Title 21

PART 600

Part 600 - Biological Products: General

PART 600 - BIOLOGICAL PRODUCTS: GENERAL 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.

21:7.0.1.1.1.1SUBPART A
Subpart A - General Provisions
21:7.0.1.1.1.1.1.1SECTION 600.2
   600.2 Mailing addresses.
21:7.0.1.1.1.1.1.2SECTION 600.3
   600.3 Definitions.
21:7.0.1.1.1.2SUBPART B
Subpart B - Establishment Standards
21:7.0.1.1.1.2.1.1SECTION 600.10
   600.10 Personnel.
21:7.0.1.1.1.2.1.2SECTION 600.11
   600.11 Physical establishment, equipment, animals, and care.
21:7.0.1.1.1.2.1.3SECTION 600.12
   600.12 Records.
21:7.0.1.1.1.2.1.4SECTION 600.13
   600.13 Retention samples.
21:7.0.1.1.1.2.1.5SECTION 600.14
   600.14 Reporting of biological product deviations by licensed manufacturers.
21:7.0.1.1.1.2.1.6SECTION 600.15
   600.15 Temperatures during shipment.
21:7.0.1.1.1.3SUBPART C
Subpart C - Establishment Inspection
21:7.0.1.1.1.3.1.1SECTION 600.20
   600.20 Inspectors.
21:7.0.1.1.1.3.1.2SECTION 600.21
   600.21 Time of inspection.
21:7.0.1.1.1.3.1.3SECTION 600.22
   600.22 [Reserved]
21:7.0.1.1.1.4SUBPART D
Subpart D - Reporting of Adverse Experiences
21:7.0.1.1.1.4.1.1SECTION 600.80
   600.80 Postmarketing reporting of adverse experiences.
21:7.0.1.1.1.4.1.2SECTION 600.81
   600.81 Distribution reports.
21:7.0.1.1.1.4.1.3SECTION 600.82
   600.82 Notification of a permanent discontinuance or an interruption in manufacturing.
21:7.0.1.1.1.4.1.4SECTION 600.90
   600.90 Waivers.