What is the scope of the federal government's authority in the regulation of pharmaceuticals?

The federal government has a wide array of legal authorities when it comes to regulating pharmaceuticals. The Federal Food, Drug, and Cosmetic Act (FDCA) is the primary law that gives the federal government authority to regulate drugs and other products that touch the human body. The FDCA gives the Food and Drug Administration (FDA) the power to review the safety and effectiveness of drugs, inspect manufacturing facilities, and set standards for drug labeling. The FDCA also provides the FDA with the authority to approve drug advertising, as well as set requirements for the protection of confidential information related to confidential clinical drug trials. The Controlled Substances Act of 1970 is another important law related to drug regulation. The act sets out regulations for drugs with addictive potential, such as prescription drugs and illicit drugs. The act also requires the registration of drug manufacturers, dealers, and distributors, and provides for criminal penalties for violations of the act. The FDCA also has a number of regulations related to the drug supply chain, including the requirement for drug manufacturers to maintain records of all transactions and the requirement for drug wholesalers to report suspicious orders to the FDA. Additionally, the FDCA provides for the establishment of drug safety monitoring systems that can detect and investigate potential adverse drug events. In California, the state Department of Public Health has additional regulations related to pharmaceuticals. These regulations may include additional requirements related to storage, distribution, and labeling, and may also cover the registration and inspection of drug manufacturers and suppliers.

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What is the scope of the federal government's authority in the regulation of pharmaceuticals?

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