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Electronic Code of Federal Regulations

e-CFR data is current as of December 5, 2019

Title 21Chapter ISubchapter FPart 600


TITLE 21—Food and Drugs

CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

SUBCHAPTER F—BIOLOGICS

PART 600—BIOLOGICAL PRODUCTS: GENERAL

rule

Subpart A—GENERAL PROVISIONS

§600.2
Mailing addresses.
§600.3
Definitions.
rule

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.
rule

Subpart C—ESTABLISHMENT INSPECTION

§600.20
Inspectors.
§600.21
Time of inspection.
§600.22
[Reserved]
rule

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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