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Regulations last checked for updates: Nov 24, 2024
Title 21 - Food and Drugs last revised: Nov 21, 2024
All Titles
Title 21
Chapter I
Part 26
Subpart 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 - Other transition activities.
§ 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
authority:
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
,
360
b,
360
c,
360
d,
360
e,
360
f,
360
g,
360
h,
360
i,
360
j,
360
l,
360
m,
371
,
374
,
381
,
382
,
383
,
393
;
42 U.S.C. 216
,
241
,
242l
,
262
,
264
,
265
source:
63 FR 60141, Nov. 6, 1998, unless otherwise noted.
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