Tenn. Code Ann. § 53-11-311 — TN Code / Title 53 / Chapter 11 / Section 53-11-311
Use of buprenorphine products
Status: in_force

(a) A 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) does not apply to a person who has a documented diagnosis of opiate addiction as shown in the person's medical record. (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, 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: (A) Is licensed and has practiced as a family, adult, or psychiatric nurse practitioner or physician assistant in this state; (B) Has had no limitations or conditions imposed on the provider's license by the provider's licensing authority within the previous three (3) years; (C) 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; (D) Is employed at a facility that is a contracted buprenorphine enhanced medication assisted recovery and treatment (BESMART) program, or a successor program, provider 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; (E) Is employed at a facility at which healthcare providers are accepting new TennCare enrollees or patients for treatment of opiate addiction; (F) Is employed by a facility that requires patients to verify identification; (G) Does not write any prescription for a buprenorphine product that exceeds a sixteen-milligram daily equivalent; (H) Does not prescribe or dispense a mono product or buprenorphine without naloxone, except to a pregnant woman or to a patient with a documented history of an adverse reaction or hypersensitivity to naloxone; (I) [Deleted by 2024 amendment.] (J) [Deleted by 2024 amendment.] (K) Prescribes buprenorphine products only to patients who are treated through the organization that employs the provider; (L) Is supervised by or collaborates with a physician who is limited to the supervision of, or collaboration for, a maximum of five (5) licensed nurse practitioners or physician assistants; (M) 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; (N) 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; (O) Writes prescriptions that can only be dispensed by a licensed pharmacy to ensure entry into the controlled substance database; and (P) Writes prescriptions of buprenorphine products to one hundred (100) or fewer patients at any given time. (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. (h) (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: (A) 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; (B) The provider practices under the direct supervision of a physician who is licensed under title 63, chapter 6 or chapter 9 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; (C) 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; (D) The facility or its healthcare providers are directly billing TennCare and TennCare's managed care organizations for the services provided within the facility; (E) The facility or its healthcare providers are accepting new TennCare enrollees or patients for treatment of opiate addiction; (F) The provider does not write any prescription for a buprenorphine product that exceeds a sixteen-milligram daily equivalent; (G) Except as provided in subdivision (h)(2)(H), the provider does not prescribe or dispense a mono product or buprenorphine without naloxone; (H) The provider uses injectable or implantable buprenorphine formulations in accordance with subdivision (b)(1)(D); (I) The provider has practiced as a family, adult, or psychiatric nurse practitioner or physician assistant in this state; (J) [Deleted by 2024 amendment.] (K) 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; (L) 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; (M) The provider writes prescriptions of buprenorphine products to one hundred (100) or fewer patients at any given time; provided, that such limit is two hundred fifty (250) or fewer patients if the provider practices in a nonresidential office-based opiate treatment facility, as defined in § 33-2-402 , that is accredited by a nationally or internationally recognized accrediting body, including the commission on the accreditation of rehabilitation facilities (CARF) or the joint commission; (N) 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; provided, that if the physician practices in a nonresidential office-based opiate treatment facility, as defined in § 33-2-402 , that is accredited by a nationally or internationally recognized accrediting body such as the commission on the accreditation of rehabilitation facilities (CARF) or the joint commission, the physician may oversee no more than five (5) providers licensed under title 63, chapter 7 or 19, and at no time may the physician oversee the treatment of more than five hundred (500) patients under this subdivision (h)(2)(N) at any one (1) time during clinical operations; and (O) 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. (i) (1) Notwithstanding 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 a buprenorphine product for a 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 a buprenorphine product for the treatment of opioid use disorder unless the provider: (A) Is licensed and has practiced as a family, adult, or psychiatric nurse practitioner or physician assistant in this state; (B) Has had no limitations or conditions imposed on the provider's license by the provider's licensing authority within the previous three (3) years; (C) Is employed by a hospital, as defined in § 68-11-201 , that operates with an agreement to train providers from a public or private medical school within this state, or an affiliated clinic operated under the hospital's license, that employs one (1) or more physicians and has adopted clinical protocols for medication-assisted treatment; (D) 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; (E) Is employed at a facility at which healthcare providers are accepting new TennCare enrollees or patients for treatment of opiate addiction; (F) Is employed by a facility that requires patients to verify identification; (G) Does not write a prescription for a buprenorphine product that exceeds a sixteen-milligram daily equivalent; (H) Does not prescribe or dispense a mono product or buprenorphine without naloxone; (I) Works under the supervision of a physician who is actively treating patients with buprenorphine products for recovery or medication-assisted treatment; (J) Prescribes buprenorphine products only to patients who are treated through the organization that employs the provider; (K) Is supervised by or collaborates with a physician who is limited to the supervision of, or collaboration with, a maximum of four (4) licensed nurse practitioners or physician assistants; (L) 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; (M) 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; (N) Initiates and leads 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; (O) Writes prescriptions that can only be dispensed by a licensed pharmacy; and (P) Writes prescriptions of buprenorphine products to fifty (50) or fewer patients at any given time. (3) The health facilities commission may inspect facilities for compliance with this subsection (i) pursuant to § 68-11-210 and shall report any violations of this subsection (i) to the appropriate licensing authority of the provider licensed under title 63. Amended by 2024 Tenn. Acts, ch. 857,s 1, eff. 5/1/2024. Amended by 2024 Tenn. Acts, ch. 980,s 2, eff. 5/21/2024. Amended by 2024 Tenn. Acts, ch. 980,s 1, eff. 5/21/2024. Amended by 2024 Tenn. Acts, ch. 808,s 6, eff. 7/1/2024. Amended by 2024 Tenn. Acts, ch. 808,s 5, eff. 7/1/2024. Amended by 2024 Tenn. Acts, ch. 808,s 4, eff. 7/1/2024. Amended by 2024 Tenn. Acts, ch. 808,s 3, eff. 7/1/2024. Amended by 2024 Tenn. Acts, ch. 808,s 2, eff. 7/1/2024. Amended by 2024 Tenn. Acts, ch. 575,s 5, eff. 3/15/2024. Amended by 2024 Tenn. Acts, ch. 575,s 4, eff. 3/15/2024. Amended by 2024 Tenn. Acts, ch. 575,s 3, eff. 3/15/2024. Amended by 2024 Tenn. Acts, ch. 575,s 2, eff. 3/15/2024. Amended by 2024 Tenn. Acts, ch. 575,s 1, eff. 3/15/2024. Amended by 2020 Tenn. Acts, ch. 771, s 1, eff. 8/1/2020. Amended by 2020 Tenn. Acts, ch. 761, s 1, eff. 7/1/2020. Amended by 2018 Tenn. Acts, ch. 978, s 7, eff. 7/1/2018. Amended by 2018 Tenn. Acts, ch. 674, s 1, eff. 4/12/2018. Added by 2015 Tenn. Acts, ch. 396, s 3, eff. 7/1/2015.
(a) A 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) does not apply to a person who has a documented diagnosis of opiate addiction as shown in the person's medical record.
(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.
(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.
(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, 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: (A) Is licensed and has practiced as a family, adult, or psychiatric nurse practitioner or physician assistant in this state; (B) Has had no limitations or conditions imposed on the provider's license by the provider's licensing authority within the previous three (3) years; (C) 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; (D) Is employed at a facility that is a contracted buprenorphine enhanced medication assisted recovery and treatment (BESMART) program, or a successor program, provider 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; (E) Is employed at a facility at which healthcare providers are accepting new TennCare enrollees or patients for treatment of opiate addiction; (F) Is employed by a facility that requires patients to verify identification; (G) Does not write any prescription for a buprenorphine product that exceeds a sixteen-milligram daily equivalent; (H) Does not prescribe or dispense a mono product or buprenorphine without naloxone, except to a pregnant woman or to a patient with a documented history of an adverse reaction or hypersensitivity to naloxone; (I) [Deleted by 2024 amendment.] (J) [Deleted by 2024 amendment.] (K) Prescribes buprenorphine products only to patients who are treated through the organization that employs the provider; (L) Is supervised by or collaborates with a physician who is limited to the supervision of, or collaboration for, a maximum of five (5) licensed nurse practitioners or physician assistants; (M) 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; (N) 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; (O) Writes prescriptions that can only be dispensed by a licensed pharmacy to ensure entry into the controlled substance database; and (P) Writes prescriptions of buprenorphine products to one hundred (100) or fewer patients at any given time.
(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: (A) Is licensed and has practiced as a family, adult, or psychiatric nurse practitioner or physician assistant in this state; (B) Has had no limitations or conditions imposed on the provider's license by the provider's licensing authority within the previous three (3) years; (C) 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; (D) Is employed at a facility that is a contracted buprenorphine enhanced medication assisted recovery and treatment (BESMART) program, or a successor program, provider 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; (E) Is employed at a facility at which healthcare providers are accepting new TennCare enrollees or patients for treatment of opiate addiction; (F) Is employed by a facility that requires patients to verify identification; (G) Does not write any prescription for a buprenorphine product that exceeds a sixteen-milligram daily equivalent; (H) Does not prescribe or dispense a mono product or buprenorphine without naloxone, except to a pregnant woman or to a patient with a documented history of an adverse reaction or hypersensitivity to naloxone; (I) [Deleted by 2024 amendment.] (J) [Deleted by 2024 amendment.] (K) Prescribes buprenorphine products only to patients who are treated through the organization that employs the provider; (L) Is supervised by or collaborates with a physician who is limited to the supervision of, or collaboration for, a maximum of five (5) licensed nurse practitioners or physician assistants; (M) 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; (N) 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; (O) Writes prescriptions that can only be dispensed by a licensed pharmacy to ensure entry into the controlled substance database; and (P) Writes prescriptions of buprenorphine products to one hundred (100) or fewer patients at any given time.
(A) Is licensed and has practiced as a family, adult, or psychiatric nurse practitioner or physician assistant in this state;
(B) Has had no limitations or conditions imposed on the provider's license by the provider's licensing authority within the previous three (3) years;
(C) 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;
(D) Is employed at a facility that is a contracted buprenorphine enhanced medication assisted recovery and treatment (BESMART) program, or a successor program, provider 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;
(E) Is employed at a facility at which healthcare providers are accepting new TennCare enrollees or patients for treatment of opiate addiction;
(F) Is employed by a facility that requires patients to verify identification;
(G) Does not write any prescription for a buprenorphine product that exceeds a sixteen-milligram daily equivalent;
(H) Does not prescribe or dispense a mono product or buprenorphine without naloxone, except to a pregnant woman or to a patient with a documented history of an adverse reaction or hypersensitivity to naloxone;
(I) [Deleted by 2024 amendment.]
(J) [Deleted by 2024 amendment.]
(K) Prescribes buprenorphine products only to patients who are treated through the organization that employs the provider;
(L) Is supervised by or collaborates with a physician who is limited to the supervision of, or collaboration for, a maximum of five (5) licensed nurse practitioners or physician assistants;
(M) 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;
(N) 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;
(O) Writes prescriptions that can only be dispensed by a licensed pharmacy to ensure entry into the controlled substance database; and
(P) Writes prescriptions of buprenorphine products to one hundred (100) or fewer patients at any given time.
(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.
(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.
(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.
(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.
(h) (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: (A) 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; (B) The provider practices under the direct supervision of a physician who is licensed under title 63, chapter 6 or chapter 9 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; (C) 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; (D) The facility or its healthcare providers are directly billing TennCare and TennCare's managed care organizations for the services provided within the facility; (E) The facility or its healthcare providers are accepting new TennCare enrollees or patients for treatment of opiate addiction; (F) The provider does not write any prescription for a buprenorphine product that exceeds a sixteen-milligram daily equivalent; (G) Except as provided in subdivision (h)(2)(H), the provider does not prescribe or dispense a mono product or buprenorphine without naloxone; (H) The provider uses injectable or implantable buprenorphine formulations in accordance with subdivision (b)(1)(D); (I) The provider has practiced as a family, adult, or psychiatric nurse practitioner or physician assistant in this state; (J) [Deleted by 2024 amendment.] (K) 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; (L) 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; (M) The provider writes prescriptions of buprenorphine products to one hundred (100) or fewer patients at any given time; provided, that such limit is two hundred fifty (250) or fewer patients if the provider practices in a nonresidential office-based opiate treatment facility, as defined in § 33-2-402 , that is accredited by a nationally or internationally recognized accrediting body, including the commission on the accreditation of rehabilitation facilities (CARF) or the joint commission; (N) 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; provided, that if the physician practices in a nonresidential office-based opiate treatment facility, as defined in § 33-2-402 , that is accredited by a nationally or internationally recognized accrediting body such as the commission on the accreditation of rehabilitation facilities (CARF) or the joint commission, the physician may oversee no more than five (5) providers licensed under title 63, chapter 7 or 19, and at no time may the physician oversee the treatment of more than five hundred (500) patients under this subdivision (h)(2)(N) at any one (1) time during clinical operations; and (O) 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.
(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: (A) 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; (B) The provider practices under the direct supervision of a physician who is licensed under title 63, chapter 6 or chapter 9 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; (C) 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; (D) The facility or its healthcare providers are directly billing TennCare and TennCare's managed care organizations for the services provided within the facility; (E) The facility or its healthcare providers are accepting new TennCare enrollees or patients for treatment of opiate addiction; (F) The provider does not write any prescription for a buprenorphine product that exceeds a sixteen-milligram daily equivalent; (G) Except as provided in subdivision (h)(2)(H), the provider does not prescribe or dispense a mono product or buprenorphine without naloxone; (H) The provider uses injectable or implantable buprenorphine formulations in accordance with subdivision (b)(1)(D); (I) The provider has practiced as a family, adult, or psychiatric nurse practitioner or physician assistant in this state; (J) [Deleted by 2024 amendment.] (K) 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; (L) 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; (M) The provider writes prescriptions of buprenorphine products to one hundred (100) or fewer patients at any given time; provided, that such limit is two hundred fifty (250) or fewer patients if the provider practices in a nonresidential office-based opiate treatment facility, as defined in § 33-2-402 , that is accredited by a nationally or internationally recognized accrediting body, including the commission on the accreditation of rehabilitation facilities (CARF) or the joint commission; (N) 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; provided, that if the physician practices in a nonresidential office-based opiate treatment facility, as defined in § 33-2-402 , that is accredited by a nationally or internationally recognized accrediting body such as the commission on the accreditation of rehabilitation facilities (CARF) or the joint commission, the physician may oversee no more than five (5) providers licensed under title 63, chapter 7 or 19, and at no time may the physician oversee the treatment of more than five hundred (500) patients under this subdivision (h)(2)(N) at any one (1) time during clinical operations; and (O) 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.
(A) 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;
(B) The provider practices under the direct supervision of a physician who is licensed under title 63, chapter 6 or chapter 9 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;
(C) 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;
(D) The facility or its healthcare providers are directly billing TennCare and TennCare's managed care organizations for the services provided within the facility;
(E) The facility or its healthcare providers are accepting new TennCare enrollees or patients for treatment of opiate addiction;
(F) The provider does not write any prescription for a buprenorphine product that exceeds a sixteen-milligram daily equivalent;
(G) Except as provided in subdivision (h)(2)(H), the provider does not prescribe or dispense a mono product or buprenorphine without naloxone;
(H) The provider uses injectable or implantable buprenorphine formulations in accordance with subdivision (b)(1)(D);
(I) The provider has practiced as a family, adult, or psychiatric nurse practitioner or physician assistant in this state;
(J) [Deleted by 2024 amendment.]
(K) 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;
(L) 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;
(M) The provider writes prescriptions of buprenorphine products to one hundred (100) or fewer patients at any given time; provided, that such limit is two hundred fifty (250) or fewer patients if the provider practices in a nonresidential office-based opiate treatment facility, as defined in § 33-2-402 , that is accredited by a nationally or internationally recognized accrediting body, including the commission on the accreditation of rehabilitation facilities (CARF) or the joint commission;
(N) 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; provided, that if the physician practices in a nonresidential office-based opiate treatment facility, as defined in § 33-2-402 , that is accredited by a nationally or internationally recognized accrediting body such as the commission on the accreditation of rehabilitation facilities (CARF) or the joint commission, the physician may oversee no more than five (5) providers licensed under title 63, chapter 7 or 19, and at no time may the physician oversee the treatment of more than five hundred (500) patients under this subdivision (h)(2)(N) at any one (1) time during clinical operations; and
(O) 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.
(i) (1) Notwithstanding 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 a buprenorphine product for a 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 a buprenorphine product for the treatment of opioid use disorder unless the provider: (A) Is licensed and has practiced as a family, adult, or psychiatric nurse practitioner or physician assistant in this state; (B) Has had no limitations or conditions imposed on the provider's license by the provider's licensing authority within the previous three (3) years; (C) Is employed by a hospital, as defined in § 68-11-201 , that operates with an agreement to train providers from a public or private medical school within this state, or an affiliated clinic operated under the hospital's license, that employs one (1) or more physicians and has adopted clinical protocols for medication-assisted treatment; (D) 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; (E) Is employed at a facility at which healthcare providers are accepting new TennCare enrollees or patients for treatment of opiate addiction; (F) Is employed by a facility that requires patients to verify identification; (G) Does not write a prescription for a buprenorphine product that exceeds a sixteen-milligram daily equivalent; (H) Does not prescribe or dispense a mono product or buprenorphine without naloxone; (I) Works under the supervision of a physician who is actively treating patients with buprenorphine products for recovery or medication-assisted treatment; (J) Prescribes buprenorphine products only to patients who are treated through the organization that employs the provider; (K) Is supervised by or collaborates with a physician who is limited to the supervision of, or collaboration with, a maximum of four (4) licensed nurse practitioners or physician assistants; (L) 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; (M) 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; (N) Initiates and leads 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; (O) Writes prescriptions that can only be dispensed by a licensed pharmacy; and (P) Writes prescriptions of buprenorphine products to fifty (50) or fewer patients at any given time. (3) The health facilities commission may inspect facilities for compliance with this subsection (i) pursuant to § 68-11-210 and shall report any violations of this subsection (i) to the appropriate licensing authority of the provider licensed under title 63.
(1) Notwithstanding 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 a buprenorphine product for a 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 a buprenorphine product for the treatment of opioid use disorder unless the provider: (A) Is licensed and has practiced as a family, adult, or psychiatric nurse practitioner or physician assistant in this state; (B) Has had no limitations or conditions imposed on the provider's license by the provider's licensing authority within the previous three (3) years; (C) Is employed by a hospital, as defined in § 68-11-201 , that operates with an agreement to train providers from a public or private medical school within this state, or an affiliated clinic operated under the hospital's license, that employs one (1) or more physicians and has adopted clinical protocols for medication-assisted treatment; (D) 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; (E) Is employed at a facility at which healthcare providers are accepting new TennCare enrollees or patients for treatment of opiate addiction; (F) Is employed by a facility that requires patients to verify identification; (G) Does not write a prescription for a buprenorphine product that exceeds a sixteen-milligram daily equivalent; (H) Does not prescribe or dispense a mono product or buprenorphine without naloxone; (I) Works under the supervision of a physician who is actively treating patients with buprenorphine products for recovery or medication-assisted treatment; (J) Prescribes buprenorphine products only to patients who are treated through the organization that employs the provider; (K) Is supervised by or collaborates with a physician who is limited to the supervision of, or collaboration with, a maximum of four (4) licensed nurse practitioners or physician assistants; (L) 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; (M) 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; (N) Initiates and leads 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; (O) Writes prescriptions that can only be dispensed by a licensed pharmacy; and (P) Writes prescriptions of buprenorphine products to fifty (50) or fewer patients at any given time.
(A) Is licensed and has practiced as a family, adult, or psychiatric nurse practitioner or physician assistant in this state;
(B) Has had no limitations or conditions imposed on the provider's license by the provider's licensing authority within the previous three (3) years;
(C) Is employed by a hospital, as defined in § 68-11-201 , that operates with an agreement to train providers from a public or private medical school within this state, or an affiliated clinic operated under the hospital's license, that employs one (1) or more physicians and has adopted clinical protocols for medication-assisted treatment;
(D) 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;
(E) Is employed at a facility at which healthcare providers are accepting new TennCare enrollees or patients for treatment of opiate addiction;
(F) Is employed by a facility that requires patients to verify identification;
(G) Does not write a prescription for a buprenorphine product that exceeds a sixteen-milligram daily equivalent;
(H) Does not prescribe or dispense a mono product or buprenorphine without naloxone;
(I) Works under the supervision of a physician who is actively treating patients with buprenorphine products for recovery or medication-assisted treatment;
(J) Prescribes buprenorphine products only to patients who are treated through the organization that employs the provider;
(K) Is supervised by or collaborates with a physician who is limited to the supervision of, or collaboration with, a maximum of four (4) licensed nurse practitioners or physician assistants;
(L) 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;
(M) 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;
(N) Initiates and leads 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;
(O) Writes prescriptions that can only be dispensed by a licensed pharmacy; and
(P) Writes prescriptions of buprenorphine products to fifty (50) or fewer patients at any given time.
(3) The health facilities commission may inspect facilities for compliance with this subsection (i) pursuant to § 68-11-210 and shall report any violations of this subsection (i) to the appropriate licensing authority of the provider licensed under title 63.
Amended by 2024 Tenn. Acts, ch. 857,s 1, eff. 5/1/2024.
Amended by 2024 Tenn. Acts, ch. 980,s 2, eff. 5/21/2024.
Amended by 2024 Tenn. Acts, ch. 980,s 1, eff. 5/21/2024.
Amended by 2024 Tenn. Acts, ch. 808,s 6, eff. 7/1/2024.
Amended by 2024 Tenn. Acts, ch. 808,s 5, eff. 7/1/2024.
Amended by 2024 Tenn. Acts, ch. 808,s 4, eff. 7/1/2024.
Amended by 2024 Tenn. Acts, ch. 808,s 3, eff. 7/1/2024.
Amended by 2024 Tenn. Acts, ch. 808,s 2, eff. 7/1/2024.
Amended by 2024 Tenn. Acts, ch. 575,s 5, eff. 3/15/2024.
Amended by 2024 Tenn. Acts, ch. 575,s 4, eff. 3/15/2024.
Amended by 2024 Tenn. Acts, ch. 575,s 3, eff. 3/15/2024.
Amended by 2024 Tenn. Acts, ch. 575,s 2, eff. 3/15/2024.
Amended by 2024 Tenn. Acts, ch. 575,s 1, eff. 3/15/2024.
Amended by 2020 Tenn. Acts, ch. 771, s 1, eff. 8/1/2020.
Amended by 2020 Tenn. Acts, ch. 761, s 1, eff. 7/1/2020.
Amended by 2018 Tenn. Acts, ch. 978, s 7, eff. 7/1/2018.
Amended by 2018 Tenn. Acts, ch. 674, s 1, eff. 4/12/2018.
Added by 2015 Tenn. Acts, ch. 396, s 3, eff. 7/1/2015.
Tenn. Code Ann. § 53-3-111 — TN Code / Title 53 / Chapter 3 / Section 53-3-111
Tests to settle disputes between buyers and sellers
Status: in_force

