GroundRules
21 CFR 610.63: Divided manufacturing responsibility to be shown.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER F—BIOLOGICS
- PART 610—GENERAL BIOLOGICAL PRODUCTS STANDARDS
- Subpart G—Labeling Standards
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.
Collected 2026-08-27T02:24:47Z. Source file · JSON