What are the regulations governing the approval of generic drugs?

In Oregon, generic drugs must meet the same standards of safety and effectiveness as their brand-name equivalents in order to be approved for sale. The U.S. Food and Drug Administration (FDA) and the Oregon Board of Pharmacy have responsibility for regulating the approval of generic drugs. As part of the approval process, the manufacturer of the drug must demonstrate to the FDA that it is a “therapeutically equivalent” product to its corresponding brand-name drug. This means that it has the same active ingredients, strength, quality, dosage forms, and route of administration as the original brand-name product. The FDA also requires that the manufacturer of the generic drug prove that the product is stable and that its manufacturing, packaging, and labeling processes are adequate to maintain the drug’s quality, strength, and purity. Additionally, the FDA requires that generic drugs not interfere with the effectiveness of other medications that may be taken in conjunction with the generic drug. Generic drugs must go through a rigorous approval process before they are approved for sale in Oregon. Once a generic drug has been approved, it may be sold at a much lower price than its brand-name equivalent due to the lack of research and development costs associated with the generic product.

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What are the regulations governing the approval of generic drugs?

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