/publications/issue/2007/2007-05/2007-05-6480

BTC CLASS OF DRUGS UNDER STUDY AT FDA

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A new class of drugs—sandwiched between prescription and OTC medications and available only from pharmacists—is under active consideration by top FDA regulators. Word of the FDA's interest in the proposed new "behind-the-counter"(BTC) class of drugs surfaced during an address by FDA Pharmacy Affairs Director Ilisa B.G. Bernstein, PharmD, JD, at the American Pharmacists Association's (APhA) Annual Meeting in Atlanta, Ga.

Although critics of a new third class of drugs contend that limiting these medicines to sale in pharmacies would restrict consumer access to medication, FDA officials insist that their BTC plan would have just the opposite effect. According to Dr. Bernstein, the goal of the plan is to increase patient access to certain medicines that would otherwise require a prescription.

APhA—a longtime advocate of a pharmacist-only third class of drugs—welcomed the FDA's interest in the plan and predicted that patients would benefit from the change.

A number of other countries already have a pharmacist-only third class of drugs, but creating such a system in the United States would require action by Congress as well as the FDA.

For a related article, visit ePharmacy Times at www.pharmacytimes.com/article Newsletter.cfm?ID=4511.