OTC NASAL DECONGESTANT FINAL MONOGRAPH IS DUE OUT IN JUNE 1989

OTC NASAL DECONGESTANT FINAL MONOGRAPH IS DUE OUT IN JUNE 1989, according to FDA's agenda for pending regulations, published in the April 24 Federal Register. The decongestant monograph, published as a proposed rule in January 1985, is one of the last three remaining documents in the cough/cold rulemaking; final rules are still pending for antitussives and cough/cold combinations. Final monographs are also anticipated in June for skin protectants and aphrodisiacs. Other OTC rulemakings expected during the year include: the proposed rule for topical antifungals, in June; revisions to the antiseptic first aid and antiseptic professional use monographs, in September; and amendments to the proposed rulemakings for external analgesics and skin protectants relating to poison ivy, in June. FDA has set a target date in June for its proposed regulations implementing Title I of the Waxman/Hatch Patent Term Restoration Act. The regs were signed off by FDA Commissioner Young in March and sent directly to the Office of Management and Budget, bypassing review by HHS ("The Pink Sheet" March 20, p. 4). The long awaited orphan drug regs are also planned for a summer release, with a July publication date for the proposed rule designated in the regulatory agenda. Among the other anticipated regs are proposed rules specifying any needed changes to the existing Good Manufacturing Practice (GMP) standards for finished pharmaceuticals and blood/blood components, scheduled for November, and the proposed rule for biological product adverse reporting requirements, scheduled for September.