(a) The commissioner is authorized and empowered to make tests that are necessary to settle disputes when called on by either a buyer or seller of milk, cream, or other dairy products, or trade products where disputes arise over dissatisfaction regarding weights or tests of dairy products. (b) The tests made by the commissioner shall be prima facie correct, and shall be taken as a basis of settlement in the disputes. Acts 1970, ch. 577, § 2; T.C.A., § 52-311.
(a) The commissioner is authorized and empowered to make tests that are necessary to settle disputes when called on by either a buyer or seller of milk, cream, or other dairy products, or trade products where disputes arise over dissatisfaction regarding weights or tests of dairy products.
(b) The tests made by the commissioner shall be prima facie correct, and shall be taken as a basis of settlement in the disputes.
Acts 1970, ch. 577, § 2; T.C.A., § 52-311.
Tenn. Code Ann. § 53-10-308 — TN Code / Title 53 / Chapter 10 / Section 53-10-308
Release of confidential information
Status: in_force

(a) Notwithstanding this part to the contrary, the committee or the commissioner: (1) May release confidential information from the database regarding healthcare practitioners, healthcare practitioner delegates, or patients to department personnel engaged in an investigation, adjudication, or prosecution of a violation under any state or federal law that involves a controlled substance; (2) May release confidential information from the database regarding healthcare practitioners, healthcare practitioner delegates, or patients to law enforcement personnel engaged in an investigation, adjudication, or prosecution of a violation under any state or federal law that involves a controlled substance, pursuant to the procedure established in § 53-10-306(a)(11) ; (3) Shall release information from the database when ordered by a court to do so upon the court's finding that disclosure is necessary for the conduct of proceedings before the court regarding the investigation, adjudication, or prosecution of a violation under any state or federal law that involves controlled substances and after an appropriate protective order is issued regarding the information to be released to the court; and (4) (A) Shall release confidential information from the database to the attorney general and reporter upon request for the purpose of reviewing, querying, or otherwise using the data in conjunction with investigating or litigating a civil action involving controlled substances. The data may be disclosed at the attorney general and reporter's discretion to: (i) Designees within the office of the attorney general and reporter who are participating in, assisting with, or supervising any such investigation or litigation; (ii) Other parties to litigation to which the attorney general and reporter is a party in which the data is relevant so long as disclosure of the data is in furtherance of litigation or resolution of litigation, and the data is provided only after an appropriate protective order is issued prohibiting the other parties from using the confidential information for any purpose other than defending or resolving the litigation and prohibiting the sharing of confidential information with litigants in other cases or other parties; (iii) Targets of an investigation conducted by the attorney general and reporter for the purpose of negotiating a settlement regarding conduct to which the data is relevant only after an appropriate protective order is issued or a confidentiality agreement is executed regarding the data; (iv) Designated consultants or experts who agree to maintain the confidentiality of the data and who are retained, in conjunction with an investigation or litigation, by: (a) The attorney general and reporter; (b) Other parties to litigation to which the attorney general and reporter is a party as described in subdivision (a)(4)(A)(ii); or (c) Targets of an investigation conducted by the attorney general and reporter as described in subdivision (a)(4)(A)(iii); and (v) A court for evidentiary or other purposes after an appropriate protective order is issued regarding the confidential information; (B) The attorney general and reporter shall comply with the Health Insurance Portability and Accountability Act of 1996 ( 42 U.S.C. § 1320d et seq.) to the extent that it applies to any such disclosure. (b) Any data authorized to be released under this section or § 53-10-306 , other than deidentified data or data released to personnel of the department, the attorney general and reporter, or a health-related board is limited to reports of drugs prescribed to specific patients or prescribed by specific providers, and nothing in this part creates a right to other data such as provider query audits or registration information, nor does anything in this part require the committee or department to provide analytics or analysis of any data available in the database. (c) Data reported to the database by a Part 2 Program shall not be released under this section or § 53-10-306 unless such release complies with 42 CFR Part 2 and the rules promulgated by the commissioner pursuant to § 53-10-304(e) . Amended by 2022 Tenn. Acts, ch. 825, s 12, eff. 4/14/2022. Amended by 2021 Tenn. Acts, ch. 136, s 9, eff. 4/13/2021. Amended by 2019 Tenn. Acts, ch. 264, Secs.s 1, s 2 eff. 4/30/2019. Acts 2002, ch. 840, § 1; 2012 , ch. 880, §§ 17, 18.
(a) Notwithstanding this part to the contrary, the committee or the commissioner: (1) May release confidential information from the database regarding healthcare practitioners, healthcare practitioner delegates, or patients to department personnel engaged in an investigation, adjudication, or prosecution of a violation under any state or federal law that involves a controlled substance; (2) May release confidential information from the database regarding healthcare practitioners, healthcare practitioner delegates, or patients to law enforcement personnel engaged in an investigation, adjudication, or prosecution of a violation under any state or federal law that involves a controlled substance, pursuant to the procedure established in § 53-10-306(a)(11) ; (3) Shall release information from the database when ordered by a court to do so upon the court's finding that disclosure is necessary for the conduct of proceedings before the court regarding the investigation, adjudication, or prosecution of a violation under any state or federal law that involves controlled substances and after an appropriate protective order is issued regarding the information to be released to the court; and (4) (A) Shall release confidential information from the database to the attorney general and reporter upon request for the purpose of reviewing, querying, or otherwise using the data in conjunction with investigating or litigating a civil action involving controlled substances. The data may be disclosed at the attorney general and reporter's discretion to: (i) Designees within the office of the attorney general and reporter who are participating in, assisting with, or supervising any such investigation or litigation; (ii) Other parties to litigation to which the attorney general and reporter is a party in which the data is relevant so long as disclosure of the data is in furtherance of litigation or resolution of litigation, and the data is provided only after an appropriate protective order is issued prohibiting the other parties from using the confidential information for any purpose other than defending or resolving the litigation and prohibiting the sharing of confidential information with litigants in other cases or other parties; (iii) Targets of an investigation conducted by the attorney general and reporter for the purpose of negotiating a settlement regarding conduct to which the data is relevant only after an appropriate protective order is issued or a confidentiality agreement is executed regarding the data; (iv) Designated consultants or experts who agree to maintain the confidentiality of the data and who are retained, in conjunction with an investigation or litigation, by: (a) The attorney general and reporter; (b) Other parties to litigation to which the attorney general and reporter is a party as described in subdivision (a)(4)(A)(ii); or (c) Targets of an investigation conducted by the attorney general and reporter as described in subdivision (a)(4)(A)(iii); and (v) A court for evidentiary or other purposes after an appropriate protective order is issued regarding the confidential information; (B) The attorney general and reporter shall comply with the Health Insurance Portability and Accountability Act of 1996 ( 42 U.S.C. § 1320d et seq.) to the extent that it applies to any such disclosure.
(1) May release confidential information from the database regarding healthcare practitioners, healthcare practitioner delegates, or patients to department personnel engaged in an investigation, adjudication, or prosecution of a violation under any state or federal law that involves a controlled substance;
(2) May release confidential information from the database regarding healthcare practitioners, healthcare practitioner delegates, or patients to law enforcement personnel engaged in an investigation, adjudication, or prosecution of a violation under any state or federal law that involves a controlled substance, pursuant to the procedure established in § 53-10-306(a)(11) ;
(3) Shall release information from the database when ordered by a court to do so upon the court's finding that disclosure is necessary for the conduct of proceedings before the court regarding the investigation, adjudication, or prosecution of a violation under any state or federal law that involves controlled substances and after an appropriate protective order is issued regarding the information to be released to the court; and
(4) (A) Shall release confidential information from the database to the attorney general and reporter upon request for the purpose of reviewing, querying, or otherwise using the data in conjunction with investigating or litigating a civil action involving controlled substances. The data may be disclosed at the attorney general and reporter's discretion to: (i) Designees within the office of the attorney general and reporter who are participating in, assisting with, or supervising any such investigation or litigation; (ii) Other parties to litigation to which the attorney general and reporter is a party in which the data is relevant so long as disclosure of the data is in furtherance of litigation or resolution of litigation, and the data is provided only after an appropriate protective order is issued prohibiting the other parties from using the confidential information for any purpose other than defending or resolving the litigation and prohibiting the sharing of confidential information with litigants in other cases or other parties; (iii) Targets of an investigation conducted by the attorney general and reporter for the purpose of negotiating a settlement regarding conduct to which the data is relevant only after an appropriate protective order is issued or a confidentiality agreement is executed regarding the data; (iv) Designated consultants or experts who agree to maintain the confidentiality of the data and who are retained, in conjunction with an investigation or litigation, by: (a) The attorney general and reporter; (b) Other parties to litigation to which the attorney general and reporter is a party as described in subdivision (a)(4)(A)(ii); or (c) Targets of an investigation conducted by the attorney general and reporter as described in subdivision (a)(4)(A)(iii); and (v) A court for evidentiary or other purposes after an appropriate protective order is issued regarding the confidential information; (B) The attorney general and reporter shall comply with the Health Insurance Portability and Accountability Act of 1996 ( 42 U.S.C. § 1320d et seq.) to the extent that it applies to any such disclosure.
(A) Shall release confidential information from the database to the attorney general and reporter upon request for the purpose of reviewing, querying, or otherwise using the data in conjunction with investigating or litigating a civil action involving controlled substances. The data may be disclosed at the attorney general and reporter's discretion to: (i) Designees within the office of the attorney general and reporter who are participating in, assisting with, or supervising any such investigation or litigation; (ii) Other parties to litigation to which the attorney general and reporter is a party in which the data is relevant so long as disclosure of the data is in furtherance of litigation or resolution of litigation, and the data is provided only after an appropriate protective order is issued prohibiting the other parties from using the confidential information for any purpose other than defending or resolving the litigation and prohibiting the sharing of confidential information with litigants in other cases or other parties; (iii) Targets of an investigation conducted by the attorney general and reporter for the purpose of negotiating a settlement regarding conduct to which the data is relevant only after an appropriate protective order is issued or a confidentiality agreement is executed regarding the data; (iv) Designated consultants or experts who agree to maintain the confidentiality of the data and who are retained, in conjunction with an investigation or litigation, by: (a) The attorney general and reporter; (b) Other parties to litigation to which the attorney general and reporter is a party as described in subdivision (a)(4)(A)(ii); or (c) Targets of an investigation conducted by the attorney general and reporter as described in subdivision (a)(4)(A)(iii); and (v) A court for evidentiary or other purposes after an appropriate protective order is issued regarding the confidential information;
(i) Designees within the office of the attorney general and reporter who are participating in, assisting with, or supervising any such investigation or litigation;
(ii) Other parties to litigation to which the attorney general and reporter is a party in which the data is relevant so long as disclosure of the data is in furtherance of litigation or resolution of litigation, and the data is provided only after an appropriate protective order is issued prohibiting the other parties from using the confidential information for any purpose other than defending or resolving the litigation and prohibiting the sharing of confidential information with litigants in other cases or other parties;
(iii) Targets of an investigation conducted by the attorney general and reporter for the purpose of negotiating a settlement regarding conduct to which the data is relevant only after an appropriate protective order is issued or a confidentiality agreement is executed regarding the data;
(iv) Designated consultants or experts who agree to maintain the confidentiality of the data and who are retained, in conjunction with an investigation or litigation, by: (a) The attorney general and reporter; (b) Other parties to litigation to which the attorney general and reporter is a party as described in subdivision (a)(4)(A)(ii); or (c) Targets of an investigation conducted by the attorney general and reporter as described in subdivision (a)(4)(A)(iii); and
(a) The attorney general and reporter;
(b) Other parties to litigation to which the attorney general and reporter is a party as described in subdivision (a)(4)(A)(ii); or
(c) Targets of an investigation conducted by the attorney general and reporter as described in subdivision (a)(4)(A)(iii); and
(v) A court for evidentiary or other purposes after an appropriate protective order is issued regarding the confidential information;
(B) The attorney general and reporter shall comply with the Health Insurance Portability and Accountability Act of 1996 ( 42 U.S.C. § 1320d et seq.) to the extent that it applies to any such disclosure.
(b) Any data authorized to be released under this section or § 53-10-306 , other than deidentified data or data released to personnel of the department, the attorney general and reporter, or a health-related board is limited to reports of drugs prescribed to specific patients or prescribed by specific providers, and nothing in this part creates a right to other data such as provider query audits or registration information, nor does anything in this part require the committee or department to provide analytics or analysis of any data available in the database.
(c) Data reported to the database by a Part 2 Program shall not be released under this section or § 53-10-306 unless such release complies with 42 CFR Part 2 and the rules promulgated by the commissioner pursuant to § 53-10-304(e) .
Amended by 2022 Tenn. Acts, ch. 825, s 12, eff. 4/14/2022.
Amended by 2021 Tenn. Acts, ch. 136, s 9, eff. 4/13/2021.
Amended by 2019 Tenn. Acts, ch. 264, Secs.s 1, s 2 eff. 4/30/2019.
Acts 2002, ch. 840, § 1; 2012 , ch. 880, §§ 17, 18.
Tenn. Code Ann. § 53-7-217 — TN Code / Title 53 / Chapter 7 / Section 53-7-217
Revocation or suspension of license - General provisions for hearings and appeals
Status: in_force

