OTC labeling reg extension

Executive Summary

FDA expects to respond to industry requests for a two-year extension of the OTC labeling final rule implementation date by Jan. 28, the agency states in recent letters to CHPA and CTFA. In the letters, FDA asks the trade groups to let it complete the request and refrain from soliciting further meetings on the subject. The agency met with CHPA and CTFA Jan. 4 and Jan. 11. "Because the primary implementation date for the rule is still more than 16 months away," FDA says, "we believe a two-week period to allow for completion of our response is reasonable." The trade associations requested the extension in October (1"The Tan Sheet" Oct. 11, 1999, p. 6)