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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
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 - Duties of inspector.

Subpart D--Reporting of Adverse Experiences
   § 600.80 - Postmarketing reporting of adverse experiences.
   § 600.81 - Distribution reports.
   § 600.90 - Waivers.

Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 360i, 371, 374; 42 U.S.C. 216, 262, 263, 263a, 264, 300aa-25.

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