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Regulations last checked for updates: May 14, 2025
Title 21 - Food and Drugs last revised: May 12, 2025
All Titles
Title 21
Chapter I
Part 212 - PART 212—CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS
Subpart A [§ 212.1 - § 212.5] - Subpart A—General Provisions
Subpart B [§ 212.10 - § 212.10] - Subpart B—Personnel and Resources
Subpart C [§ 212.20 - § 212.20] - Subpart C—Quality Assurance
Subpart D [§ 212.30 - § 212.30] - Subpart D—Facilities and Equipment
Subpart E [§ 212.40 - § 212.40] - Subpart E—Control of Components, Containers, and Closures
Subpart F [§ 212.50 - § 212.50] - Subpart F—Production and Process Controls
Subpart G [§ 212.60 - § 212.61] - Subpart G—Laboratory Controls
Subpart H [§ 212.70 - § 212.71] - Subpart H—Finished Drug Product Controls and Acceptance
Subpart I [§ 212.80 - § 212.80] - Subpart I—Packaging and Labeling
Subpart J [§ 212.90 - § 212.90] - Subpart J—Distribution
Subpart K [§ 212.100 - § 212.100] - Subpart K—Complaint Handling
Subpart L [§ 212.110 - § 212.110] - Subpart L—Records
authority:
21 U.S.C. 321
,
351
,
352
,
355
,
371
,
374
; Sec. 121, Pub. L. 105-115, 111 Stat. 2296
source:
74 FR 65431, Dec. 10, 2009, unless otherwise noted.
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