OTC Labeling Final Rule Two-Year Extension Requested By CTFA
This article was originally published in The Rose Sheet
Executive Summary
A stay of implementation of the OTC labeling final rule would allow industry and FDA to address outstanding issues, the Cosmetic, Toiletry and Fragrance Association says in an Oct. 22 citizen petition.
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OTC labeling reg
FDA expects to respond to CTFA's request for a two-year extension of the OTC labeling final rule implementation date by Jan. 28, the agency states in a recent letter to the trade group. FDA asks CTFA to allow it to complete the request and refrain from soliciting further meetings on the subject. The agency met with CTFA staff Jan. 4 and Jan. 11 to discuss various issues in the group's petition. "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." CTFA requested the extension Oct. 22 (1"The Rose Sheet" Nov. 1, 1999, p. 7)
OTC labeling reg
FDA expects to respond to CTFA's request for a two-year extension of the OTC labeling final rule implementation date by Jan. 28, the agency states in a recent letter to the trade group. FDA asks CTFA to allow it to complete the request and refrain from soliciting further meetings on the subject. The agency met with CTFA staff Jan. 4 and Jan. 11 to discuss various issues in the group's petition. "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." CTFA requested the extension Oct. 22 (1"The Rose Sheet" Nov. 1, 1999, p. 7)
OTC Label Exemption Procedure Clarification Urged By CTFA
FDA should establish a well-defined process for manufacturers filing for exemptions under the OTC labeling final rule, the Cosmetic, Toiletry and Fragrance Association maintains in comments filed with FDA's Division of OTC Drugs Dec. 13.