(a) (1) If any establishment licensed under this part is deemed by the commissioner to be operated or maintained in any unsanitary manner, or in violation of any of this part or of any regulation duly promulgated pursuant to this part, the commissioner may give written notice of at least ten (10) days to the person operating the establishment to appear before the commissioner or the commissioner's designated hearing officer at a time and place to be set out in the written notice, to show cause why the license of the establishment should not be suspended or revoked. Upon the hearing, the person or establishment cited may be heard in person or with counsel, or both, may present evidence, and may cross-examine witnesses. A full and complete record of the hearing shall be recorded and any party to the proceedings, upon request, shall be supplied with a transcript of the proceedings at the usual cost. (2) The commissioner is authorized, in the commissioner's discretion, to appoint and designate a hearing officer who shall preside at the hearing in the place of and in the absence of the commissioner. The hearing officer shall have the power and authority to conduct the hearing, to administer oaths, and make findings of fact, conclusions of law, and the proposed order based on the findings of fact and conclusions of law. If the commissioner concurs, the commissioner shall issue the order; or the commissioner may, upon review of the record, make findings, conclusions and issue orders that, in the commissioner's discretion, the record justifies. (3) Any person whose license has been suspended or revoked by the commissioner pursuant to a hearing under this section shall be assessed and shall pay all costs in connection with the hearing. The commissioner shall take all steps necessary to collect the costs as may be authorized under the statutes of the state in the same manner as now authorized for the collection of taxes by the state. (4) No later than sixty (60) days following the hearing, the commissioner shall issue any order that may be appropriate under the circumstances, and the commissioner may, if the facts adduced at the hearing warrant, suspend for any period or revoke any license issued under this part. (b) (1) The action of the commissioner and the order issued by the commissioner may be reviewed by petition for common law writ of certiorari, addressed to the circuit court of Davidson County, which petition shall be filed within ten (10) days from the date the order of the commissioner is made. (2) Immediately upon the grant of the writ of certiorari, the commissioner shall cause to be made, certified and forwarded to the court a complete transcript of the proceedings in the cause, which shall contain all the proof submitted before the commissioner. All defendants named in the petition desiring to make defense shall answer or otherwise plead to the petition within ten (10) days from the date of the filing of the transcript, unless the time is extended by the court. (3) The decision of the commissioner shall be reviewed by the circuit court solely upon the pleadings and the transcript of the proceedings before the commissioner or the hearing examiner, and neither party shall be entitled to introduce any additional evidence in the circuit court. (4) Either party dissatisfied with the judgment or decree of the circuit court may, upon giving bond as required in other suits, appeal, and have a reexamination, in that court, of the whole matter of law and fact appearing in the record. When the appeal is made, the clerk of the circuit court in which the suit was pending shall include as a part of the record the original certified transcript of the proceedings had before the commissioner. (c) This section with regard to hearing and appeal shall also apply to actions of the commissioner pursuant to §§ 53-7-205 , 53-7-212 , 53-7-218 and 53-7-220 , and shall be available to any party aggrieved by any act of the commissioner pursuant thereto. Acts 1967, ch. 99, § 17; 1981, ch. 449, § 2; T.C.A., § 52-931; Acts 1989, ch. 147, § 4.
(a) (1) If any establishment licensed under this part is deemed by the commissioner to be operated or maintained in any unsanitary manner, or in violation of any of this part or of any regulation duly promulgated pursuant to this part, the commissioner may give written notice of at least ten (10) days to the person operating the establishment to appear before the commissioner or the commissioner's designated hearing officer at a time and place to be set out in the written notice, to show cause why the license of the establishment should not be suspended or revoked. Upon the hearing, the person or establishment cited may be heard in person or with counsel, or both, may present evidence, and may cross-examine witnesses. A full and complete record of the hearing shall be recorded and any party to the proceedings, upon request, shall be supplied with a transcript of the proceedings at the usual cost. (2) The commissioner is authorized, in the commissioner's discretion, to appoint and designate a hearing officer who shall preside at the hearing in the place of and in the absence of the commissioner. The hearing officer shall have the power and authority to conduct the hearing, to administer oaths, and make findings of fact, conclusions of law, and the proposed order based on the findings of fact and conclusions of law. If the commissioner concurs, the commissioner shall issue the order; or the commissioner may, upon review of the record, make findings, conclusions and issue orders that, in the commissioner's discretion, the record justifies. (3) Any person whose license has been suspended or revoked by the commissioner pursuant to a hearing under this section shall be assessed and shall pay all costs in connection with the hearing. The commissioner shall take all steps necessary to collect the costs as may be authorized under the statutes of the state in the same manner as now authorized for the collection of taxes by the state. (4) No later than sixty (60) days following the hearing, the commissioner shall issue any order that may be appropriate under the circumstances, and the commissioner may, if the facts adduced at the hearing warrant, suspend for any period or revoke any license issued under this part.
(1) If any establishment licensed under this part is deemed by the commissioner to be operated or maintained in any unsanitary manner, or in violation of any of this part or of any regulation duly promulgated pursuant to this part, the commissioner may give written notice of at least ten (10) days to the person operating the establishment to appear before the commissioner or the commissioner's designated hearing officer at a time and place to be set out in the written notice, to show cause why the license of the establishment should not be suspended or revoked. Upon the hearing, the person or establishment cited may be heard in person or with counsel, or both, may present evidence, and may cross-examine witnesses. A full and complete record of the hearing shall be recorded and any party to the proceedings, upon request, shall be supplied with a transcript of the proceedings at the usual cost.
(2) The commissioner is authorized, in the commissioner's discretion, to appoint and designate a hearing officer who shall preside at the hearing in the place of and in the absence of the commissioner. The hearing officer shall have the power and authority to conduct the hearing, to administer oaths, and make findings of fact, conclusions of law, and the proposed order based on the findings of fact and conclusions of law. If the commissioner concurs, the commissioner shall issue the order; or the commissioner may, upon review of the record, make findings, conclusions and issue orders that, in the commissioner's discretion, the record justifies.
(3) Any person whose license has been suspended or revoked by the commissioner pursuant to a hearing under this section shall be assessed and shall pay all costs in connection with the hearing. The commissioner shall take all steps necessary to collect the costs as may be authorized under the statutes of the state in the same manner as now authorized for the collection of taxes by the state.
(4) No later than sixty (60) days following the hearing, the commissioner shall issue any order that may be appropriate under the circumstances, and the commissioner may, if the facts adduced at the hearing warrant, suspend for any period or revoke any license issued under this part.
(b) (1) The action of the commissioner and the order issued by the commissioner may be reviewed by petition for common law writ of certiorari, addressed to the circuit court of Davidson County, which petition shall be filed within ten (10) days from the date the order of the commissioner is made. (2) Immediately upon the grant of the writ of certiorari, the commissioner shall cause to be made, certified and forwarded to the court a complete transcript of the proceedings in the cause, which shall contain all the proof submitted before the commissioner. All defendants named in the petition desiring to make defense shall answer or otherwise plead to the petition within ten (10) days from the date of the filing of the transcript, unless the time is extended by the court. (3) The decision of the commissioner shall be reviewed by the circuit court solely upon the pleadings and the transcript of the proceedings before the commissioner or the hearing examiner, and neither party shall be entitled to introduce any additional evidence in the circuit court. (4) Either party dissatisfied with the judgment or decree of the circuit court may, upon giving bond as required in other suits, appeal, and have a reexamination, in that court, of the whole matter of law and fact appearing in the record. When the appeal is made, the clerk of the circuit court in which the suit was pending shall include as a part of the record the original certified transcript of the proceedings had before the commissioner.
(1) The action of the commissioner and the order issued by the commissioner may be reviewed by petition for common law writ of certiorari, addressed to the circuit court of Davidson County, which petition shall be filed within ten (10) days from the date the order of the commissioner is made.
(2) Immediately upon the grant of the writ of certiorari, the commissioner shall cause to be made, certified and forwarded to the court a complete transcript of the proceedings in the cause, which shall contain all the proof submitted before the commissioner. All defendants named in the petition desiring to make defense shall answer or otherwise plead to the petition within ten (10) days from the date of the filing of the transcript, unless the time is extended by the court.
(3) The decision of the commissioner shall be reviewed by the circuit court solely upon the pleadings and the transcript of the proceedings before the commissioner or the hearing examiner, and neither party shall be entitled to introduce any additional evidence in the circuit court.
(4) Either party dissatisfied with the judgment or decree of the circuit court may, upon giving bond as required in other suits, appeal, and have a reexamination, in that court, of the whole matter of law and fact appearing in the record. When the appeal is made, the clerk of the circuit court in which the suit was pending shall include as a part of the record the original certified transcript of the proceedings had before the commissioner.
(c) This section with regard to hearing and appeal shall also apply to actions of the commissioner pursuant to §§ 53-7-205 , 53-7-212 , 53-7-218 and 53-7-220 , and shall be available to any party aggrieved by any act of the commissioner pursuant thereto.
Acts 1967, ch. 99, § 17; 1981, ch. 449, § 2; T.C.A., § 52-931; Acts 1989, ch. 147, § 4.
Tenn. Code Ann. § 53-11-413 — TN Code / Title 53 / Chapter 11 / Section 53-11-413
Prior actions and pending litigation
Status: in_force

(a) Prosecution for any violation of law occurring prior to July 1, 1971, is not affected or abated by part 3 of this chapter and this part, or former title 39, chapter 6, part 4 [repealed]. If the offense being prosecuted is similar to one set out in [former] §§ 39-6-417 - 39-6-419 [repealed], or in §§ 53-11-401 - 53-11-403, then the penalties under former §§ 39-6-417 - 39-6-419 [repealed], and under §§ 53-11-401 and 53-11-402 apply if they are less than those under prior law. (b) Civil seizures or forfeitures and injunctive proceedings commenced prior to July 1, 1971, are not affected by part 3 of this chapter and this part, or former title 39, chapter 6, part 4 [repealed]. (c) All administrative proceedings pending under prior laws that are superseded by part 3 of this chapter and this part, or former title 39, chapter 6, part 4 [repealed], shall be continued and brought to a final determination in accordance with the laws and rules in effect prior to July 1, 1971. Any substance controlled under prior law that is not listed within Schedules I through VI is automatically controlled without further proceedings and shall be listed in the appropriate schedule. (d) The board of pharmacy shall initially permit persons to register who own or operate any establishment engaged in the manufacture, distribution or dispensing of any controlled substance prior to July 1, 1971, and who are registered or licensed by the state. (e) (1) Part 3 of this chapter and this part, and former title 39, chapter 6, part 4 [repealed], apply to violations of law, seizures and forfeitures, injunctive proceedings, administrative proceedings and investigations that occur after July 1, 1971, and before November 1, 1989. (2) Part 3 of this chapter, this part and title 39, chapter 17, part 4 apply to violations of law, seizures and forfeitures, injunctive proceedings, administrative proceedings and investigations that occur on or after November 1, 1989. Acts 1971, ch. 163, § 40; T.C.A., § 52-1447; Acts 1990, ch. 883, § 2.
(a) Prosecution for any violation of law occurring prior to July 1, 1971, is not affected or abated by part 3 of this chapter and this part, or former title 39, chapter 6, part 4 [repealed]. If the offense being prosecuted is similar to one set out in [former] §§ 39-6-417 - 39-6-419 [repealed], or in §§ 53-11-401 - 53-11-403, then the penalties under former §§ 39-6-417 - 39-6-419 [repealed], and under §§ 53-11-401 and 53-11-402 apply if they are less than those under prior law.
(b) Civil seizures or forfeitures and injunctive proceedings commenced prior to July 1, 1971, are not affected by part 3 of this chapter and this part, or former title 39, chapter 6, part 4 [repealed].
(c) All administrative proceedings pending under prior laws that are superseded by part 3 of this chapter and this part, or former title 39, chapter 6, part 4 [repealed], shall be continued and brought to a final determination in accordance with the laws and rules in effect prior to July 1, 1971. Any substance controlled under prior law that is not listed within Schedules I through VI is automatically controlled without further proceedings and shall be listed in the appropriate schedule.
(d) The board of pharmacy shall initially permit persons to register who own or operate any establishment engaged in the manufacture, distribution or dispensing of any controlled substance prior to July 1, 1971, and who are registered or licensed by the state.
(e) (1) Part 3 of this chapter and this part, and former title 39, chapter 6, part 4 [repealed], apply to violations of law, seizures and forfeitures, injunctive proceedings, administrative proceedings and investigations that occur after July 1, 1971, and before November 1, 1989. (2) Part 3 of this chapter, this part and title 39, chapter 17, part 4 apply to violations of law, seizures and forfeitures, injunctive proceedings, administrative proceedings and investigations that occur on or after November 1, 1989.
(1) Part 3 of this chapter and this part, and former title 39, chapter 6, part 4 [repealed], apply to violations of law, seizures and forfeitures, injunctive proceedings, administrative proceedings and investigations that occur after July 1, 1971, and before November 1, 1989.
(2) Part 3 of this chapter, this part and title 39, chapter 17, part 4 apply to violations of law, seizures and forfeitures, injunctive proceedings, administrative proceedings and investigations that occur on or after November 1, 1989.
Acts 1971, ch. 163, § 40; T.C.A., § 52-1447; Acts 1990, ch. 883, § 2.
Tenn. Code Ann. § 53-3-118 — TN Code / Title 53 / Chapter 3 / Section 53-3-118
Filing of a corporate surety bond by processors and distributors
Status: in_force

