TCA 53-10-113
Off-label drug use
PENDINGUnknown
What does this charge mean?
Physicians may prescribe FDA-approved drugs for conditions other than those on the drug's label (off-label use) when medically appropriate, based on their professional judgment.
Penalty Details
ClassificationUnknown
Penalty SummaryClassification not specified
(a) As used in this section, and unless the context otherwise requires: Ask a legal question, get an answer ASAP!(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.
View on official sourceLast verified: Feb 26, 2026
Quick Facts
PENDING
TCA Section53-10-113