What are the regulations governing the approval of generic drugs?

In North Dakota, the regulations governing the approval of generic drugs are governed by the Federal Food and Drug Administration (FDA). Generic drugs are, in essence, copies of the same drugs that are already on the market. The approval process is in place to ensure that generic drugs are of the same high quality as the brand-name drugs, and thus safe and effective for the patient. In order for a generic drug to be approved in North Dakota, it must meet several criteria set forth by the FDA. First, the generic drug must contain the same active ingredients, strengths, dosage forms, and routes of administration as the original brand-name drug. Second, it must be considered bioequivalent, meaning that the rate and extent of absorption of the generic drug must be the same as that of the brand-name drug. Third, the generic drug must meet the same safety standards as the brand-name drug; this includes having a long shelf life, stability in storage, and no potential for contamination. Fourth, the generic drug must have the same labeling as the brand-name drug and must be made according to the same good manufacturing practices as the brand-name drug. Once the generic drug meets all of these criteria, then it may be approved in North Dakota and allowed to be sold in pharmacies. Generic drugs are generally much cheaper than the brand-name drugs, which often leads to greater accessibility of certain medicines for those who otherwise could not afford them.

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What are the regulations governing the approval of generic drugs?

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