Title 21

PART 600 SUBPART B

Subpart B - Establishment Standards

• 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.

21:7.0.1.1.1.2.1.1	SECTION 600.10	600.10 Personnel.
21:7.0.1.1.1.2.1.2	SECTION 600.11	600.11 Physical establishment, equipment, animals, and care.
21:7.0.1.1.1.2.1.3	SECTION 600.12	600.12 Records.
21:7.0.1.1.1.2.1.4	SECTION 600.13	600.13 Retention samples.
21:7.0.1.1.1.2.1.5	SECTION 600.14	600.14 Reporting of biological product deviations by licensed manufacturers.
21:7.0.1.1.1.2.1.6	SECTION 600.15	600.15 Temperatures during shipment.

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