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Executive Summary

BAXTER HEALTHCARE ENJOINED FROM SELLING SIX REPACKAGED ANTIBIOTICS as a result of an April 26 decision by the Chicago Federal Court, the company said. The injunction applies to piperacillin, nafcillin, cefamandole, penicillin G, ticarcillin and tobramycin. The court decision enjoins Baxter and Glaxo Specialties "from preparing, repackaging, or distributing" 35 reconstituted antibiotic and chemotherapeutic products, equaling 17 different compounds, "pending trial." The court determined that the marketing of the products is in violation of the FD&C Act since they are considered "new drugs" without approved marketing applications. The U.S. Attorney for the Northern District of Illinois filed a complaint and a request for injunction against Baxter on April 26, 1988 with regard to the products ("The Pink Sheet" May 2, 1988, T&G-11). Baxter stated that only six of its products are affected by the decision, since it suspended its chemotherapeutic repackaging program for hospitals about one year ago ("The Pink Sheet" March 14, 1988, T&G-9). The firm said that it continues to sell one anticancer product, doxorubicin, to doctors, and that this distribution is not at issue since it is regulated at the state level. The court filing cites eight other anticancer drugs: mitomycin, bleomycin, vinblastine, cyclophosphamide, cisplatin, fluorouracil, vincristine, and methotrexate. Baxter added that the decision does not apply to two antibiotics, cefuroxime (Glaxo's Zinacef) and ceftazidime (Glaxo's Fortaz), since they were removed from the repackaging program following NDA approvals allowing manufacture of the compounds from their bulk forms. Baxter's Travenol Regional Compounding Centers (TRCs) either reconstitute or dilute the antibiotics and chemotherapeutic products into single-dosage units or consolidate the compounds into larger pooling bags. The products are then relabeled. Baxter and FDA have been disputing the regulatory status of the repackaged products for several years. While FDA views the products as new drugs, Baxter contends that they are not new drugs, since the compounds and the packaging have independently been approved by FDA. Baxter also argues that it is only providing a service that hospitals and physicians would otherwise have to perform. "Because this court owes deference in considering the FDA's application procedures, the court must reject Baxter's argument the FDA approved the TRC operations when it approved the active ingredients used by the TRCs," the decision states. The court concluded that "Baxter has not received certification of its antibiotic TRC products," and that "the chemotherapeutic TRC products . . . are new drugs" and "have not received FDA approval." The injunction was slated to go into effect 10 days after the April 26 decision, according to Baxter. However, FDA and Baxter are negotiating the effective date. Baxter also has asked the court for an extension of the effective date in order to alert its hospital customers of the situation. While the company is disputing FDA's interpretation of the products' regulatory status, Baxter noted that it may pursue NDA approval for the products in the repackaging program. FDA's first legal action against Baxter was the seizure of 15 repackaged antibiotics and chemotherapeutics from the TRC in Morton Grove, Illinois on May 27, 1987 ("The Pink Sheet" June 1, 1987, T&G-6). The 15 products seized include all those mentioned in the recent decision, except Fortaz and Zinacef. Glaxo has an agreement with Baxter, under which Fortaz and Zinacef would be repackaged and sold to hospitals.

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