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 2015-12-03

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

Title 21 published on 2015-12-03.

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 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