What is the law regarding the manufacture of unapproved drugs?

In Oregon, the law regarding the manufacture of unapproved drugs is set out in the Oregon Administrative Rules. According to these rules, it is illegal to manufacture a drug in Oregon that is not approved by the U.S. Food and Drug Administration (FDA). Manufacturers of unapproved drugs can face significant fines and other penalties if they do not comply with the FDA’s regulations. In order to manufacture an unapproved drug, manufacturers need to obtain an Investigational New Drug Application (IND) from the FDA. This application must be submitted and reviewed before the drug can be manufactured. It must include information on the drug’s composition, testing procedures, and other safety and efficacy information. In addition, manufacturers of unapproved drugs must comply with state regulations that apply to the manufacture and distribution of drugs. This includes requirements such as Good Manufacturing Practices, labeling requirements, record-keeping requirements, and more. Any companies found to be in violation of the law regarding the manufacture of unapproved drugs can face significant fines and other penalties, such as the revocation of their license to manufacture. As such, it is important for companies to ensure they understand and follow all relevant laws and regulations when they are manufacturing drugs.

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What is the law regarding the manufacture of unapproved drugs?

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