts, and its Expert Committeesvention occurred in April 2010 in Washington, DC. A listingare not allowed to take part in the final discussion or voteof all current Voting Delegates of the USP Convention ison any matter in which they have a conflict of interest orincluded in the People section.the appearance of a conflict of interest. Members of ExpertBoard of Trustees—USP’s Board of Trustees is responsi-Panels may participate and vote, so long as any conflictsble for the management of the business affairs, finances,have been adequately and promptly disclosed and are com-and property of USP. During its 5-year term, the Board de-municated to the relevant Expert Committee along with anyfines USP’s strategic direction through its key policy and op-Expert Panel recommendations.erational decisions. A listing of the members of the

Confidentiality and Document Disclosure—Members of2010–2015 Board of Trustees is included in the People sec-the Council of Experts, Expert Committees, and Experttion.Panels sign confidentiality agreements, in keeping withCouncil of Experts—The Council of Experts is the stan-USP’s Confidentiality Policy and the confidentiality provisionsdards-setting body of USP. For the 2010–2015 cycle it isof the Rules and Procedures of the Council of Experts. The USPcomposed of 22 members, elected to 5-year terms by USP’sDocument Disclosure Policy, available on USP’s website,Convention, each of whom chairs an Expert Committee.contributes to the transparency of the standards-setting pro-These Chairs in turn elect the members of their Expert Com-




Figure 1. 2010–2015 USP Council of Experts.

cess by making information available to the public, yet pro- mittees vote to make them official text in USP–NF. Thus, thevides protection to manufacturers and others who submit USP standards-setting process gives those who manufacture,confidential information to USP. regulate, and use therapeutic products the opportunity to

comment on the development and revision of USP–NF stan-Authority for Publication—USP–NF is published in accor-dards. Figure 2 shows the public review and comment pro-dance with Article II, Purposes, of the USP Bylaws, whichcess and its relationship to standards development. states, “The purposes for which the Convention is formed

are as set forth in the Articles of Incorporation and include Working with the Food and Drug Administrationdeveloping and disseminating public standards for (FDA)—As specified in U.S. law, USP works with the Secre-medicines and other articles, and engaging in related public tary of the Department of Health and Human Services inhealth programs.” many ways. The principal agency in the Department for this

work is the Food and Drug Administration. The FDA LiaisonProgram allows FDA representatives to participate in ExpertUSP–NF REVISION PROCESS Committee and Expert Panel meetings, enabling interactionsbetween FDA scientific staff and Expert Committees. Staff inthe FDA Centers who are responsible for review of com-Public Participation—Although USP’s Council of Expertspendial activities provide specific links and opportunities foris the ultimate decision-making body for USP–NF standards,exchange of comments. Dr. Paul Seo in the Center for Drugthese standards are developed by an exceptional process ofEvaluation and Research provides a primary compendialpublic involvement and substantial interaction between USPpoint of contact between FDA and USP.and its stakeholders, both domestically and internationally.

Participation in the revision process results from the supportof many individuals and groups and also from scientific, LEGAL RECOGNITIONtechnical, and trade organizations.

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




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 (Biologics Price Competi-of any other nonproprietary name the “established” name, tion and Innovation Act, Title VII, Subtitle A of the Patientwhich ordinarily is the compendial name (see discussion of Protection and Affordable Care Act, Public Law 111-148).Nomenclature, below). A drug with a name recognized in Medical Devices—Section 201(h) of the FD&C Act de-USP–NF must comply with the identity/identification require- fines a device as an instrument, apparatus, similar article, orments of its monograph, or be deemed adulterated, mis- component thereof recognized in USP–NF. Section 502(e) ofbranded, or both. Drugs also must comply with compendial the FD&C Act defines the established name of a device instandards for strength, quality, and purity (tests for assay the absence of an FDA designation of the official name asand impurities), unless labeled to show all respects in which the official title in an official compendium. Despite thesethe drugs differ. FDA requires that names for articles that statutory provisions, there is no comparable recognition ofare not official must be clearly distinguished and differenti- USP’s role in establishing compendial standards for medicalated from any name recognized in an official compendium. devices as exists for drugs and biologics. Under authorityDrugs with a name recognized in USP–NF also will be con- granted by the Food and Drug Administration Moderniza-sidered misbranded unless they meet compendial standards tion Act of 1997, the Center for Devices and Radiologicalfor packaging and labeling. Health recognizes national and international standards, in-

