CFR section
21 CFR 610.63: Divided manufacturing responsibility to be shown
PART 610-GENERAL BIOLOGICAL PRODUCTS STANDARDS · Subpart G-Labeling Standards
Key facts
| Citation | 21 CFR 610.63 |
|---|---|
| Section | Divided manufacturing responsibility to be shown |
| Part | PART 610-GENERAL BIOLOGICAL PRODUCTS STANDARDS |
| Subpart | Subpart G-Labeling Standards |
| Subchapter | 21 CFR F Biologics |
| Product types cited | Biologics |
| Regulation text (excerpt) | If two or more licensed manufacturers participate in the manufacture of a biological product, the name, address, and license number of each must appear on the package label, and on the label of the container if capable of bearing a full label. |
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About CFR sections cited by the FDA
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.