BTC CLASS OF DRUGS UNDER STUDY AT FDA

Pharmacy Times, Volume 0, 0

A new class of drugs—sandwichedbetween prescription and OTC medicationsand available only from pharmacists—is under active considerationby top FDA regulators. Word of theFDA's interest in the proposed new"behind-the-counter"(BTC) class ofdrugs surfaced during an address byFDA Pharmacy Affairs Director IlisaB.G. Bernstein, PharmD, JD, at theAmerican Pharmacists Association's(APhA) Annual Meeting in Atlanta, Ga.

Although critics of a new third classof drugs contend that limiting thesemedicines to sale in pharmacies wouldrestrict consumer access to medication,FDA officials insist that their BTCplan would have just the oppositeeffect. According to Dr. Bernstein, thegoal of the plan is to increase patientaccess to certain medicines thatwould otherwise require a prescription.

APhA—a longtime advocate of apharmacist-only third class of drugs—welcomed the FDA's interest in theplan and predicted that patients wouldbenefit from the change.

A number of other countries alreadyhave a pharmacist-only third class ofdrugs, but creating such a system inthe United States would require actionby Congress as well as the FDA.

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