(Swedesboro NJ, May 25, 2010) Wedgewood Pharmacy and the United States Department of Justice, Drug Enforcement Administration (DEA) have agreed to settle an eight-year dispute over the interpretation of certain DEA regulations that had prevented the company from receiving, storing and dispensing controlled substances since a 2003 move to a new pharmacy location. Over the course of that dispute there was a 2006 attempt by DEA to revoke the company’s DEA registration. That attempt was rebuffed and vacated in 2007 by the United States Court of Appeals for the D.C. Circuit. This settlement now restores the company’s ability to dispense controlled substances pursuant to its DEA registration.
Complying with the terms of the agreement will require Wedgewood to make changes to its systems and procedures and, as a result, it will not begin immediately to dispense controlled substances.
The complete text of the agreement is available here:
George J. Malmberg, R.Ph., F.A.C.A., F.A.C.V.P., the president and CEO of Wedgewood Pharmacy noted, “This agreement not only restores our registration but also confirms that Wedgewood has always conducted itself respectfully and in good faith in advancing its position throughout this dispute.”
The dispute centered on the DEA’s and Wedgewood Pharmacy’s different interpretations of whether or not the Controlled Substances Act allows compounding pharmacies to dispense controlled substances directly to veterinarians for administration to their patients.
The DEA argued that, by dispensing a controlled substance to a veterinarian rather than to the ultimate patient’s owner, a pharmacy is “distributing,” rather than “dispensing” and thus may undermine existing controls to avoid the illicit diversion of controlled substances. Wedgewood’s position, supported by a Federal Appeals court in 2007, has been that this definition fails to recognize the difference between the practices of animal medicine and human medicine and that delivering controlled substances to the animal owner may make it more likely that controlled substances will fall into the wrong hands. The agreement acknowledges that the parties’ “competing positions … have been held respectfully and in good faith.”
Malmberg added, “While we continue to disagree with the DEA, as a practical matter our disagreement has deprived our customers’ of access to controlled substances through us for more than eight years. So to avoid further inconvenience to our customers and the uncertainty and costs of continued litigation, we have agreed to put the dispute behind us and to act according to the DEA’s interpretation.”
Under the terms of the agreement, Wedgewood Pharmacy has agreed to dispense controlled substances under the DEA’s interpretation of the law, that is, directly to a human patient or to an animal’s owner. For its part, the DEA said that the agreement “signal[s] its intention to enforce” its interpretation no differently with “any similarly-situated compounding pharmacy” and that “Wedgewood shall not be restricted from transferring controlled substances in any greater or different degree than are comparably-situated registrants … .”
The agreement allows Wedgewood to benefit from any new legislative or regulatory rules or court decisions that would be in its favor and does not restrict the company “from pursuing efforts to alter DEA’s interpretation through lawful channels … .”
About Wedgewood Pharmacy
Established in 1980, Wedgewood Pharmacy is one of the largest compounding pharmacies in the United States, providing more than 25,000 prescribers with compounds for their human and veterinary patients. It is located in Swedesboro NJ and licensed throughout the United States.
Background: About Compounding Pharmacy
A compounding pharmacy creates customized medications for individual patients in response to a licensed practitioner’s prescription. Because every patient is different and has different needs, customized, compounded medications are a vital part of quality medical care.
Through this relationship, patient needs are determined by a doctor, who chooses a treatment regimen that may include a compounded medication. Physicians and veterinarians often prescribe compounded medications for reasons that include (but are not limited to) the following situations:
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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 -
When medications require flavor additives to make them more palatable for some patients, most often children and pets