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

Résumé

The Food and Drug Administration (FDA) is extending to September 27, 1995, the period for comments for the notice of proposed rulemaking to amend the monograph for over-the-counter (OTC) bronchodilator drug products that was published in the Federal Register of July 27, 1995. That document proposed to remove the ingredients ephedrine, ephedrine hydrochloride, ephedrine sulfate, and racephedrine hydrochloride from the final monograph for OTC bronchodilator drug products and to classify these ingredients as not generally recognized as safe and effective for OTC use. FDA is taking this action in response to several requests to extend the period for comments to allow interested persons adequate time to assess and respond to the proposal.