User Fees Could Chafe Cosmetics In OTC Monograph Reform Proposal

Products marketed for cosmetic use but formulated with drugs are regulated as topical drugs and would be subject to potential OTC user fees, although the products have little similarity with oral or nasal delivery nonprescription drugs also available under FDA's monograph system, consultant David Steinberg says.

Personal care and cosmetic product manufacturers should take note that legislation on reforming FDA's OTC drug monograph program with a user fee program might regain momentum, says regulatory consultant David Steinberg.

Steinberg, president of Plainsboro, N.J.-based Steinberg & Associates Inc., a consultancy specializing in the OTC drug and personal care industries,...

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