(a) Any processor or distributor required to be licensed under, or whose product is required to be registered under, the dairy law of this state, compiled in this chapter, who acquires or receives, on consignment or otherwise, market or fluid milk from producers or cooperative associations composed of producers, shall file with the commissioner a corporate surety bond payable to the state, for the use and benefit of any aggrieved person and in the form prescribed by the commissioner and conditioned for the payment by the processor or distributor of all amounts due for market or fluid milk purchased or otherwise acquired from producers or cooperative associations of producers by the processor or distributor. (b) The bond shall be in an amount equal to the total purchases of market or fluid milk by the processor or distributor during the month of May of the preceding year, or if the processor or distributor was not engaged in business during the month of May of the preceding year, the bond shall be in an amount fixed by the commissioner. The bond required shall not, in any event, exceed fifty thousand dollars ($50,000). (c) Any producer or cooperative association of producers aggrieved by reason of a processor's or distributor's failure or refusal to pay any amount of money due for purchases of market or fluid milk shall have a right of action to sue in its own name upon the bond and against the surety in any court of law or equity of this state having jurisdiction. (d) The processor or distributor shall, at the time of paying the annual license or registration fees, file a corporate surety bond as provided in this section, which shall cover the term of the license or registration. (e) If any applicant for the license or registration fails to file the corporate surety bond as required in this section, the commissioner may refuse to issue or renew the applicant's license or registration, or the commissioner may issue the license or registration conditioned upon the applicant's paying cash for all the applicant's market or fluid milk purchases; provided, that the applicant furnishes the commissioner with the names and addresses of all persons from whom the applicant purchases milk. Acts 2005, ch. 300, § 6.
(a) Any processor or distributor required to be licensed under, or whose product is required to be registered under, the dairy law of this state, compiled in this chapter, who acquires or receives, on consignment or otherwise, market or fluid milk from producers or cooperative associations composed of producers, shall file with the commissioner a corporate surety bond payable to the state, for the use and benefit of any aggrieved person and in the form prescribed by the commissioner and conditioned for the payment by the processor or distributor of all amounts due for market or fluid milk purchased or otherwise acquired from producers or cooperative associations of producers by the processor or distributor.
(b) The bond shall be in an amount equal to the total purchases of market or fluid milk by the processor or distributor during the month of May of the preceding year, or if the processor or distributor was not engaged in business during the month of May of the preceding year, the bond shall be in an amount fixed by the commissioner. The bond required shall not, in any event, exceed fifty thousand dollars ($50,000).
(c) Any producer or cooperative association of producers aggrieved by reason of a processor's or distributor's failure or refusal to pay any amount of money due for purchases of market or fluid milk shall have a right of action to sue in its own name upon the bond and against the surety in any court of law or equity of this state having jurisdiction.
(d) The processor or distributor shall, at the time of paying the annual license or registration fees, file a corporate surety bond as provided in this section, which shall cover the term of the license or registration.
(e) If any applicant for the license or registration fails to file the corporate surety bond as required in this section, the commissioner may refuse to issue or renew the applicant's license or registration, or the commissioner may issue the license or registration conditioned upon the applicant's paying cash for all the applicant's market or fluid milk purchases; provided, that the applicant furnishes the commissioner with the names and addresses of all persons from whom the applicant purchases milk.
Acts 2005, ch. 300, § 6.
Tenn. Code Ann. § 53-3-201 — TN Code / Title 53 / Chapter 3 / Section 53-3-201
Part definitions and general provisions
Status: in_force

As used in this part, unless the context otherwise requires: (1) "Bulk milk" means milk in bulk form that is furnished to a processor for the purpose of processing and manufacturing into milk products; (2) "Commissioner" means the commissioner of agriculture; (3) (A) "Cost to the processor or distributor" means the actual cost of bulk milk and other ingredients, plus the cost of doing business properly allocable to each item covered by the term "milk products," which cost of doing business includes, but is not limited to, labor, employee salaries, rent, maintenance and depreciation on real and personal property, shrinkage, interest, power, supplies, advertising, transportation and delivery costs, credit losses, all permits and license fees, all taxes, insurance and any and all other overhead expenses; (B) In the absence of proof to the contrary, the actual cost of bulk milk shall be presumed to be the cost as established by a federal marketing order effective in the area, or, if higher, the price established by a producer cooperative; or, in the absence of either, then the price that is effective in the nearest marketing area covered by a federal marketing order; and (C) The profit derived from the sale of one (1) product, whether the product is one of those included in the term "milk products," or some other product, shall not be utilized in cost computations as a credit to, or deductions from, the cost of doing business properly allocable to any product embraced by the term milk products, so as to subsidize or lower the cost of doing business with respect to the milk products; (4) (A) "Cost to the retailer" means the invoice price paid by the retailer for milk products, plus that portion of the retailer's overhead or cost of doing business properly allocable to the milk products, which cost of doing business shall include the same items of expense as are enumerated in the definition of cost to the processor or distributor in subdivision (3); (B) In the absence of specific evidence, the cost of doing business of a retailer shall be presumed to be ten percent (10%) of the invoice price, this cost to be calculated to the nearest whole cent on each sales unit; and (C) The cost of doing business of a retailer includes the fair value of any concession, of any kind whatever, that has the effect of reducing the actual sales price or increasing the cost of the goods delivered for the price stated in the invoice, including, but not limited to, the cost to the retailer of trading stamps or redeemable coupons; (5) "Distributor" means any person engaged in the business of selling or offering for sale within the state milk products for consideration, where the property is sold for the purpose of resale or further processing, or is to be used or consumed by the purchaser and not resold or used for the purpose of further processing; (6) "Milk products" means all or any one (1) of the following: market milk, pasteurized milk, vitamin-D milk, homogenized milk, flavored milk or flavored milk drinks, sweet cream, whipping cream, homogenized cream, skim milk, cottage cheese, buttermilk, and cultured buttermilk, as those products are defined by the commissioner under § 53-3-104 , bulk milk as defined in this section, and all other products offered for sale by a milk processor or distributor, derived, in whole or in part, from milk, and frozen desserts, as described and defined by the commissioner under § 53-3-104 ; (7) "Person" means and includes one (1) or more individuals, partnerships, associations, incorporated, unincorporated or cooperative, corporations, legal representatives, trustees in bankruptcy, receivers, or any other business unit, or any combination of these, except where the context otherwise requires; (8) "Processor" means any person engaged in the business of processing or packaging bulk milk and other materials into milk products; and (9) "Retailer" means any person, whether or not a processor or distributor, engaged in the business of selling or offering for sale within the state milk products for a consideration, where the milk products are to be used or consumed by the purchaser and are not to be resold or used for the purpose of manufacture or further processing. Acts 1955, ch. 74, § 1; 1957, ch. 109, § 1; 1961, ch. 203, § 1; modified; T.C.A., § 52-331; Acts 2005, ch. 300, § 1.
As used in this part, unless the context otherwise requires:
(1) "Bulk milk" means milk in bulk form that is furnished to a processor for the purpose of processing and manufacturing into milk products;
(2) "Commissioner" means the commissioner of agriculture;
(3) (A) "Cost to the processor or distributor" means the actual cost of bulk milk and other ingredients, plus the cost of doing business properly allocable to each item covered by the term "milk products," which cost of doing business includes, but is not limited to, labor, employee salaries, rent, maintenance and depreciation on real and personal property, shrinkage, interest, power, supplies, advertising, transportation and delivery costs, credit losses, all permits and license fees, all taxes, insurance and any and all other overhead expenses; (B) In the absence of proof to the contrary, the actual cost of bulk milk shall be presumed to be the cost as established by a federal marketing order effective in the area, or, if higher, the price established by a producer cooperative; or, in the absence of either, then the price that is effective in the nearest marketing area covered by a federal marketing order; and (C) The profit derived from the sale of one (1) product, whether the product is one of those included in the term "milk products," or some other product, shall not be utilized in cost computations as a credit to, or deductions from, the cost of doing business properly allocable to any product embraced by the term milk products, so as to subsidize or lower the cost of doing business with respect to the milk products;
(A) "Cost to the processor or distributor" means the actual cost of bulk milk and other ingredients, plus the cost of doing business properly allocable to each item covered by the term "milk products," which cost of doing business includes, but is not limited to, labor, employee salaries, rent, maintenance and depreciation on real and personal property, shrinkage, interest, power, supplies, advertising, transportation and delivery costs, credit losses, all permits and license fees, all taxes, insurance and any and all other overhead expenses;
(B) In the absence of proof to the contrary, the actual cost of bulk milk shall be presumed to be the cost as established by a federal marketing order effective in the area, or, if higher, the price established by a producer cooperative; or, in the absence of either, then the price that is effective in the nearest marketing area covered by a federal marketing order; and
(C) The profit derived from the sale of one (1) product, whether the product is one of those included in the term "milk products," or some other product, shall not be utilized in cost computations as a credit to, or deductions from, the cost of doing business properly allocable to any product embraced by the term milk products, so as to subsidize or lower the cost of doing business with respect to the milk products;
(4) (A) "Cost to the retailer" means the invoice price paid by the retailer for milk products, plus that portion of the retailer's overhead or cost of doing business properly allocable to the milk products, which cost of doing business shall include the same items of expense as are enumerated in the definition of cost to the processor or distributor in subdivision (3); (B) In the absence of specific evidence, the cost of doing business of a retailer shall be presumed to be ten percent (10%) of the invoice price, this cost to be calculated to the nearest whole cent on each sales unit; and (C) The cost of doing business of a retailer includes the fair value of any concession, of any kind whatever, that has the effect of reducing the actual sales price or increasing the cost of the goods delivered for the price stated in the invoice, including, but not limited to, the cost to the retailer of trading stamps or redeemable coupons;
(A) "Cost to the retailer" means the invoice price paid by the retailer for milk products, plus that portion of the retailer's overhead or cost of doing business properly allocable to the milk products, which cost of doing business shall include the same items of expense as are enumerated in the definition of cost to the processor or distributor in subdivision (3);
(B) In the absence of specific evidence, the cost of doing business of a retailer shall be presumed to be ten percent (10%) of the invoice price, this cost to be calculated to the nearest whole cent on each sales unit; and
(C) The cost of doing business of a retailer includes the fair value of any concession, of any kind whatever, that has the effect of reducing the actual sales price or increasing the cost of the goods delivered for the price stated in the invoice, including, but not limited to, the cost to the retailer of trading stamps or redeemable coupons;
(5) "Distributor" means any person engaged in the business of selling or offering for sale within the state milk products for consideration, where the property is sold for the purpose of resale or further processing, or is to be used or consumed by the purchaser and not resold or used for the purpose of further processing;
(6) "Milk products" means all or any one (1) of the following: market milk, pasteurized milk, vitamin-D milk, homogenized milk, flavored milk or flavored milk drinks, sweet cream, whipping cream, homogenized cream, skim milk, cottage cheese, buttermilk, and cultured buttermilk, as those products are defined by the commissioner under § 53-3-104 , bulk milk as defined in this section, and all other products offered for sale by a milk processor or distributor, derived, in whole or in part, from milk, and frozen desserts, as described and defined by the commissioner under § 53-3-104 ;
(7) "Person" means and includes one (1) or more individuals, partnerships, associations, incorporated, unincorporated or cooperative, corporations, legal representatives, trustees in bankruptcy, receivers, or any other business unit, or any combination of these, except where the context otherwise requires;
(8) "Processor" means any person engaged in the business of processing or packaging bulk milk and other materials into milk products; and
(9) "Retailer" means any person, whether or not a processor or distributor, engaged in the business of selling or offering for sale within the state milk products for a consideration, where the milk products are to be used or consumed by the purchaser and are not to be resold or used for the purpose of manufacture or further processing.
Acts 1955, ch. 74, § 1; 1957, ch. 109, § 1; 1961, ch. 203, § 1; modified; T.C.A., § 52-331; Acts 2005, ch. 300, § 1.
Tenn. Code Ann. § 53-1-117 — TN Code / Title 53 / Chapter 1 / Section 53-1-117
No criminal or civil liability in the absence of gross negligence or intentional misconduct for feminine hygiene product donation
Status: in_force

(a) The good faith donor of an apparently usable feminine hygiene product to a bona fide charitable or nonprofit organization for free distribution to persons in need of the product is not subject to criminal penalty for violation of unfair trade practice laws or civil damages arising from the nature, age, packaging, or condition of an apparently usable feminine hygiene product. (b) A bona fide charitable or nonprofit organization that in good faith receives an apparently usable feminine hygiene product and distributes the product to persons in need is not subject to criminal penalty for violation of unfair trade practice laws or civil damages arising from the nature, age, packaging, or condition of an apparently usable feminine hygiene product. (c) Subsections (a) and (b) do not apply when a good faith donor or bona fide charitable or nonprofit organization's actions constitute gross negligence or intentional misconduct that results in injury or death to a person who uses the apparently usable feminine hygiene product. (d) As used in this section: (1) "Apparently usable" means that a product meets all quality and labeling standards imposed by federal and state laws and regulations even if the product may not be readily marketable; (2) "Bona fide charitable or nonprofit organization" has the same meaning as defined in § 57-4-102 ; and (3) "Feminine hygiene product": (A) Means a product used for a female's menstruation or other genital-tract secretions; and (B) Includes tampons and sanitary napkins. Added by 2021 Tenn. Acts, ch. 207, s 1, eff. 7/1/2021.
(a) The good faith donor of an apparently usable feminine hygiene product to a bona fide charitable or nonprofit organization for free distribution to persons in need of the product is not subject to criminal penalty for violation of unfair trade practice laws or civil damages arising from the nature, age, packaging, or condition of an apparently usable feminine hygiene product.
(b) A bona fide charitable or nonprofit organization that in good faith receives an apparently usable feminine hygiene product and distributes the product to persons in need is not subject to criminal penalty for violation of unfair trade practice laws or civil damages arising from the nature, age, packaging, or condition of an apparently usable feminine hygiene product.
(c) Subsections (a) and (b) do not apply when a good faith donor or bona fide charitable or nonprofit organization's actions constitute gross negligence or intentional misconduct that results in injury or death to a person who uses the apparently usable feminine hygiene product.
(d) As used in this section: (1) "Apparently usable" means that a product meets all quality and labeling standards imposed by federal and state laws and regulations even if the product may not be readily marketable; (2) "Bona fide charitable or nonprofit organization" has the same meaning as defined in § 57-4-102 ; and (3) "Feminine hygiene product": (A) Means a product used for a female's menstruation or other genital-tract secretions; and (B) Includes tampons and sanitary napkins.
(1) "Apparently usable" means that a product meets all quality and labeling standards imposed by federal and state laws and regulations even if the product may not be readily marketable;
(2) "Bona fide charitable or nonprofit organization" has the same meaning as defined in § 57-4-102 ; and
(3) "Feminine hygiene product": (A) Means a product used for a female's menstruation or other genital-tract secretions; and (B) Includes tampons and sanitary napkins.
(A) Means a product used for a female's menstruation or other genital-tract secretions; and
(B) Includes tampons and sanitary napkins.
Added by 2021 Tenn. Acts, ch. 207, s 1, eff. 7/1/2021.
Tenn. Code Ann. § 53-7-208 — TN Code / Title 53 / Chapter 7 / Section 53-7-208
Records required - Inspection - Retention
Status: in_force

