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Executive Summary

Rx TO-OTC SWITCH DRUGS MAY NOT USE ALTERNATIVE LABELINC LANGUAGE prior to issuance of a final monograph for such drugs, FDA said in a July 12 letter to Biocraft. "Present policy does not allow interim use of alternative language for those drugs previously sold by Rx only that are allowed. . .to be marketed OTC before a final monograph is issued (the so-called Rx-to-OTC -switch drugs)," FDA Drug Labeling Compliance Div. Director Rudolf Apodaca stated. "For those drugs, the exact wording of the proposed or tentative final monograph must be used until a final monograph is issued. At that point, alternative language will be allowed, assuming the 'exclusivity' proposal is implemented in the form it was proposed." Apodaca noted, however, that use of alternative language, in general, is not barred by present policy prior to issuance of a final monograph. FDA's comments were made in response to an April letter from Biocraft in which the firm asked if the agency's proposed exclusivity policy would be applicable to topical antibiotic ointments, such as Bacitracin ointment USP, topical steroid creams, such as hydrocortisone cream USP, 0.5% and topical antifungal ointments, such as tolnaftate cream USP, 1%. FDA's proposed flexibility policy for OTC label claims, published in the April 22 Federal Register, gives mfrs. three options for presenting labeling claims: (l) exact FDA terminology within a boxed area designated "approved uses," or a similar term; (2) a mfr.'s own synonymous alternative language in an unboxed area; or (3) a combination of boxed, approved terms and unboxed alternative language. Apodaca said the use of the box and the "approved uses" designation will not be allowed for any of the drugs cited in Biocraft's letter "until both the 'exclusivity' proposal and the relevant monographs are issued in final form." He explained that "a product cannot bear an 'approved uses' designation until the use has, in fact, been approved by the FDA, which will occur only when a final monograph is issued. Moreover, the boxed area/'approved uses' concept is only a proposal and may be modified before the final 'exclusivity' regulation is issued." Apodaca also commented on antacids, noting that they have a "special status." He said FDA "implemented the present exclusivity policy for antacids through notice and comment rulemaking. Therefore, until the April 22 [flexibility] proposal is implemented in final form, the present requirement that the specific wording of the monograph be used remains in effect."

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