21 CFR parts 300s is related to which category of products?

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21 CFR Part 300 specifically addresses regulations concerning human drugs. This part of the Code of Federal Regulations outlines the requirements and standards for the approval, labeling, and manufacturing of human drugs intended for use in the United States.

The regulations ensure that human drugs are safe and effective for consumers, detailing procedures for drug approval applications as well as compliance requirements for manufacturers. This part is part of the overall framework that governs various aspects of human pharmaceuticals, including those that require FDA approval before they can be marketed.

In contrast, other categories such as animal drugs, foods, and cosmetics are governed by different parts of the CFR, which are tailored specifically to the safety and efficacy concerns relevant to those products. This distinction is crucial for regulatory professionals to understand, as it influences the product development and approval processes within each category.

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