Title 21

PART 26 SUBPART A

Subpart A - Specific Sector Provisions for Pharmaceutical Good Manufacturing Practices

• 5 U.S.C. 552; 15 U.S.C. 1453, 1454, 1455; 18 U.S.C. 1905; 21 U.S.C. 321, 331, 351, 352, 355, 360, 360b, 360c, 360d, 360e, 360f, 360g, 360h, 360i, 360j, 360l, 360m, 371, 374, 381, 382, 383, 393; 42 U.S.C. 216, 241, 242l, 262, 264, 265.
• 63 FR 60141, Nov. 6, 1998, unless otherwise noted.

21:1.0.1.1.20.1.63.1	SECTION 26.1	26.1 Definitions.
21:1.0.1.1.20.1.63.2	SECTION 26.2	26.2 Purpose.
21:1.0.1.1.20.1.63.3	SECTION 26.3	26.3 Scope.
21:1.0.1.1.20.1.63.4	SECTION 26.4	26.4 Product coverage.
21:1.0.1.1.20.1.63.5	SECTION 26.5	26.5 Length of transition period.
21:1.0.1.1.20.1.63.6	SECTION 26.6	26.6 Equivalence assessment.
21:1.0.1.1.20.1.63.7	SECTION 26.7	26.7 Participation in the equivalence assessment and determination.
21:1.0.1.1.20.1.63.8	SECTION 26.8	26.8 Other transition activities.
21:1.0.1.1.20.1.63.9	SECTION 26.9	26.9 Equivalence determination.
21:1.0.1.1.20.1.63.10	SECTION 26.10	26.10 Regulatory authorities not listed as currently equivalent.
21:1.0.1.1.20.1.63.11	SECTION 26.11	26.11 Start of operational period.
21:1.0.1.1.20.1.63.12	SECTION 26.12	26.12 Nature of recognition of inspection reports.
21:1.0.1.1.20.1.63.13	SECTION 26.13	26.13 Transmission of postapproval inspection reports.
21:1.0.1.1.20.1.63.14	SECTION 26.14	26.14 Transmission of preapproval inspection reports.
21:1.0.1.1.20.1.63.15	SECTION 26.15	26.15 Monitoring continued equivalence.
21:1.0.1.1.20.1.63.16	SECTION 26.16	26.16 Suspension.
21:1.0.1.1.20.1.63.17	SECTION 26.17	26.17 Role and composition of the Joint Sectoral Committee.
21:1.0.1.1.20.1.63.18	SECTION 26.18	26.18 Regulatory collaboration.
21:1.0.1.1.20.1.63.19	SECTION 26.19	26.19 Information relating to quality aspects.
21:1.0.1.1.20.1.63.20	SECTION 26.20	26.20 Alert system.
21:1.0.1.1.20.1.63.21	SECTION 26.21	26.21 Safeguard clause.
21:1.0.1.1.20.1.63.22.1	APPENDIX Appendix A	Appendix A to Subpart A of Part 26 - List of Applicable Laws, Regulations, and Administrative Provisions
21:1.0.1.1.20.1.63.22.2	APPENDIX Appendix B	Appendix B to Subpart A of Part 26 - List of Authorities
21:1.0.1.1.20.1.63.22.3	APPENDIX Appendix C	Appendix C to Subpart A of Part 26 - Indicative List of Products Covered by Subpart A
21:1.0.1.1.20.1.63.22.4	APPENDIX Appendix D	Appendix D to Subpart A of Part 26 - Criteria for Assessing Equivalence for Post- and Preapproval
21:1.0.1.1.20.1.63.22.5	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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