Readers search for the Montana stem cell law, but what Montana passed is two experimental treatment bills. SB 422 (2023) widened the state’s Right to Try Act, and SB 535 (2025) created a license for experimental treatment centers. Neither mentions tissue banks, stem cells, or adipose tissue. This post explains what each law says, what it does not say, and why banking is untouched by both.
TLDR Montana’s SB 422 (2023) removed the terminal illness restriction from the state’s Right to Try Act. SB 535 (2025) created a state license for experimental treatment centers, effective May 13, 2025. The statute’s own definition says an experimental treatment is not yet FDA approved for general use. Neither law names tissue banks, stem cells, or adipose tissue. Banking adipose tissue does not guarantee eligibility or access, and any future use depends on FDA status, physician guidance, and pathway availability.
Important Disclaimer: Save My Fat does not provide FDA-approved treatments or cures for any disease, including neurologic or degenerative conditions. Banking adipose tissue today does not guarantee eligibility, access, or clinical benefit from any future therapy, clinical trial, or medical program. No state law, including Montana’s, can make a product FDA approved. All content is for educational purposes only and does not constitute medical advice. Patients must consult their own licensed healthcare professionals regarding all medical decisions.
Whether stem cell therapy is legal, and where, is the question readers bring to this site more than any other. Montana comes up often because in 2023 it widened its Right to Try Act and in 2025 it created a license for a new kind of facility, the experimental treatment center. Readers call the result the Montana stem cell law. The bills never use those words.
If you have banked adipose tissue, you may wonder whether a Montana facility license changes what can be done with stored tissue. The short answer is no. This post walks through both bills as they read, and where the law is silent, it says so.
What SB 422 (2023) Changed in the Right to Try Act
SB 422 expanded Montana’s Right to Try Act by removing the restriction that limited eligibility to patients with a terminal illness. It amended MCA 50-12-102 through 50-12-110, which sit in Title 50, chapter 12, part 1, and it took effect October 1, 2023. It created no new facility type and no license.
The bill’s title states its purpose: “EXPANDING THE RIGHT TO TRY ACT; REMOVING THE RESTRICTION ON PATIENTS WHO ARE ELIGIBLE TO RECEIVE EXPERIMENTAL MEDICATIONS UNDER THE RIGHT TO TRY ACT; EXTENDING GOVERNMENTAL IMMUNITY,” as the title appears in the 2023 Legislative Review, which lists it as Chapter 413, effective October 1, 2023.
Read what Right to Try is and how it compares with expanded access. Expanded access and post-trial access are recurring reader questions on this site.
What SB 535 (2025) Set Up: Experimental Treatment Center Licensing
SB 535 created a state license for experimental treatment centers, codified at MCA 50-5-250, and bars operating one without a license. It became effective May 13, 2025 and was assigned Chapter 621, Laws of 2025. Its title is “Revise laws related to experimental treatments.”
The licensing section reads: “A person may not operate an experimental treatment center without a license,” per MCA 50-5-250. It sets a $10,000 application fee and a $5,000 annual renewal fee, with details left to Department of Public Health and Human Services rules. Section 50-5-251 directs 2 percent of net annual profits to an access requirement, and 50-5-252 creates an insurance premium support account.
MCA 50-5-101 now defines the term: “‘Experimental treatment center’ means a facility that specializes in providing experimental treatments pursuant to Title 50, chapter 12, part 1.” The bill also amended 50-12-102 through 50-12-109 and 33-1-102. Section 15 of Chapter 621 says the act “is effective on passage and approval,” and the 2025 Legislative Review gives May 13, 2025 as that date.
Both bills amend the same part of Title 50, so they are easy to confuse. The table below separates them.
| Item | SB 422 (2023) | SB 535 (2025) |
|---|---|---|
| Session law | Chapter 413, Laws of 2023 | Chapter 621, Laws of 2025 |
| What it did | Removed the terminal illness eligibility restriction; extended governmental immunity | Created experimental treatment center licensing with fees and DPHHS rules |
| Sections | Amended MCA 50-12-102 through 50-12-110 | Added 50-5-250 through 50-5-252 and a 50-5-101 definition; amended 50-12-102 through 50-12-109 and 33-1-102 |
| New facility type | None | Experimental treatment center |
| Effective date | October 1, 2023 | May 13, 2025 |
| Mentions tissue banks, stem cells, or adipose | No | No |
If a claim about Montana does not point to one of these sections, ask for the citation.
What the Montana Stem Cell Law Says About FDA Status
The Montana stem cell law, as readers call it, says in its own definition that an experimental treatment “has not yet been approved for general use by the United States food and drug administration.” A state license does not change that. Only FDA approves a product, and Montana’s statute does not claim otherwise.
