C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER F—BIOLOGICS › PART 606—CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS › Subpart G—Additional Labeling Standards for Blood and Blood Components

21 C.F.R. § 606.120

Labeling, general requirements

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(a) Labeling operations shall be separated physically or spatially from other operations in a manner adequate to prevent mixups.

(b) The labeling operation shall include the following labeling controls:

(1) Labels shall be held upon receipt, pending review and proofing against an approved final copy, to ensure accuracy regarding identity, content, and conformity with the approved copy.

(2) Each type of label representing different products shall be stored and maintained in a manner to prevent mixups, and stocks of obsolete labels shall be destroyed.

(3) All necessary checks in labeling procedures shall be utilized to prevent errors in translating test results to container labels.

(c) All labeling shall be clear and legible.

[50 FR 35469, Aug. 30, 1985]
Notes of Decisions
Cited in 2 cases, 1983–2007 · leading case: Sykes v. Glaxo-SmithKline, 484 F. Supp. 2d 289 (E.D. Pa. 2007).
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Sykes v. Glaxo-SmithKline, 484 F. Supp. 2d 289 (E.D. Pa. 2007). “§ 262(b); 21 C.F.R. §§ 606.120 -.122, 610.60-65; 21 C.”
Belle Bonfils Mem'l Blood Bank v. Hansen, 665 P.2d 118 (Colo. 1983). “The ratio of hepatitis cases resulting from transfusions of commercial blood to those resulting from transfusions of volunteer blood has been estimated to be at least ten to one.”
Annotations are extracted automatically from the opinions in the Syfert caselaw corpus and ranked by authority, recency, and treatment. Dots show Syfertize treatment of the citing case itself.