21 CFR § 606.120 - Labeling, general requirements.
(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.
(c) All labeling shall be clear and legible.