What is the law regarding the manufacture of unapproved drugs?

In the state of Washington, there are specific regulations regarding the manufacture of unapproved drugs. According to the Washington Administrative Code (WAC), it is unlawful for any person, firm, corporation, or other entity to manufacture any drug, herbal compound, or therapeutic device that has not been approved for sale by the FDA or other governmental agency. Additionally, Washington State law prohibits any unlicensed person from practicing pharmacy without a valid pharmacy license. Furthermore, the manufacture of any unapproved drug or herbal compound, or any non-pharmaceutical product or device that is intended to be used or is likely to be used in the diagnosis, cure, mitigation, treatment, or prevention of any disease, injury, or condition of a human or animal must comply with Washington State’s Good Manufacturing Practices (GMP). These regulations are designed to ensure the safety and quality of any product manufactured, distributed, or sold in the state. Finally, the manufacture of any unapproved drug or herbal compound, or any non-pharmaceutical product or device that is intended to be used or is likely to be used in the diagnosis, cure, mitigation, treatment, or prevention of any disease, injury, or condition of a human or animal must also be registered with the Washington State Department of Health and meet additional requirements specified in the WAC. Failure to comply with any of these regulations can result in civil penalties or criminal prosecution.

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What is the law regarding the manufacture of unapproved drugs?

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