OTC labeling reg
This article was originally published in The Rose Sheet
Executive Summary
Additional extensions beyond the May 16, 2002 compliance deadline may be necessary "to compensate for agency inaction on several important issues related to the OTC labeling rule," CHPA maintains. The association's Sept. 18 letter responds to FDA's decision to grant a one-year partial extension to the rule (1"The Rose Sheet" Feb. 14, p. 3). CHPA "welcomes the additional time," but says it "may not be enough due to a lack of clear direction in several areas," including issues related to small packages and convenience-size products, the agency's failure to release a final guidance on columns and a draft guidance on exemption petitions, and FDA's handling, "in at least one circumstance," of confidential information included in exemption petitions. Block Drug recently challenged FDA's approach to confidentiality during the agency's review and subsequent denial of a Block exemption request (2"The Rose Sheet" Sept. 11, In Brief)