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Right to Try and Consented Regenerative Medicine

Last updated June 2026

This page is for general informational purposes only. It is not legal advice and not medical advice. Consult qualified legal counsel and a licensed physician before acting on anything described here. Nothing on this site is an offer to treat. Eligibility and informed consent are determined by licensed physicians under applicable law.

Federal Right to Try Act

The Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 became Public Law 115-176, signed May 30, 2018. It is codified at 21 U.S.C. 360bbb-0a. It creates a pathway for an eligible patient to seek access to an eligible investigational drug outside a clinical trial, without a separate authorization of the individual request by the United States Food and Drug Administration.

An eligible patient is a person diagnosed with a life-threatening disease or condition who has exhausted approved treatment options, cannot participate in a clinical trial of the drug, is certified by a treating physician in good standing who is not directly compensated by the manufacturer, and has given written informed consent. An eligible investigational drug is one that has completed a Phase 1 trial, has not been approved or licensed for any use under section 505 of the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act, is the subject of an active investigational new drug application, and remains in ongoing active development and not on clinical hold.

The federal Act does not require any manufacturer or sponsor to provide a product. By its own terms it does not create a new entitlement or a positive right to treatment, and it cannot create a cure or effective therapy where none exists. The FDA role is limited to receiving and posting annual summary reports. Official sources: Public Law 115-176 and the FDA Right to Try page.

Investigational status and consented regenerative medicine

Any cell, tissue, exosome, or other regenerative therapy referenced anywhere on this site is investigational. It is not approved or licensed by the FDA. There are no FDA approved exosome products. Exosomes intended to treat disease in humans are regulated as drugs and biological products under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act and are subject to premarket review.

Human cells, tissues, and cellular and tissue based products are governed by 21 CFR Part 1271. A product that meets every criterion in 21 CFR 1271.10(a), including minimal manipulation and homologous use, may be regulated solely under section 361 of the Public Health Service Act. A product that does not meet those criteria is regulated as a drug, device, or biological product and requires premarket review, which for an unapproved biologic means a 351(a) biologics license application supported by an active investigational new drug application. Expanded Access, also called compassionate use, is a separate FDA pathway for access to investigational products outside a trial.

Nothing on this site is an offer to treat or a solicitation to receive treatment. Whether any therapy is appropriate, available, or lawful for a given person is determined solely by a licensed physician under applicable law, with informed consent. There is no guarantee of any outcome.

State Right to Try laws

The federal Right to Try Act applies nationwide. In addition, 42 states have enacted their own Right to Try laws. The table below lists each jurisdiction, whether it has a state law, the statutory citation, and a link to an official government source. States shown without a state law rely on the federal Act.

JurisdictionState lawCitationSource
AlabamaYesAla. Code 22-5D-1 to 22-5D-9Official source
AlaskaYesAlaska Stat. 08.64.367Official source
ArizonaYesAriz. Rev. Stat. 36-1311 to 36-1314 (Prop 303, 2014)Official source
ArkansasYesArk. Code 20-15-2101 to 2111 (Act 374, 2015)Official source
CaliforniaYesCal. Health & Safety Code 111548-111548.5 (AB 159, 2016)Official source
ColoradoYesColo. Rev. Stat. 25-45-101 to 108 (HB14-1281)Official source
ConnecticutYesConn. Gen. Stat. 21a-70g (P.A. 15-179)Official source
DelawareNoNo state Right to Try statute. Federal Act applies.Federal Act applies
FloridaYesFla. Stat. 499.0295Official source
GeorgiaYesO.C.G.A. 31-52-1 to 31-52-10 (HB 34 / Act 422, 2016)Official source
HawaiiNoNo enacted state Right to Try statute (SB2023 of 2024 did not become law). Federal Act applies.Federal Act applies
IdahoYesIdaho Code 39-9401 to 39-9409Official source
IllinoisYes410 ILCS 649Official source
IndianaYesInd. Code 16-42-26 (SEA 73, 2015)Official source
IowaYesIowa Code 144E.1-144E.7Official source
KansasYesK.S.A. 65-694 (2025)Official source
KentuckyYesKy. Rev. Stat. 217.5401-217.5408Official source
LouisianaYesLa. R.S. 40:1300.381 to 1300.386 (HB 891, 2014)Official source
MaineYesMe. Rev. Stat. tit. 22, 2671-2677Official source
MarylandYesMd. Health-General 21-2B-01 et seq.Official source
MassachusettsNoNo state Right to Try statute. Federal Act applies.Federal Act applies
MichiganYesMich. Comp. Laws 333.26451-333.26457 (Act 345, 2014)Official source
MinnesotaYesMinn. Stat. 151.375Official source
MississippiYesMiss. Code 41-131-1 et seq. (SB 2485, 2015)Official source
MissouriYesMo. Rev. Stat. 191.480Official source
MontanaYesMont. Code 50-12-101 to 50-12-110Official source
NebraskaYesNeb. Rev. Stat. 71-9601 to 71-9611Official source
NevadaYesNev. Rev. Stat. 454.690Official source
New HampshireYesN.H. Rev. Stat. ch. 126-ZOfficial source
New JerseyNoNo state Right to Try statute. Federal Act applies.Federal Act applies
New MexicoNoNo state Right to Try statute. Federal Act applies.Federal Act applies
New YorkNoNo state Right to Try statute. Federal Act applies.Federal Act applies
North CarolinaYesN.C. Gen. Stat. ch. 90, art. 23AOfficial source
North DakotaYesN.D. Cent. Code 23-48-01 to 23-48-05Official source
OhioYesOhio Rev. Code 4731.97Official source
OklahomaYesOkla. Stat. tit. 63, 3091.1 to 3091.7Official source
OregonYes2015 Or. Laws ch. 819 (HB 2300)Official source
PennsylvaniaYesRight-to-Try Act, Act 33 of 2017 (P.L. 347)Official source
Rhode IslandNoNo state Right to Try statute. Federal Act applies.Federal Act applies
South CarolinaYesS.C. Code 44-137-10 to 44-137-70Official source
South DakotaYesS.D. Codified Laws ch. 34-51 (HB 1080, 2015)Official source
TennesseeYesTenn. Code 63-6-301 to 309 (Pub. Ch. 376, 2015)Official source
TexasYesTex. Health & Safety Code ch. 489Official source
UtahYesUtah Code 58-85-101 to 107 (HB 94, 2015)Official source
VermontNoNo state Right to Try statute. Federal Act applies.Federal Act applies
VirginiaYesVa. Code 54.1-3442.1 to 54.1-3442.4Official source
WashingtonYesRCW ch. 69.77Official source
West VirginiaYesW. Va. Code 16-51-1 et seq.Official source
WisconsinYesWis. Stat. 450.137Official source
WyomingYesWyo. Stat. 35-7-1801 to 1806 (SF 3, 2015)Official source
District of ColumbiaNoNo Right to Try statute. Federal Act applies.Federal Act applies

Citations were checked against official government sources. Links open official legislature, code, or enrolled-bill pages. Some official state portals render only in a full browser. This table is informational and is not legal advice.

Summary

Nothing on this site is an offer to treat. Any therapy discussed is investigational, is not FDA approved, and carries no guaranteed outcome. Eligibility and informed consent are determined by licensed physicians under applicable law. For legal questions, consult qualified counsel. For medical questions, consult a licensed physician.