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.
21 CFR Part 610 · General Biological Products Standards
§ 610.63 Divided manufacturing responsibility to be shown
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What FDA inspectors cite under § 610.63
Form FDA 483 observations citing this section, fiscal years 2013–2013 (Biologics).
- Divided manufacturing 1
FDA guidance that cites § 610.63
- The “Deemed to be a License” Provision of the BPCI Act: Questions and Answers : Guidance for Industry 4 Mar 2020
- Cooperative Manufacturing Arrangements for Licensed Biologics: Guidance for Industry 28 Nov 2008
Amendment history
Federal Register documents that created or amended this section.
- 64 FR 56453 20 Oct 1999