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In Brief: OTC monograph program

This article was originally published in The Tan Sheet

Executive Summary

OTC monograph program: Based on FDA's semi-annual regulatory agenda, monograph documents closest to publication include: a proposed amendment to the monograph on weight control products; a proposed amendment to the internal analgesics monograph on an alcohol warning; and final action on the use of phenolphthalein in OTC laxatives. Documents targeted for early 1998 release include a proposal on OTC adverse reactions reporting, final action on the poison ivy indication in the skin protectant monograph and final action on the use of sodium phosphates in laxatives, as well as a final amendment to the laxatives monograph on phosphates labeling. The agency lists July 1998 as the target date for release of a final rule on standardized OTC labeling and estimates a proposal revising the agency's requirements for internal analgesic label indications will be issued in October 1998. The regulatory agenda, published in the Oct. 29 Federal Register, is required four times a year, but the timetables are often only guess-timates...
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