Reference Anti-Human Globulin preparations shall be obtained from the Center for Biologics Evaluation and Research (HFM-407) (see mailing addresses in Sec. 600.2 of this chapter), 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]