Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use; final monograph for combination drug products. Final rule.Fed Regist. 2002 Dec 23; 67(246):78158-72.FR
The Food and Drug Administration (FDA) is issuing a final rule in the form of a final monograph that establishes conditions under which over-the-counter (OTC) cold, cough, allergy, bronchodilator, and antiasthmatic (cough-cold) combination drug products are generally recognized as safe and effective and not misbranded as part of its ongoing review of OTC drug products. FDA is issuing this final rule after considering public comments on the agency's proposed regulation (tentative final monograph) and new data and information on OTC cough- cold combination drug products that have come to the agency's attention.