Regulations last checked for updates: May 18, 2024

Title 21 - Food and Drugs last revised: May 15, 2024
All TitlesTitle 21Chapter IPart 26Subpart A - Subpart A—Specific Sector Provisions for Pharmaceutical Good Manufacturing Practices
View all text of Subpart A [§ 26.1 - § 26.21]
§ 26.3 - Scope.

(a) The provisions of this subpart shall apply to pharmaceutical inspections carried out in the United States and Member States of the European Community (EC) before products are marketed (hereafter referred to as “preapproval inspections”) as well as during their marketing (hereafter referred to as “postapproval inspections”).

(b) Appendix A of this subpart names the laws, regulations, and administrative provisions governing these inspections and the good manufacturing practices (GMP's) requirements.

(c) Appendix B of this subpart lists the authorities participating in activities under this subpart.

(d) Sections 26.65, 26.66, 26.67, 26.68, 26.69, and 26.70 of subpart C of this part do not apply to this subpart.

authority: 5 U.S.C. 552; 15 U.S.C. 1453,1454,1455; 18 U.S.C. 1905; 21 U.S.C. 321,331,351,352,355,360,360b,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
source: 63 FR 60141, Nov. 6, 1998, unless otherwise noted.
cite as: 21 CFR 26.3
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