GENERAL NOTICES AND REQUIREMENTS

1 USP 37 GENERAL Notices1 GENERAL NOTICES ANDREQUIREMENTSThe GENERAL NOTICES and REQUIREMENTS section (the Generalmandatory REQUIREMENTS applicable to any official article un- NOTICES ) presents the basic assumptions, definitions, and de-less specifically referenced in GENERAL NOTICES , a monograph,fault conditions for the interpretation and application of theor a GENERAL chapter numbered below 1000. GENERAL chap-United States Pharmacopeia (USP) and the National Formularyters numbered above 2000 apply only to articles that are(NF).intended for use as dietary ingredients and dietaryRequirements stated in these GENERAL NOTICES apply to recognized in the USP and NF (the compendia ) Official Articlesand to all GENERAL chapters unless specifically stated other-An official article is an article that is recognized in USP orwise. Where the REQUIREMENTS of an individual monographNF. An article is deemed to be recognized and included in adiffer from the GENERAL NOTICES or a GENERAL chapter, thecompendium when a monograph for the article is publishedmonograph REQUIREMENTS apply and supersede the require-in the compendium and an official date is generally or spe-ments of the GENERAL NOTICES or the GENERAL chapter,cifically assigned to the or not the monograph explicitly states theThe title specified in a monograph is the official title article.

2 Other names considered to be synonyms of theofficial titles may not be used as substitutes for official articles include both official substances and officialChange to read:products. An official substance is a drug substance, excipient,dietary ingredient, other ingredient, or component of a fin-1. TITLE AND REVISION ished device for which the monograph title includes no indi-The full title of this publication (consisting of four volumescation of the nature of the finished including its Supplements), is The Pharmacopeia of theAn official product is a drug product, dietary supplement,United States of America, Thirty-Seventh Revision and thecompounded preparation, or finished device for which aNational Formulary, Thirty-Second Edition. These titles maymonograph is abbreviated to USP 37, to NF 32, and to USP 37 NF Legal RecognitionThe United States Pharmacopeia, Thirty-Seventh Revision,The USP and NF are recognized in the laws and regula-and the National Formulary, Thirty-Second Edition, supersedetions of many countries throughout the world.

3 Regulatoryall earlier revisions. Where the terms USP, NF, orauthorities may enforce the standards presented in the USP USP NF are used without further qualification during theand NF, but because recognition of the USP and NF mayperiod in which these compendia are official, they refer onlyvary by country, users should understand applicable lawsto USP 37, NF 32, and any Supplement(s) thereto. The sameand regulations. In the United States under the Federaltitles, with no further distinction, apply equally to print orFood, Drug, and Cosmetic Act (FDCA), both USP and NF areelectronic presentation of these contents. Although USP andrecognized as official compendia. A drug with a name rec-NF are published under one cover and share these Generalognized in USP NF must comply with compendial identityNotices, they are separate or be deemed adulterated, misbranded, or revision is official beginning May 1, 2014, unless oth-See, , FDCA 501(b) and 502(e)(3)(b); also FDA regula-erwise indicated in specific , 21 CFR (a&b).

4 To avoid being deemedSupplements to USP and NF are published , such drugs must also comply with compendialInterim Revision Announcements are revisions to USP andstandards for strength, quality, and purity, unless labeled toNF that are published on the USP website. Interim Revisionshow all respects in which the drug differs. See, , FDCAA nnouncements contain official revisions and their effective 501(b) and 21 CFR (c). In addition, to avoiddates. Announcements of the availability of new USP Refer-being deemed misbranded, drugs recognized in USP NFence Standards and announcements of tests or proceduresmust also be packaged and labeled in compliance withthat are held in abeyance pending availability of requiredcompendial standards. See FDCA 502(g).USP Reference Standards are also available on the New Of-A dietary supplement represented as conforming to speci-ficial Text tab of USP s in USP will be deemed a misbranded food if it failsRevision Bulletins are revisions to official text or postpone-to so conform.

5 See FDCA 403(s)(2)(D).ments that require expedited publication. They are pub-Enforcement of USP standards is the responsibility of FDAlished on the USP website and generally are official immedi-and other government authorities in the and unless otherwise specified in the Revision has no role in are corrections to items erroneously published thathave not received the approval of the Council of Expertsand that do not reflect the official REQUIREMENTS . ssUSP37 Change to read:2. OFFICIAL STATUS AND LEGAL Official Text3. CONFORMANCE TO STANDARDSO fficial text is text contained in USP and NF, Applicability of Standardsmonographs, GENERAL chapters, and these GENERAL for an article recognized in sthe compendiaRevisions to official text are provided in Supplements, Interim(USP NF)sUSP37 are expressed in the article s monograph, ap-Revision Announcements, and Revision Bulletins. GENERAL chap-plicable GENERAL chapters, and GENERAL NOTICES . Unless specif-ters numbered from 1000 to 1999 are considered interpre-ically exempted elsewhere in a compendium, the identity,tive and are intended to provide information on, give defini-strength, quality, and purity of an article are determined bytion to, or describe a particular subject.

