Regulation Text
Each filling of the product shall be specific for Hepatitis B Surface Antigen as determined by specificity tests found acceptable to the Director, Center for Biologics Evaluation and Research.
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.