Wedgewood Pharmacy: U.S. Court of Appeals vacates DEA action

(Swedesboro NJ, December 12, 2007) Yesterday, the U.S. Court of Appeals for the District of Columbia Circuit vacated the Drug Enforcement Administration’s (DEA) 2006 revocation of Wedgewood Pharmacy’s registration to dispense controlled substances. Wedgewood has been challenging the DEA’s decision since it first was issued.

The ruling consolidated two petitions: the company’s appeal of the DEA’s decision and the DEA’s denial of Wedgewood’s petition for reconsideration. The court explained that it does not set-aside Federal agency rulings “unless the interpretation is arbitrary, capricious, or manifestly contrary to the statute . . . [and] if the agency . . . entirely failed to consider an important aspect of the problem, offered an explanation for its decision that runs counter to the evidence before the agency, or is so implausible that it could not be ascribed to a difference in view or the product of agency expertise.” The unanimous ruling, authored by Circuit Judge Karen LeCraft Henderson, noted “we cannot help but conclude that the DA’s [DEA’s Deputy Administrator] decision ‘entirely failed to consider an important aspect of the problem,’” that is, “whether animal medicine operates differently from human medicine.”

George J. Malmberg, R.Ph., F.A.C.A, F.A.C.V.P., the pharmacist president and CEO of Wedgewood Pharmacy, noted: “The Court made clear its concern that the practice of veterinary medicine differs from the practice of human medicine. We believe that the current standard of practice in our profession, which is to dispense controlled substances to veterinarians rather than to horse owners or stable personnel, is consistent with the law’s intention to prevent the improper use of controlled substances. We look forward to having our registration restored by the DEA, though the timing of that will depend upon the agency’s response to this ruling.”

The DEA objected to Wedgewood’s practice of preparing compounded controlled-substances and then delivering the medications to veterinarians and physicians instead of directly to their patients. DEA viewed these practices as “manufacturing” and “distributing” controlled substances as defined by the Controlled Substances Act. Under Wedgewood’s then DEA-registration as a “practitioner,” however, it was authorized only to “compound” and “dispense” controlled substances. Wedgewood argued that “dispensing” includes constructive delivery to an animal patient through a licensed veterinarian.

In vacating the revocation of Wedgewood’s registration to dispense controlled substances, the court remanded the case to the DEA “for further proceedings consistent with this order,” saying that the “DEA should clarify its interpretation of ‘general office use,’ ‘order’ and ‘prescription’” and that the agency should “explain how the difference, if any, between the practices of human and veterinary medicine might affect its analysis.”

Malmberg added, “This ruling tells us that we were correct in making arguments that the DEA rejected or ignored. We welcome the opportunity that this ruling now creates to arrive at a clear, sound understanding that works for all concerned. We want nothing more than to work cooperatively with DEA to resolve any issues it may still have with the current state of compounding- pharmacy practice in the veterinary profession.”

The court decision is available at http://pacer.cadc.uscourts.gov/docs/common/opinions/200712/06-1156a.pdf.

A compounding pharmacy creates customized medications for individual patients in response to a licensed practitioner’s prescription. Wedgewood Pharmacy is one of the largest compounding pharmacies in the United States, serving more than 25,000 prescribers of compounded medications. It is located in Swedesboro NJ and licensed throughout the United States.

Because every patient is different and has different needs, customized, compounded medications are a vital part of quality medical care. The basis of the profession of pharmacy has always been the "triad," the patient-prescriber-pharmacist relationship.

Through this relationship, patient needs are determined by a prescriber, who chooses a treatment regimen that may include a compounded medication. Prescribers often prescribe compounded medications for reasons that include (but are not limited to) the following situations:

• When needed medications are discontinued by or generally unavailable from pharmaceutical companies, often because the medications are no longer profitable to manufacture;
• When the patient is allergic to certain preservatives, dyes or binders in available off-the shelf medications;
• When treatment requires tailored dosage strengths for patients with unique needs (for example, an infant);
• When a pharmacist can combine several medications the patient is taking to increase compliance;
• When the patient cannot ingest the medication in its commercially available form and a pharmacist can prepare the medication in cream, liquid or other form that the patient can easily take; and
• When medications require flavor additives to make them more palatable for some patients.

For additional information, visit the International Academy of Compounding Pharmacists’ Web site at www.iacprx.org and www.compoundingfacts.org.