Licensees who prescribe buprenorphine and certain combination drugs such as Suboxone for the treatment of opioid addiction are required to register annually with the North Carolina Department of Health and Human Services. Licensees who are not currently registered are out of compliance with state law. Please take swift action to obtain a Controlled Substance Registration for "Office Based Treatment."
There is no fee at this time to register. Contact the DHHS Drug Control Unit at 919-733-1765 to request a registration application, or for more information regarding the registration requirement. The U.S. Drug Enforcement Agency has mailed letters to advise DEA-registered prescribers of their legal obligation to register with the state.
About buprenorphine and other synthetic opioids
Buprenorphine and Suboxone are drugs approved by the FDA and DEA for the treatment of opioid addiction. These drugs may be prescribed for this purpose by physicians who have completed specific training approved by Center for Substance Abuse Treatment (CSAT) and who have received special permission from the Drug Enforcement Administration (DEA) under the DATA 2000 Federal Legislation. Physicians approved under this section, known as DATA 2000 waiver physicians, are limited to 30 patients during the first year. After reapplying to CSAT for an increase, they may increase their patient load to 100 total patients in aggregate (regardless of the number of locations in which they practice).
Additional NC requirements
North Carolina Law (NC GS §90-101 (a1) also states that physicians must provide written documentation of a plan to engage or refer patients to qualified providers to receive counseling and case management as appropriate and must acknowledge the application of Federal confidentiality regulations under 42 CFR to patient information. DHHS Drug Control Inspectors will consult with applicants to achieve compliance with these provisions either through an onsite visit or a telephone consultation and desk review. Dispensers of buprenorphine must also follow other Federal and State regulations related to the ordering, storage, dispensing and record keeping of controlled substances.
