Which pharmacopoeias may recognize drugs under FDA definitions?

• A. USP/NF or homeopathic pharmacopeia
• B. British Pharmacopoeia only
• C. European Pharmacopoeia only
• D. Japanese Pharmacopoeia only

Answer: (A)

In the United States, drug quality standards that the FDA recognizes come from official compendia. The primary source is the United States Pharmacopoeia and National Formulary (USP‑NF), which provides monographs for drug substances, dosage forms, excipients, and related quality criteria that the FDA references or incorporates into law. For homeopathic drugs, standards come from the Homeopathic Pharmacopoeia of the United States (HPUS), and the FDA recognizes HPUS as the official standards for homeopathic drug products. Other pharmacopoeias—British, European, or Japanese—apply in their own regions and aren’t the FDA-recognized sources for defining drugs under FDA definitions in the U.S. Therefore, USP/NF or HPUS are the pharmacopoeias recognized by the FDA in this context.