1. Regulations
  2. title 21
  3. chapter I-i6
  4. part 660
  5. subpart A
  6. § 660.5

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