Under which regulation would you classify a prescription drug?

A prescription drug is classified primarily under the Federal Food, Drug, and Cosmetic Act (FDCA). This regulation provides the fundamental legal framework for the approval, labeling, and regulation of drugs and medical devices. The FDCA ensures that any drug, including prescription medications, must be proven safe and effective before it can be marketed to the public. Additionally, it addresses issues such as the quality of the drugs, the manner in which they are manufactured, and their labeling requirements.

While the Controlled Substances Act pertains specifically to the regulation and scheduling of drugs that have a potential for abuse and addiction, which can include some prescription drugs, it does not encompass the broader scope of all prescription medications as the FDCA does. The Drug Enforcement Administration Guidelines serve to enforce the provisions of the Controlled Substances Act and regulate the distribution and handling of controlled substances but do not directly classify prescription drugs overall. The Food Safety Modernization Act is focused on food safety and does not address prescription drugs at all.

Thus, the correct classification of prescription drugs falls under the FDCA, as it encompasses all aspects of drug regulation necessary for public safety and efficacy.