Tennessee § 53-10-113 Off-label drug use

Tennessee Statutes

§ 53-10-113 — Off-label drug use

Tennessee § 53-10-113

Title53

This text of Tennessee § 53-10-113 (Off-label drug use) is published on Counsel Stack Legal Research, covering Tennessee primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook

Tenn. Code Ann. § 53-10-113 (2026).

Text

(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 co

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(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.