DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 310 and 341

[Docket No. 95N-0205]

RIN 0905-AA06

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of proposed rulemaking.

SUMMARY: 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.

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Also....
Since publication of the final monograph for OTC bronchodilator drug products, the agency's views about OTC ephedrine-containing bronchodilator drug products have changed for several reasons: (1) A large-scale diversion of OTC ephedrine-containing drug products to illicit use in the manufacture of the controlled substances methamphetamine and methcathinone, (2) new information that ephedrine may be unsafe for OTC use and has the potential for causing harm as a result of misuse and abuse, due to widespread and easy availability as an OTC drug, and (3) the consensus of FDA's Pulmonary-Allergy Drugs Advisory Committee and the Nonprescription Drugs Advisory Committee (the Committee) on November 14, 1994, that the use of oral ephedrine drug products as an OTC bronchodilator to relieve the symptoms of asthma can no longer be justified when the drug's potential for illicit use and misuse is considered.