USP–NF Compendial Notices are designed to inform stakeholders of the changing status of USP–NF monographs and general chapters, as well as other USP–NF standards-setting initiatives. Accelerated Revisions can be found through links on the Revision Bulletin and Interim Revision Announcement pages.

A monograph is a written document that reflects the quality attributes of medicines approved by the U.S. Food and Drug Administration (US FDA). Some of these attributes include: Identity - Tests to identify that a particular substance is the medicine that it claims to be.

There are two regulatory pathways to bring a nonprescription drug to market in the US -- the drug application process and the Over-the-Counter (OTC) Drug Review (OTC drug monograph) process.

USP offers over 7,000 USP Reference Standards, highly characterized physical specimens of drug substances, excipients, food ingredients, impurities, degradation products, dietary supplements, compendial reagents, and performance calibrators.

USP-NF includes three types of quality standards for prescription medicines: Monographs articulate the quality expectations for a medicine including its identity, strength, and purity. They also describe the tests to validate that a medicine and its ingredients meet these criteria.

2024年7月22日 · Monographs: Over 4,900 monographs with specifications for identity, strength, quality, purity, packaging, and labeling for substances and dosage forms. General Chapters: More than 330 general chapters providing step-by-step guidance for assays, tests, and procedures.

2014年7月10日 · Much of the work the U.S. Pharmacopeial Convention (USP) does in setting quality standards for foods and dietary supplements involves writing and revising ingredients monographs for the USP–NF and the Food Chemicals Codex (FCC). So when we hear someone ask, "what is a pharmacopeial monograph?"

2021年11月1日 · Monographs The specification consists of tests, procedures, and acceptance crite-ria that help ensure the identity, strength, quality, and purity of the article. For general requirements relating to specific monog sections, see section 5, Monograph Components.

The USP-NF is a combination of two compendia, the United States Pharmacopeia (USP) and the National Formulary (NF). It contains standards for medicines, dosage forms, drug substances, excipients, biologics, compounded preparations, medical …

The United States Pharmacopeia–National Formulary (USP–NF) is continuously revised. Revisions are presented three times a year in the USP-NF as Issues 1, 2, and 3, and as monthly Accelerated Revisions on the USP website.