21 CFR 610.63 - Divided manufacturing responsibility to be shown.

Beta! The text on the eCFR tab represents the unofficial eCFR text at ecfr.gov.
§ 610.63 Divided manufacturing responsibility to be shown.

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.

[64 FR 56453, Oct. 20, 1999]

Title 21 published on 2015-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 610 after this date.

  • 2015-07-02; vol. 80 # 127 - Thursday, July 2, 2015
    1. 80 FR 37971 - Revocation of General Safety Test Regulations That Are Duplicative of Requirements in Biologics License Applications
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective August 3, 2015.
      21 CFR Parts 601, 610, and 680
The section you are viewing is cited by the following CFR sections.