§ 226.80. Packaging and labeling.
164 words·~1 min read·
/us/cfr/t21/s§ 226.80·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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.