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tirzepatide · tennessee

Is Tirzepatide legal in Tennessee?

status · caveats apply
FDA-approved GIP/GLP-1 dual agonist (Mounjaro/Zepbound); compounded copies broadly restricted post-shortage; FDA has issued 30+ Warning Letters to GLP-1 telehealth vendors. Tennessee AG led 38-state coalition letter to FDA (Feb 20, 2025) on counterfeit GLP-1s; Nashville compounding pharmacy was shut down after state inspection.

category: fda approved · last verified May 13, 2026

§ 01

Quick answer

FDA-approved GIP/GLP-1 dual agonist (Mounjaro/Zepbound); compounded copies broadly restricted post-shortage; FDA has issued 30+ Warning Letters to GLP-1 telehealth vendors. Tennessee AG led 38-state coalition letter to FDA (Feb 20, 2025) on counterfeit GLP-1s; Nashville compounding pharmacy was shut down after state inspection.
§ 02

Full status breakdown

Federal status

FDA approval
approved as drug · brand: Mounjaro, Zepbound · NDA 215866 (Mounjaro); NDA 217806 (Zepbound) · approved May 13, 2022
Indications: T2DM; chronic weight management; OSA
DEA scheduling
not scheduled
503A compounding
Bulks list: not on list
Do-not-compound list: not on list
Approved drug; 503A 'essentially a copy' rule applies post-shortage. 503A enforcement discretion ended Feb 18, 2025; 503B Mar 19, 2025. FDA proposed April 2026 to exclude tirzepatide from 503B bulks list.
FDA Warning Letters
  • Dec 10, 2024 — Summit Research Peptides (cited: tirzepatide, retatrutide) · letter ↗
  • Sep 9, 2025 — Hims & Hers Health Inc dba Hers (cited: tirzepatide, semaglutide) · letter ↗
  • Feb 20, 2026 — Better Health Labs Inc dba Measured (cited: tirzepatide) · letter ↗
  • Mar 31, 2026 — Gram Peptides (cited: tirzepatide, retatrutide) · letter ↗
Shortage status
not currently on shortage list
Historical shortage window: Apr 1, 2024 → Dec 19, 2024
Sale framing
Research-use-only posture: RUO label does not legalize sale to consumers when site evidence shows human-use intent. FDA has issued 30+ warning letters across 2024-2026.
Personal possession: Federally unscheduled; possession by an end-user is not a federal criminal offense, but unapproved compounded/illicit tirzepatide carries FDA enforcement risk on the seller side plus state pharmacy law risk.

Tennessee — state-specific

ag enforcement · Tennessee

Tennessee AG led 38-state coalition letter to FDA (Feb 20, 2025) on counterfeit GLP-1s; Nashville compounding pharmacy was shut down after state inspection.

Sport-body status

WADA 2026
on prohibited list · class S2 · both
S2 (Peptide hormones / GLP-1 agonist class). WADA does not name tirzepatide explicitly; class-language capture.
USADA
NCAA

What we couldn’t verify

§ 03

Also known as

Tirzepatide is also marketed or referenced under the following names (vendor pseudonyms, brand names, chemical identifiers):

  • LY3298176
  • Mounjaro
  • Zepbound
  • GIP/GLP-1 dual agonist
  • Tirz
  • Tirze
§ 04

Disclaimer

§ 05

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