(a) As used in this section, and unless the context otherwise requires:

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Terms Used In Tennessee Code 53-10-113

  • Prosecute: To charge someone with a crime. A prosecutor tries a criminal case on behalf of the government.
  • Representative: when applied to those who represent a decedent, includes executors and administrators, unless the context implies heirs and distributees. See Tennessee Code 1-3-105
  • State: when applied to the different parts of the United States, includes the District of Columbia and the several territories of the United States. See Tennessee Code 1-3-105
  • United States: includes the District of Columbia and the several territories of the United States. See Tennessee Code 1-3-105
(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.
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