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

In North Carolina, all generic drugs must conform to state and federal regulations before they can be approved for public use. The Federal Food, Drug, and Cosmetic Act requires that generic drugs be “the same as, or substantially similar to” the brand-name version of the drug they are based on, and must pass quality standards in order to be approved for sale. In terms of testing and approval, the U.S. Food and Drug Administration (FDA) requires generic manufacturers to conduct a series of tests and surveys to demonstrate the safety, efficacy, and potency of their products. These tests include laboratory tests that measure the active ingredients in the drug, as well as clinical trials in order to assess how the drug is absorbed and metabolized in the body. In addition, the FDA requires manufacturers to demonstrate that their products are able to maintain their stability and effectiveness over time. This is done through a series of stability studies that look at how the product behaves when exposed to environmental conditions like heat and light. Once the tests are completed, the FDA will review the data and decide whether or not to approve the drug for sale in North Carolina. If the drug is approved, it can be sold in pharmacies and other retail outlets. The testing and approval process is a rigorous one, but it helps ensure that generic drugs are safe and effective for public use.

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

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