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Executive Summary

ACCUPHARMA RETAIL PHARMACY WILL REGISTER AS A REPACKER following receipt of a reg letter from tioned the company's function as a mfr. In a July 27 letter to AccuPharma President John Kapoor, FDA noted that AccuPharma "functions as a source of parenteral medication for a related facility, known as AcuCare, Inc., and for several hospital pharmacies." The agency stated: "It is FDA's position that in this type of operation AccuPharma, Inc. is functioning as a mfr. . . and not as a retail pharmacy." FDA explained that AcuCare "receives the Rx from the physician or the patient and maintains the Rx files," while AccuPharma "fills an order received by phone from AcuCare, Inc., never sees the Rx, and maintains only records pertaining to their deliveries to AcuCare, Inc." The agency said "in this type of operation AcuCare, Inc., is functioning as the pharmacy and AccuPharma, Inc., as the mfr. of the drug." In addition, FDA said AccuPharma "also prepares admixtures for parenteral use in hospitals based on a purchase order received from the hospital pharmacy or purchasing department." FDA stated that "this type of operation is deemed to be outside the normal practice of pharmacy in that this is not regarded as the extemporaneous compounding and dispensing of a Rx drug based on an oral or written Rx of practitioners duly licensed to administer such drugs to patients under the care of such practitioner in the course of their professional practice." The hospital services group comprised of AcuCare and AccuPharma is a subsidiary of LyphoMed, which bought the group two years ago. LyphoMed President Kapoor told "The Pink Sheet" that AccuPharma met with FDA the week of July 8 at which time it agreed to register as a repacker. Because FDA regarded the Illinois based AccuPharma as a manufacturing facility, the drugs it produces were considered to be new drugs. AccuPharma's nitroglycerin 100 mg dextrose 5% in water, 250 ml "and other similarly prepared drug products manufactured on the basis of a hospital purchase order, are new drugs within the meaning of Section 201 (p) of the Act, and no approval of an application. . .is effective for such drugs, and no Notice of Claimed Investigational Exemption. . .is on file for such drugs," FDA stated in its reg letter. In addition, "said products are misbranded in that they were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered. . . nor were they included in a list." The letter to the Illinois pharmacy is the first such reg letter to be issued to a pharmacy by FDA. The agency reportedly is aware of similar practices by other pharmacies.

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