OTC Label Exemption Procedure Clarification Urged By CTFA
This article was originally published in The Rose Sheet
Executive Summary
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.
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OTC labeling
Block Drug awaits FDA ruling on labeling exemption request for BC analgesic powder after Aug. 22 submission of information previously regarded confidential. Block initially requested an exemption in August 1999. According to the firm, FDA told Block it had ruled on the matter but would not file its decision in the docket unless the confidential information was either removed or opened to public record. "Consequently, in order to move the process forward and receive FDA's response...Block has decided to waive confidentiality," the company says. The petition, filed by Hyman, Phelps & McNamara (D.C.), suggests FDA's actions mark a change in attitude toward confidentiality. Agency statements on the issue have varied, ranging from an Aug. 9, 1999 letter to CTFA stating some exemption request sections may be made public to assurances at a November feedback meeting that handling of exemption requests would be in keeping with Freedom of Information Act standards. CTFA has encouraged FDA to allow certain information to remain confidential (1"The Rose Sheet" Dec. 20, 1999, p. 7)
OTC labeling
Block Drug awaits FDA ruling on labeling exemption request for BC analgesic powder after Aug. 22 submission of information previously regarded confidential. Block initially requested an exemption in August 1999. According to the firm, FDA told Block it had ruled on the matter but would not file its decision in the docket unless the confidential information was either removed or opened to public record. "Consequently, in order to move the process forward and receive FDA's response...Block has decided to waive confidentiality," the company says. The petition, filed by Hyman, Phelps & McNamara (D.C.), suggests FDA's actions mark a change in attitude toward confidentiality. Agency statements on the issue have varied, ranging from an Aug. 9, 1999 letter to CTFA stating some exemption request sections may be made public to assurances at a November feedback meeting that handling of exemption requests would be in keeping with Freedom of Information Act standards. CTFA has encouraged FDA to allow certain information to remain confidential (1"The Rose Sheet" Dec. 20, 1999, p. 7)
OTC Inactive Ingredient Labeling Exemption Requested - Citizen Petition
An across-the-board inactive ingredient variance on labeling for OTC drug products with differing ingredients from multiple suppliers is requested in a citizen petition filed with FDA May 16. A slightly revised petition followed on May 23.