General Notices and Requirements - uspnf.com

1 USP 32 General Notices1 General Notices andRequirementsApplying to Standards, Tests,Assays, and Other Specificationsof the United States Pharmacopeia1. Title and 37. Test Interpretation of Rounding 72. Official Status and Legal Official Official 38. Terms and Legal Alcohol 83. Conformance and Atomic Applicability of Blank Indicating 84. monographs and General Microbial General 85. Monograph Molecular Added Substances, Excipients, and Percentage Description and Identification Reaction Specific Impurities and Foreign Performance USP Reference Vacuum 86. Testing Practices and Safe Laboratory Weights and Automated Alternative and Harmonized Methods 69.

2 Prescribing and Dried, Anhydrous, Ignited, or Solvent-Free Use of Metric Preparation of Changes in Units Necessary to Complete a 710. Preservation, Packaging, 7and Storage Under 92 General NoticesUSP Guidelines for Packaging and StorageStatements in USP NF Storage Temperature and 11 USP 32 General Notices3 General Notices andRequirementsChange to read:dium when a monograph for the article is published in the compen-dium and an official date is generally or specifically assigned to thesThe General Notices and Requirements section (the ) presents the basic assumptions, definitions, and defaultThe title specified in a monograph is the official title for suchconditions for the interpretation and application of the United Statesarticle. Other names considered to be synonyms of the official titlesPharmacopeia (USP) and the National Formulary (NF).

3 May not be used as substitutes for official stated in these General Notices apply to all articlesOfficial articles include both official substances and officialrecognized in the USP and NF (the compendia ) and to all generalproducts. An official substance is a drug substance, excipient, diet-chapters unless specifically stated otherwise. Where the require-ary ingredient, other ingredient, or component of a finished devicements of an individual monograph differ from the General Noticesfor which the monograph title includes no indication of the natureor a General chapter, the monograph Requirements apply and super-of the finished the Requirements of the General Notices or the General chapter,An official product is a drug product, dietary supplement, com-whether or not the monograph explicitly states the preparation, or finished device for which a monograph TITLE AND REVISIONThe full title of this publication (consisting of three volumes Legal Recognitionincluding its Supplements), is The Pharmacopeia of the UnitedThe USP and NF are recognized in the laws and regulations ofStates of America, Thirty-Second Revision and the National For-many countries throughout the world.

4 Regulatory authorities maymulary, Twenty-Seventh Edition. These titles may be abbreviated toenforce the standards presented in the USP and NF, but becauseUnited States Pharmacopeia, Thirty-Second Revision (or to USPrecognition of the USP and NF may vary by country, users should32), to NF 27, and to USP 32 NF 27. The United Statesunderstand applicable laws and regulations. More informationPharmacopeia, Thirty-Second Revision, and the National Formu-about the legal status of the USP and NF is provided in the Missionlary, Twenty-Seventh Edition, supersede all earlier the terms USP, NF, or USP NF are used without fur-3. CONFORMANCE TO STANDARDS ther qualification during the period in which these compendia Applicability of Standardsofficial, they refer only to USP 32, NF 27, and any Supplement(s)Standards for an article recognized in a USP compendium are ex-thereto.

5 The same titles, with no further distinction, apply equally topressed in the article s monograph, applicable General chapters, andprint or electronic presentation of these contents. Although USP andthese General Notices . Unless specifically exempted elsewhere in aNF are published under one cover and share these General Notices ,compendium, the identity, strength, quality, and purity of an articlethey are separate determined by the official tests, procedures, and acceptance cri-This revision is official beginning May 1, 2009, unless otherwiseteria, whether incorporated in the monograph itself, in the Generalindicated in specific , or in the applicable General to USP and NF are published standards in the relevant monograph, General chapter(s), andInterim Revision Announcements are revisions to USP and NFGeneral Notices apply at any time in the life of the article fromthat are published in Pharmacopeial Forum.

