21 CFR §226.80

1. (a)Packaging and labeling operations shall be adequately controlled:
   1. (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. (2)To prevent mixups during the packaging and labeling operations.
   3. (3)To assure that correct labeling is employed for each Type A medicated article(s).
   4. (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).
2. (b)Packaging and labeling operations shall provide:
   1. (1)For storage of labeling in a manner to avoid mixups.
   2. (2)For careful checking of labeling for identity and conformity to the labeling specified in the batch-production records.
   3. (3)For adequate control of the quantities of labeling issued for use with the Type A medicated article(s).
3. (c)Type A medicated article(s) shall be distributed in suitable containers to insure the safety, identity, strength, and quality of the finished product.