21 CFR 660.52 - Reference preparations.

Regulations last checked for updates: Nov 22, 2024

Title 21 - Food and Drugs last revised: Nov 19, 2024

View all text of Subpart F [§ 660.50 - § 660.55]

§ 660.52 - Reference preparations.

Reference Anti-Human Globulin preparations shall be obtained from the Food and Drug Administration, Center for Biologics Evaluation and Research, Reagents and Standards Shipping, 10903 New Hampshire Ave., Bldg. 75, Rm. G704, Silver Spring, MD 20993-0002, and shall be used as described in the accompanying package insert for determining the potency of Anti-Human Globulin.

[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; 67 FR 9587, Mar. 4, 2002; 70 FR 14986, Mar. 24, 2005; 80 FR 18093, Apr. 3, 2015]

authority: 21 U.S.C. 321,331,351,352,353,355,360,360c,360d,360h,360i,371,372; 42 U.S.C. 216,262,263,263a,264

cite as: 21 CFR 660.52