Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Proposed Amendment of Monograph for OTC Bronchodilator Drug Products

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The Food and Drug Administration (FDA) is proposing to amend the final monograph for over-the-counter (OTC) bronchodilator drug products to remove the ingredients ephedrine, ephedrine hydrochloride, ephedrine sulfate, and racephedrine hydrochloride and to classify these ingredients as not generally recognized as safe and effective for OTC use. This action is being taken in response to a request from the U.S. Department of Justice, Drug Enforcement Administration (DEA) to restrict OTC availability of ephedrine because of its illicit use as the primary precursor utilized in the synthesis of the controlled substances methamphetamine and methcathinone. This action is also based on new information that shows that the misuse and abuse of OTC ephedrine drug products has the potential for causing harm and on comments made by FDA's Pulmonary-Allergy Drugs Advisory Committee and the Nonprescription Drugs Advisory Committee on November 14, 1994. This proposal is part of the ongoing review of OTC drug products conducted by FDA.