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Now in its 43rd edition (from May 2021), the current USP-NF remains true to its original mandate: to be an accessible source of information for quality of prescription, nonprescription, and compounded medicines; excipients; biologics; medical devices; and dietary supplements.

The United States Pharmacopeia – National Formulary (USP-NF) includes over 5000 quality standards for medicines, both chemical and biologic; active pharmaceutical ingredients (APIs); and excipients (inactive ingredients). It is the most comprehensive source for medicine quality standards in the world.

Key components of a USP monograph. 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.

USP Official Reference Standards 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.

The current version of USP–NF standards deemed official by USP are enforceable by the U.S. Food and Drug Administration for medicines manufactured and marketed in the United States. The current version, USP–NF 2023, Issue 1, will become official on May 1, 2023.

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USP–NF is a combination of two compendia, the United States Pharmacopeia (USP) and the National Formulary (NF). Monographs for drug substances, dosage forms, and compounded preparations are featured in the USP. Monographs for dietary supplements and ingredients appear in a separate section of the USP.