2019 Tennessee Code
Title 53 - Food, Drugs and Cosmetics
Chapter 11 - Narcotic Drugs and Drug Control
Part 3 - Regulations and Registration
§ 53-11-311. Use of buprenorphine products.
(a) Any product containing buprenorphine, whether with or without naloxone, may only be prescribed for a use recognized by the federal food and drug administration. This subsection (a) shall not apply to a person:
(1) Who has a documented diagnosis of opiate addiction as shown in their medical record;
(2) Who receives treatment from a provider practicing under 21 U.S.C. § 823(g)(2); and
(3) Who is counted against the total number of patients allowed to the provider as set forth in 21 U.S.C. § 823(g)(2).
(b)
(1) Any prescription for buprenorphine mono or for buprenorphine without use of naloxone for the treatment of substance use disorder shall only be permitted to a patient who is:
(A) Pregnant;
(B) A nursing mother;
(C) Has a documented history of an adverse reaction or hypersensitivity to naloxone; or
(D) Directly administered the buprenorphine mono or buprenorphine without use of naloxone by a healthcare provider, acting within the healthcare provider's scope of practice, for the treatment of substance use disorder pursuant to a medical order or prescription order from a physician licensed under title 63, chapter 6 or 9; provided, however, that this subdivision (b)(1)(D) does not permit buprenorphine mono or buprenorphine without use of naloxone to be dispensed to a patient in a manner that would permit it to be administered away from the premises on which it is dispensed.
(2) If the prescriber of buprenorphine mono or buprenorphine without use of naloxone for a patient under subdivision (b)(1)(A) or (b)(1)(B) is not the patient's obstetrical or gynecological provider, the prescriber shall consult with the patient's obstetrical or gynecological provider to the extent possible to determine whether the prescription is appropriate for the patient.
(c)
(1) Notwithstanding any other provision of this title, a physician licensed under title 63, chapter 6 or 9, is the only healthcare provider authorized to prescribe any buprenorphine product for any federal food and drug administration approved use in recovery or medication-assisted treatment.
(2) Healthcare providers not licensed pursuant to title 63, chapter 6 or 9 and who are otherwise permitted to prescribe Schedule II or III drugs under this title, are prohibited from prescribing any buprenorphine product for treatment of opioid dependence. However, the providers may participate in the assessment and management of patients with an opiate addiction.
(d)
(1) A prescriber who treats a patient with more than sixteen milligrams (16 mg) per day of buprenorphine or its therapeutic equivalent for more than thirty (30) consecutive days for treatment of opioid dependence shall clearly document in the patient's medical record why the patient needs the higher dosage amounts of buprenorphine. A prescriber who does not meet the requirements established in the manner described in subdivision (d)(2) and treats a patient with more than twenty milligrams (20 mg) per day of buprenorphine or its therapeutic equivalent for more than thirty (30) consecutive days for treatment of opioid dependence shall, to the extent possible, either consult with an addiction specialist meeting the requirements established in the manner described in subdivision (d)(2) or refer the patient to the addiction specialist for management of the patient's treatment plan. If a prescribing physician cannot make the required consultation or referral as outlined in this subsection (d), the reasons shall be set out in the medical record.
(2) The board of medical examiners and the board of osteopathic examination shall promulgate rules establishing the requirements for licensees to qualify as addiction specialists.
(e) This section shall not apply to perioperative surgery or ventilator sedation that is performed in a licensed healthcare facility set forth in § 68-11-201(3) or (26).
(f) When patients are admitted as inpatients of a hospital, or registered as outpatients of a hospital, prescribers may continue orders for these drug products as part of a medication reconciliation process to continue home medications as previously prescribed and without restrictions pertaining to the use of the product until the patient is discharged from the facility. However, prescriptions written upon discharge from the facility and intended to be filled by the patient at a retail pharmacy and consumed post-discharge shall follow the requirements of this section.
(g)
(1)
(A) Notwithstanding any other law, the dispensing of buprenorphine products is prohibited by any person or entity unless the dispensing is done by a nonresidential office-based opiate treatment facility, as defined in § 33-2-402, with approval from the department of mental health and substance abuse services, a nonresidential substitution-based treatment center for opiate addiction as defined in § 33-2-402, a pharmacy licensed under title 63, chapter 10, or a hospital licensed under title 33, or title 68, chapter 11. This subsection (g) does not apply to the administering of buprenorphine products as otherwise permitted by law.
(B) A pharmacy and a distributor, as defined in § 63-10-204, shall report to the department of health the quantities of buprenorphine that the pharmacy or distributor delivers to nonresidential office-based opiate treatment facilities in this state.
(2) The department of mental health and substance abuse services shall promulgate rules to establish requirements for approval of dispensing of buprenorphine products at a nonresidential office-based opiate treatment facility as defined in § 33-2-402. These rules shall include a requirement that a provider who dispenses buprenorphine products at a nonresidential office-based opiate treatment facility must report the fact that the provider dispenses buprenorphine products to the provider's licensing board, check the controlled substance database prior to dispensing, and enter the amounts dispensed into the controlled substance database, to the extent permitted by 42 CFR part 2.