The definition in MCA 50-12-102 covers “an investigational drug, biological product, device, or other treatment that has successfully completed phase 1 of a clinical trial” and is not yet approved for general use. It must also either remain “under investigation in a clinical trial approved by the United States food and drug administration” or have “a demonstrated safety record” documented by a qualified medical institution as defined by department rule.
Offering is permissive. “A manufacturer, health care provider, or health care facility may make an experimental treatment available upon a patient’s request,” per MCA 50-12-103, and charging is allowed. The patient must have evaluated FDA-approved options, have a provider recommendation, and give informed consent covering eight listed items in 50-12-105(2), including liability for all expenses.
Federal rules run alongside. 21 CFR 1271.10(a) lists four criteria a human cell or tissue product must meet, all of them, starting with minimal manipulation and homologous use only, and establishments handling such products “must register with FDA” under 1271.10(b). A Montana license does not speak to any of those criteria.
What the Law Does Not Say
Neither SB 422 nor SB 535 mentions tissue banks, stem cells, or adipose tissue. The law also does not approve, clear, or license any product, and it does not change any product’s FDA status.
It does not create a Montana tissue bank license either, and it does not say who may use banked tissue, where, or for what. Those questions belong to FDA’s framework and a licensed physician’s judgment.
Some states have written informed-consent and disclosure rules aimed at stem cell services. Montana’s two bills are not that kind of law. See the disclosure law comparison for the states that did, and the state law map for where Montana sits among them.
What It Means for a Montana Resident Who Banks Fat
Nothing about banking adipose tissue changes because of SB 422 or SB 535. Banking preserves your own tissue. Any future use still depends on FDA regulatory status, physician guidance, and the availability of approved or investigational pathways at that time.
The experimental treatment center license is a facility license under Title 50, chapter 5. It is not a route for stored tissue, and it says nothing about stored tissue.
If a facility says a Montana license makes a stored-tissue product available, ask which section of the Montana Code covers that product and what its FDA status is. A state license answers neither question on its own.
Frequently Asked Questions
Is there a Montana stem cell law?
No statute in Montana carries that name, and neither SB 422 nor SB 535 uses the words stem cell. Montana has a Right to Try Act, expanded in 2023, and an experimental treatment center license at MCA 50-5-250, created in 2025.
Does SB 535 make experimental treatments FDA approved?
No. The definition in MCA 50-12-102 requires that the treatment “has not yet been approved for general use by the United States food and drug administration.” The license regulates the facility, not the product.
Can banked adipose tissue be used at an experimental treatment center?
The law does not address banked tissue at all. Whether any adipose-derived product could ever be offered depends on its FDA regulatory status and a licensed physician’s guidance. Banking does not create eligibility or access.
Does Montana license tissue banks?
No Montana tissue bank licensing statute was found in this review, which is a finding of absence, not a confirmed exemption. Ask any bank you consider which state and federal registrations it holds, and request the documents.
Key Takeaways
Montana’s SB 422 (2023) removed the terminal illness restriction from its Right to Try Act, effective October 1, 2023. SB 535 (2025) created a license for experimental treatment centers at MCA 50-5-250, effective May 13, 2025. The statute’s own definition says an experimental treatment is not yet FDA approved for general use, and a state license cannot change that. Neither bill mentions tissue banks, stem cells, or adipose tissue. For a Montana resident who banks adipose tissue, nothing changes: any future use depends on FDA status, physician guidance, and pathway availability.
Save My Fat connects patients and providers with a U.S.-based tissue bank. It is not a tissue bank, a laboratory, a medical practice, or a treatment provider. Stem cell and regenerative medicine regulations vary by state, including specific informed-consent and disclosure requirements in Florida, Utah, California, Georgia, and Tennessee governing tissue and stem cell services. Banking adipose tissue does not connect patients to any treatment pathway, and any future use depends on FDA regulatory status, physician guidance, and the availability of approved or investigational pathways at that time.
Readers weighing adipose tissue banking for potential future use can review current pricing or ask a question through the contact page.
Save My Fat works with a U.S.-based tissue bank for laboratory processing and storage.
This article is for educational purposes only and does not constitute medical or legal advice. Please consult your own licensed healthcare provider before making any decisions about treatment or research participation.
About the author: Oscar Tellez is the founder and CEO of Save My Fat. He holds a Bachelor of Science in Exercise Science and Health Promotion from Florida Atlantic University. He has spent a decade in the regenerative medicine industry across product distribution, laboratory and vendor relationships, and provider training. He is not a licensed clinician, and this article is educational, not medical advice.
Related guide: state stem cell laws.
