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

In Nebraska, the state has specific regulations governing the testing and approval of generic drugs. Any drug submitted for approval must meet certain standards to gain the approval of the Nebraska Board of Pharmacy and the Food and Drug Administration (FDA). The generic drugs must prove to have equal potency, safety, and effectiveness as compared to the brand-name drug. The generic drugs must be found to contain the same active ingredient as the brand-name drug and must be bioequivalent to the brand-name drug. Bioequivalence is determined by analyzing the rate and extent of absorption of the active ingredient between the brand-name and generic drug. Bioequivalence testing is done by comparing pharmacokinetic properties such as the time it takes for the drug to reach its peak blood concentration and the extent of the drug’s absorption. The FDA then reviews the results of the bioequivalence testing and approves or denies the drug’s application. If approved, the drug is then subject to additional monitoring for safety and effectiveness. The FDA requires that all approved generic drugs be manufactured, labeled, and distributed according to current Good Manufacturing Practice (cGMP) regulations. The regulation of generic drugs in Nebraska helps to ensure patient safety while also offering a cost effective alternative to the more expensive brand-name drugs. Generic drugs provide access to life-saving medications to more people and help to keep prescription costs down.

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

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