21 CFR § 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.