21 C.F.R. § 226.80 Packaging and labeling.
(a) Packaging and labeling operations shall be adequately controlled:
(1) To assure that only those Type A medicated article(s) that have met the specifications established in the master-formula records shall be distributed.
(2) To prevent mixups during the packaging and labeling operations.
(3) To assure that correct labeling is employed for each Type A medicated article(s).
(4) To identify Type A medicated article(s) with lot or control numbers that permit determination of the history of the manufacture and control of the batch of Type A medicated article(s).
(b) Packaging and labeling operations shall provide:
(1) For storage of labeling in a manner to avoid mixups.
(2) For careful checking of labeling for identity and conformity to the labeling specified in the batch-production records.
(3) For adequate control of the quantities of labeling issued for use with the Type A medicated article(s).
(c) Type A medicated article(s) shall be distributed in suitable containers to insure the safety, identity, strength, and quality of the finished product.