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In Brief: Antacid monograph amendment

This article was originally published in The Tan Sheet

Executive Summary

Antacid monograph amendment: FDA deletes parts of the monograph's testing procedures, including the acid neutralizing capacity test, in a Feb. 8 Federal Register notice. The deleted sections are being replaced with reference to the U.S. Pharmacopeia National Formulary, which has been updated. The "test modification" section is being retained, the notice states, in case manufacturers need to petition for a proposed modification. This action finalizes a Sept. 23, 1993 proposed rule made in an effort to align the monograph with USP recommendations ("The Tan Sheet" Sept. 27, 1993)...
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