Court files order in pharmacies' case against FDA

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Following an initial ruling from the bench in May, U.S. District Court Judge Robert Junell filed a court order Aug. 30 that addressed a handful of issues related to compounding drugs.

The case—Medical Center Pharmacy, et al. v. Gonzalez, et al. in the U.S. District Court for the Western District of Texas, Midland-Odessa Division—was filed in September 2004 by 10 state-licensed pharmacies against the Food and Drug Administration.

In the court order, Judge Junell ruled that compounded drugs, when created for an individual patient following a prescription from a licensed practitioner, are implicitly exempt from the "new drugs" definitions in the Federal Food, Drug and Cosmetic Act. Drugs that are compounded in large quantities before a prescription is received from a practitioner do not fall within the exemption.

If compounded drugs were required to undergo the new drug approval process, the result would be that patients needing individually tailored prescriptions would not be able to receive the necessary medication as a result of the cost and time associated with obtaining approval, according to the court order.

Next, the court ruled that if pharmacies are compliant with local laws, dispense drugs following the receipt of prescriptions from licensed practitioners, and compound drugs in the regular course of their individualized businesses, the pharmacies are exempt from the FDA's enhanced inspection. An enhanced inspection allows the FDA to access not just the pharmacies' records, but any files, papers, processes, controls, or facilities if the pharmacies were engaged in certain designated activities. The court ruled that the FDA had not demonstrated that any of the 10 pharmacies involved in the case did not qualify for exemption.

Also of note, the court ruled that pharmacies may compound drugs for non-food-producing animals from legal bulk ingredients. Drugs compounded from legal bulk ingredients do not violate the FFDCA's provisions on unsafe, adulterated, or misbranded drugs. However, if pharmacies use illegal bulk ingredients, they lose the protection afforded by the FFDCA and are subject to enforcement actions.

The court order drew distinction between pharmacists and veterinarians compounding from bulk ingredients for non-food-producing animals. Veterinarians were not afforded the same protection under the FFDCA that was given to compliant compounding pharmacies.

When asked about the court order, FDA spokesperson Susan Cruzan commented that the administration will consider all options, including seeking an appeal.

At press time, the AVMA was researching how the court order would affect veterinarians, including clarifying the interpretation of legal versus illegal bulk ingredients for non-food-producing animals.