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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER F - BIOLOGICS
 
PART 600BIOLOGICAL 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.

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.

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