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Ephedrine OTC status should not be threatened by WHO controls -- NDMA, Whitehall.

This article was originally published in The Tan Sheet

Executive Summary

FDA ENDORSEMENT OF OTC EPHEDRINE AVAILABILITY IN WHO RESPONSE URGED by the Nonprescription Drug Manufacturers Association in April 17 comments to the agency. Addressing the World Health Organization's possible rescheduling or controlling of ephedrine under the U.N. Conventions on Psychotropic Substances, the association suggests FDA stress to WHO the proven safety and efficacy of ephedrine as an OTC treatment for mild asthma and the relief of hemorrhoidal swelling. FDA requested comments on the abuse potential, "medical usefulness" and trafficking of ephedrine and two prescription drug ingredients in a March 18 Federal Register notice ("The Tan Sheet" March 23, In Brief). The agency plans to use the comments in developing a response to WHO.
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