What are the regulations governing the production of generic drugs?

In Nebraska, the regulation of generic drugs is governed by the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FD&C Act requires that generic drugs contain the same active ingredients as the brand name drug, though they may look different. To be approved for sale, the generic drugs must meet the same safety and effectiveness standards as brand name drugs. The Nebraska Department of Health and Human Services (DHHS) requires that generic drug manufacturers provide the same quality standards as brand name drugs. Generic drugs must be approved by the Food and Drug Administration (FDA) through an Abbreviated New Drug Application (ANDA). The ANDA process requires generic drug manufacturers to demonstrate that their medicines are safe and effective and meet all other requirements of the FD&C Act for brand name drugs. The DHHS will not approve a generic drug until the FDA has approved the original brand-name drug. The DHHS also requires generic drug makers to comply with the Good Manufacturing Practices (GMP) set by the FDA. GMPs ensure that generic drugs are manufactured in compliance with control processes and quality standards. The DHHS also monitors the handling, storage, and distribution of generic drugs for safety, efficacy, and security purposes. To ensure that generic drugs are safe and effective, manufacturers must provide evidence of bioequivalence to the FDA. Bioequivalence is the degree to which a drug is equal in its pharmacological effect to the original, brand name drug. A generic drug must show that it has the same amount of active ingredient and reaches the same concentration in the blood at the same time as the brand name drug. These regulations ensure that generic drugs are safe, effective, and provide the same quality standards as brand name drugs. It is important that consumers rely on the safety and efficacy of generic drugs, as they are often more affordable alternatives to brand name drugs.

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What are the regulations governing the production of generic drugs?

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