Biologics are defined by which statute?

Biologics are defined by which statute?

• A. They are defined by the Federal Food, Drug, and Cosmetic Act
• B. They are defined by the Dietary Supplement Health and Education Act
• C. They are defined by Section 351 of the Public Health Service Act
• D. They are defined by the Controlled Substances Act

Answer: (C)

Biologics are defined under the Public Health Service Act, specifically Section 351. That provision creates the framework for FDA licensing of biological products—such as vaccines, blood components, and gene therapies—through the Biologics License Application process to ensure safety, purity, and potency. The Dietary Supplement Health and Education Act governs dietary supplements, the Federal Food, Drug, and Cosmetic Act covers conventional drugs and many devices, and the Controlled Substances Act regulates controlled substances. So the statute that defines and governs biologics is Section 351 of the Public Health Service Act.

Biologics are defined under the Public Health Service Act, specifically Section 351. That provision creates the framework for FDA licensing of biological products—such as vaccines, blood components, and gene therapies—through the Biologics License Application process to ensure safety, purity, and potency. The Dietary Supplement Health and Education Act governs dietary supplements, the Federal Food, Drug, and Cosmetic Act covers conventional drugs and many devices, and the Controlled Substances Act regulates controlled substances. So the statute that defines and governs biologics is Section 351 of the Public Health Service Act.