21CFRs
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Popular References

11  -  26  -  58  -  210  -  211

Scroll down to find the section of the 21 CFR that you need. Please revisit periodically as we add additional Parts to this page.

Part 1 - General Enforcement

Part 2 - General Administrative Rulings and Decisions

Part 3 - Product Jurisdiction 

Part 5 - Delegations of Authority and Organization

Part 7 - Enforcement Policy

Part 10 - Administrative Practices and Procedures

Part 11 - Electronic Records and Electronic Signatures

Part 12 - Formal Public Evidentiary and Public Hearing

Part 13 - Public Hearing Before A Public Board of Inquiry

Part 14 - Public Hearing Before A Public Advisory Committee

Part 15 - Public Hearing Before the Commissioner

Part 16 - Regulatory Hearing Before the Food and Drug Administration

Part 17 - Civil Money Penalties Hearings

Part 19 - Standards of conduct and Conflicts of Interest

Part 20 - Public Information

Part 21 - Protection of Privacy

Part 25 - Environmental Impact Considerations

Part 26 - Mutual Recognition

Part 50 - Protection of Human Subjects

Part 54-  Financial Disclosure by Clinical Investigators

Part 56 - Institutional Review Boards

Part 58 - Good Laboratory Practice for Nonclinical Laboratory

Part 60 - Patent Term Restoration

Part 210 - CGMP for Manufacturing, Processing, Packing, and Holding Drug Products

Part 211 - CGMP for Finished Pharmaceuticals

Part 290 - Controlled Drugs

 

Other documents

Can the FDA see an internal audit report? Yes

Investigations Operations Manual 2008

 

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