Regulation Text
A Reference Hepatitis B Surface Antigen Panel 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 for determining the potency and specificity of Antibody to Hepatitis B Surface Antigen.
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.