Which act established annual licensing for biologics manufacturing and authorized inspections for purity and potency?

• A. Drug Importation Act 1848
• B. Kefauver-Harris Amendments 1962
• C. Food and Drug and Cosmetic Act 1938
• D. Biologics Control Act 1902

Answer: (D)

Regulation of biological products through licensing and facility inspections to ensure product quality is what's being tested. The Biologics Control Act of 1902 established a system requiring annual licenses for biologic manufacturers and gave federal authorities the power to inspect manufacturing facilities to verify purity and potency of biologics. This created the first dedicated federal framework for overseeing how biologics are produced, ensuring that vaccines and other biologic products meet basic quality standards before reaching patients. Earlier acts targeted drugs or importation; later laws (like the 1938 act) expanded safety requirements for drugs more broadly and required other demonstrations, but this specific act set up the licensing-and-inspection regime unique to biologics.