Electronic Code of Federal Regulations

We invite you to try out our new beta eCFR site at https://ecfr.federalregister.gov. We have made big changes to make the eCFR easier to use. Be sure to leave feedback using the Feedback button on the bottom right of each page!

e-CFR data is current as of January 25, 2021

Title 21 → Chapter I → Subchapter F → Part 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

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.

Need assistance?