Issue of the Case

Ten pharmacies where pharmacists engage in the traditional pharmacy activity of customizing medications for patients by compounding finished dosage forms filed an action in a US District Court in Texas seeking a declaratory judgment clarifying the FDA's authority, or lack thereof, to regulate their compounding activities. A declaratory judgment is a decision of a court in a civil proceeding that clarifies and declares the rights, duties, or obligations of each party to the proceeding. Such a judgment is binding, but it does not necessarily order any action by one or both parties. This preemptive legal procedural move is typically pursued when a party is threatened with a lawsuit, but the impending lawsuit is not yet filed; it is designed to get official clarification of the applicable law from the relevant court.

Facts of the Case

The plaintiff pharmacies filed suit in 2004, challenging the FDA's authority to regulate compounded medications and to conduct inspections of pharmacies holding valid state pharmacy permits to operate.

The pharmacies made a motion for summary judgment (ie, a judgment without a full trial). A judge may issue such a judgment regarding the merits of the entire case or on one or more specific issues in that case. The latter situation applied here. The pharmacies asked the judge to rule that, among other things, compounded medications are not "new drugs" or "new animal drugs" under the Federal Food, Drug, and Cosmetic (FD&C) Act, and the FDA does not have authority to declare compounding of dosage forms for non-food animals to be illegal. The plaintiffs also sought to limit the scope of FDA inspections of pharmacies.

The Court's Ruling

The court ruled that, if pharmacists are acting pursuant to a valid prescription and are performing their duties in a fashion consistent with the state laws regulating the practice of the profession, the dosage forms they create are not to be considered "new drugs" under the FD&C Act. Moreover, if the patient is a species other than human, the newly fabricated medicinal dosage units are not "new animal drugs" subject to FDA jurisdiction.

The Court's Reasoning

The judge in the case acknowledged that the FDA is authorized to conduct inspections under the FD&C Act [21 USC §374(a)(1)(B)]:

In the case of any factory, warehouse, establishment, or consulting laboratory in which prescription drugs, nonprescription drugs intended for human use, or restricted devices are manufactured, processed, packed, or held, the inspection shall extend to all things therein (including records, files, papers, processes, controls, and facilities) bearing on whether prescription drugs, nonprescription drugs intended for human use, or restricted devices which are adulterated or misbranded within the meaning of this chapter, or which may not be manufactured, introduced into interstate commerce, or sold, or offered for sale by reason of any provision of this chapter, have been or are being manufactured, processed, packed, transported, or held in any such place, or otherwise bearing on violation of this chapter.

Someone reading that provision in the statute, however, must then continue on to read 21 USC §374(a)(2), which provides an exception or exemption for pharmacies operated in compliance with state laws:

(2) The provisions of the third sentence of paragraph (1) (the provision immediately above) shall not apply to—

(A) pharmacies which maintain establishments in conformance with any applicable local laws regulating the practice of pharmacy and medicine and which are regularly engaged in dispensing prescription drugs or devices, upon prescriptions of practitioners licensed to administer such drugs or devices to patients under the care of such practitioners in the course of their professional practice, and which do not, either through a subsidiary or otherwise, manufacture, prepare, propagate, compound, or process drugs or devices for sale other than in the regular course of their business of dispensing or selling drugs or devices at retail?

The judge also indicated that "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 due to the cost and time associated with obtaining approval."

He concluded that "it is in the best interest of public health to recognize an exemption for compounded drugs that are created based on a prescription written for an individual patient by a licensed practitioner."

Dr. Fink is professor of pharmacy law and policy at the University of Kentucky College of Pharmacy, Lexington.