The name and address of the distributor of a product may appear on the label provided that the name, address, and license number of the manufacturer also appears on the label and the name of the distributor is qualified by one of the following phrases: “Manufactured for _____”, “Distributed by ______”, “Manufactured by _____ for _____”, “Manufactured for _____ by ____”, “Distributor: _____”, or “Marketed by _____”. The qualifying phrases may be abbreviated.
21 CFR Part 610 · General Biological Products Standards
§ 610.64 Name and address of distributor
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FDA guidance that cites § 610.64
Amendment history
Federal Register documents that created or amended this section.
- 61 FR 57330 6 Nov 1996