Question

Through a comprehensive collection of statutes and regulations, the federal government controls the

manufacturing, distributing and selling of those drug products designated as "controlled substances." The
primary statute is the __________________________________, with the primary regulations being those promulgated by the _________________________.

Answer 1

The Federal Food, Drug, and Cosmetic Act is the primary statute for controlling substances, with the FDA enforcing regulations for safety and efficacy of drugs, supplements, biological products, and medical devices.

Step-by-step explanation:

The primary statute that controls the manufacturing, distributing, and selling of controlled substances is the Federal Food, Drug, and Cosmetic Act, which was first passed in 1938 and has since been extensively amended.

The primary regulations are promulgated by the U.S. Food and Drug Administration (FDA).

The FDA enforces various legislations including the Public Health Service Act, subsets of the Controlled Substances Act, as well as other laws like the Federal Anti-Tampering Act.

The FDA's jurisdiction includes ensuring safety and efficacy of prescription drugs, regulation of food and dietary supplements, as well as oversight of biological products and medical devices.