Under which act are labeling requirements for prescription and OTC drugs established?

The Food, Drug, and Cosmetic Act is the legislation that establishes the labeling requirements for both prescription and over-the-counter (OTC) drugs. This act ensures that pharmaceuticals are safe, effective, and properly labeled, outlining the necessary information that needs to appear on drug packaging to protect consumers and provide important usage instructions.

Labeling requirements include essential details such as active ingredients, dosage instructions, warnings, and any necessary precautions. This regulation helps ensure that consumers receive clear and accurate information about medications, which is crucial for safe and effective use.

The other acts mentioned address different aspects of drug regulation but do not specifically cover labeling requirements in the same comprehensive manner as the Food, Drug, and Cosmetic Act. For example, the Controlled Substances Act primarily focuses on the regulation of controlled substances, including their distribution and scheduling, while the Drug Listing Act establishes a system for the identification of drug products. The Drug Approval Modernization Act facilitates a more efficient drug approval process but does not specifically dictate labeling standards.