What are the regulations regarding the manufacture of pharmaceuticals?

In California, the manufacture of pharmaceuticals is regulated by several laws and agencies. The California Board of Pharmacy is the main governing body for the regulations concerning the manufacturing of pharmaceuticals. This agency works with the U.S. Food and Drug Administration (FDA) to ensure the quality, safety and efficacy of all medications. Manufacturers must abide by the regulations outlined in the California Pharmacy Law and in the California Food, Drug and Cosmetic Act. These regulations include requirements for labeling, storage, packaging and quality control. Manufacturers must also meet the standards set by the FDA in order to gain approval to market their products in California. In addition to the legal regulations, all pharmaceutical manufacturers must maintain a quality system that meets the international standards of Good Manufacturing Practices (GMP). This includes establishing operational procedures, controlling raw materials and processes, and maintaining the necessary documentation. Finally, all pharmaceuticals must be tested in clinical trials before they are approved for sale in the state. The manufacturers must provide data showing that the medications are safe and effective before they can be made available to the public. In summary, California has several regulations in place to ensure the quality and safety of all pharmaceutical products. Manufacturers must meet the standards set by the FDA, maintain a quality system that meets the GMP standards, and provide data from clinical trials before they can be approved for sale.

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What are the regulations regarding the manufacture of pharmaceuticals?

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