(a) For the purpose of enforcing this part, persons engaged in this state in the business of processing for intrastate commerce or transporting, shipping or receiving in intrastate commerce livestock or poultry slaughtered for human consumption, or meat, meat food products or poultry products, or holding the articles so received, shall maintain records the commissioner, by regulation, may require, showing, to the extent that they are concerned with the receipt, delivery, sale, movement or disposition of such articles, and shall, upon the request of a duly authorized representative of the commissioner, permit the duly authorized representative at reasonable times to have access to and to copy all the records. (b) Any record required to be maintained by this section shall be maintained for a period of two (2) years after the transaction that is the subject of the record has taken place. Acts 1967, ch. 99, § 8; T.C.A., § 52-922.
(a) For the purpose of enforcing this part, persons engaged in this state in the business of processing for intrastate commerce or transporting, shipping or receiving in intrastate commerce livestock or poultry slaughtered for human consumption, or meat, meat food products or poultry products, or holding the articles so received, shall maintain records the commissioner, by regulation, may require, showing, to the extent that they are concerned with the receipt, delivery, sale, movement or disposition of such articles, and shall, upon the request of a duly authorized representative of the commissioner, permit the duly authorized representative at reasonable times to have access to and to copy all the records.
(b) Any record required to be maintained by this section shall be maintained for a period of two (2) years after the transaction that is the subject of the record has taken place.
Acts 1967, ch. 99, § 8; T.C.A., § 52-922.
Tenn. Code Ann. § 53-1-114 — TN Code / Title 53 / Chapter 1 / Section 53-1-114
Exemptions from labeling requirements
Status: in_force

Notwithstanding any law or rule to the contrary, a food item, including, but not limited to, biscuits, sandwiches, salads, slaw, cookies, candy and other desserts, shall be exempt from the labeling requirements of this chapter if the food item is: (1) Made on site; (2) Sold at retail to consumers on site; and (3) Made from products that are commercially available. Acts 1990, ch. 1054, § 1.
Notwithstanding any law or rule to the contrary, a food item, including, but not limited to, biscuits, sandwiches, salads, slaw, cookies, candy and other desserts, shall be exempt from the labeling requirements of this chapter if the food item is:
(1) Made on site;
(2) Sold at retail to consumers on site; and
(3) Made from products that are commercially available.
Acts 1990, ch. 1054, § 1.
Tenn. Code Ann. § 53-7-219 — TN Code / Title 53 / Chapter 7 / Section 53-7-219
Fees for licenses and inspections
Status: in_force

The fee for licenses and inspection issued pursuant to this part shall be set by rule pursuant to § 43-1-703 . Amended by 2015 Tenn. Acts, ch. 485,s 36, eff. 7/1/2015. Acts 1967, ch. 99, § 19; 1969, ch. 108, § 3; T.C.A., § 52-933.
The fee for licenses and inspection issued pursuant to this part shall be set by rule pursuant to § 43-1-703 .
Amended by 2015 Tenn. Acts, ch. 485,s 36, eff. 7/1/2015.
Acts 1967, ch. 99, § 19; 1969, ch. 108, § 3; T.C.A., § 52-933.
Tenn. Code Ann. § 53-10-101 — TN Code / Title 53 / Chapter 10 / Section 53-10-101
"Legend Drugs" defined
Status: in_force

(a) For the purpose of this part, "legend drugs" means any item that federal law prohibits dispensing without a prescription from a licensed doctor, dentist, optometrist or veterinarian. (b) This definition of legend drugs shall not be construed to include blood and blood fractions. Acts 1939, ch. 164, § 1; C. Supp. 1950, § 6632.24 (Williams, § 6632.6); Acts 1955, ch. 89, § 1; 1959, ch. 52, § 1; 1971, ch. 163, § 43; 1980, ch. 710, § 1; T.C.A. (orig. ed.), § 52-1201; Acts 1993, ch. 295, § 7.
(a) For the purpose of this part, "legend drugs" means any item that federal law prohibits dispensing without a prescription from a licensed doctor, dentist, optometrist or veterinarian.
(b) This definition of legend drugs shall not be construed to include blood and blood fractions.
Acts 1939, ch. 164, § 1; C. Supp. 1950, § 6632.24 (Williams, § 6632.6); Acts 1955, ch. 89, § 1; 1959, ch. 52, § 1; 1971, ch. 163, § 43; 1980, ch. 710, § 1; T.C.A. (orig. ed.), § 52-1201; Acts 1993, ch. 295, § 7.
Tenn. Code Ann. § 53-2-104 — TN Code / Title 53 / Chapter 2 / Section 53-2-104
[Repealed]
Status: repealed

Repealed by 2020 Tenn. Acts, ch. 727, s 2, eff. 6/22/2020. Acts 1951, ch. 124, § 4 (Williams, § 6579.32); 1981, ch. 322, §§ 3, 4; T.C.A. (orig. ed.), § 52-204.
Repealed by 2020 Tenn. Acts, ch. 727, s 2, eff. 6/22/2020.
Acts 1951, ch. 124, § 4 (Williams, § 6579.32); 1981, ch. 322, §§ 3, 4; T.C.A. (orig. ed.), § 52-204.
Tenn. Code Ann. § 53-10-211 — TN Code / Title 53 / Chapter 10 / Section 53-10-211
Interchangeable biological products
Status: in_force

(a) A prescriber shall allow for substitution with an interchangeable biological product of a prescribed biological product under all circumstances unless: (1) The prescriber determines the medical necessity of a prescribed biological product due to: (A) An adverse reaction previously experienced by the patient to an interchangeable biological product; (B) An interchangeable biological product having previously been demonstrated as ineffective for the patient; or (C) Any other clinically based, prescriber-determined need; or (2) An interchangeable biological product is not available. (b) (1) If the prescriber determines a prescribed biological product is medically necessary for a patient, the prescriber shall, in the prescriber's own handwriting, place the instructions showing intent upon the prescription at the time it is prepared and issued. (2) For the purposes of this subsection (b), "instructions showing intent" includes, but is not limited to, the following language: (A) "Brand name medically necessary," "dispense as written," "medically necessary," "brand name," or "no generic"; (B) Any abbreviation of the language in subdivision (b)(1)(A); or (C) Any other prescriber handwritten notation, such as circling a preprinted instruction to dispense as written on the prescription order, that clearly conveys the intent that a brand name is necessary for this patient. (c) If the prescriber determines that a prescribed biological product is medically necessary for a patient and the prescription order is issued orally, the prescriber shall alert the pharmacist that use of the prescribed biological product is medically necessary for the patient. (d) If the prescriber determines that a prescribed biological product is medically necessary for a patient and the prescription order is issued by the prescriber in the form of an electronic prescription order or facsimile prescription order, the prescriber shall place, or cause to be placed, the proper instruction on the electronic prescription order or facsimile prescription order prior to it being transmitted to the pharmacist. (e) Nothing in this section shall prevent a prescriber or dispenser from informing a patient of the prescriber or dispenser's professional opinion as to the capabilities, effectiveness, and acceptability of any biological product. (f) A pharmacist who selects an interchangeable biological product for substitution, pursuant to this section, has the same responsibility for the selected product as the pharmacist would in dispensing a prescription for the product prescribed. (g) The manufacturer, packager, or distributor of any human use legend drug or biological product sold, delivered, or offered for sale in this state shall have printed on the label of the immediate container of the biological product the name and address of the manufacturer, packager, or distributor of the finished dosage form of the biological product. (h) The pharmacist shall notify the patient of the substitution with an interchangeable biological product by noting the substitution on the prescription label. (i) Within five (5) business days following the dispensing of a biological product, the dispensing pharmacist or the pharmacist's designee shall communicate to the prescriber the specific product provided to the patient, including the name of the product and the manufacturer. The communication shall be conveyed by making an entry in an interoperable electronic medical records system, through an electronic prescribing technology or a pharmacy record that can be accessed electronically by the prescriber, or as set forth in a collaborative pharmacy practice agreement as defined in § 63-10-217 ; otherwise, the pharmacist or the pharmacist's designee shall communicate to the prescriber the biological product dispensed to the patient, using facsimile, telephone, electronic transmission, or other prevailing means; provided, that communication shall not be required where: (1) There is no FDA-approved interchangeable biological product for the product prescribed; or (2) A prescription is not changed from the product dispensed on the prior filling of the prescription. (j) This section shall not apply to prescriptions administered to patients in a hospital, a nursing home, or an assisted-care living facility, as defined in § 68-11-201 . (k) The notification and communication requirements in this section shall not apply to vaccines. (l) The board of pharmacy shall maintain a link on its website to the current list of all biological products determined by the federal food and drug administration to be interchangeable biological products. (m) The pharmacist shall maintain a record of the biological product dispensed as required pursuant to § 53-14-110 . (n) If this state mandates electronic medical records between a pharmacist and a prescriber as described in subsection (i), then the pharmacist shall only be required to communicate the biological product dispensed through an electronic medical records system when such a system is in place and the information is accessible to prescribers. Added by 2015 Tenn. Acts, ch. 371, s 2, eff. 5/4/2015.
(a) A prescriber shall allow for substitution with an interchangeable biological product of a prescribed biological product under all circumstances unless: (1) The prescriber determines the medical necessity of a prescribed biological product due to: (A) An adverse reaction previously experienced by the patient to an interchangeable biological product; (B) An interchangeable biological product having previously been demonstrated as ineffective for the patient; or (C) Any other clinically based, prescriber-determined need; or (2) An interchangeable biological product is not available.
(1) The prescriber determines the medical necessity of a prescribed biological product due to: (A) An adverse reaction previously experienced by the patient to an interchangeable biological product; (B) An interchangeable biological product having previously been demonstrated as ineffective for the patient; or (C) Any other clinically based, prescriber-determined need; or
(A) An adverse reaction previously experienced by the patient to an interchangeable biological product;
(B) An interchangeable biological product having previously been demonstrated as ineffective for the patient; or
(C) Any other clinically based, prescriber-determined need; or
(2) An interchangeable biological product is not available.
(b) (1) If the prescriber determines a prescribed biological product is medically necessary for a patient, the prescriber shall, in the prescriber's own handwriting, place the instructions showing intent upon the prescription at the time it is prepared and issued. (2) For the purposes of this subsection (b), "instructions showing intent" includes, but is not limited to, the following language: (A) "Brand name medically necessary," "dispense as written," "medically necessary," "brand name," or "no generic"; (B) Any abbreviation of the language in subdivision (b)(1)(A); or (C) Any other prescriber handwritten notation, such as circling a preprinted instruction to dispense as written on the prescription order, that clearly conveys the intent that a brand name is necessary for this patient.
(1) If the prescriber determines a prescribed biological product is medically necessary for a patient, the prescriber shall, in the prescriber's own handwriting, place the instructions showing intent upon the prescription at the time it is prepared and issued.
(2) For the purposes of this subsection (b), "instructions showing intent" includes, but is not limited to, the following language: (A) "Brand name medically necessary," "dispense as written," "medically necessary," "brand name," or "no generic"; (B) Any abbreviation of the language in subdivision (b)(1)(A); or (C) Any other prescriber handwritten notation, such as circling a preprinted instruction to dispense as written on the prescription order, that clearly conveys the intent that a brand name is necessary for this patient.
(A) "Brand name medically necessary," "dispense as written," "medically necessary," "brand name," or "no generic";
(B) Any abbreviation of the language in subdivision (b)(1)(A); or
(C) Any other prescriber handwritten notation, such as circling a preprinted instruction to dispense as written on the prescription order, that clearly conveys the intent that a brand name is necessary for this patient.
(c) If the prescriber determines that a prescribed biological product is medically necessary for a patient and the prescription order is issued orally, the prescriber shall alert the pharmacist that use of the prescribed biological product is medically necessary for the patient.
(d) If the prescriber determines that a prescribed biological product is medically necessary for a patient and the prescription order is issued by the prescriber in the form of an electronic prescription order or facsimile prescription order, the prescriber shall place, or cause to be placed, the proper instruction on the electronic prescription order or facsimile prescription order prior to it being transmitted to the pharmacist.
(e) Nothing in this section shall prevent a prescriber or dispenser from informing a patient of the prescriber or dispenser's professional opinion as to the capabilities, effectiveness, and acceptability of any biological product.
(f) A pharmacist who selects an interchangeable biological product for substitution, pursuant to this section, has the same responsibility for the selected product as the pharmacist would in dispensing a prescription for the product prescribed.
(g) The manufacturer, packager, or distributor of any human use legend drug or biological product sold, delivered, or offered for sale in this state shall have printed on the label of the immediate container of the biological product the name and address of the manufacturer, packager, or distributor of the finished dosage form of the biological product.
(h) The pharmacist shall notify the patient of the substitution with an interchangeable biological product by noting the substitution on the prescription label.
(i) Within five (5) business days following the dispensing of a biological product, the dispensing pharmacist or the pharmacist's designee shall communicate to the prescriber the specific product provided to the patient, including the name of the product and the manufacturer. The communication shall be conveyed by making an entry in an interoperable electronic medical records system, through an electronic prescribing technology or a pharmacy record that can be accessed electronically by the prescriber, or as set forth in a collaborative pharmacy practice agreement as defined in § 63-10-217 ; otherwise, the pharmacist or the pharmacist's designee shall communicate to the prescriber the biological product dispensed to the patient, using facsimile, telephone, electronic transmission, or other prevailing means; provided, that communication shall not be required where: (1) There is no FDA-approved interchangeable biological product for the product prescribed; or (2) A prescription is not changed from the product dispensed on the prior filling of the prescription.
(1) There is no FDA-approved interchangeable biological product for the product prescribed; or
(2) A prescription is not changed from the product dispensed on the prior filling of the prescription.
(j) This section shall not apply to prescriptions administered to patients in a hospital, a nursing home, or an assisted-care living facility, as defined in § 68-11-201 .
(k) The notification and communication requirements in this section shall not apply to vaccines.
(l) The board of pharmacy shall maintain a link on its website to the current list of all biological products determined by the federal food and drug administration to be interchangeable biological products.
(m) The pharmacist shall maintain a record of the biological product dispensed as required pursuant to § 53-14-110 .
(n) If this state mandates electronic medical records between a pharmacist and a prescriber as described in subsection (i), then the pharmacist shall only be required to communicate the biological product dispensed through an electronic medical records system when such a system is in place and the information is accessible to prescribers.
Added by 2015 Tenn. Acts, ch. 371, s 2, eff. 5/4/2015.
Tenn. Code Ann. § 53-1-204 — TN Code / Title 53 / Chapter 1 / Section 53-1-204
License requirements - Issuance - Expiration - Fees
Status: in_force

(a) (1) Except as provided in § 53-1-118 , a person shall not manufacture, process, pack, or hold food for introduction into commerce unless the person holds a valid license issued by the commissioner. (2) (A) Applicants for licensure shall apply for the license on forms provided by the commissioner. (B) The commissioner may issue a license to an applicant only upon receipt of the proper license fee and an inspection of the applicant's facility that indicates the applicant is in compliance with the requirements of this chapter and the rules promulgated thereunder. (C) Licenses issued under this section expire on July 1 of each year, or as the commissioner may otherwise provide by rule. (D) The commissioner shall set annual fees for licenses issued under this section by rule pursuant to § 43-1-703 . (b) The commissioner shall set, by rule under § 43-1-703 , a fee for a certificate of free sale. (c) [Deleted by 2022 amendment.] (d) [Deleted by 2022 amendment.] Amended by 2022 Tenn. Acts, ch. 862, s 5, eff. 7/1/2022. Amended by 2022 Tenn. Acts, ch. 862, s 4, eff. 7/1/2022. Added by 2021 Tenn. Acts, ch. 202, s 1, eff. 4/22/2021. Acts 1941, ch. 120, § 8; C. Supp. 1950, § 6580.8; T.C.A. (orig. ed.), § 52-108.
(a) (1) Except as provided in § 53-1-118 , a person shall not manufacture, process, pack, or hold food for introduction into commerce unless the person holds a valid license issued by the commissioner. (2) (A) Applicants for licensure shall apply for the license on forms provided by the commissioner. (B) The commissioner may issue a license to an applicant only upon receipt of the proper license fee and an inspection of the applicant's facility that indicates the applicant is in compliance with the requirements of this chapter and the rules promulgated thereunder. (C) Licenses issued under this section expire on July 1 of each year, or as the commissioner may otherwise provide by rule. (D) The commissioner shall set annual fees for licenses issued under this section by rule pursuant to § 43-1-703 .
(1) Except as provided in § 53-1-118 , a person shall not manufacture, process, pack, or hold food for introduction into commerce unless the person holds a valid license issued by the commissioner.
(2) (A) Applicants for licensure shall apply for the license on forms provided by the commissioner. (B) The commissioner may issue a license to an applicant only upon receipt of the proper license fee and an inspection of the applicant's facility that indicates the applicant is in compliance with the requirements of this chapter and the rules promulgated thereunder. (C) Licenses issued under this section expire on July 1 of each year, or as the commissioner may otherwise provide by rule. (D) The commissioner shall set annual fees for licenses issued under this section by rule pursuant to § 43-1-703 .
(A) Applicants for licensure shall apply for the license on forms provided by the commissioner.
(B) The commissioner may issue a license to an applicant only upon receipt of the proper license fee and an inspection of the applicant's facility that indicates the applicant is in compliance with the requirements of this chapter and the rules promulgated thereunder.
(C) Licenses issued under this section expire on July 1 of each year, or as the commissioner may otherwise provide by rule.
(D) The commissioner shall set annual fees for licenses issued under this section by rule pursuant to § 43-1-703 .
(b) The commissioner shall set, by rule under § 43-1-703 , a fee for a certificate of free sale.
(c) [Deleted by 2022 amendment.]
(d) [Deleted by 2022 amendment.]
Amended by 2022 Tenn. Acts, ch. 862, s 5, eff. 7/1/2022.
Amended by 2022 Tenn. Acts, ch. 862, s 4, eff. 7/1/2022.
Added by 2021 Tenn. Acts, ch. 202, s 1, eff. 4/22/2021.
Acts 1941, ch. 120, § 8; C. Supp. 1950, § 6580.8; T.C.A. (orig. ed.), § 52-108.
Tenn. Code Ann. § 53-8-123 — TN Code / Title 53 / Chapter 8 / Section 53-8-123
Limited authority of local government to regulate food or drink
Status: in_force

