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

In New Hampshire, generic drugs must be approved by the United States Food and Drug Administration (FDA) in order to be sold in the state. All generic drugs must meet two criteria: they must be found to be bioequivalent to the brand-name product, and they must go through the same rigorous testing as any other medication. In order for a generic drug to be approved, it must be the same as the brand-name product in terms of quality, strength, purity, and stability. This is determined through laboratory tests and clinical studies to make sure the generic drug is as safe and effective as the original product. The FDA also requires manufacturers of generic drugs to ensure their products meet applicable Current Good Manufacturing Practices (cGMP) regulations. This is to ensure that the drugs are produced properly in a safe and reliable manner. Once a generic drug is approved, it will then be registered with the state. This allows for the sale of the drug in New Hampshire pharmacies, and it also ensures that the drug meets quality standards. Generic drugs are an important part of the healthcare industry, as they can provide cost-savings to consumers while still being held to the same standards of rigor and safety as any other medication. With proper testing and approval, generic drugs can become a reliable and cost-effective way to provide drugs to those in need.

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

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