Learn About The Law
Get help with your legal needs
FindLaw’s Learn About the Law features thousands of informational articles to help you understand your options. And if you’re ready to hire an attorney, find one in your area who can help.
Current as of January 02, 2025 | Updated by Findlaw Staff
(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.
Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.226.80 Packaging and labeling - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-226-80/
FindLaw Codes may not reflect the most recent version of the law in your jurisdiction. Please verify the status of the code you are researching with the state legislature before relying on it for your legal needs.
A free source of state and federal court opinions, state laws, and the United States Code. For more information about the legal concepts addressed by these cases and statutes, visit FindLaw’s Learn About the Law.
Get help with your legal needs
FindLaw’s Learn About the Law features thousands of informational articles to help you understand your options. And if you’re ready to hire an attorney, find one in your area who can help.
Search our directory by legal issue
Enter information in one or both fields (Required)