What is the legal framework governing the manufacture of drugs?

In Virginia, the legal framework governing the manufacture of drugs is established by the Code of Virginia, the Virginia Board of Pharmacy, and the Virginia Department of Health Professions. The Code of Virginia defines the requirements for the manufacture of drugs, including labeling, packaging, standards of purity, quality control, and testing requirements. The Board of Pharmacy regulates the practice of pharmacy and is responsible for overseeing the distribution of pharmaceuticals. The Department of Health Professions sets standards of pharmacy practice, including those related to the manufacture of drugs. The Code of Virginia requires manufacturers of drugs to obtain a license from the Department of Health Professions and to comply with all applicable laws and regulations. This includes regulations governing the manufacturing process, such as the Good Manufacturing Practice (GMP) regulations, which provide guidance on the quality and safety of pharmaceuticals. In addition, manufacturers are required to adhere to safety protocols, including those related to the storage and handling of drugs. Manufacturers of drugs are also required to submit a Drug Master File to the U.S. Food and Drug Administration for review and approval before the drugs can be marketed. This file must include detailed information on the identity, strength, and composition of the drug, as well as the manufacturing process, equipment, and packaging. In conclusion, the legal framework governing the manufacture of drugs in Virginia is regulated by the Code of Virginia, the Board of Pharmacy, and the Department of Health Professions. All manufacturers of drugs must comply with applicable laws and regulations, including those related to the GMP and the Drug Master File, to ensure the safety and quality of the drugs.

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What is the legal framework governing the manufacture of drugs?

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