A proposed rule on fixed-combination OTC products derived from natural sources, including animal and botanical raw materials, could be issued by FDA as early as July, according to the agency's "unified agenda" published in the Federal Register April 24.

The proposal would expand upon provisions in the FD&C Act, which outline the conditions under which two or more active ingredients may be combined in a single OTC dosage form.

A proposed reg requiring adverse drug reaction reporting by OTC manufacturers is tentatively slated for September. Indicative of semi-annual agenda dates that often are only rough estimates, the OTC adverse event reporting proposed rule has been pushed back from prior agenda forecasts.

On the OTC monograph front, FDA expects to finalize in June a vasoconstrictor pupil dilation warning for the ophthalmic products monograph.

Final action on an amendment to the final monograph for topical OTC antifungals also is slated for June. The agency is proposing the word "most" be inserted into the allowable indications for antifungal treatments. A notice of proposed rulemaking related to clotrimazole is slated for August. Lotrimin marketer Schering-Plough has been seeking addition of the ingredient into the monograph since late 1996.

August also is the targeted date for final action on a proposed amendment to the topical otic drugs monograph to include "ear drying aid" products with the active ingredient 95% isopropyl alcohol in a 5% anhydrous glycerin base.

Final action on the poison ivy/skin protectant monograph is targeted for October, as is final action on FDA's "material time, material extent" proposed rule for marketing of new OTC conditions.

Final action amending the antitussive products monograph to expand flammability warnings and publication of a final reg on cough/cold bronchodilator products containing ephedrine are slated for October.

The agency projects September publication of a proposed rule on dietary supplement GMPs. FDA published an industry-drafted set of GMP standards in February 1997 and last year sponsored three public forums to solicit comments from small businesses.

Fixed-Combination OTCs Derived From Botanicals Due For Rulemaking

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