The U.S. Court of Appeals for the Third Circuit ruled in September that the Food and Drug Administration has the authority to inspect pharmacies. The ruling was announced during a recent case involving the FDA's inspection of Wedgewood Village Pharmacy, a pharmacy based in Swedesboro, N.J., that specializes in drug compounding from bulk substances for human and animal patients.
States regulate the practice of drug compounding as part of their regulation of pharmacies, the court stated, and the FDA was content to allow the states to regulate drug compounding for 50 years after the enactment of the federal Food, Drug and Cosmetic Act. The FDA eventually became concerned that some pharmacies were manufacturing and selling drugs under the false appearance of compounding and, in turn, were avoiding the FDCA's regulation of new drugs. In response, the FDA released the Compliance Policy Guide in 1992, which allowed the agency to initiate enforcement actions when a pharmacy's activities raised concerns normally associated with manufacturers. Since the CPG's revision in 2003, the FDA has aggressively enforced drug compounding laws, and several suits involving pharmacies were filed in the past few years (see JAVMA, July 1, 2005, page 9).
On March 10, 2003, the FDA applied for a warrant to inspect Wedgewood. In the warrant, the FDA stated that it sought access to Wedgewood's production and distribution records "to determine the extent to which (Wedgewood's) activities are consistent with those of a drug manufacturer rather than a retail pharmacy, and to evaluate the extent of violations of the (FDCA), including the new drug and new animal drug approval requirements, and the act's adulteration provisions."
Although the FDCA provided pharmacies with a limited exemption from intrusive inspection, the FDA argued that Wedgewood did not qualify for the exemption because the pharmacy did not operate strictly as a retail business. The warrant was approved and later served March 12, 2003. Several days later, Wedgewood filed a motion to annul the warrant. The pharmacy claimed that state-licensed pharmacies were exempt from FDA inspection, and that the agency had acted in bad faith by obtaining the warrant because it didn't have probable cause to search the pharmacy.
The U.S. District Court for the District of New Jersey concluded that Wedgewood was not exempt from inspection, and the ruling was subsequently affirmed by the court of appeals.
For the full court file, log on to the Third Judicial Circuit's Web site at www.ca3.uscourts.gov/opinarch/041175p.pdf.