6 They contain nothe official tests, procedures, and acceptance criteria,Date: 1-JUL-2013 Time:7:56(P) \\usp-netapp2\share\SHARE\USPNF\PRINTQ\p ager\xmlIn\ NoticesUSP 37whether incorporated in the monograph itself, in the Gen-incorporation into a dietary supplement, and is labeled aseral NOTICES , or in the applicable GENERAL chapters. Earlyconforming to the USP or of revised standards is allowed. Where revisedGenerally, dietary supplements are prepared from ingredi-standards for an existing article have been published as finalents that meet USP, NF, or Food Chemicals Codex official text (as approved in section ) butWhere such standards do not exist, substances may be usedare not yet official (six months after publication, unless oth-in dietary supplements if they have been shown to be oferwise specified; see official date, section ) compli-acceptable food grade quality using other suitableance with the revised standard shall not preclude a indication of conformance with scompendialsUSP37 Indicating Conformancedards, unless USP specifies otherwise by prohibiting earlyA drug product, drug substance, or excipient may use theadoption in a particular USP or NF in conjunction with its officialThe standards in the relevant monograph, GENERAL chap-title or elsewhere on the label only when (1) a monographter(s), and GENERAL NOTICES apply at all times in the life of theis provided in the specified compendium and (2) the articlearticle from production to expiration.

7 The manufacturer scomplies with the identity prescribed in the specifiedspecifications, and good manufacturing practices generallycompendium.(including, , Quality by Design initiatives), are developedWhen a drug product, drug substance, or excipient differsand followed to ensure that the article will comply withfrom the relevant USP or NF standard of strength, quality, orcompendial standards until its expiration date, when storedpurity, as determined by the application of the tests, proce-as directed. Thus, any official article is expected to meet thedures, and acceptance criteria set forth in the relevant com-compendial standards if tested, and any official article actu-pendium, its difference shall be plainly stated on its tested as directed in the relevant monograph must meetWhen a drug product, drug substance, or excipient failssuch standards to demonstrate comply with the identity prescribed in USP or NF or con-At times, compendial standards take on the character oftains an added substance that interferes with the prescribedstatistical procedures, with multiple units involved and per-tests and procedures, the article shall be designated by ahaps a sequential procedural design to allow the user toname that is clearly distinguishing and differentiating fromdetermine that the tested article meets or does not meetany name recognized in USP or standard.

8 The similarity to statistical procedures mayA medical device, dietary supplement, or ingredient orseem to suggest an intent to make inference to some largercomponent of a medical device or dietary supplement maygroup of units, but in all cases, statements about whetheruse the designation USP or NF in conjunction with itsthe compendial standard is met apply only to the unitsofficial title or elsewhere on the label only when (1) a mon-tested. Repeats, replicates, statistical rejection of outliers, orograph is provided in the specified compendium and (2)extrapolations of results to larger populations, as well as thethe article complies with the monograph standards andnecessity and appropriate frequency of batch testing, areother applicable standards in the specified nor proscribed by the compendia. Fre-The designation USP or NF on the label may not andquency of testing and sampling are left to the preferencesdoes not constitute an endorsement by USP and does notor direction of those performing compliance testing, andrepresent assurance by USP that the article is known toother users of USP NF, including manufacturers, buyers, orcomply with the relevant standards.

9 USP may seek legal re-regulatory if an article purports to be or is represented as anOfficial products are prepared according to recognizedofficial article in one of USP s compendia and such claim isprinciples of good manufacturing practice and from ingredi-determined by USP not to be made in good that meet USP or NF standards, where standards forThe designation USP NF may be used on the label ofsuch ingredients exist (for dietary supplements, see sectionan article provided that the label also bears a ).such as Meets NF standards as published by USP, indicat-Official substances are prepared according to recognizeding the particular compendium to which the article purportsprinciples of good manufacturing practice and from ingredi-to complying with specifications designed to ensure thatWhen the letters USP, NF, or USP NF are used onthe resultant substances meet the REQUIREMENTS of the com-the label of an article to indicate compliance with com-pendial standards, the letters shall appear in Applicability of Standards to Drug Products,with the official title of the article.

10 The letters are not to beDrug Substances, and Excipientsenclosed in any symbol such as a circle, square, etc., andThe applicable USP or NF standard applies to any articleshall appear in capital in the United States that (1) is recognized in theIf a dietary supplement does not comply with all applica-compendium and (2) is intended or labeled for use as able compendial REQUIREMENTS but contains one or more die-drug or as an ingredient in a drug. sSuch articles (drugtary ingredients or other ingredients that are recognized inproducts, drug substances, and excipients) include bothUSP or NF, the individual ingredient(s) may be designated ashuman drugs (whether dispensed by prescription, over thecomplying with USP or NF standards or being of USP or NFcounter, or otherwise), as well as animal Thequality provided that the designation is limited to the indi-applicable standard applies to such articles whether or notvidual ingredient(s) and does not suggest that the dietarythe added designation USP or NF is used.