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CHPA Requests Two-Year Extension For OTC Labeling Final Rule

This article was originally published in The Tan Sheet

Executive Summary

A two-year extension of the implementation deadlines for FDA's final rule on over-the-counter drug labeling is requested by the Consumer Healthcare Products Association in a citizen petition submitted to the agency Oct. 1.

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OTC labeling reg extension

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)

OTC labeling reg extension

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)

OTC labeling reg extension

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)

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