§226.80. Packaging and labeling.
21 C.F.R. § 226.80
Packaging and labeling operations shall be adequately controlled:
To assure that only those Type A medicated article(s) that have met the specifications established in the master-formula records shall be distributed.
To prevent mixups during the packaging and labeling operations.
To assure that correct labeling is employed for each Type A medicated article(s).
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).
Packaging and labeling operations shall provide:
For storage of labeling in a manner to avoid mixups.
For careful checking of labeling for identity and conformity to the labeling specified in the batch-production records.
For adequate control of the quantities of labeling issued for use with the Type A medicated article(s).
Type A medicated article(s) shall be distributed in suitable containers to insure the safety, identity, strength, and quality of the finished product.
Notes, amendments, and revision history
Authority
Authority: 21 U.S.C. 351, 352, 360b, 371, 374.
Source
Source: 40 FR 14031, Mar. 27, 1975, unless otherwise noted.