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"INTERCHANGEABLE" TERMS FOR OTC DRUG MONOGRAPHS ARE SOLICITED BY FDA

This article was originally published in The Tan Sheet

Executive Summary

"INTERCHANGEABLE" TERMS FOR OTC DRUG MONOGRAPHS ARE SOLICITED BY FDA in an April 5 Federal Register notice. Acknowledging that certain "terms included in various OTC drug monographs may be used interchangeably," FDA said it is calling for "comments and suggestions as to such" terms. The terms "should be general in nature and appear in more than one OTC drug monograph," the agency suggested. After considering the suggestions it receives, FDA said it will issue another notice listing appropriate interchangeable terms. FDA is proposing to amend general OTC labeling to allow for the interchangeable use of "doctor" and "physician" in OTC drug monographs. The agency explained that it has included in a number of tentative final monographs and final monographs a provision that the words "doctor" and "physician" can be used interchangeably in the labeling of products covered by those monographs. "Instead of including this provision in each OTC drug monograph," the agency is proposing to include this clause in its general labeling policy "as part of the general conditions under which an OTC drug is generally recognized as safe, effective and not misbranded," the notice states. Other terms FDA believes can be used interchangeably are "consult" and "ask." Although 'consult' appears in the directions for many OTC drug monograph ingredients," the agency said it "believes the simpler term 'ask' could be used in its place" because it is "shorter and may be better understood by consumers." For example, the phrases "consult a physician," "consult a doctor," "ask a doctor," "ask a physician" would all be interchangeable, FDA suggested. FDA noted that if the proposal becomes a final rule, "the labeling options could be implemented at very little cost by manufacturers at the next printing of labels, for those products which the manufacturer chooses to make a change." Comments on the proposed rule are being accepted until June 5.
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