Ohio Laws

Requirements for Licensure and Operations of Medications for Opioid Use Disorder Treatment

Question:

Does the state regulate the operation of office-based opioid treatment (OBOT)?

Answer:
Yes
This answer is derived from 4 section of law
Citation:
  • citation 1: see full citation
    (1) Except as provided in division (B)(2) of this section, no person shall knowingly operate a facility, clinic, or other location where a prescriber provides office-based opioid treatment to more than thirty patients or that meets any other identifying criteria established in rules adopted under this section without holding a category III terminal distributor of dangerous drugs license with an office-based opioid treatment classification.(2) Division (B)(1) of this section does not apply to any of the following:(a) A hospital;(b) A facility for the treatment of opioid dependence or addiction that is operated by a hospital;(c) A physician practice owned or controlled, in whole or in part, by a hospital or by an entity that owns or controls, in whole or in part, one or more hospitals;(d) A facility that conducts only clinical research and uses controlled substances in studies approved by a hospital-based institutional review board or an institutional review board that is accredited by the association for the accreditation of human research protection programs, inc.;(e) A facility that holds a category III terminal distributor of dangerous drugs license in accordance with section 4729.54 of the Revised Code for the purpose of treating drug dependence or addiction as part of an opioid treatment program and is the subject of a current, valid certification from the substance abuse and mental health services administration of the United States department of health and human services pursuant to 42 C.F.R. 8.11;(f) A program or facility that holds a license or certification issued by the department of mental health and addiction services under Chapter 5119. of the Revised Code if the license or certification is approved by the state board of pharmacy;(g) A federally qualified health center or federally qualified health center look-alike, as defined in section 3701.047 of the Revised Code;(h) A state or local correctional facility, as defined in section 5163.45 of the Revised Code;(i) Any other facility specified in rules adopted under this section. see full law
  • citation 2: see full citation
    (7) “Office-based opioid treatment” or “OBOT” means medication-assisted treatment of opioid dependence or addiction utilizing controlled substances, in a private office or public sector clinic that is not otherwise regulated, by practitioners who are authorized to prescribe outpatient supplies of medications approved by the FDA for the treatment of opioid addiction or prevention of relapse. OBOT includes treatment with all controlled substance medications approved by the FDA for such treatment. OBOT does not include treatment that occurs in the following settings:(a) A state or local correctional facility, as defined in section 5163.45 of the Revised Code;(b) A hospital, as defined in section 3727.01 of the Revised Code;(c) A provider certified to provide residential and inpatient substance use disorder services, including withdrawal management, by the Ohio department of mental health and addiction services;(d) A provider certified to provide residential and inpatient substance use disorder services, including withdrawal management, by the Ohio department of mental health and addiction services;(e) A youth services facility, as defined in section 103.75 of the Revised Code. see full law
  • citation 3: see full citation
    (A) "Office-based opioid treatment" or "OBOT" means medication-assisted treatment, as that term is defined in this rule, in a private office or public sector clinic that is not otherwise regulated, by practitioners authorized to prescribe outpatient supplies of medications approved by the United States food and drug administration for the treatment of opioid addiction or dependence, prevention of relapse of opioid addiction or dependence, or both. OBOT includes treatment with all controlled substance medications approved by the United Stated food and drug administration for such treatment. OBOT does not include treatment that occurs in the following settings:(1) A state or local correctional facility, as defined in section 5163.45 of the Revised Code;(2) A hospital, as defined in section 3727.01 of the Revised Code;(3) A provider certified to provide residential and inpatient substance use disorder services, including withdrawal management, by the Ohio department of mental health and addiction services;(4) An opioid treatment program certified by SAMHSA and accredited by an independent SAMHSA-approved accrediting body; or(5) A youth services facility, as defined in section 103.75 of the Revised Code. see full law
  • citation 4: see full citation
    (A) "Office-based opioid treatment" or "OBOT" means medication-assisted treatment, as that term is defined in this rule, in a private office or public sector clinic that is not otherwise regulated, by practitioners authorized to prescribe outpatient supplies of medications approved by the United States food and drug administration for the treatment of opioid addiction or dependence, prevention of relapse of opioid addiction or dependence, or both. OBOT includes treatment with all controlled substance medications approved by the United States food and drug administration for such treatment. OBOT does not include treatment that occurs in the following settings:(1) A state or local correctional facility, as defined in section 5163.45 of the Revised Code;(2) A hospital, as defined in section 3727.01 of the Revised Code;(3) A provider certified to provide residential and inpatient substance use disorder services, including withdrawal management, by the Ohio department of mental health and addiction services;(4) An opioid treatment program certified by SAMHSA and accredited by an independent SAMHSA-approved accrediting body; or(5) A youth services facility, as defined in section 103.75 of the Revised Code. see full law