(a) Notwithstanding any law to the contrary, and except for subdivision (c)(1), the local government's authority under title 13, chapters 7, 16, and 28, and the local government's authority to regulate roadways, traffic, and the provision of utility services, this state is the exclusive regulator of food and drink sellers, vendors, vending machine operators, food establishments, and food service establishments in this state. (b) A local government, as that term is defined in § 7-51-2001 , shall not impose a tax, fee, or otherwise regulate the wholesale or retail sale, manufacture, or distribution of any food or drink, food or drink content, amount of food or drink content, or food or drink ingredients, except as authorized under title 67, chapter 6, or § 67-4-504 , or pursuant to a contract with the department of agriculture. (c) This section: (1) Does not prohibit a local government from regulating zoning, building codes, locations, hours of operation, or the issuance of permits, or from performing any other local governmental functions as authorized by existing state law, with respect to food and drink sellers and vendors, vending machine operators, food establishments, and food service establishments; and (2) Applies to both the sale and distribution of food or drink by food and drink sellers, food establishments, food service establishments, manufacturers of food and drink products regulated under chapter 1 of this title, and vending machines. Acts 2019, ch. 158, § 2; T.C.A., § 53-8-223 .
(a) Notwithstanding any law to the contrary, and except for subdivision (c)(1), the local government's authority under title 13, chapters 7, 16, and 28, and the local government's authority to regulate roadways, traffic, and the provision of utility services, this state is the exclusive regulator of food and drink sellers, vendors, vending machine operators, food establishments, and food service establishments in this state.
(b) A local government, as that term is defined in § 7-51-2001 , shall not impose a tax, fee, or otherwise regulate the wholesale or retail sale, manufacture, or distribution of any food or drink, food or drink content, amount of food or drink content, or food or drink ingredients, except as authorized under title 67, chapter 6, or § 67-4-504 , or pursuant to a contract with the department of agriculture.
(c) This section: (1) Does not prohibit a local government from regulating zoning, building codes, locations, hours of operation, or the issuance of permits, or from performing any other local governmental functions as authorized by existing state law, with respect to food and drink sellers and vendors, vending machine operators, food establishments, and food service establishments; and (2) Applies to both the sale and distribution of food or drink by food and drink sellers, food establishments, food service establishments, manufacturers of food and drink products regulated under chapter 1 of this title, and vending machines.
(1) Does not prohibit a local government from regulating zoning, building codes, locations, hours of operation, or the issuance of permits, or from performing any other local governmental functions as authorized by existing state law, with respect to food and drink sellers and vendors, vending machine operators, food establishments, and food service establishments; and
(2) Applies to both the sale and distribution of food or drink by food and drink sellers, food establishments, food service establishments, manufacturers of food and drink products regulated under chapter 1 of this title, and vending machines.
Acts 2019, ch. 158, § 2; T.C.A., § 53-8-223 .
Tenn. Code Ann. § 53-8-101 — TN Code / Title 53 / Chapter 8 / Section 53-8-101
Short title
Status: in_force

This chapter shall be known as the "Tennessee Retail Food Safety Act." Repealed by 2017 Tenn. Acts, ch. 150, s 5, eff. 4/17/2017. Acts 1909, ch. 473, §§ 1, 2; 1913 (1st E.S.), ch. 15, § 1; Shan., §§ 3473a41, 3473a43; mod. Code 1932, §§ 6598, 6600; T.C.A. (orig. ed.), §§ 53-1001, 53-1002.
This chapter shall be known as the "Tennessee Retail Food Safety Act."
Repealed by 2017 Tenn. Acts, ch. 150, s 5, eff. 4/17/2017.
Acts 1909, ch. 473, §§ 1, 2; 1913 (1st E.S.), ch. 15, § 1; Shan., §§ 3473a41, 3473a43; mod. Code 1932, §§ 6598, 6600; T.C.A. (orig. ed.), §§ 53-1001, 53-1002.
Tenn. Code Ann. § 53-1-101 — TN Code / Title 53 / Chapter 1 / Section 53-1-101
Administration - Short title
Status: in_force

This chapter shall be administered by the state department of agriculture and shall be known and may be cited as the "Tennessee Food, Drug and Cosmetic Act." Acts 1941, ch. 120, § 1; C. Supp. 1950, § 6580.1; T.C.A. (orig. ed.), § 52-101.
This chapter shall be administered by the state department of agriculture and shall be known and may be cited as the "Tennessee Food, Drug and Cosmetic Act."
Acts 1941, ch. 120, § 1; C. Supp. 1950, § 6580.1; T.C.A. (orig. ed.), § 52-101.
Tenn. Code Ann. § 53-1-103 — TN Code / Title 53 / Chapter 1 / Section 53-1-103
Prohibited acts - Penalties - Exceptions
Status: in_force

(a) The following acts, and the causing of the following acts, within the state are prohibited: (1) The manufacture, sale, or delivery, holding or offering for sale of any food, drug, device or cosmetic that is adulterated or misbranded; (2) The adulteration or misbranding of any food, drug, device or cosmetic; (3) The receipt of any food, drug, device or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery of any food, drug, device or cosmetic that is adulterated or misbranded for pay or otherwise; (4) The sale, delivery for sale, holding for sale, or offering for sale of any article in violation of § 53-1-110 , § 53-1-201 , § 53-1-203 , § 53-1-204 , or any rule promulgated thereunder; (5) The dissemination, in any manner or by any means or through any medium, of any false advertisement or for any advertising medium to knowingly publish false or misleading advertising; (6) The refusal to permit: (A) Entry or inspection, or refusal to permit the taking of a sample, as authorized by § 53-1-203 ; or (B) Access to or copying of any record as authorized by § 53-1-203 ; (7) The giving of a guaranty or undertaking, which guaranty or undertaking is false, except by a person who relied on a guaranty or undertaking to the same effect signed by, and containing the name and address of the person residing in the United States from whom this person received in good faith the food, drug, device or cosmetic; (8) The removal or disposal of a detained or embargoed article in violation of § 53-1-201 ; (9) The alteration, mutilation, destruction, obliteration or removal of the whole or any part of the labeling of, or the doing of any other act with respect to, a food, drug, device or cosmetic, if the act is done while the article is held for sale and results in the article's being misbranded; (10) The forging, counterfeiting, simulating or falsely representing, or without proper authority using any mark, stamp, tag, label or other identification device authorized or required by regulations promulgated under this chapter; (11) The using, on the labeling of any drug or in any advertisement relating to the drug, of any representation or suggestion that an application with respect to the drug is effective under § 53-1-110 , or that the drug complies with § 53-1-110 ; (12) The sale of alcohol in violation of rules and regulations adopted by the United States treasury department, alcohol tax division, or by the department of revenue or the alcoholic beverage commission; (13) The sale by vending machines of any drugs that are capable of causing physical or mental harm if taken internally in overdoses; (14) The manufacture, sale, or delivery, holding or offering for sale of any food, drug, device or cosmetic that contains any level of radiation or any amount of pesticide residue, food additive, color additive or other substance, in excess of the amount adopted or prescribed by regulation of the commissioner under authority of § 53-1-107 ; or (15) The sale, delivery, holding, processing, or offering for sale any salvageable merchandise in violation of this chapter or any regulation promulgated under this chapter. (b) (1) Any person who violates subsection (a) commits a Class C misdemeanor. (2) No person shall be subject to the penalties of subdivision (b)(1) for having violated subdivision (a)(1) or (a)(3) if the person established a guaranty or undertaking signed by, and containing the name and address of, the person residing in the United States from whom the person received in good faith the article, to the effect that the article is not adulterated or misbranded within the meaning of this chapter. (c) No publisher, radio-broadcast licensee, or agency or medium for the dissemination of an advertisement, except the manufacturer, packer, distributor, or seller of the article to which a false advertisement relates, shall be liable under this section by reason of the dissemination by the publisher, licensee, agency or medium of the false advertisement unless the publisher, licensee, agency or medium has refused, on the request of the commissioner, to furnish the commissioner with the name and post office address of the manufacturer, packer, distributor, seller or advertising agency, who caused the publisher, licensee, agency or medium to disseminate the advertisement. Amended by 2021 Tenn. Acts, ch. 202, Secs.s2, s3, s4, s5 eff. 4/22/2021. Amended by 2017 Tenn. Acts, ch. 150, s 1, eff. 4/17/2017. Acts 1941, ch. 120, §§ 3, 5; C. Supp. 1950, §§ 6580.3, 6580.5; impl. am. Acts 1959, ch. 9, § 14; Acts 1961, ch. 55, § 2; 1963, ch. 226, § 1; impl. am. Acts 1963, chs. 257-259; Acts 1967, ch. 42, § 2; 1971, ch. 163, § 44; 1974, ch. 626, § 1; 1976, ch. 658, § 2; T.C.A. (orig. ed.), §§ 52-103, 52-105; Acts 1989, ch. 591, § 113.
(a) The following acts, and the causing of the following acts, within the state are prohibited: (1) The manufacture, sale, or delivery, holding or offering for sale of any food, drug, device or cosmetic that is adulterated or misbranded; (2) The adulteration or misbranding of any food, drug, device or cosmetic; (3) The receipt of any food, drug, device or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery of any food, drug, device or cosmetic that is adulterated or misbranded for pay or otherwise; (4) The sale, delivery for sale, holding for sale, or offering for sale of any article in violation of § 53-1-110 , § 53-1-201 , § 53-1-203 , § 53-1-204 , or any rule promulgated thereunder; (5) The dissemination, in any manner or by any means or through any medium, of any false advertisement or for any advertising medium to knowingly publish false or misleading advertising; (6) The refusal to permit: (A) Entry or inspection, or refusal to permit the taking of a sample, as authorized by § 53-1-203 ; or (B) Access to or copying of any record as authorized by § 53-1-203 ; (7) The giving of a guaranty or undertaking, which guaranty or undertaking is false, except by a person who relied on a guaranty or undertaking to the same effect signed by, and containing the name and address of the person residing in the United States from whom this person received in good faith the food, drug, device or cosmetic; (8) The removal or disposal of a detained or embargoed article in violation of § 53-1-201 ; (9) The alteration, mutilation, destruction, obliteration or removal of the whole or any part of the labeling of, or the doing of any other act with respect to, a food, drug, device or cosmetic, if the act is done while the article is held for sale and results in the article's being misbranded; (10) The forging, counterfeiting, simulating or falsely representing, or without proper authority using any mark, stamp, tag, label or other identification device authorized or required by regulations promulgated under this chapter; (11) The using, on the labeling of any drug or in any advertisement relating to the drug, of any representation or suggestion that an application with respect to the drug is effective under § 53-1-110 , or that the drug complies with § 53-1-110 ; (12) The sale of alcohol in violation of rules and regulations adopted by the United States treasury department, alcohol tax division, or by the department of revenue or the alcoholic beverage commission; (13) The sale by vending machines of any drugs that are capable of causing physical or mental harm if taken internally in overdoses; (14) The manufacture, sale, or delivery, holding or offering for sale of any food, drug, device or cosmetic that contains any level of radiation or any amount of pesticide residue, food additive, color additive or other substance, in excess of the amount adopted or prescribed by regulation of the commissioner under authority of § 53-1-107 ; or (15) The sale, delivery, holding, processing, or offering for sale any salvageable merchandise in violation of this chapter or any regulation promulgated under this chapter.
(1) The manufacture, sale, or delivery, holding or offering for sale of any food, drug, device or cosmetic that is adulterated or misbranded;
(2) The adulteration or misbranding of any food, drug, device or cosmetic;
(3) The receipt of any food, drug, device or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery of any food, drug, device or cosmetic that is adulterated or misbranded for pay or otherwise;
(4) The sale, delivery for sale, holding for sale, or offering for sale of any article in violation of § 53-1-110 , § 53-1-201 , § 53-1-203 , § 53-1-204 , or any rule promulgated thereunder;
(5) The dissemination, in any manner or by any means or through any medium, of any false advertisement or for any advertising medium to knowingly publish false or misleading advertising;
(6) The refusal to permit: (A) Entry or inspection, or refusal to permit the taking of a sample, as authorized by § 53-1-203 ; or (B) Access to or copying of any record as authorized by § 53-1-203 ;
(A) Entry or inspection, or refusal to permit the taking of a sample, as authorized by § 53-1-203 ; or
(B) Access to or copying of any record as authorized by § 53-1-203 ;
(7) The giving of a guaranty or undertaking, which guaranty or undertaking is false, except by a person who relied on a guaranty or undertaking to the same effect signed by, and containing the name and address of the person residing in the United States from whom this person received in good faith the food, drug, device or cosmetic;
(8) The removal or disposal of a detained or embargoed article in violation of § 53-1-201 ;
(9) The alteration, mutilation, destruction, obliteration or removal of the whole or any part of the labeling of, or the doing of any other act with respect to, a food, drug, device or cosmetic, if the act is done while the article is held for sale and results in the article's being misbranded;
(10) The forging, counterfeiting, simulating or falsely representing, or without proper authority using any mark, stamp, tag, label or other identification device authorized or required by regulations promulgated under this chapter;
(11) The using, on the labeling of any drug or in any advertisement relating to the drug, of any representation or suggestion that an application with respect to the drug is effective under § 53-1-110 , or that the drug complies with § 53-1-110 ;
(12) The sale of alcohol in violation of rules and regulations adopted by the United States treasury department, alcohol tax division, or by the department of revenue or the alcoholic beverage commission;
(13) The sale by vending machines of any drugs that are capable of causing physical or mental harm if taken internally in overdoses;
(14) The manufacture, sale, or delivery, holding or offering for sale of any food, drug, device or cosmetic that contains any level of radiation or any amount of pesticide residue, food additive, color additive or other substance, in excess of the amount adopted or prescribed by regulation of the commissioner under authority of § 53-1-107 ; or
(15) The sale, delivery, holding, processing, or offering for sale any salvageable merchandise in violation of this chapter or any regulation promulgated under this chapter.
(b) (1) Any person who violates subsection (a) commits a Class C misdemeanor. (2) No person shall be subject to the penalties of subdivision (b)(1) for having violated subdivision (a)(1) or (a)(3) if the person established a guaranty or undertaking signed by, and containing the name and address of, the person residing in the United States from whom the person received in good faith the article, to the effect that the article is not adulterated or misbranded within the meaning of this chapter.
(1) Any person who violates subsection (a) commits a Class C misdemeanor.
(2) No person shall be subject to the penalties of subdivision (b)(1) for having violated subdivision (a)(1) or (a)(3) if the person established a guaranty or undertaking signed by, and containing the name and address of, the person residing in the United States from whom the person received in good faith the article, to the effect that the article is not adulterated or misbranded within the meaning of this chapter.
(c) No publisher, radio-broadcast licensee, or agency or medium for the dissemination of an advertisement, except the manufacturer, packer, distributor, or seller of the article to which a false advertisement relates, shall be liable under this section by reason of the dissemination by the publisher, licensee, agency or medium of the false advertisement unless the publisher, licensee, agency or medium has refused, on the request of the commissioner, to furnish the commissioner with the name and post office address of the manufacturer, packer, distributor, seller or advertising agency, who caused the publisher, licensee, agency or medium to disseminate the advertisement.
Amended by 2021 Tenn. Acts, ch. 202, Secs.s2, s3, s4, s5 eff. 4/22/2021.
Amended by 2017 Tenn. Acts, ch. 150, s 1, eff. 4/17/2017.
Acts 1941, ch. 120, §§ 3, 5; C. Supp. 1950, §§ 6580.3, 6580.5; impl. am. Acts 1959, ch. 9, § 14; Acts 1961, ch. 55, § 2; 1963, ch. 226, § 1; impl. am. Acts 1963, chs. 257-259; Acts 1967, ch. 42, § 2; 1971, ch. 163, § 44; 1974, ch. 626, § 1; 1976, ch. 658, § 2; T.C.A. (orig. ed.), §§ 52-103, 52-105; Acts 1989, ch. 591, § 113.
Tenn. Code Ann. § 53-3-117 — TN Code / Title 53 / Chapter 3 / Section 53-3-117
Disposition of funds
Status: in_force

