21 CFR 660.5 - Specificity.

Regulations last checked for updates: Feb 11, 2026

Title 21 - Food and Drugs last revised: Dec 18, 2026

View all text of Subpart A [§ 660.1 - § 660.6]

§ 660.5 - Specificity.

Each filling of the product shall be specific for antibody to hepatitis B surface antigen, as determined by specificity tests found acceptable by the Director, Center for Biologics Evaluation and Research.

[40 FR 29712, July 15, 1975, as amended at 49 FR 23834, June 8, 1984; 55 FR 11013, Mar. 26, 1990]

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 660.5