Which act authorized the Hygienic Laboratory to conduct inspections for purity and potency of biologics?

• 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)

The key idea is federal regulatory authority for biologic products, established to protect public health by ensuring quality. The Biologics Control Act of 1902 gave the Hygienic Laboratory of the U.S. Public Health Service the explicit power to regulate biologics, including inspecting manufacturers and testing products for purity and potency, and to license biologic producers. This created a federal framework focused specifically on biologics (such as vaccines and antitoxins), separate from general drug regulation.

Later laws addressed other areas: the Drug Importation Act of 1848 dealt with import controls, the Food, Drug and Cosmetic Act of 1938 broadened safety and labeling requirements for drugs and cosmetics, and the Kefauver-Harris Amendments of 1962 added rigorous efficacy and safety standards for new drugs. None of these introduced the Hygienic Laboratory’s authorization to inspect biologics for purity and potency in the way the 1902 Biologics Control Act did.