What is the legal framework governing the manufacture of drugs?

In Washington, the manufacture of drugs is regulated by both federal and state laws. The federal government’s authority to regulate drugs is granted through the Food, Drug, and Cosmetic Act (FDCA). The FDCA requires that all drugs be safe and effective for their intended use, be properly labeled, and be manufactured in accordance with current good manufacturing practices. All manufacturers must also obtain approval from the U.S. Food and Drug Administration (FDA) to market their drugs before they can be sold or distributed. The State of Washington also has regulations governing drug manufacture. The Washington State Board of Pharmacy is responsible for the regulation and enforcement of drug laws. The Board has the authority to make rules and regulations relating to the manufacture and sale of drugs and to license drug manufacturers. The Board also has the authority to approve the labeling of products and inspect manufacturers to ensure they are complying with state and federal regulations. Finally, the Washington State Department of Health also has the authority to regulate the manufacture of drugs. The Department has the authority to inspect manufacturers, investigate reported violations, and pursue enforcement actions. The Department also works with the FDA in an effort to ensure that the manufacture of drugs is safe and in compliance with applicable regulations.

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What is the legal framework governing the manufacture of drugs?

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