21 CFR 610.63

§ 610.63 Divided manufacturing responsibility to be shown.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 610.63, § 610.63 Divided manufacturing responsibility to be shown, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88441
Permanent ID: ys:prov:88441@1
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Full text

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.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.