CFR section
21 CFR 601.22: Products in short supply; initial manufacturing at other than licensed location
PART 601-LICENSING · Subpart C-Biologics Licensing
Key facts
| Citation | 21 CFR 601.22 |
|---|---|
| Section | Products in short supply; initial manufacturing at other than licensed location |
| Part | PART 601-LICENSING |
| Subpart | Subpart C-Biologics Licensing |
| Subchapter | 21 CFR F Biologics |
| Product types cited | Biologics, Drugs |
| Regulation text (excerpt) | A biologics license issued to a manufacturer and covering all locations of manufacture shall authorize persons other than such manufacturer to conduct at places other than such locations the initial, and partial manufacturing of a product for shipment solely to such manufacturer only to the extent that the names of such persons and places are registered with the Commissioner of Food and Drugs and it is found upon application of such manufacturer, that the product is in short supply due either to… |
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Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.