What is the legal framework governing the manufacture of drugs?

In Florida, the legal framework governing the manufacture of drugs is centered around the Florida Pharmaceutical Laws, which are designed to ensure that drugs manufactured and sold in the state are safe, effective, and of the highest quality. These laws set forth standards for the manufacture, distribution, storage, advertising, and sale of drugs and establish requirements for licensing of manufacturers. Drug manufacturers must adhere to the following regulations: they must maintain a current good manufacturing practice (GMP) program; must maintain adequate records; must ensure that drugs are not contaminated with any foreign materials; and must ensure that drugs are accurately labeled and packaged to the standards set by the Food and Drug Administration (FDA). Additionally, manufacturers must obtain and maintain a valid Florida pharmacy license to lawfully manufacture or distribute drugs in the state. In addition, drug production must meet the standards of the FDA, including the Safe and Effective Drug Administration (SAFA) rule, which requires drug manufacturers to establish quality control systems and safety protocols to ensure the safety and effectiveness of drugs. SAFA also requires manufacturers to submit to pre-approval inspections and to submit to FDA audits. All drugs manufactured or distributed in Florida must also meet the standards of the Florida Drug and Cosmetic Act (FDC), which establishes requirements for the manufacture, labeling, packaging, and distribution of drugs. This act also sets forth standards for the registration, inspection, and recall of drugs. Finally, all drugs manufactured in or shipped to the state must be registered with the Florida Department of Health, which reviews and approves all drugs for sale to ensure compliance with the state’s laws and regulations.

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What is the legal framework governing the manufacture of drugs?

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