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 February 24, 2021 |
Title 21 → Chapter I → Subchapter F → Part 600 → Subpart C → §600.21 |
Title 21: Food and Drugs
PART 600—BIOLOGICAL PRODUCTS: GENERAL
Subpart C—Establishment Inspection
§600.21 Time of inspection.
The inspection of an establishment for which a biologics license application is pending need not be made until the establishment is in operation and is manufacturing the complete product for which a biologics license is desired.
[38 FR 32048, Nov. 20, 1973, as amended at 48 FR 26314, June 7, 1983; 64 FR 56449, Oct. 20, 1999; 84 FR 12508, Apr. 2, 2019]