What are the regulations governing the production of generic drugs?

In Maryland, the regulations governing the production of generic drugs are found in the Maryland Code. These regulations are designed to ensure that generic drugs are safe, effective, and of consistent quality for their intended use. Generic drugs are identified by their active ingredient, which is the same as the active ingredient in the branded version of the drug. To be approved as a generic equivalent, the generic drug must meet rigorous scientific and quality standards set by the U.S. Food and Drug Administration (FDA). The FDA requires that a generic drug contain the same active ingredients, strength, dosage form, route of administration, and label warnings as the branded version. Generic drugs must also show the same effectiveness and safety profiles as the branded version. To ensure that generic drugs meet these requirements, manufacturers must follow the production guidelines set by the FDA. These production guidelines require that all components used in the production of generic drugs are of uniform quality, and that all manufacturing and packaging processes are conducted in accordance with FDA standards. This includes detailed record-keeping and quality controls. Additionally, manufacturers must complete testing to ensure that the generic drug is equivalent to the branded version in terms of safety, effectiveness, and quality. Generic drugs must also be stored, shipped, and labeled in accordance with FDA regulations. These regulations are designed to ensure the safety and quality of generic drugs. By following these regulations, manufacturers of generic drugs can ensure that their products are safe and effective for their intended use.

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What are the regulations governing the production of generic drugs?

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