February 01, 2008


 Court overturns DEA's revocation of pharmacy's controlled substance registration

Posted Jan. 15, 2008

The U.S. Court of Appeals for the District of Columbia Circuit has vacated the Drug Enforcement Administration's revocation of Wedgewood Village Pharmacy's certificate of registration to dispense or compound controlled substances. The revocation had not affected the pharmacy's license or ability to compound other prescription drugs.

At press time, the DEA had 45 days after the Dec. 11 court ruling during which it could appeal the decision. A spokesperson for Wedgewood told JAVMA that at the end of that period, the company hopes to work with the agency to obtain a modification to its pharmacy license—to move to another location—and to resolve any lingering concerns related to its controlled substance registration.

Wedgewood has been challenging the DEA's decision since it was issued in April 2006 (see JAVMA, June 1, 2006). At the time, the DEA reported that the Swedesboro, N.J.-based pharmacy was operating beyond the scope of its registration as a retail pharmacy and was acting as a manufacturer and distributor of controlled substances and listed chemicals.

The appellate court ruling consolidated two petitions: Wedgewood's appeal of the DEA's decision and the DEA's denial of the company'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 ruling, authored by Circuit Judge Karen LeCraft Henderson, noted "we cannot help but conclude that the (DEA's Deputy Administrator) decision 'entirely failed to consider an important aspect of the problem,'" including whether animal medicine operates differently from human medicine.

"The court made clear its concern that the practice of veterinary medicine differs from the practice of human medicine," said George J. Malmberg, president of Wedgewood. "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. The 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 retail pharmacy, 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, the court remanded the case to the DEA "for further proceedings consistent with this opinion," saying that the DEA should address the scope of "constructive transfer" and should "clarify its interpretation of 'general office use,' 'order' and 'prescription.'" The court also noted that the administration should "explain how the difference, if any, between the practices of human and veterinary medicine might affect its analysis."