6 Interim Revision An-production to expiration. The manufacturer s specifications, andnouncements contain official revisions and their effective dates, an-good manufacturing practices generally, are developed and fol-nouncements of the availability of new USP Reference Standards,lowed to ensure that the article will comply with compendial stan-and announcements of tests or procedures that are held in abeyancedards until its expiration date, when stored as directed. Thus, anypending availability of required USP Reference article tested as directed in the relevant monograph shallRevision Bulletins are revisions to official text or require expedited publication. They are published on the USPAt times, compendial standards take on the character of statisticalwebsite and generally are official immediately unless otherwiseprocedures, with multiple units involved and perhaps a sequentialspecified in the Revision design to allow the user to determine that the tested arti-Errata are corrections to items erroneously published that havecle meets or does not meet the standard.

7 The similarity to statisticalnot received the approval of the Council of Experts and that do notprocedures may seem to suggest an intent to make inference toreflect the official Requirements . Errata are effective uponsome larger group of units, but in all cases, statements the compendial standard is met apply only to the units2. OFFICIAL STATUS AND LEGAL RECOGNITION tested. Repeats, replicates, statistical rejection of outliers, or Official Textolations of results to larger populations, as well as the necessity andOfficial text is text contained in USP and NF, includingappropriate frequency of batch testing, are neither specified nor pro- monographs , General chapters, and these General Notices . Revi-scribed by the compendia. First-party (manufacturer), second-partysions to official text are provided in Supplements, Interim Revision(buyer), or third-party (regulator) compliance testing may or mayAnnouncements, and Revision Bulletins.

8 General chapters numberednot require examination of additional specimens, in accordancefrom 1000 to 1999 are considered interpretive and are intended towith predetermined guidelines or sampling information on, give definition to, or describe a particularOfficial products other than dietary supplements are preparedsubject. They contain no mandatory Requirements applicable to anyfrom ingredients that meet USP or NF standards, where standardsofficial article unless specifically referenced in these General No-for such ingredients , a monograph, or a General chapter numbered below substances are prepared according to recognized princi- General chapters numbered above 2000 apply only to articles thatples of good manufacturing practice and from ingredients comply-are intended for use as dietary ingredients and dietary with specifications designed to ensure that the resultant sub-stances meet the Requirements of the compendial Official ArticlesAn official article is an article that is recognized in USP or article is deemed to be recognized and included in a compen-4 General NoticesUSP Applicability of Standards to Drug Products, Drugarticle.

9 For General Requirements relating to specific monographSubstances, and Excipientssections, see section 5, Monograph applicable USP or NF standard applies to any article mar-Because monographs may not provide standards for all relevantketed in the United States that (1) is recognized in the compendiumcharacteristics, some official substances may conform to the USP orand (2) is intended or labeled for use as a drug or as an ingredient inNF standard but differ with regard to nonstandardized propertiesa drug. The applicable standard applies to such articles whether orthat are relevant to their use in specific preparations. To assure in-not the added designation USP or NF is used. The standardsterchangeability in such instances, users may wish to ascertain func-apply equally to articles bearing the official titles or names derivedtional equivalence or determine such characteristics before transposition of the definitive words of official titles or Applicability of Test Proceduressition in the order of the names of two or more active ingredients inA single monograph may include several different tests, proce-official , and/or acceptance criteria that reflect attributes of Applicability of Standards to Medical Devices,manufacturers articles.

10 Such alternatives may be presented for dif-Dietary Supplements, and Their Components and Ingredientsferent polymorphic forms, impurities, hydrates, and dissolutionAn article recognized in USP or NF shall comply with the com-cases. monographs indicate the tests, procedures, and/or acceptancependial standards if the article is a medical device, component in-criteria to be used and the required for a medical device, dietary supplement, dietary ingredient, Acceptance Criteriaor other ingredient that is intended for incorporation into a dietaryThe acceptance criteria allow for analytical error, for unavoidablesupplement, and is labeled as conforming to the USP or in manufacturing and compounding, and for deteriorationGenerally, dietary supplements are prepared from ingredients thatto an extent considered acceptable under practical conditions. Themeet USP, NF, or Food Chemicals Codex standards.