U.S. Code of Federal Regulations

Regulations most recently checked for updates: Aug 28, 2025

All TitlesTitle 21Chapter IPart 26Subpart A - Subpart A—Specific Sector Provisions for Pharmaceutical Good Manufacturing Practices
§ 26.1 - Definitions.
§ 26.2 - Purpose.
§ 26.3 - Scope.
§ 26.4 - Product coverage.
§ 26.5 - Length of transition period.
§ 26.6 - Equivalence assessment.
§ 26.7 - Participation in the equivalence assessment and determination.
§ 26.8 -
§ 26.9 - Equivalence determination.
§ 26.10 - Regulatory authorities not listed as currently equivalent.
§ 26.11 - Start of operational period.
§ 26.12 - Nature of recognition of inspection reports.
§ 26.13 - Transmission of postapproval inspection reports.
§ 26.14 - Transmission of preapproval inspection reports.
§ 26.15 - Monitoring continued equivalence.
§ 26.16 - Suspension.
§ 26.17 - Role and composition of the Joint Sectoral Committee.
§ 26.18 - Regulatory collaboration.
§ 26.19 - Information relating to quality aspects.
§ 26.20 - Alert system.
§ 26.21 - Safeguard clause.
Appendix Appendix A - Appendix A to Subpart A of Part 26—List of Applicable Laws, Regulations, and Administrative Provisions
Appendix Appendix B - Appendix B to Subpart A of Part 26—List of Authorities
Appendix Appendix C - Appendix C to Subpart A of Part 26—Indicative List of Products Covered by Subpart A
Appendix Appendix D - Appendix D to Subpart A of Part 26—Criteria for Assessing Equivalence for Post- and Preapproval
Appendix Appendix E - Appendix E to Subpart A of Part 26—Elements To Be Considered in Developing a Two-Way Alert System
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