Drugs—USP’s goal is to have substance and preparation cluding some USP tests and assays, for medical devices.(product) monographs in USP–NF for all FDA-approved Dietary Supplements—The Dietary Supplement Healthdrugs, including biologics, and their ingredients. USP also and Education Act of 1994 amendments to the FD&C Actdevelops monographs for therapeutic products not ap- name USP and NF as official compendia for dietary supple-proved by FDA, e.g., pre-1938 drugs, dietary supplements, ments. The amendments also provide that a dietary supple-and compounded preparations. Although submission of in- ment may be deemed misbranded if it is covered by a mon-formation needed to develop a monograph by the Council ograph in an official compendium, is represented asof Experts is voluntary, compliance with a USP–NF mono- conforming to this monograph, but fails to so conform. Thegraph, if available, is mandatory. dietary supplement must be represented as conforming to a

Biologics—In the United States, all biologics are consid- USP–NF dietary supplement monograph for the compendialered a subset of drugs, whether they are approved by FDA standards to apply. This contrasts with pharmaceutical prod-under the FD&C Act (and receive a new drug application ucts, wherein conformance to the monograph is mandatory,[NDA]) or under the Public Health Service Act (PHS Act, whether or not the product claims to conform.where they receive a biologics license application [BLA]). As Compounded Preparations—Compounding means thea result, all PHS Act biologics are subject to the drug regula- preparation, mixing, assembling, altering, packaging, andtory requirements of the FD&C Act, which means they are labeling of a drug or device or other article, as the result ofrequired to comply with the adulteration and misbranding a practitioner’s order or in anticipation of such an orderprovisions of the FD&C Act, including USP–NF compendial based on routine, regularly observed prescribing patterns.




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

procedures found in USP–NF. Chromatographic Columns listsNomenclature—In the United States, FDA generally de-the brand names of the column reagents cited in every pro-fers to USP to create established (nonproprietary) names forposal for new or revised gas- or liquid-chromatographic ana-drug products, including “proper” names for biologics. USP,lytical procedures that have been published in PF sinceas a member of the United States Adopted Names (USAN)1980. Chromatographic Columns also helps to track whichCouncil, works to determine names for drug and biologicalcolumn reagents were used to validate analytical proceduressubstances. USP’s authority to develop official nonproprie-that have become official. The branded column reagents listtary names is identified in section 502(e) of the FD&C Act.is updated bimonthly and maintained on USP’s website.FDA’s policy on established names is set forth in 21 CFR

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

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

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

USP Medicines Compendium—The USP Medicines Compen-stances in the United States.dium (MC) is an online compendium that includesmonographs, general chapters, and reference materials forHARMONIZATION ACTIVITIES suitable chemical and biological medicines and their ingredi-ents approved by national regulatory authorities. The pur-pose of the MC is to help ensure that these medicines are ofPharmacopeial Discussion Group—USP harmonizesgood quality by providing up-to-date, relevant public stan-pharmacopeial excipient monographs and general chaptersdards and reference materials. MC standards are availablethrough the Pharmacopeial Discussion Group (PDG), whichto manufacturers, purchasers, national regulatory authorities,includes representatives from the European, Japanese, andand others to ensure conformity of a medicine to MC stan-United States pharmacopeias, and WHO (as an observer).dards through testing. The MC does not include standardsAccording to the PDG definition, “a pharmacopeial generalfor foods or for traditional medicines/dietary supplements.chapter or other pharmacopeial document is harmonizedThe MC is available at www.usp-mc.org.when a pharmaceutical substance or product tested by the

document’s harmonized procedure yields the same results,



Second Supplement to USP 35–NF 30 People / Committees 5569

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 R. 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 D. Maves, M.D., M.B.A. Langhorne, PATrustee Representing the Medical Sciences Gigi S. Davidson, B.S.Pharm., DICVPMillwood, VA Chair, CompoundingThomas E. 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 Compendium—South AsiaThomas 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

