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OTC antacids

This article was originally published in The Tan Sheet

Executive Summary

In a notice of proposed rulemaking published in the Sept. 23 Federal Register, FDA proposed deleting the acid neutralizing capacity test for antacids that is currently contained in the OTC antacid final monograph, and replace it with the U.S. Pharmacopeia's procedures for determination of antacid acid neutralizing capacity. The revision is being proposed, the agency said, to align the monograph with the USP compendia and because the USP test "is appropriate" for determining acid neutralizing capacity. Comments on the proposal are being accepted until Nov. 22.





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