I got a non-answer answer from the DEA ODLP:
You asked if a DEA registrant could prescribe buprenorphine products, approved by the Food and Drug Administration for the treatment of Opioid Use Disorder, for the off-label use of treating pain. You also asked if this prescriber would first need to obtain a Unique Identification Number (UIN), as required under the Drug Addiction Treatment Act of 2000, before taking such action.
The Controlled Substances Act and its implementing regulations do not prohibit the prescribing and dispensing of buprenorphine (suboxone) products for the treatment of pain. They do however require that a controlled substance be prescribed for a legitimate medical purpose by a DEA registered individual practitioner acting in the usual course of his or her professional practice, as noted in Title 21, Code of Federal Regulations, Section 1306.04(a). The specific prescribing or dispensing of buprenorphine for the treatment of pain is an off-label use of this product, and it is the Food and Drug Administration that regulates the off-label use of pharmaceuticals.
The Unique Identification Number (X number) is certification that the qualified practitioner has meet the training and other requirements necessary to be allowed to issue prescriptions for opioid addiction treatment. The Unique Identification Number is not related to prescribing for pain management
Buprenorphine is a Schedule III controlled substance. 21 C.F.R. § 1308.13(e)(2)(i). As with all controlled substances, buprenorphine may only be prescribed, administered, or dispensed for a legitimate medical purpose by a DEA-registered practitioner acting in the usual course of professional practice and otherwise in accordance with the Controlled Substances Act (CSA) and DEA regulations. The general registration requirement applicable to all practitioners (registration under 21 U.S.C. § 823(f)) applies to a practitioner who dispenses buprenorphine for the legitimate treatment of pain in the usual course of professional practice. No additional DEA registration is required for such purpose.
While the DEA is the agency responsible for administering the Controlled Substances Act, it is the State medical boards, which collectively regulate the practice of medicine. Furthermore,
it is the FDA that regulates the off label use of pharmaceuticals. DEA’s role under the CSA is to ensure that controlled substances are prescribed, administered, and dispensed only for legitimate medical purpose by DEA registered practitioners acting in the usual course of professional practice and otherwise in accordance with the CSA and DEA regulations. Also, DEA does not define and regulate the practice of Medicine and again it is the state medical boards who oversee this provision. The DEA does not dictate to practitioners what to prescribe, how often, what doses and what quantities, again these are handled by the State Boards of Medicine.
You can refer your question to your state board of Medicine and the off-label use question to the FDA at,
www.fda.gov
As a general matter, it has been DEA’s longstanding policy not to provide legal advice to private parties. At the same time, DEA recognizes the importance of working with regulated entities to help guide them toward compliance with the law and regulations.
