(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.
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