21 CFR Part 600
PART 600—BIOLOGICAL PRODUCTS: GENERAL
- PART 600—BIOLOGICAL PRODUCTS: GENERAL
- Chapter I—Food and Drug Administration, Department of Health and Human Services › Subchapter F—Biologics
- Subpart A—General Provisions
- § 600.2 Mailing addresses.
- § 600.3 Definitions.
- Subpart B—Establishment Standards
- § 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.
- Subpart C—Establishment Inspection
- § 600.20 Inspectors.
- § 600.21 Time of inspection.
- § 600.22 [Reserved]
- Subpart D—Reporting of Adverse Experiences
- § 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.
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