Official drug standards for purity and dosage?

• A. World Health Organization
• B. United States Pharmacopeia (USP)
• C. FDA
• D. Drug Enforcement Agencies

Answer: (B)

Standards for drug purity and dosage come from a pharmacopoeia, a reference that defines what a medicine is, its strength, quality, and the tests it must pass. The United States Pharmacopeia publishes monographs that specify identity, strength, quality, and purity, along with the methods used to test each drug. These USP standards are widely adopted by manufacturers and are recognized by the FDA as the official reference for drug quality. In practice, drugs marketed in the United States must comply with USP standards (often referred to as USP-NF). The other options play important roles—the FDA regulates and enforces compliance, the DEA handles controlled substances, and the World Health Organization provides an international pharmacopoeia—but they are not the official compendium of U.S. drug standards.