Which act identified USP and NF as official standards?

• A. Kefauver-Harris Amendments 1962
• B. Pure Food and Drug Act 1906
• C. FDA Act 1988
• D. Dietary Supplement Health and Education Act 1994

Answer: (B)

Understanding how official drug standards are established is key here. The Pure Food and Drug Act of 1906 set the precedent for federal regulation of drugs and foods and tied drug quality to the standards published by the United States Pharmacopeia and the National Formulary. By recognizing USP and NF as the official standards, this act gave the government a framework to enforce quality, strength, and purity, and to target adulterated or misbranded products.

The other acts shifted focus—Kefauver-Harris Amendments in 1962 emphasized safety and efficacy and introduced new manufacturing controls, but did not designate USP/NF as official standards. The FDA Act reference isn’t the historical anchor for official standards, and DSHEA in 1994 governs dietary supplements rather than establishing USP/NF as official standards.