21 CFR 640.101 - General requirements.

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There is 1 rule appearing in the Federal Register for 21 CFR Part 640. View below or at eCFR (GPOAccess)
§ 640.101 General requirements.
(a) Heat stability test. Approximately 2 ml. of completely processed material of each lot shall not show any visible sign of gelation after heating in a 12×75 mm. stoppered glass tube at 57 °C for 4 hours.
(b) pH. The pH of final container material shall be 6.8 ±0.4 when measured in a solution diluted to 1 percent protein with 0.15 molar sodium chloride.
(c) Turbidity. The product shall be free of turbidity as determined by visual inspection of final containers.
(d) Date of manufacture. The date of manufacture is the date of initiating the last valid measles or poliomyelitis antibody test (§ 640.104(b) (2) and (3)) whichever date is earlier.
(e) Labeling. In addition to complying with all applicable labeling required in this subchapter, labeling shall indicate that:
(1) There is no prescribed potency for viral hepatitis antibodies.
(2) The product is not recommended for intravenous administration.
[38 FR 32089, Nov. 20, 1973; 48 FR 13026, Mar. 29, 1983, as amended at 49 FR 23834, June 8, 1984; 50 FR 4140, Jan. 29, 1985; 51 FR 15611, Apr. 25, 1986; 55 FR 11013, Mar. 26, 1990; 63 FR 16685, Apr. 6, 1998; 64 FR 26287, May 14, 1999]

Title 21 published on 2014-04-01.

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.

  • 2015-05-22; vol. 80 # 99 - Friday, May 22, 2015
    1. 80 FR 29842 - Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective May 23, 2016.
      21 CFR Parts 606, 610, 630, 640, 660, and 820

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United States Code

Title 21 published on 2014-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 640 after this date.

  • 2015-05-22; vol. 80 # 99 - Friday, May 22, 2015
    1. 80 FR 29842 - Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective May 23, 2016.
      21 CFR Parts 606, 610, 630, 640, 660, and 820