Part 600 — Biological Products: General
Current through Sep 8, 2026
Authority: 21 U.S.C. 321, 351, 352, 353, 355, 356c, 356e, 360, 360i, 371, 374, 379k-l; 42 U.S.C. 216, 262, 263, 263a, 264.
Cross References:
For U.S. Customs Service regulations relating to viruses, serums, and toxins, see 19 CFR 12.21-12.23. For U.S. Postal Service regulations relating to the admissibility to the United States mails see parts 124 and 125 of the Domestic Mail Manual, that is incorporated by reference in 39 CFR part 111.
Sections
- § 600.2 Mailing addresses.
- § 600.3 Definitions.
- § 600.10 Personnel.
- § 600.11 Physical establishment, equipment, animals, and care.
- § 600.12 Records.
- § 600.13 Retention samples.
- § 600.14 Reporting of biological product deviations by licensed manufacturers.
- § 600.15 Temperatures during shipment.
- § 600.20 Inspectors.
- § 600.21 Time of inspection.
- § 600.22 [Reserved]
- § 600.80 Postmarketing reporting of adverse experiences.
- § 600.81 Distribution reports.
- § 600.82 Notification of a permanent discontinuance or an interruption in manufacturing.
- § 600.90 Waivers.