21 CFR 660.40 - Hepatitis B Surface Antigen.

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§ 660.40 Hepatitis B Surface Antigen.

(a)Proper name and definition. The proper name of this product shall be Hepatitis B Surface Antigen (HBsAg), which shall consist of a serum or tissue preparation containing one or more subtypes of the Hepatitis B Surface Antigen.

(b)Source. The source of the product shall be blood, plasma, serum, or tissue, obtained aseptically from nonhuman primates that have met the applicable requirements of § 600.11 of this chapter, or from human donors whose blood is positive for the Hepatitis B Surface Antigen.

Title 21 published on 10-May-2017 03:43

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 660 after this date.

  • 2016-06-15; vol. 81 # 115 - Wednesday, June 15, 2016
    1. 81 FR 38911 - Use of Symbols in Labeling
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective September 13, 2016.
      21 CFR Parts 660, 801, and 809