Role of Pharmacists in Compounding Upheld

Issue of the Case

Ten pharmacies where pharmacistsengage in the traditional pharmacyactivity of customizing medications forpatients by compounding finisheddosage forms filed an action in a USDistrict Court in Texas seeking adeclaratory judgment clarifying theFDA's authority, or lack thereof, to regulatetheir compounding activities. Adeclaratory judgment is a decision of acourt in a civil proceeding that clarifiesand declares the rights, duties, or obligationsof each party to the proceeding.Such a judgment is binding, but it doesnot necessarily order any action by oneor both parties. This preemptive legalprocedural move is typically pursuedwhen a party is threatened with a lawsuit,but the impending lawsuit is notyet filed; it is designed to get officialclarification of the applicable law fromthe relevant court.

Facts of the Case

The plaintiff pharmacies filed suit in2004, challenging the FDA's authority toregulate compounded medications andto conduct inspections of pharmaciesholding valid state pharmacy permits tooperate.

The pharmacies made a motion forsummary judgment (ie, a judgmentwithout a full trial). A judge may issuesuch a judgment regarding the merits ofthe entire case or on one or more specificissues in that case. The latter situationapplied here. The pharmacies askedthe judge to rule that, among otherthings, compounded medications arenot "new drugs" or "new animal drugs"under the Federal Food, Drug, andCosmetic (FD&C) Act, and the FDA doesnot have authority to declare compoundingof dosage forms for non-foodanimals to be illegal. The plaintiffs alsosought to limit the scope of FDA inspectionsof pharmacies.

The Court's Ruling

The court ruled that, if pharmacists areacting pursuant to a valid prescriptionand are performing their duties in a fashionconsistent with the state laws regulatingthe practice of the profession, thedosage forms they create are not to beconsidered "new drugs" under the FD&CAct. Moreover, if the patient is a speciesother than human, the newly fabricatedmedicinal dosage units are not "new animaldrugs" subject to FDA jurisdiction.

The Court's Reasoning

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

In the case of any factory, warehouse,establishment, or consultinglaboratory in which prescriptiondrugs, nonprescription drugs intendedfor human use, or restricteddevices are manufactured, processed,packed, or held, the inspectionshall extend to all things therein(including records, files, papers,processes, controls, and facilities)bearing on whether prescriptiondrugs, nonprescription drugs intendedfor human use, or restricteddevices which are adulterated ormisbranded within the meaning ofthis chapter, or which may not bemanufactured, introduced into interstatecommerce, or sold, or offeredfor sale by reason of any provision ofthis chapter, have been or are beingmanufactured, processed, packed,transported, or held in any suchplace, or otherwise bearing on violationof this chapter.

Someone reading that provision in thestatute, however, must then continue onto read 21 USC §374(a)(2), which providesan exception or exemption forpharmacies operated in compliance withstate laws:

(2) The provisions of the third sentenceof paragraph (1) (the provisionimmediately above) shall not applyto—

(A) pharmacies which maintainestablishments in conformance withany applicable local laws regulatingthe practice of pharmacy and medicineand which are regularly engagedin dispensing prescriptiondrugs or devices, upon prescriptionsof practitioners licensed to administersuch drugs or devices to patientsunder the care of such practitionersin the course of their professionalpractice, and which do not, eitherthrough a subsidiary or otherwise,manufacture, prepare, propagate,compound, or process drugs ordevices for sale other than in theregular course of their business ofdispensing or selling drugs or devicesat retail?

The judge also indicated that "if compoundeddrugs were required to undergothe new drug approval process, the resultwould be that patients needing individuallytailored prescriptions would not beable to receive the necessary medicationdue to the cost and time associated withobtaining approval."

He concluded that "it is in the bestinterest of public health to recognize anexemption for compounded drugs thatare created based on a prescription writtenfor an individual patient by a licensedpractitioner."

Dr. Fink is professor of pharmacylaw and policy at theUniversity of KentuckyCollege of Pharmacy,Lexington.