[Code of Federal Regulations] [Title 21, Volume 7] [Revised as of April 1, 2001] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR660.52] [Page 119] TITLE 21--FOOD AND DRUGS DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued) PART 660--ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS--Table of Contents Subpart F--Anti-Human Globulin Sec. 660.52 Reference preparations. Reference Anti-Human Globulin preparations shall be obtained from the Center for Biologics Evaluation and Research (HFB-221), Food and Drug Administration, 8800 Rockville Pike, Bethesda, MD 20892, and shall be used as described in the accompanying package insert for determining the potency of Anti-Human Globulin. (Approved by the Office of Management and Budget under control number 0910-0208) [50 FR 5579, Feb. 11, 1985, as amended at 50 FR 16474, Apr. 26, 1985; 51 FR 15611, Apr. 25, 1986; 55 FR 11015, Mar. 26, 1990]