What is the legal framework governing the manufacture of drugs?

In North Carolina, the legal framework governing the manufacture of drugs is largely set by federal law. The Federal Food, Drug, and Cosmetic Act is the primary law covering the manufacture of drugs. This law requires that pharmaceutical companies follow strict guidelines when producing medications, such as ensuring the drugs are safe, pure, and effective. To ensure these standards are met, the law also requires that drug manufacturers register their facility, list their drugs, and report adverse events to the U.S. Food and Drug Administration (FDA). The FDA also enforces the Good Manufacturing Practices (GMPs) which are standards that must be followed by pharmaceutical manufacturers. These standards include detailed definitions of what is allowed in the production, packaging, labeling, and storage of drugs. Additionally, the FDA makes sure that drugs are manufactured in a sanitary manner that will protect consumers from contamination. The Drug Supply Chain Security Act is another law related to pharmaceutical manufacturing. This law requires pharmaceutical companies to use technology that allows them to track and trace drugs from their source to their destination. This helps reduce the risk of counterfeit drugs being produced and distributed, thus protecting consumers from harm. Finally, the North Carolina Board of Pharmacy has implemented its own set of regulations enforcing the laws and guidelines established by the FDA. These regulations require drug manufacturers to be licensed in the state, adhere to safety requirements, and provide budget and financial information. They also require that drug manufacturers regularly inspect their facility and keep records of production and distribution.

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What is the legal framework governing the manufacture of drugs?

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