Food and Drug Administration (FDA) regulations can be found in which documentation?

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The correct answer is The Code of Federal Regulations because this is the formal documentation where federal rules and regulations, including those set forth by the Food and Drug Administration (FDA), are compiled and published. The Code of Federal Regulations (CFR) contains all the rules that govern food, drugs, biological products, medical devices, and other related areas under FDA jurisdiction. Specifically, Title 21 of the CFR is dedicated to food and drugs, detailing compliance requirements for various industry practices.

While the other options provide valuable information and guidance, they do not serve as the primary legal framework. For instance, Guidelines for Good Manufacturing Practices outlines best practices but is more of a guideline rather than a legally binding document. The FDA Compliance Manual offers internal guidance for FDA staff but does not encompass regulations themselves. The Biopharmaceutical Standards Manual is focused on specific standards within the biopharmaceutical industry, but it is not the legal codification of regulations. Thus, for any official references to FDA regulations, The Code of Federal Regulations is the definitive source.

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