Section 0940-05-36-.02 - DEFINITIONS(1) Definitions of general terms used in these rules can be found in Rule 0940-05-01.(2) Definitions specific to this chapter are as follows:(a) "Nonresidential office-based opiate treatment facility with dispensing authorization" or "Facility" or "OBOT Plus" is a service entity that includes, but is not limited to, standalone clinics, treatment resources, individual physical locations occupied as the professional practice of a prescriber or prescribers licensed pursuant to Title 63, or other entities prescribing and dispensing products containing buprenorphine, or products containing any other controlled substance designed to treat opioid use disorder by preventing symptoms of withdrawal to twenty-five percent (25%) or more of its patients or to one hundred fifty (150) or more patients. An association by contract, fee for service, business arrangement, or two or more unaffiliated authorized providers with a DATA 2000 waiver operating at the same physical location and who dispense products containing buprenorphine shall be considered an OBOT Plus. An OBOT Plus does not include any facility that meets the definition of a nonresidential substitution-based treatment center for opiate addiction.(b) "Authorized provider" means a healthcare provider authorized by the state or federal government who has authority to issue and dispense prescriptions for buprenorphine.(c) "Authorized caregiver" means any person who is given written authorization by the patient to act on the patient's behalf.(d) "Buprenorphine" means a semi-synthetic opioid partial agonist that activates the opioid receptors but not to the same degree as full agonists such as morphine and heroin, as well as any FDA-approved pharmaceutical product that contains buprenorphine.(e) "Care Team" means the group of healthcare professionals, social workers, and counselors who help manage the patient's detoxification and maintenance of abstinence from the patient's drug of choice.(f) "Central Registry" means an electronic system approved by the Department to register patients currently receiving treatment at an Opiate Treatment Program ("OTP") or OBOT Plus.(g) "Controlled substance(s)" means a drug, substance, or immediate precursor in Schedules I through VI as defined or listed in the Tennessee Drug Control Act, compiled in T.C.A., Title 39, Chapter 17, part 4.(h) "DATA 2000 waiver" means the registered authority given to a qualified health care professional by the U.S. Drug Enforcement Administration to prescribe FDA-approved narcotic medication for opioid detoxification or maintenance treatment pursuant to 21 U.S.C. § 823(g).(i) "DEA" means the United States Drug Enforcement Agency.(j) "Dispense" means preparing, packaging, compounding or labeling for delivery and actual delivery of a prescription drug, nonprescription drug or device in the course of professional practice to a patient or the patient's agent, to include a licensed health care practitioner or a health care facility providing services or treatment to the patient or patients, by or pursuant to the lawful order of a prescriber. This definition does not include administration, or supervised self-administration, as otherwise permitted by law.(k) ''Dispenser'' means an authorized provider who dispenses buprenorphine to an ultimate user.(l) "Dispensing area" refers to the actual physical location where dispensing occurs. It does not include any waiting or common areas.(m) "Drug" means a substance recognized by the official United States pharmacopeia or formulary intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or, a substance intended to alter the structure or function of the human body.(n) "Facility director" means the person designated by the Facility's governing body who is responsible for the operation of the Facility, for the Facility's overall compliance with federal, state and local laws and regulations regarding the operation of a non-residential office-based opiate treatment facility with dispensing authorization, and for all Facility employees including practitioners, agents, or other persons providing services at the Facility. Non-physician facility directors shall not supervise medical staff.(o) "FDA" means the United States Food and Drug Administration.(p) "Licensee" means a proprietorship, partnership, association, governmental agency, or corporation, that operates a facility or a service and has obtained a license under this part.(q) "Medication order" or "prescription order" means a prescription order for any prescription drug or device or related material issued by an authorized prescriber to authorized healthcare personnel in a practice site or facility.(r) "Office of Licensure" means the Tennessee Department of Mental Health and Substance Abuse Services Office of Licensure.(s) "Opiate" or "opioid" means a drug that contains opium, derivatives of opium, or any of several semi-synthetic or synthetic drugs with agonist activity at the opioid receptor(s).(t) "Patient" or "service recipient" means an individual receiving treatment for opiate use disorder at an OBOT Plus.(u) "Patient counseling" means communication, by an authorized provider, of information to the patient or authorized caregiver in order to improve therapeutic outcomes and ensure optimal care.(v) "Consultant Pharmacist" means a pharmacist with an active license in good standing from the Tennessee Board of Pharmacy that is employed or contracted by the OBOT Plus.(w) "Physical location" means real property on which is located a physical structure, whether or not that structure is attached to real property, containing one (1) or more units and includes an individual apartment, office, condominium, cooperative unit, mobile or manufactured home, or trailer, if used as a site for prescribing and/or dispensing products containing buprenorphine, or products containing any other controlled substance designed to treat opiate use disorder by preventing symptoms of withdrawal.(x) "Professional samples" means small quantities (less than a typical 30, 60, or 90-day supply) of medication provided to prescribers or authorized healthcare personnel to be administered to patients.(y) "State Opioid Treatment Authority" or "SOTA" means any individual person designated by the commissioner to exercise the responsibility and authority for governing the treatment of opioid addiction in accordance with all applicable state and federal regulations, and serves as a liaison with the appropriate federal agencies.(z) "TDMHSAS" or "Department" means the Tennessee Department of Mental Health and Substance Abuse Services.Tenn. Comp. R. & Regs. 0940-05-36-.02
Original rule filed August 29, 2003; effective December 29, 2003. Repeal filed July 21, 2004; effective November 26, 2004. New rules filed March 29, 2019; effective 6/27/2019.Authority: T.C.A. §§ 4-3-1601, 4-4-103, 4-5-202, 4-5-204, 33-1-302, 33-1-305, 33-1-309, 33-2-301, 33-2-302, 33-2-402, 33-2-403, 33-2-404, 33-2-407, and Chapter 978 of the Public Acts of 2018.