Small package exemptions
This article was originally published in The Rose Sheet
Executive Summary
NDMA requests a small package exemption for all OTC products, as well as cosmetic-drugs, housed in small containers in March 19 comments to FDA. In addition, the Nonprescription Drug Manufacturers Association suggests that adding certain modifications to the OTC drug labeling rule would reduce the number of exemptions needed. Specifically, the trade association suggests the use of 5-point type, elimination of leading, the use of any sans serif font and the ability to put warnings on more than one information panel. The NDMA proposal is consistent with recommendations previously submitted to FDA by CTFA in response to FDA's plan to revise OTC and cosmetic- drug labeling ("The Rose Sheet" March 3, 21, 1997, pp. 11-13)...