(a) All licenses, registration and inspection fees collected under this chapter shall be paid into the state treasury. (b) The fees are appropriated exclusively to the department to be used solely and specifically in carrying out this chapter. Acts 1970, ch. 577, § 2; T.C.A., § 52-317.
(a) All licenses, registration and inspection fees collected under this chapter shall be paid into the state treasury.
(b) The fees are appropriated exclusively to the department to be used solely and specifically in carrying out this chapter.
Acts 1970, ch. 577, § 2; T.C.A., § 52-317.
Tenn. Code Ann. § 53-7-206 — TN Code / Title 53 / Chapter 7 / Section 53-7-206
Prohibited acts
Status: in_force

The following acts or the causing of the following acts within this state is prohibited: (1) The processing for, or the sale or offering for sale, transportation, or delivery or receiving for transportation, in intrastate commerce, of any livestock carcass or part of any livestock carcass, meat food product, or poultry product, unless the article has been inspected for wholesomeness, and unless the article and its shipping container and immediate container, if any, are marked in accordance with the requirements under this part or the federal Meat Inspection Act ( 21 U.S.C. § 601 et seq.), or the federal Poultry Products Inspection Act ( 21 U.S.C. § 451 et seq.); (2) The sale or other disposition for human food of any livestock, deer, or poultry carcass or part of any livestock, deer, or poultry carcass, meat food product, or poultry product that has been inspected and declared to be unwholesome or adulterated under this part; (3) Falsely making or issuing, altering, forging, simulating, or counterfeiting, or using without proper authority any official inspection certificate, memorandum, mark, or other identification, or device for making the mark or identification, used in connection with inspection under this part, or causing, procuring, aiding, assisting in, or being a party to, the false making, issuing, altering, forging, simulating, counterfeiting, or unauthorized use, or knowingly processing, without promptly notifying the commissioner or the commissioner's representative, uttering, publishing, or using as true, or causing to be uttered, published, or used as true, any falsely made or issued, altered, forged, simulated, or counterfeited official inspection certificate, memorandum, mark, or other identification, or device for making the mark or identification, or representing that any article has been officially inspected under the authority of this part when the article has in fact not been so inspected, or knowingly making any false representation in any certificate prescribed by the commissioner in rules or regulations under this part or any form resembling the certificate; (4) Using in intrastate commerce a false or misleading label on any livestock, deer, or poultry carcass or part of any livestock, deer, or poultry carcass, meat food product, or poultry product; (5) Engaging in or abetting another in bait and switch tactics in promoting for sale and selling livestock and poultry carcasses or parts of any livestock or poultry carcass, or meat products or poultry products and using false or misleading advertisements or for any advertising medium to knowingly publish false or misleading advertising; (6) Using any container bearing an official inspection mark, except for the article in the original form in which it was inspected and covered by the mark, unless the mark is removed, obliterated or otherwise destroyed; (7) Refusing to permit access by any duly authorized representative of the commissioner, at all reasonable times, to the premises of an establishment in this state at which livestock or poultry are slaughtered or livestock, deer, or poultry carcasses or parts of livestock, deer, or poultry carcasses, meat, meat food products, or poultry products are processed for intrastate commerce, upon presentation of appropriate credentials; (8) Refusing to permit access to and the copying of any record as authorized by § 53-7-208 ; (9) Using by any person to the person's own advantage, or revealing, other than to the authorized representatives of any government agency in their official capacity, or to the courts when relevant in any judicial proceeding, any information acquired under the authority of this part, concerning any matter that is entitled to protection as a trade secret; (10) Holding, delivering, receiving, transporting, selling, or offering for sale or transportation in intrastate commerce, for human consumption, any uneviscerated slaughtered poultry, or any livestock, deer, or poultry carcass or part of any livestock, deer, or poultry carcass, meat food product or poultry product that has been processed in violation of any requirements under this part, except as may be authorized by and pursuant to rules and regulations prescribed by the commissioner; (11) Holding, delivering, receiving, transporting, selling, or offering for sale or transportation in intrastate commerce any livestock or poultry carcass or part of any livestock or poultry carcass, meat food product, or poultry product exempted under § 53-7-209 that is unwholesome or adulterated, and is intended for human consumption; (12) Applying to any livestock, deer, or poultry carcass or part of any livestock, deer, or poultry carcass, meat food product, or poultry product, or any container of any livestock, deer, or poultry carcass or any part of any livestock, deer, or poultry carcass, meat food product or poultry product, any official inspection mark or label required under this part, except by, or under the supervision of, an inspector; (13) Refusing to make application for a license and refusing to pay, or operating a plant without payment of all license and inspection fees; (14) Removing or selling any article detained or embargoed by an inspector; (15) Violating any rule or regulation as authorized by this part; (16) Disposing of or selling any dead, dying, diseased or disabled animals or poultry or carcasses or parts of any carcasses, except in a manner as prescribed by regulations of the commissioner; and (17) The continued operation of any custom or commercial slaughterhouse or meat or poultry processing establishment that is in an unsanitary condition or that fails to comply with the specifications and standards that have been established by regulation by the commissioner. Acts 1967, ch. 99, § 6; 1969, ch. 108, § 1; 1974, ch. 626, § 1; T.C.A., § 52-920; Acts 2007 , ch. 421, §§ 9-13.
The following acts or the causing of the following acts within this state is prohibited:
(1) The processing for, or the sale or offering for sale, transportation, or delivery or receiving for transportation, in intrastate commerce, of any livestock carcass or part of any livestock carcass, meat food product, or poultry product, unless the article has been inspected for wholesomeness, and unless the article and its shipping container and immediate container, if any, are marked in accordance with the requirements under this part or the federal Meat Inspection Act ( 21 U.S.C. § 601 et seq.), or the federal Poultry Products Inspection Act ( 21 U.S.C. § 451 et seq.);
(2) The sale or other disposition for human food of any livestock, deer, or poultry carcass or part of any livestock, deer, or poultry carcass, meat food product, or poultry product that has been inspected and declared to be unwholesome or adulterated under this part;
(3) Falsely making or issuing, altering, forging, simulating, or counterfeiting, or using without proper authority any official inspection certificate, memorandum, mark, or other identification, or device for making the mark or identification, used in connection with inspection under this part, or causing, procuring, aiding, assisting in, or being a party to, the false making, issuing, altering, forging, simulating, counterfeiting, or unauthorized use, or knowingly processing, without promptly notifying the commissioner or the commissioner's representative, uttering, publishing, or using as true, or causing to be uttered, published, or used as true, any falsely made or issued, altered, forged, simulated, or counterfeited official inspection certificate, memorandum, mark, or other identification, or device for making the mark or identification, or representing that any article has been officially inspected under the authority of this part when the article has in fact not been so inspected, or knowingly making any false representation in any certificate prescribed by the commissioner in rules or regulations under this part or any form resembling the certificate;
(4) Using in intrastate commerce a false or misleading label on any livestock, deer, or poultry carcass or part of any livestock, deer, or poultry carcass, meat food product, or poultry product;
(5) Engaging in or abetting another in bait and switch tactics in promoting for sale and selling livestock and poultry carcasses or parts of any livestock or poultry carcass, or meat products or poultry products and using false or misleading advertisements or for any advertising medium to knowingly publish false or misleading advertising;
(6) Using any container bearing an official inspection mark, except for the article in the original form in which it was inspected and covered by the mark, unless the mark is removed, obliterated or otherwise destroyed;
(7) Refusing to permit access by any duly authorized representative of the commissioner, at all reasonable times, to the premises of an establishment in this state at which livestock or poultry are slaughtered or livestock, deer, or poultry carcasses or parts of livestock, deer, or poultry carcasses, meat, meat food products, or poultry products are processed for intrastate commerce, upon presentation of appropriate credentials;
(8) Refusing to permit access to and the copying of any record as authorized by § 53-7-208 ;
(9) Using by any person to the person's own advantage, or revealing, other than to the authorized representatives of any government agency in their official capacity, or to the courts when relevant in any judicial proceeding, any information acquired under the authority of this part, concerning any matter that is entitled to protection as a trade secret;
(10) Holding, delivering, receiving, transporting, selling, or offering for sale or transportation in intrastate commerce, for human consumption, any uneviscerated slaughtered poultry, or any livestock, deer, or poultry carcass or part of any livestock, deer, or poultry carcass, meat food product or poultry product that has been processed in violation of any requirements under this part, except as may be authorized by and pursuant to rules and regulations prescribed by the commissioner;
(11) Holding, delivering, receiving, transporting, selling, or offering for sale or transportation in intrastate commerce any livestock or poultry carcass or part of any livestock or poultry carcass, meat food product, or poultry product exempted under § 53-7-209 that is unwholesome or adulterated, and is intended for human consumption;
(12) Applying to any livestock, deer, or poultry carcass or part of any livestock, deer, or poultry carcass, meat food product, or poultry product, or any container of any livestock, deer, or poultry carcass or any part of any livestock, deer, or poultry carcass, meat food product or poultry product, any official inspection mark or label required under this part, except by, or under the supervision of, an inspector;
(13) Refusing to make application for a license and refusing to pay, or operating a plant without payment of all license and inspection fees;
(14) Removing or selling any article detained or embargoed by an inspector;
(15) Violating any rule or regulation as authorized by this part;
(16) Disposing of or selling any dead, dying, diseased or disabled animals or poultry or carcasses or parts of any carcasses, except in a manner as prescribed by regulations of the commissioner; and
(17) The continued operation of any custom or commercial slaughterhouse or meat or poultry processing establishment that is in an unsanitary condition or that fails to comply with the specifications and standards that have been established by regulation by the commissioner.
Acts 1967, ch. 99, § 6; 1969, ch. 108, § 1; 1974, ch. 626, § 1; T.C.A., § 52-920; Acts 2007 , ch. 421, §§ 9-13.
Tenn. Code Ann. § 53-7-220 — TN Code / Title 53 / Chapter 7 / Section 53-7-220
Licensing of custom slaughterers - Fee
Status: in_force

(a) Upon application, custom slaughterers shall also be licensed by the department of agriculture for the same periods of time as other licensees; provided, that the custom slaughterers first satisfy the commissioner that they are qualified and competent to conduct their operations in conformity with the applicable provisions of this part and regulations duly promulgated pursuant to this part. (b) No person shall engage in custom slaughtering or deer processing without first being licensed. (c) The department shall collect from each custom slaughterer or deer processor an annual license fee set by rule pursuant to § 43-1-703 . Amended by 2015 Tenn. Acts, ch. 485,s 37, eff. 7/1/2015. Acts 1967, ch. 99, § 20; T.C.A., § 52-934; Acts 2007, ch. 421, § 19.
(a) Upon application, custom slaughterers shall also be licensed by the department of agriculture for the same periods of time as other licensees; provided, that the custom slaughterers first satisfy the commissioner that they are qualified and competent to conduct their operations in conformity with the applicable provisions of this part and regulations duly promulgated pursuant to this part.
(b) No person shall engage in custom slaughtering or deer processing without first being licensed.
(c) The department shall collect from each custom slaughterer or deer processor an annual license fee set by rule pursuant to § 43-1-703 .
Amended by 2015 Tenn. Acts, ch. 485,s 37, eff. 7/1/2015.
Acts 1967, ch. 99, § 20; T.C.A., § 52-934; Acts 2007, ch. 421, § 19.
Tenn. Code Ann. § 53-3-108 — TN Code / Title 53 / Chapter 3 / Section 53-3-108
Revocation of licenses and registrations - Reissuance
Status: in_force

(a) The commissioner has the authority to revoke any license or registration certificate for violation of any section of this chapter. Upon information received, the commissioner shall, by written notice, establish a hearing for the licensee or registrant. The hearing shall be held within fifteen (15) days from the date of the mailing of the notice. If, after the hearing, the commissioner revokes the license, then the right of appeal is reserved to the licensee or registrant. The commissioner has the power to subpoena any persons or records incident to the hearing and further to administer oaths to those giving evidence. In case of contumacy or refusal to obey a subpoena issued to any person, any circuit or chancery court of this state within the county in which the investigation is carried on, or in which the person guilty of contumacy or refusal to obey is found or resides or transacts business, or has the person's principal place of business, upon application by the commissioner, shall have jurisdiction to issue to the person an order requiring the person to appear before the commissioner at a specified time and place and then and there produce evidence, if so ordered, or there to give testimony touching the matter under investigation or subject of inquiry, or answer any question, and any failure to obey the order of the court may be punished by the court as a contempt of the order as provided by law. A court reporter shall be in attendance at all revocation hearings other than testers or samplers. (b) The action of the commissioner may be reviewed by petition for common law writ of certiorari addressed to the circuit or chancery court of Davidson County, and the petition shall be filed within ten (10) days from the date of the order of revocation issued by the commissioner. Upon the grant of the writ of certiorari, the commissioner shall certify to the court a complete transcript of the proceedings instituted before the commissioner. This certified transcript shall constitute the whole record, and no additional proof or evidence shall be considered by the circuit or chancery court of Davidson County. The decision of the commissioner shall remain final until the matter has been finally resolved by the courts. (c) If, after revocation of the licensee's or registrant's license or registration, the licensee or registrant complies with the requirements of the law as provided and makes manifest, in writing, the licensee's or registrant's intentions to immediately observe the law, upon payment of the cost of the hearing, the commissioner may reissue a new license or registration certificate upon payment of the required fees. Reapplication may be made on forms provided by the commissioner, except in no case will reissuance of a license or registration certificate be allowed where fraudulent manipulation of tests or records is shown. (d) It is the expressed intent of this section to preserve any appeal set forth in parts 2 and 3 of this chapter and to leave the appeal set forth in parts 2 and 3 of this chapter unaffected. Acts 1970, ch. 577, § 2; T.C.A., § 52-308.
(a) The commissioner has the authority to revoke any license or registration certificate for violation of any section of this chapter. Upon information received, the commissioner shall, by written notice, establish a hearing for the licensee or registrant. The hearing shall be held within fifteen (15) days from the date of the mailing of the notice. If, after the hearing, the commissioner revokes the license, then the right of appeal is reserved to the licensee or registrant. The commissioner has the power to subpoena any persons or records incident to the hearing and further to administer oaths to those giving evidence. In case of contumacy or refusal to obey a subpoena issued to any person, any circuit or chancery court of this state within the county in which the investigation is carried on, or in which the person guilty of contumacy or refusal to obey is found or resides or transacts business, or has the person's principal place of business, upon application by the commissioner, shall have jurisdiction to issue to the person an order requiring the person to appear before the commissioner at a specified time and place and then and there produce evidence, if so ordered, or there to give testimony touching the matter under investigation or subject of inquiry, or answer any question, and any failure to obey the order of the court may be punished by the court as a contempt of the order as provided by law. A court reporter shall be in attendance at all revocation hearings other than testers or samplers.
(b) The action of the commissioner may be reviewed by petition for common law writ of certiorari addressed to the circuit or chancery court of Davidson County, and the petition shall be filed within ten (10) days from the date of the order of revocation issued by the commissioner. Upon the grant of the writ of certiorari, the commissioner shall certify to the court a complete transcript of the proceedings instituted before the commissioner. This certified transcript shall constitute the whole record, and no additional proof or evidence shall be considered by the circuit or chancery court of Davidson County. The decision of the commissioner shall remain final until the matter has been finally resolved by the courts.
(c) If, after revocation of the licensee's or registrant's license or registration, the licensee or registrant complies with the requirements of the law as provided and makes manifest, in writing, the licensee's or registrant's intentions to immediately observe the law, upon payment of the cost of the hearing, the commissioner may reissue a new license or registration certificate upon payment of the required fees. Reapplication may be made on forms provided by the commissioner, except in no case will reissuance of a license or registration certificate be allowed where fraudulent manipulation of tests or records is shown.
(d) It is the expressed intent of this section to preserve any appeal set forth in parts 2 and 3 of this chapter and to leave the appeal set forth in parts 2 and 3 of this chapter unaffected.
Acts 1970, ch. 577, § 2; T.C.A., § 52-308.
Tenn. Code Ann. § 53-11-401 — TN Code / Title 53 / Chapter 11 / Section 53-11-401
Miscellaneous offenses - Penalties
Status: in_force

