Tenn. Code Ann. § 53-10-113: Off-label drug use

(a) As used in this section, and unless the context otherwise requires: (1) "Misbranding" means either the federal definition under 21 U.S.C. § 352 or drugs or devices that are misbranded under § 53-10-106 ; and (2) "Off-label" means the use of a United States food and drug administration (FDA) approved drug, biological product, or device other than the use or uses approved by the FDA. (b) (1) A pharmaceutical manufacturer or its representatives may engage in truthful promotion of off-label uses. (2) This section does not require a health insurance entity, as defined in § 56-7-109 , other third-party payer, or other health plan sponsor to provide coverage for the cost of any off-label treatment. A health insurance entity, other third-party payer, or other health plan sponsor may provide coverage for an off-label treatment. (c) (1) Notwithstanding any other law, no official, employee, or agent of this state shall enforce or apply § 53-10-106(a)(2) against or otherwise prosecute a pharmaceutical manufacturer or its representatives for engaging in truthful promotion of off-label uses. (2) Notwithstanding any other law, no state regulatory board may revoke, fail to renew or take any other action against a pharmaceutical manufacturer's or representative's, healthcare institution's, or physician's license solely for engaging in truthful promotion of off-label uses. Acts 2018 , ch. 893, § 1.

(a) As used in this section, and unless the context otherwise requires: (1) "Misbranding" means either the federal definition under 21 U.S.C. § 352 or drugs or devices that are misbranded under § 53-10-106 ; and (2) "Off-label" means the use of a United States food and drug administration (FDA) approved drug, biological product, or device other than the use or uses approved by the FDA.

(1) "Misbranding" means either the federal definition under 21 U.S.C. § 352 or drugs or devices that are misbranded under § 53-10-106 ; and

(2) "Off-label" means the use of a United States food and drug administration (FDA) approved drug, biological product, or device other than the use or uses approved by the FDA.

(b) (1) A pharmaceutical manufacturer or its representatives may engage in truthful promotion of off-label uses. (2) This section does not require a health insurance entity, as defined in § 56-7-109 , other third-party payer, or other health plan sponsor to provide coverage for the cost of any off-label treatment. A health insurance entity, other third-party payer, or other health plan sponsor may provide coverage for an off-label treatment.

(1) A pharmaceutical manufacturer or its representatives may engage in truthful promotion of off-label uses.

(2) This section does not require a health insurance entity, as defined in § 56-7-109 , other third-party payer, or other health plan sponsor to provide coverage for the cost of any off-label treatment. A health insurance entity, other third-party payer, or other health plan sponsor may provide coverage for an off-label treatment.

representatives may engage in truthful promotion of off-label uses.

(2) This section does not require a health insurance entity, as defined in § 56-7-109 , other third-party payer, or other health plan sponsor to provide coverage for the cost of any off-label treatment. A health insurance entity, other third-party payer, or other health plan sponsor may provide coverage for an off-label treatment.

(c) (1) Notwithstanding any other law, no official, employee, or agent of this state shall enforce or apply § 53-10-106(a)(2) against or otherwise prosecute a pharmaceutical manufacturer or its representatives for engaging in truthful promotion of off-label uses. (2) Notwithstanding any other law, no state regulatory board may revoke, fail to renew or take any other action against a pharmaceutical manufacturer's or representative's, healthcare institution's, or physician's license solely for engaging in truthful promotion of off-label uses.

(1) Notwithstanding any other law, no official, employee, or agent of this state shall enforce or apply § 53-10-106(a)(2) against or otherwise prosecute a pharmaceutical manufacturer or its representatives for engaging in truthful promotion of off-label uses.

(2) Notwithstanding any other law, no state regulatory board may revoke, fail to renew or take any other action against a pharmaceutical manufacturer's or representative's, healthcare institution's, or physician's license solely for engaging in truthful promotion of off-label uses.