Code of Federal Regulations · Section
§ 610.63 — Divided Manufacturing Responsibility To Be Shown
21 C.F.R. § 610.63
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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.
Authorizing Statute
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Regulations42 U.S.C. § 216
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Definitions; generally21 U.S.C. § 321