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Sodium phosphate enema warning may be reconsidered by FDA after feedback meeting.

This article was originally published in The Tan Sheet

Executive Summary

SODIUM PHOSPHATE ENEMA FINAL RULE WARNING RECONSIDERATION by FDA may be possible, the agency indicated at a July 15 "feedback" meeting on the agency's final rule that covers warnings and directions for OTC sodium phosphate laxative products. The meeting was held in response to comments submitted by C.B. Fleet and the private label firm Nutramax that the wording of the warning in the May 21 final rule differs materially from the proposed rule and was changed without allowing public comment ("The Tan Sheet" July 6, p. 6). C.B. Fleet and Nutramax attended the meeting, as did representatives of the Nonprescription Drug Manufacturers Association. Lynchburg, Va.-based C.B. Fleet manufactures Fleet Phospho-Soda Oral Saline Laxative, Fleet Ready-to-Use Enema and Fleet Enema for Children.

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