Pharmacy PEBC Practice Exam

The regulation of the manufacture and distribution of controlled substances in the USA is primarily governed by the Controlled Substances Act (CSA). Enacted in 1970, the CSA was established to create a legal framework for the regulation of substances that have the potential for abuse and dependency. This act categorizes controlled substances into schedules based on their medical use, potential for abuse, and safety or dependence liability.

The CSA outlines the requirements for the registration and monitoring of individuals and businesses involved in the manufacture, distribution, and dispensing of these substances, ensuring that they are handled in a controlled and regulated manner to prevent misuse. It is essential for pharmacy professionals to understand the implications of the CSA, as it directly impacts prescribing practices, storage, and record-keeping related to controlled substances.

While other laws, such as the Food, Drug, and Cosmetic Act, address the regulation of food and drug safety, and the Comprehensive Drug Abuse Prevention and Control Act encompasses elements related to drug abuse prevention, it is the Controlled Substances Act that fundamentally shapes the regulations specifically governing controlled substances.