What are the regulations governing the production of generic drugs?

In Hawaii, the production of generic drugs is governed by the state’s pharmacy laws. According to these laws, generic drugs must meet the same standards of safety and effectiveness as the brand-name drugs from which they are modeled. Generic drugs must also meet the same active ingredient requirements, dosage form, route of administration and strength as the brand-name drug. In addition, the manufacturer of a generic drug must demonstrate that the drug is bioequivalent to the brand-name drug. Bioequivalence means that the generic drug is absorbed in the body at the same rate and to the same extent as the brand-name drug. The only differences between generic drugs and brand-name drugs should be price and inactive ingredients, such as dyes, flavors and packaging materials. Manufacturers of generic drugs must also comply with Good Manufacturing Practices, which are set by the U.S. Food and Drug Administration. These are standards that enable manufacturers to produce drugs with consistency and accuracy in order to ensure the drug meets the quality and purity requirements as established by the FDA. Finally, all manufacturers of generic drugs must register with the FDA and obtain a Drug Establishment License. This license must be renewed every two years and the manufacturing facility must be inspected annually to ensure it is meeting all of the production requirements.

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What are the regulations governing the production of generic drugs?

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