Office Based Opioid Treatment (OBOT)

OBOT Registration and Renewal Process 

Under North Carolina General Statute §90-101(a1), any individual physician who independently prescribes or dispenses Buprenorphine for the treatment of opiate dependence in an office-based setting must annually register with the Department of Health and Human Services, in accordance with rules adopted by the Commission for Mental Health, Developmental Disabilities and Substance Abuse Services. An individual practitioner applying for Office Based Opioid Treatment (OBOT) registration for the first time must complete the OBOT Application for Registration (Form DHHS 224-E).  An individual practitioner who is renewing his/her OBOT registration must complete the OBOT Application for Renewal (Form DHHS 226-E). There is no application fee. 

Office Based Opioid Treatment registration is required only for individual practitioners who are prescribing and/or dispensing Buprenorphine for the treatment of opioid use disorder, in accordance with the Drug Addiction Treatment Act of 2000 (DATA 2000). For more information about DATA 2000 see the Substance Abuse and Mental Health Services Administration’s Buprenorphine Waiver Management webpage. 

The registration process is as follows:

  • For new applicants who will only prescribe Buprenorphine - Upon review of your application and receipt of all required information, a NC DHHS controlled substances registration certificate will be issued. The registration will be emailed unless otherwise instructed by the applicant. If a submitted application is incomplete and additional information is required, the assigned Drug Control Unit inspector will contact the applicant with the specific requests and work with the applicant to complete the application.
  • For new applicants who will prescribe Buprenorphine and only administer extended-release injectable Buprenorphine formulations (e.g., Sublocade) - Upon review of your application and receipt of any additional information that may be required, a NC DHHS controlled substances registration certificate will be issued. The registration will be emailed unless otherwise instructed by the applicant. An on-site inspection is not required as a prerequisite for registration. The on-site inspection will be scheduled to be conducted within 90 days of issuing the registration. Requirements for recordkeeping and storage are available through DEAdiversion.usdoj.gov at the following links (respectively):
    1. §1304.22 - Records for manufacturers, distributors, dispensers, researchers, importers, exporters, registrants that reverse distribute, and collectors.
    2. §1301.75 - Physical security controls for practitioners.

    A registrant must be in compliance with applicable Federal and State requirements in order to maintain a NC DHHS controlled substances registration. A Drug Control Unit inspector can assist each registrant with compliance during the application and on-site inspection process.

  • For new applicants who will prescribe and dispense Buprenorphine - Following review of your application, an on-site inspection will be scheduled by the assigned Drug Control Unit inspector to ensure Federal and State requirements regarding the storage, dispensing and/or administering controlled substances are met. Requirements for recordkeeping and storage are available through DEAdiversion.usdoj.gov at the following links (respectively):
    1. §1304.22 - Records for manufacturers, distributors, dispensers, researchers, importers, exporters, registrants that reverse distribute, and collectors.
    2. §1301.75 - Physical security controls for practitioners.

    The applicant must be in compliance with requirements before a NC DHHS controlled substances registration certificate will be issued.  A Drug Control Unit inspector can assist each applicant with compliance during the application and on-site inspection process.

NOTE: A copy of your current DEA registration is required to be submitted along with your registration application.

  • For all registrants completing renewal applications - If no changes have occurred and no additional information is required, a NC DHHS controlled substances registration will be issued by email unless otherwise instructed by the registrant. If there are no changes or issues from the preceding year, on-site inspections for dispensing and/or administering Buprenorphine are not required for renewals,.

Please e-mail an electronic version of your application form with electronic signature to NCCSAREG@DHHS.NC.GOV.

NOTE: NC DHHS controlled substances registrations are not transferrable in the event of a change of location or type of business activity involving controlled substances. A new registration is required in those instances.

Links to applications are listed below:

The NC Drug Control Unit can be contacted at 919-733-1765 or NCCSAREG@DHHS.NC.GOV

OBOT – Registration FAQs 

Per North Carolina General Statute §90-101(a1), any individual physician practicing independently in an office-based setting and planning to prescribe or dispense Buprenorphine to treat patients suffering from an opioid use disorder must first register with the North Carolina Department of Health and Human Services Drug Control Unit. Below are some frequently asked questions and answers to assist you in the registration process.

  • Q: How do I register with the NC DHHS Drug Control Unit as an Office Based Opioid Treatment practitioner?
  • Q: How often am I required to register?
    • Your registrations must be renewed annually for as long as you continue to independently prescribe or dispense Buprenorphine to treat patients suffering from an opioid use disorder in an office-based setting. Registration expiration dates are based on the county in which you are registered. Please note the expiration date on your registration certificate.
  • Q: I only prescribe Buprenorphine, I do not dispense Buprenorphine to my patients nor do I directly administer it to my patients. Am I still required to register?
    • Yes. If you are a practitioner who prescribes Buprenorphine to treat patients suffering from an opioid use disorder in an office-based setting, you are required under North Carolina law to register with the Drug Control Unit.
  • Q: I work at more than one office. Am I required to register for each office where I work?
    • If you are only prescribing Buprenorphine, then no, you are not required to maintain a separate registration for each office location where you work. You are only required to maintain a single registration associated with the primary location where you prescribe Buprenorphine.

      However, if you are dispensing or administering Buprenorphine, then yes, you must maintain a separate registration for each office location where you physically store Buprenorphine, whether it is your own stock or you are storing ultimate user medications that were prescribed, filled, and then delivered to your office.

  • Q: How much is the annual registration fee?
    • Zero! There is no charge for a practitioner applying for or renewing an NC DHHS Office Based Opioid Treatment registration.
  • Q: If multiple office-based opioid treatment physicians work in the same office, can they apply collectively for registration as a group?
    • No. Each physician is required under North Carolina law to register as an individual to prescribe or dispense Buprenorphine to treat patients suffering from an opioid use disorder in an office-based setting.