What are the regulations governing the testing and approval of generic drugs?

The regulations governing the testing and approval of generic drugs in Washington are established by the Washington State Department of Health. These regulations are based on requirements set out by the U.S. Food and Drug Administration (FDA) and must be met in order for generic drugs to be approved for sale in the state. The testing and approval process begins with an application to the FDA. The application must include detailed information on the manufacturer, the active ingredients of the drug, any impurities, studies of the drug in humans, and any other pertinent information. The Washington State Department of Health then reviews the application and if approved, issues a Certificate of Pharmaceutical Product. This certificate demonstrates that the drug has been tested and approved by the state. Once the drug is approved, it must then meet all Good Manufacturing Practices requirements. This ensures that the drug is consistently manufactured and tested for quality, strength, and purity. It also requires that the drug labeling is accurate and easily understood by consumers. Finally, the drug must be tested to ensure that it is therapeutically equivalent to a brand-name drug. This means that the generic drug must contain the same active ingredients and work in the same way as the brand-name drug. Once these tests are complete, the generic drug is approved for sale in the state.

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What are the regulations governing the testing and approval of generic drugs?

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