FDA Final Rule Amends Human & Vet Drug Labeling Requirements

March 20, 2012 by Brian Feito|FDA and EPA

The Food and Drug Administration has issued a final rule amending the packaging and labeling control provisions of the current good manufacturing practice (CGMP) regulations for human and veterinary drug products. The final rule amends 21 CFR Part 211 by limiting the application of special control procedures for the use of cut labeling to immediate container labels, individual unit cartons, or multiunit cartons containing immediate containers that are not packaged in individual unit cartons.

FDA is also permitting the use of any automated technique, including differentiation by labeling size and shape, that physically prevents incorrect labeling from being processed by labeling and packaging equipment when cut labeling is used. The final rule is effective March 20, 2013, except for the provision permitting any automated technique to physically prevent incorrect labeling, which is effective April 19, 2012.

FDA Contact - Brian Hasselbalch (301) 796-3279, email brian.hasselbalch@fda.hhs.gov

(FR Pub 03/20/12)