§ 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.