Rep. Markey Letter To Department of Justice to Investigate New England Compounding Center, and to Probe into DEA’s Past Oversight of Pharmaceutical Compounding

On October 22, 2012, the FDA Blog has a post written by By Karla L. Palmer & Larry K. Houck, which addresses Representative Markey's Letter to the Department of Justice as it relates to the DEA.  The blog post provides in part:

The letter notes that almost 1,000 specific formulations of recalled NECC drug products contain controlled substances such as cocaine, morphine, hydromorphone, meperidine, sufentanil, fentanyl and ketamine. (All of these substances are schedule II substances except for ketamine, which is a schedule III substance).

The letter further states that Drug Enforcement Administration (“DEA”) regulations require that “retail pharmacies that compound or sell controlled substances” must be registered with the DEA as retail pharmacies. DEA-registered compounding pharmacies can only sell directly to patients (specifically, the “end user” of the product) compounded pharmaceuticals that contain controlled substances pursuant to a patient-specific prescription from a DEA-registered practitioner. If the pharmacy compounds controlled substances and distributes the formulations to other DEA registrants, it must also be registered with DEA as a manufacturer. Citing to a letter from John Partridge, then-Chief of DEA’s Liaison and Policy Section, dated June 19, 2012, yet not citing to any statute, regulation or DEA guidance document (likely because there is none), Congressman Markey reiterates DEA’s “position” that “compounding a controlled substance other than pursuant to a valid patient-specific prescription or medical order, is manufacturing.” According to a conversation between Markey’s congressional staff and DEA on October 16, 2012, DEA stated that NECC is not registered with DEA as a manufacturer. (Manufacturing, in addition to requiring DEA registration as a manufacturer, also subjects the manufacturer to DEA quota, ARCOS reporting, labeling/packaging and DEA-222 official order form requirements.).

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