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

§ 53-10-113. Off-label drug use.

As used in this section, and unless the context otherwise requires: “Misbranding” means either the federal definition under 21 U.S.C. § 352 or drugs or devices that are misbranded under § 53-10-106; and “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. A pharmaceutical manufacturer or its representatives may engage in truthful promotion of off-label uses. 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. 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. 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. Effective Dates. Acts 2018, ch. 893 § 2. July 1, 2018.