Tennessee Statutes
§ 53-10-113 — Off-label drug use
Tennessee·Title 53
(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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Related
§ 352
21 U.S.C. § 352
Legislative History
Acts 2018 , ch. 893, § 1.
Nearby Sections
15
§ 53-1-101
Administration - Short title§ 53-1-102
Chapter definitions§ 53-1-103
Prohibited acts - Penalties - Exceptions§ 53-1-104
Food deemed adulterated§ 53-1-105
Food deemed misbranded§ 53-1-108
Drugs or devices deemed adulterated§ 53-1-110
Sale of new drugs§ 53-1-111
Cosmetics deemed adulterated§ 53-1-112
Cosmetics deemed misbranded§ 53-1-113
False advertising§ 53-1-114
Exemptions from labeling requirements