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

Generic drugs are drugs that are chemically and biologically identical to a previously approved brand-name drug to treat the same condition. The US Food and Drug Administration (FDA) has established regulations governing the testing and approval of generic drugs in Oregon. The FDA requires that the generic drug must have the same active ingredients, dosage form, strength, and route of administration as the brand-name drug. The generic drug must also demonstrate that it is bioequivalent to the brand-name drug, meaning that it has the same rate and extent of absorption when taken under the same conditions. In addition, the generic drug must be manufactured in accordance with Good Manufacturing Practices (GMPs). To ensure that generic drugs are safe and effective, the FDA requires manufacturers to submit an Abbreviated New Drug Application (ANDA) to the FDA for approval. This application must include data that demonstrates that the generic drug is as safe and effective as the brand-name drug. Once approved, the FDA inspects the facility where the generic drug is produced to ensure GMPs are followed. In Oregon, the Oregon Board of Pharmacy is responsible for monitoring the quality and safety of generic drugs. Pharmacists must have reasonable knowledge of the generic drugs that they sell and must verify that they come from a licensed source. The Board also requires pharmacists to alert consumers of any potential risks associated with generic drugs.

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

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