(a) It is unlawful for any person: (1) Who is subject to part 3 of this chapter, to distribute or dispense a controlled substance in violation of § 53-11-308 or to distribute or dispense any controlled substance for any purposes other than those authorized by and consistent with the person's professional or occupational licensure or registration law, or to distribute or dispense any controlled substance in a manner prohibited by the person's professional or occupational licensure or registration law; (2) Who is a registrant to manufacture a controlled substance not authorized by the registrant's registration, or to distribute or dispense a controlled substance not authorized by the registrant's registration to another registrant or other authorized person; (3) To refuse or fail to make, keep or furnish any record, notification, order form, statement, invoice or information required under part 3 of this chapter and this part, or title 39, chapter 17, part 4, except sanctions against a health care provider for the provider's failure to make a report required by § 53-11-309(a) shall be limited only to cases involving a pattern of willful failure to make such reports and, in those instances, the health care provider shall only be subject to a civil penalty assessed by the provider's licensing board; (4) To refuse an entry into any premises for any inspection authorized by part 3 of this chapter and this part, or title 39, chapter 17, part 4; or (5) Knowingly to keep or maintain any store, shop, warehouse, dwelling, building, vehicle, boat, aircraft or other structure or place that is resorted to by persons using controlled substances in violation of part 3 of this chapter and this part, or title 39, chapter 17, part 4, for the purpose of using these substances, or that is used for keeping or selling them in violation of part 3 of this chapter and this part, or title 39, chapter 17, part 4. (b) (1) A violation of this section is a Class D felony; provided, however, a healthcare provider who fails to make a report required by § 53-11-309 shall not be guilty of a felony and shall be punishable only by the sanctions set forth in subdivision (a)(3); and provided, further, that a person who fails to comply with § 53-11-308(h) or § 53-11-308(i) is not guilty of a felony and shall be punishable only by a civil penalty assessed by the provider's licensing board and only in cases involving a pattern of willful failure to comply. (2) Notwithstanding § 40-35-111 , regarding the authorized fine for a Class D felony, the authorized fine for a violation of this section shall be as follows: For a violation involving a Schedule I or II controlled substance $ 100,000 For a violation involving a Schedule III or IV controlled substance 50,000 For a violation involving a Schedule V or VI controlled substance 5,000 For a violation involving a Schedule VII controlled substance 1,000 For any other violation of this section not involving a scheduled controlled substance 20,000 (3) Nothing contained in this section shall preclude a prosecution under the general drug laws. Amended by 2022 Tenn. Acts, ch. 1061, s 3, eff. 7/1/2022. Amended by 2018 Tenn. Acts, ch. 901, s 2, eff. 7/1/2018. Acts 1971, ch. 163, § 28; 1976, ch. 579, § 1; T.C.A., § 52-1435; Acts 1990, ch. 980, § 13; 2010 , ch. 663, §§ 2, 3.
(a) It is unlawful for any person: (1) Who is subject to part 3 of this chapter, to distribute or dispense a controlled substance in violation of § 53-11-308 or to distribute or dispense any controlled substance for any purposes other than those authorized by and consistent with the person's professional or occupational licensure or registration law, or to distribute or dispense any controlled substance in a manner prohibited by the person's professional or occupational licensure or registration law; (2) Who is a registrant to manufacture a controlled substance not authorized by the registrant's registration, or to distribute or dispense a controlled substance not authorized by the registrant's registration to another registrant or other authorized person; (3) To refuse or fail to make, keep or furnish any record, notification, order form, statement, invoice or information required under part 3 of this chapter and this part, or title 39, chapter 17, part 4, except sanctions against a health care provider for the provider's failure to make a report required by § 53-11-309(a) shall be limited only to cases involving a pattern of willful failure to make such reports and, in those instances, the health care provider shall only be subject to a civil penalty assessed by the provider's licensing board; (4) To refuse an entry into any premises for any inspection authorized by part 3 of this chapter and this part, or title 39, chapter 17, part 4; or (5) Knowingly to keep or maintain any store, shop, warehouse, dwelling, building, vehicle, boat, aircraft or other structure or place that is resorted to by persons using controlled substances in violation of part 3 of this chapter and this part, or title 39, chapter 17, part 4, for the purpose of using these substances, or that is used for keeping or selling them in violation of part 3 of this chapter and this part, or title 39, chapter 17, part 4.
(1) Who is subject to part 3 of this chapter, to distribute or dispense a controlled substance in violation of § 53-11-308 or to distribute or dispense any controlled substance for any purposes other than those authorized by and consistent with the person's professional or occupational licensure or registration law, or to distribute or dispense any controlled substance in a manner prohibited by the person's professional or occupational licensure or registration law;
(2) Who is a registrant to manufacture a controlled substance not authorized by the registrant's registration, or to distribute or dispense a controlled substance not authorized by the registrant's registration to another registrant or other authorized person;
(3) To refuse or fail to make, keep or furnish any record, notification, order form, statement, invoice or information required under part 3 of this chapter and this part, or title 39, chapter 17, part 4, except sanctions against a health care provider for the provider's failure to make a report required by § 53-11-309(a) shall be limited only to cases involving a pattern of willful failure to make such reports and, in those instances, the health care provider shall only be subject to a civil penalty assessed by the provider's licensing board;
(4) To refuse an entry into any premises for any inspection authorized by part 3 of this chapter and this part, or title 39, chapter 17, part 4; or
(5) Knowingly to keep or maintain any store, shop, warehouse, dwelling, building, vehicle, boat, aircraft or other structure or place that is resorted to by persons using controlled substances in violation of part 3 of this chapter and this part, or title 39, chapter 17, part 4, for the purpose of using these substances, or that is used for keeping or selling them in violation of part 3 of this chapter and this part, or title 39, chapter 17, part 4.
(b) (1) A violation of this section is a Class D felony; provided, however, a healthcare provider who fails to make a report required by § 53-11-309 shall not be guilty of a felony and shall be punishable only by the sanctions set forth in subdivision (a)(3); and provided, further, that a person who fails to comply with § 53-11-308(h) or § 53-11-308(i) is not guilty of a felony and shall be punishable only by a civil penalty assessed by the provider's licensing board and only in cases involving a pattern of willful failure to comply. (2) Notwithstanding § 40-35-111 , regarding the authorized fine for a Class D felony, the authorized fine for a violation of this section shall be as follows: For a violation involving a Schedule I or II controlled substance $ 100,000 For a violation involving a Schedule III or IV controlled substance 50,000 For a violation involving a Schedule V or VI controlled substance 5,000 For a violation involving a Schedule VII controlled substance 1,000 For any other violation of this section not involving a scheduled controlled substance 20,000 (3) Nothing contained in this section shall preclude a prosecution under the general drug laws.
(1) A violation of this section is a Class D felony; provided, however, a healthcare provider who fails to make a report required by § 53-11-309 shall not be guilty of a felony and shall be punishable only by the sanctions set forth in subdivision (a)(3); and provided, further, that a person who fails to comply with § 53-11-308(h) or § 53-11-308(i) is not guilty of a felony and shall be punishable only by a civil penalty assessed by the provider's licensing board and only in cases involving a pattern of willful failure to comply.
(2) Notwithstanding § 40-35-111 , regarding the authorized fine for a Class D felony, the authorized fine for a violation of this section shall be as follows: For a violation involving a Schedule I or II controlled substance $ 100,000 For a violation involving a Schedule III or IV controlled substance 50,000 For a violation involving a Schedule V or VI controlled substance 5,000 For a violation involving a Schedule VII controlled substance 1,000 For any other violation of this section not involving a scheduled controlled substance 20,000
For a violation involving a Schedule I or II controlled substance $ 100,000 For a violation involving a Schedule III or IV controlled substance 50,000 For a violation involving a Schedule V or VI controlled substance 5,000 For a violation involving a Schedule VII controlled substance 1,000 For any other violation of this section not involving a scheduled controlled substance 20,000
For a violation involving a Schedule I or II controlled substance
$ 100,000
For a violation involving a Schedule III or IV controlled substance
50,000
For a violation involving a Schedule V or VI controlled substance
5,000
For a violation involving a Schedule VII controlled substance
1,000
For any other violation of this section not involving a scheduled controlled substance
20,000
(3) Nothing contained in this section shall preclude a prosecution under the general drug laws.
Amended by 2022 Tenn. Acts, ch. 1061, s 3, eff. 7/1/2022.
Amended by 2018 Tenn. Acts, ch. 901, s 2, eff. 7/1/2018.
Acts 1971, ch. 163, § 28; 1976, ch. 579, § 1; T.C.A., § 52-1435; Acts 1990, ch. 980, § 13; 2010 , ch. 663, §§ 2, 3.
Tenn. Code Ann. § 53-3-308 — TN Code / Title 53 / Chapter 3 / Section 53-3-308
Sale of milk to dairy or trade products plant
Status: in_force

In order to facilitate the production and sale of Tennessee prime milk, dairy cooperatives doing business in Tennessee shall sell any reasonable quantity of milk to a dairy products plant or trade products plant that processes or packages Tennessee prime milk at the request of any such plant. Acts 2010, ch. 627, § 9.
In order to facilitate the production and sale of Tennessee prime milk, dairy cooperatives doing business in Tennessee shall sell any reasonable quantity of milk to a dairy products plant or trade products plant that processes or packages Tennessee prime milk at the request of any such plant.
Acts 2010, ch. 627, § 9.
Tenn. Code Ann. § 53-1-115 — TN Code / Title 53 / Chapter 1 / Section 53-1-115
Use of the term "catfish" - Enforcement - Rules and regulations - Violations - Penalties - Hearing
Status: in_force

(a) (1) The term "catfish" shall not be used as a common name or brand name or used to advertise, distribute, or label any fish or fish product, except for those species within the definition of catfish set out in § 53-1-102 . (2) It is a violation of this section to use the term "catfish" in the advertisement, distribution, processing, labeling, or wholesale or retail sale of any of those species within the family of Siluridae , Clariidae and Pangasiidaae or any other species of fish not included within the definition of catfish set out in § 53-1-102 . (b) This section shall apply only to the advertisement, distribution, processing, labeling, or wholesale or retail sale of: (1) Unprepared or packaged imported catfish and imported catfish products; and (2) Unprepared or packaged fish and fish products described in subsection (a). (c) The commissioner shall enforce the requirements of this section and is authorized to promulgate rules and regulations pursuant to the Uniform Administrative Procedures Act, compiled in title 4, chapter 5, to implement this section. (d) In the event of a violation of this section, the commissioner is authorized to: (1) Order the processor, distributor, wholesaler or retailer to cease the distribution or sale of imported catfish or imported catfish products that are not labeled or are labeled in violation of this section; (2) Order the processor, distributor, wholesaler or retailer to cease the advertisement, distribution, labeling or sale of all other fish or fish products that are being advertised, distributed, labeled or sold in violation of this section; (3) Seek injunctive relief to stop practices that are in violation of this section; and (4) Order the processor, distributor, wholesaler or retailer to comply with this section or any rule or regulation promulgated pursuant to this section. (e) Any person who violates this section shall be subject to a civil penalty of not more than one thousand dollars ($1,000) for each violation. Each day of continued violation constitutes a separate violation. (f) Any person aggrieved by an order or civil penalty imposed by the commissioner shall be entitled to a hearing in accordance with the Uniform Administrative Procedures Act. Acts 2002, ch. 634, § 2.
(a) (1) The term "catfish" shall not be used as a common name or brand name or used to advertise, distribute, or label any fish or fish product, except for those species within the definition of catfish set out in § 53-1-102 . (2) It is a violation of this section to use the term "catfish" in the advertisement, distribution, processing, labeling, or wholesale or retail sale of any of those species within the family of Siluridae , Clariidae and Pangasiidaae or any other species of fish not included within the definition of catfish set out in § 53-1-102 .
(1) The term "catfish" shall not be used as a common name or brand name or used to advertise, distribute, or label any fish or fish product, except for those species within the definition of catfish set out in § 53-1-102 .
(2) It is a violation of this section to use the term "catfish" in the advertisement, distribution, processing, labeling, or wholesale or retail sale of any of those species within the family of Siluridae , Clariidae and Pangasiidaae or any other species of fish not included within the definition of catfish set out in § 53-1-102 .
(b) This section shall apply only to the advertisement, distribution, processing, labeling, or wholesale or retail sale of: (1) Unprepared or packaged imported catfish and imported catfish products; and (2) Unprepared or packaged fish and fish products described in subsection (a).
(1) Unprepared or packaged imported catfish and imported catfish products; and
(2) Unprepared or packaged fish and fish products described in subsection (a).
(c) The commissioner shall enforce the requirements of this section and is authorized to promulgate rules and regulations pursuant to the Uniform Administrative Procedures Act, compiled in title 4, chapter 5, to implement this section.
(d) In the event of a violation of this section, the commissioner is authorized to: (1) Order the processor, distributor, wholesaler or retailer to cease the distribution or sale of imported catfish or imported catfish products that are not labeled or are labeled in violation of this section; (2) Order the processor, distributor, wholesaler or retailer to cease the advertisement, distribution, labeling or sale of all other fish or fish products that are being advertised, distributed, labeled or sold in violation of this section; (3) Seek injunctive relief to stop practices that are in violation of this section; and (4) Order the processor, distributor, wholesaler or retailer to comply with this section or any rule or regulation promulgated pursuant to this section.
(1) Order the processor, distributor, wholesaler or retailer to cease the distribution or sale of imported catfish or imported catfish products that are not labeled or are labeled in violation of this section;
(2) Order the processor, distributor, wholesaler or retailer to cease the advertisement, distribution, labeling or sale of all other fish or fish products that are being advertised, distributed, labeled or sold in violation of this section;
(3) Seek injunctive relief to stop practices that are in violation of this section; and
(4) Order the processor, distributor, wholesaler or retailer to comply with this section or any rule or regulation promulgated pursuant to this section.
(e) Any person who violates this section shall be subject to a civil penalty of not more than one thousand dollars ($1,000) for each violation. Each day of continued violation constitutes a separate violation.
(f) Any person aggrieved by an order or civil penalty imposed by the commissioner shall be entitled to a hearing in accordance with the Uniform Administrative Procedures Act.
Acts 2002, ch. 634, § 2.
Tenn. Code Ann. § 53-14-103 — TN Code / Title 53 / Chapter 14 / Section 53-14-103
Chapter definitions
Status: in_force

As used in this chapter, unless the context otherwise requires: (1) "Board" means the board of pharmacy created by § 63-10-301 ; (2) "Commissioner" means the commissioner of health; (3) "Controlled substance analogues" is defined as in § 39-17-454 ; (4) "Controlled substances" is defined as in § 39-17-402 ; (5) "Director" means the director of the board of pharmacy elected pursuant to § 63-10-303 ; (6) "Legend drugs" is defined as in § 53-10-101 ; and (7) "Person" means an individual, corporation, government or governmental subdivision or agency, business trust, estate, trust, partnership or association, or any other legal entity. Acts 1984, ch. 717, §3; 2012 , ch. 848, § 50.
As used in this chapter, unless the context otherwise requires:
(1) "Board" means the board of pharmacy created by § 63-10-301 ;
(2) "Commissioner" means the commissioner of health;
(3) "Controlled substance analogues" is defined as in § 39-17-454 ;
(4) "Controlled substances" is defined as in § 39-17-402 ;
(5) "Director" means the director of the board of pharmacy elected pursuant to § 63-10-303 ;
(6) "Legend drugs" is defined as in § 53-10-101 ; and
(7) "Person" means an individual, corporation, government or governmental subdivision or agency, business trust, estate, trust, partnership or association, or any other legal entity.
Acts 1984, ch. 717, §3; 2012 , ch. 848, § 50.