What is the legal status of the USP–NF?
A. References to the USP and the NF occur in U.S. federal and state statutes regulating articles (substances and preparations) used in medical practice. The 1938 Food, Drug, and Cosmetic (FDC) Act recognizes USP–NF standards as enforceable by the Food and Drug Administration for drugs manufactured and marketed in the U.S. Such drugs must meet USP–NF standards to avoid possible charges of adulteration and misbranding.The USP–NF is also recognized in the 1994 Dietary Supplement Health and Education Act (DSHEA) as an official compendium for dietary supplement standards. DSHEA specifically provides that a dietary supplement represented as conforming to the specifications of an official compendium shall be deemed misbranded if it fails to do so. Many statutes and regulations governing the practice of pharmacy at the state level reference USP–NF requirements for compounding, packaging and storage of drugs.
