21 CFR 660.22 - Potency requirements with reference preparations.

§ 660.22 Potency requirements with reference preparations.
(a) Potency requirements. Products for which reference Blood Grouping Reagents are available shall have a potency titer value at least equal to that of the reference preparation.
(b) Reference preparations. Reference Blood Grouping Reagents shall be obtained from the Center for Biologics Evaluation and Research (HFM-407) (see mailing addresses in § 600.2 of this chapter), and shall be used as described in the accompanying package insert for determining the potency of Blood Grouping Reagents.
[53 FR 12764, Apr. 19, 1988, as amended at 67 FR 9587, Mar. 4, 2002; 70 FR 14985, Mar. 24, 2005]

Title 21 published on 2013-04-01

no entries appear in the Federal Register after this date.

Title 21 published on 2013-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 660 after this date.

  • 2013-04-19; vol. 78 # 76 - Friday, April 19, 2013
    1. 78 FR 23508 - Use of Certain Symbols in Labeling
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Proposed rule.
      Submit electronic or written comments on the proposed rule by June 18, 2013. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 (the PRA) by May 20, 2013, (see section VII). See section IX for the proposed effective date of a final rule based on the proposed rule in this document.
      21 CFR Parts 660, 801, and 809