OTC Drug Labeling Implementation Date Extended One Year To 2002
This article was originally published in The Rose Sheet
Executive Summary
FDA is extending the OTC drug labeling implementation date to May 2002 to allow time for the agency to develop "forthcoming guidances" regarding a number of outstanding concerns from trade organizations.
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OTC drug reg
CTFA requests additional one-year extension to FDA's OTC drug labeling reg in Sept. 18 letter to the agency. "More than one additional year is necessary to resolve all the issues related to this regulation in order to make compliance feasible and to permit sufficient time to comply," the trade group says. CHPA made a similar case in same-day comments (1"The Rose Sheet" Sept. 25, In Brief). FDA extended the labeling reg's 2001 deadline to May 16, 2002 in response to trade associations' October 1999 citizen petition requesting a two-year stay (2"The Rose Sheet" Feb. 14, p. 3). "The fact that almost one year has passed since filing of the CTFA and CHPA citizen petition with little progress strengthens this position," the association maintains
OTC drug reg
CTFA requests additional one-year extension to FDA's OTC drug labeling reg in Sept. 18 letter to the agency. "More than one additional year is necessary to resolve all the issues related to this regulation in order to make compliance feasible and to permit sufficient time to comply," the trade group says. CHPA made a similar case in same-day comments (1"The Rose Sheet" Sept. 25, In Brief). FDA extended the labeling reg's 2001 deadline to May 16, 2002 in response to trade associations' October 1999 citizen petition requesting a two-year stay (2"The Rose Sheet" Feb. 14, p. 3). "The fact that almost one year has passed since filing of the CTFA and CHPA citizen petition with little progress strengthens this position," the association maintains
OTC labeling reg
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)