1. Regulations
  2. title 21
  3. chapter I-i6
  4. part 660
  5. subpart E
  6. § 660.44

View all text of Subpart E [§ 660.40 - § 660.46]

§ 660.44 - Specificity.

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.

[44 FR 36382, June 22, 1979, 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 660.44