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2021 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

Universal Citation: TN Code § 53-11-311 (2021)
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  1. 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).


    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:

      1. Pregnant;

      2. A nursing mother;

      3. Has a documented history of an adverse reaction or hypersensitivity to naloxone; or

      4. 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.


    1. Notwithstanding any other provision of this title, and except as otherwise provided in subdivision (c)(2), 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 the treatment of opioid use disorder unless the provider:

      1. Is licensed and has practiced as a family, adult, or psychiatric nurse practitioner or physician assistant in this state;

      2. Has had no limitations or conditions imposed on the provider's license by the provider's licensing authority within the previous three (3) years;

      3. Is employed by a community mental health center, as defined in § 33-1-101, or a federally qualified health center, as defined in § 63-10-601(a), that employs one (1) or more physicians and has adopted clinical protocols for medication-assisted treatment;

      4. Is employed at a facility at which healthcare providers are contracted and credentialed with TennCare and TennCare's managed care organizations to treat opioid use disorder with buprenorphine products for use in recovery or medication-assisted treatment;

      5. Is employed at a facility at which healthcare providers are accepting new TennCare enrollees or patients for treatment of opiate addiction;

      6. Is employed by a facility that requires patients to verify identification;

      7. Does not write any prescription for a buprenorphine product that exceeds a sixteen-milligram daily equivalent;

      8. Does not prescribe or dispense a mono product or buprenorphine without naloxone;

      9. Works under the supervision of a physician who holds an active federal Drug Addiction Treatment Act of 2000 (DATA 2000) waiver registration from the federal drug enforcement agency that authorizes the physician to prescribe buprenorphine products and is actively treating patients with buprenorphine products for recovery or medication-assisted treatment;

      10. Obtains a waiver registration pursuant to the federal Drug Addiction Treatment Act of 2000 (DATA 2000) from the federal drug enforcement agency that authorizes the provider to prescribe buprenorphine products under federal law;

      11. Prescribes buprenorphine products only to patients who are treated through the organization that employs the provider;

      12. Is supervised by or collaborates with a physician who is limited to the supervision of, or collaboration for, a maximum of four (4) licensed nurse practitioners or physician assistants;

      13. Is supervised by or collaborates with a physician who reviews one hundred percent (100%) of the charts of the patients being prescribed a buprenorphine product;

      14. Weighs the risk of relapse with the benefit of tapering down or off of buprenorphine when, similar to other disease states, tapering from the treatment medication is clinically appropriate and in agreement with the patient and tapering schedules and durations are patient specific. Providers shall initiate and lead a discussion regarding patient readiness to taper down or taper off treatment medications employed in the patient's treatment with each patient at any time upon the patient's request but no later than one (1) year after initiating treatment and then every six (6) months thereafter;

      15. Writes prescriptions that can only be dispensed by a licensed pharmacy to ensure entry into the controlled substance database; and

      16. Writes prescriptions of buprenorphine products to fifty (50) or fewer patients at any given time.


    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.

  5. 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).

  6. 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.



      1. 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.

      2. 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.


    1. Notwithstanding subsection (c), this subsection (h) controls the prescription of buprenorphine products by any healthcare provider licensed under title 63, chapter 7 or 19, who is employed by or contracted with a nonresidential office-based opiate treatment facility, as defined in § 33-2-402.

    2. A healthcare provider licensed under title 63, chapter 7 or 19, may prescribe a buprenorphine product, as approved by the federal food and drug administration for use in recovery or medication-assisted treatment if:

      1. The provider works in a nonresidential office-based opiate treatment facility, as defined in § 33-2-402, that is licensed by the department of mental health and substance abuse services and that does not have authority to dispense buprenorphine products;

      2. The provider practices under the direct supervision of a physician who is licensed under title 63, chapter 6 or chapter 9; holds an active Drug Addiction Treatment Act of 2000 (DATA 2000) waiver from the United States drug enforcement administration; and is actively treating patients with buprenorphine products for recovery or medication-assisted treatment at the same nonresidential office-based opiate treatment facility, as defined in § 33-2-402, as the provider;

      3. The facility and its healthcare providers are contracted and credentialed with TennCare and TennCare's managed care organizations to treat opioid use disorder with buprenorphine products for use in recovery or medication-assisted treatment;

      4. The facility or its healthcare providers are directly billing TennCare and TennCare's managed care organizations for the services provided within the facility;

      5. The facility or its healthcare providers are accepting new TennCare enrollees or patients for treatment of opiate addiction;

      6. The provider does not write any prescription for a buprenorphine product that exceeds a sixteen-milligram daily equivalent;

      7. Except as provided in subdivision (h)(2)(H), the provider does not prescribe or dispense a mono product or buprenorphine without naloxone;

      8. The provider uses injectable or implantable buprenorphine formulations in accordance with subdivision (b)(1)(D);

      9. The provider has practiced as a family, adult, or psychiatric nurse practitioner or physician assistant in this state;

      10. The provider obtains a waiver registration from the United States drug enforcement administration that authorizes the provider to prescribe buprenorphine products under federal law and regulations;

      11. The provider prescribes buprenorphine products only to patients who are treated through a nonresidential office-based opiate treatment facility, as defined in § 33-2-402, that employs or contracts with the provider;

      12. The provider writes prescriptions of buprenorphine products that can only be dispensed by a licensed pharmacy to ensure entry into the controlled substance monitoring database;

      13. The provider writes prescriptions of buprenorphine products to one hundred (100) or fewer patients at any given time;

      14. When providing direct supervision, the physician does not oversee more than two (2) providers licensed under title 63, chapter 7 or 19, at one (1) time during clinical operations; and

      15. The supervising physician ensures all rules of operation for a nonresidential office-based opiate treatment facility, as defined in § 33-2-402; the Tennessee Nonresidential Buprenorphine Treatment Guidelines as established by the department of mental health and substance abuse services and the department of health; and all other state laws, rules, and guidelines regarding use of buprenorphine products for medication assisted treatment are followed.
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