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

§ 606.120 Labeling, general requirements

Subpart G - Additional Labeling Standards for Blood and Blood Components Official text on eCFR Amendment history

(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.

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 § 606.120

Form FDA 483 observations citing this section, fiscal years 2012–2025 (Biologics).

Destruction of obsolete labels 4
Separation of labeling operations 3

FDA guidance that cites § 606.120

Amendment history

Federal Register documents that created or amended this section.

50 FR 35469 30 Aug 1985