What are the regulations governing the production of generic drugs?

Generic drugs are drugs that are approved by the U.S. Food and Drug Administration (FDA) for use as a replacement for a brand-name drug. In North Carolina, the regulations governing the production of generic drugs are set out in the North Carolina General Statutes Chapter 90 Article 11. Generic drugs must have the same active ingredients, strength, dosage form, and route of administration as the brand-name drug. The FDA also requires that generic drugs meet the same standards of quality, purity, and potency as their brand-name counterparts. In order to ensure that generic drugs are safe and effective, manufacturers must submit an Abbreviated New Drug Application (ANDA) to the FDA. This application must include information about the ingredients, the manufacturing process, and testing procedures. Once an application is approved, generic drug manufacturers must adhere to the same quality standards as brand-name drug manufacturers. This includes Good Manufacturing Practices (GMPs). GMPs are standards that are designed to ensure that drug products meet their product specifications and are not contaminated or adulterated. Additionally, drug manufacturers must comply with Drug Supply Chain Security Act (DSCSA) regulations in order to track and trace the distribution of drugs and prevent counterfeiting. Generic drugs are an important part of the healthcare landscape and it is important that drug manufacturers adhere to the regulations governing production. Following these regulations ensures that generic drugs are safe, effective, and of high quality.

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What are the regulations governing the production of generic drugs?

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