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Code of Federal Regulations (Last Updated: November 8, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter F - Biologics |
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Part 600 - Biological Products: General |
| 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. |