The National Formulary, along with the United States Pharmacopeia (USP-NF), is an authoritative publication initially released by the American Pharmaceutical Association and now published annually by the United States Pharmacopeial Convention. It details the composition, descriptions, preparation methods, and dosages of drugs, comprising two distinct official sections: the USP and the NF.The United States Pharmacopeia (USP), which has been in existence since 1820, sets legally recognized standards for the identity, strength, quality, purity, packaging, and labeling of drug substances, dosage forms, and other therapeutic products, such as nutritional and dietary supplements.The National Formulary (NF), founded by the American Pharmaceutical Association in 1888, defines standards for excipients, botanicals, and related items. In 1975, the USP acquired the NF, merging both publications into a single volume, known as the USP-NF.Monographs in the USP-NF provide specifications, including tests, procedures, and acceptance criteria, to ensure the strength, quality, and purity of listed items. It also provides monographs and general guidelines to maintain the quality of compounded preparations. Recognized globally, USP-NF monographs can be enforced by the US Food and Drug Administration (FDA) as well as state regulatory bodies.
