21 CFR 601.22 - Products in short supply; initial manufacturing at other than licensed location.

§ 601.22 Products in short supply; initial manufacturing at other than licensed location.
A biologics license issued to a manufacturer and covering all locations of manufacture shall authorize persons other than such manufacturer to conduct at places other than such locations the initial, and partial manufacturing of a product for shipment solely to such manufacturer only to the extent that the names of such persons and places are registered with the Commissioner of Food and Drugs and it is found upon application of such manufacturer, that the product is in short supply due either to the peculiar growth requirements of the organism involved or to the scarcity of the animal required for manufacturing purposes, and such manufacturer has established with respect to such persons and places such procedures, inspections, tests or other arrangements as will ensure full compliance with the applicable regulations of this subchapter related to continued safety, purity, and potency. Such persons and places shall be subject to all regulations of this subchapter except §§ 601.2 to 601.6, 601.9, 601.10, 601.20, 601.21 to 601.33, and 610.60 to 610.65 of this chapter. For persons and places authorized under this section to conduct the initial and partial manufacturing of a product for shipment solely to a manufacturer of a product subject to licensure under § 601.2(c), the following additional regulations shall not be applicable: §§ 600.10(b) and (c), 600.11, 600.12, 600.13, 610.11, and 610.53 of this chapter. Failure of such manufacturer to maintain such procedures, inspections, tests, or other arrangements, or failure of any person conducting such partial manufacturing to comply with applicable regulations shall constitute a ground for suspension or revocation of the authority conferred pursuant to this section on the same basis as provided in §§ 601.6 to 601.8 with respect to the suspension and the revocation of licenses.
[42 FR 4718, Jan. 25, 1977, as amended at 61 FR 24233, May 14, 1996; 64 FR 56452, Oct. 20, 1999]

Title 21 published on 2014-04-01

no entries appear in the Federal Register after this date.

Title 21 published on 2014-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 601 after this date.

  • 2015-02-18; vol. 80 # 32 - Wednesday, February 18, 2015
    1. 80 FR 8577 - Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products; Public Meeting; Request for Comments; Reopening of the Comment Period
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Notice of public meeting; request for comments; reopening of the comment period.
      Meeting. The public meeting will be held on March 27, 2015, from 8 a.m. to 5 p.m. Registration to attend the meeting must be received by March 20, 2015. See the SUPPLEMENTARY INFORMATION section for information on how to register for the meeting. Comments. The comment period for the proposed rule publilshed November 13, 2013 (78 FR 67985), is reopened. Submit either electronic or written comments regarding proposed alternatives to the proposed rule by April 27, 2015.
      21 CFR Parts 314 and 601