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USP–NF—An OverviewWhat is the USP–NF?The United States Pharmacopeia–National Formulary (USP–NF) is a book of public pharmacopeial standards. It contains standards for medicines, dosage forms, drug substances, excipients, medical devices, and dietary supplements. Monographs and General ChaptersThe USP–NF is a combination of two official compendia, the United States Pharmacopeia (USP) and the National Formulary (NF). Monographs for drug substances and preparations are featured in the USP. Monographs for dietary supplements and ingredients appear in a separate section of the USP. Excipient monographs are in the NF. A monograph includes the name of the ingredient or preparation; the definition; packaging, storage, and labeling requirements; and the specification. The specification consists of a series of tests, procedures for the tests, and acceptance criteria. These tests and procedures require the use of official USP Reference Standards. Medicinal ingredients and products will have the stipulated strength, quality, and purity if they conform to the requirements of the monograph and relevant general chapters. Read more. Warning: USP–NF on Unauthorized Web SitesThe USP–NF is fully copyrighted by the U.S. Pharmacopeia. The official Web site of the USP–NF Online is www.uspnf.com. Web sites other than the official Web site that claim to offer the content of the USP–NF to viewers are not authorized by USP, and are committing copyright infringement. The content on those unauthorized Web sites is not validated by USP, and may include incorrect or out–of–date information. Users should not rely on an unauthorized Web site for USP–NF content. If you are aware of an unauthorized Web site that claims to include the USP–NF, please report the Web site's address to . What's NewPF 36(5), September-October 2010: IRAs, Errata, Highlights, and Stimuli Articles (08/31/10) New Pending and Non-US Monographs (08/27/10) Revision Bulletin: Acetaminophen and Tramadol Hydrochloride Tablets (08/27/10) Revision Bulletin: Levothyroxine Sodium (08/27/10) Revision Bulletin: Nateglinide (08/27/10) Revision Bulletin: Oxaliplatin for Injection (08/27/10) Revision Bulletin: Tamsulosin Hydrochloride Capsules (08/27/10) Revision Bulletin: Tetracycline Hydrochloride Capsules (08/27/10) Revision Bulletin: Topiramate Tablets (08/27/10) USP Guideline on Use of Accelerated Processes for Revisions to the USP-NF Updated (08/27/10) USP 34-NF 29: Revisions, Deferrals, and Cancellations posted (08/27/10) Small Molecules and Excipients Monographs Needing Modernization list updated (08/27/10) Compendial Notice: General Chapter <1> Injections, Labeling of Ferrules and Cap Overseals Section (08/04/10) Related Resources |
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