FDA Approves Buprenorphine for Office-based Opioid Addiction Treatment

The U.S. Food and Drug Administration announced approval of buprenorphine for use in treating opioid addiction in the physician's office on October 8, 2002. This new treatment modality, authorized by the Drug Addiction Treatment Act (DATA), allows qualified physicians to prescribe FDA approved Schedule III, IV, and V medications for office-based treatment of opioid-dependent patients. In order to assist physicians considering office-based treatment under the new law, the Federation of State Medical Boards has developed Model Guidelines for Opioid Addiction Treatment in the Medical Office in cooperation with Substance Abuse and Mental Health Services Administration, Center for Substance Abuse Treatment (SAMHSA/CSAT). The Federation's guidelines are available at www.fsmb.org under policy documents.

Treatment for opioid dependence has traditionally been provided in federally regulated opioid treatment programs with limited involvement by physicians not employed in such programs. In contrast, office-based treatment is a new model that allows individual physicians to treat opioid addiction in their practice and thus creates a new regulatory role for the state medical board.

DATA stipulates that qualified physicians must demonstrate required qualifications as defined in the law and be licensed in the state(s) where the physician practices, and hold an addiction-related certification from the American Board of Medical Specialties, the American Osteopathic Association or the American Society of Addiction Medicine. Physicians may also qualify if they receive at least eight (8) hours of training, provided by designated medical and specialty organizations, in the care of opioid-dependent patients. Additionally, the DATA requires that physicians have the capacity to refer patients for counseling and appropriate ancillary services. Each physician or practice is allowed to treat a maximum of 30 such patients simultaneously. Additional qualifications may be enacted by individual states.

In order to offer office-based opioid addiction treatment, physicians must apply for a waiver through SAMHSA. To obtain a waiver, the physician must submit written notification to SAMHSA of their intent to provide office-based treatment, certifying the physician's qualifications and listing his/her DEA registration number. SAMHSA will notify DEA whether a waiver is granted. Upon approval of the waiver, DEA will issue the qualifying physician an identification number. SAMHSA is required to act on a waiver application within 45 days. If a physician finds it necessary to prescribe or dispense approved drugs for maintenance or detoxification treatment for an individual patient in an emergency situation prior to approval of a waiver application, the physician must notify SAMHSA and the DEA of the physician's intent to provide such treatment.

Under DATA, physicians are specifically prohibited from delegating prescribing opioids for detoxification and/or maintenance treatment to non-physicians. Physicians are advised to consult DEA regulations, 21 CFR, Part 1300 to end, and the DEA Physicians Manual, guidelines, issued by the state medical board, and other applicable state regulations relating to issuance of controlled substance prescriptions.

If you have other questions, contact the South Carolina Board of Medical Examiners at (803) 896-4500, or SAMHSA/CSAT at (301) 443-7614, or https://www.samhsa.gov/about-us/who-we-are/offices-centers/csat