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21 CFR Part 606 · Current Good Manufacturing Practice for Blood and Blood Components

§ 606.151 Compatibility testing

Subpart H - Laboratory Controls Official text on eCFR Amendment history

Standard operating procedures for compatibility testing shall include the following:

(a) A method of collecting and identifying the blood samples of recipients to ensure positive identification.

(b) The use of fresh recipient serum or plasma samples less than 3 days old for all pretransfusion testing if the recipient has been pregnant or transfused within the previous 3 months.

(c) Procedures to demonstrate incompatibility between the donor's cell type and the recipient's serum or plasma type.

(d) A provision that, if the unit of donor's blood has not been screened by a method that will demonstrate agglutinating, coating and hemolytic antibodies, the recipient's cells shall be tested with the donor's serum (minor crossmatch) by a method that will so demonstrate.

(e) Procedures to expedite transfusion in life-threatening emergencies. Records of all such incidents shall be maintained, including complete documentation justifying the emergency action, which shall be signed by a physician.

Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.

What FDA inspectors cite under § 606.151

Form FDA 483 observations citing this section, fiscal years 2009–2026 (Biologics).

  • Procedures to maintain records of emergency transfusions 59
  • Procedures to expedite transfusions in emergencies 2
  • Crossmatching of donor/recipient cells 1
  • Method of collecting and identifying blood samples 1

FDA guidance that cites § 606.151

Amendment history

Federal Register documents that created or amended this section.