Sourcing Exosomes in Montana
Licensed Montana practices order Kimera exosome material from ExaVeyra for topical aesthetic use, shipped frozen from Florida with a Certificate of Analysis and lot traceability on every vial. Montana buyers need their own professional license and NPI; the wholesale distributor license is the supplier’s obligation, not the purchaser’s, and Montana’s lack of a general sales tax means there is no resale certificate to manage.
Montana has gone further than any other state on experimental treatment access: SB 422 (2023) removed the terminal-illness restriction from its Right to Try Act, and SB 535 (2025) made it the first state to license experimental treatment centers. Both laws are about patient access under physician recommendation and consent, so it is worth knowing exactly what they cover, and what they do not.
At a glance
| Question | Answer |
|---|---|
| Does ExaVeyra ship to Montana? | Yes. Shipped frozen from Florida, as we do to all 50 states |
| Cold-chain shipping from Florida | Overnight shipping; arrival can take 1 to 3 business days |
| State regenerative-medicine statute | SB 422 (2023); SB 535 (2025) (2025) |
| Does that statute reach exosomes? | No. Its definition is written around cells; exosomes are acellular and governed federally |
| Physician delegation required to hand off medical acts | No |
| Who holds the licensure to ship into the state | The pharmacy partner and the tissue bank that ship, not the purchasing practice |
| What ExaVeyra supplies here | Kimera exosome material; compounded preparations available through the 503A pharmacy partner |
| Last reviewed | 16 October 2026 |
Ordering from Montana
ExaVeyra ships to licensed practices in all 50 states, Montana included. Licensure for shipping into the state is held by the entities that ship: our 503A pharmacy partner holds nonresident pharmacy licenses in 33 jurisdictions, including Puerto Rico, and exosome material ships from a registered tissue bank licensed to ship to all 50 states and Puerto Rico. Your practice orders against its own professional license and NPI and needs no wholesale permit to purchase.
What your practice provides
- An active Montana professional license in good standing, verifiable through the Department of Labor and Industry licensee lookup covering the Board of Medical Examiners and the Board of Nursing.
- A valid NPI, which ExaVeyra verifies at account setup.
- A signed professional-use acknowledgment on file for exosome material.
- No resale certificate: Montana imposes no general sales tax, so the resale documentation other states require for purchase-for-resale has no Montana equivalent.
How the state permits wholesale distribution
Montana licenses wholesale drug distributors, third-party logistics providers, manufacturers, and repackagers through the Board of Pharmacy, which sits within the Department of Labor and Industry. Title 37, chapter 7, part 6 carries the regime: 37-7-604 sets the licensing requirements, and 37-7-605 provides that an out-of-state wholesale distributor, third-party logistics provider, manufacturer, or repackager may not conduct business in the state without first obtaining a license from the board, and that a person acting as principal or agent for an out-of-state firm may not sell or distribute prescription drugs in Montana unless that firm is licensed. The license sits with the distributor, not with the purchasing practice.
Mont. Code Ann. 37-7-604, 37-7-605 · Montana Board of Pharmacy (Department of Labor and Industry)
Montana regenerative-medicine law
Montana enacted SB 422 (2023); SB 535 (2025), codified at Mont. Code Ann. 50-12-101 to 50-12-110; 50-5-250 to 50-5-252, effective 12 May 2025.
The Right to Try Act in Title 50, chapter 12 applies to health care providers, defined since SB 535 as physicians, advanced practice registered nurses with prescriptive authority, physician assistants, and registered nurses performing services at an experimental treatment center. A patient qualifies by evaluating FDA-approved options, obtaining a treating provider’s recommendation, and giving informed consent, which since 2025 may be documented in writing or through recorded interactive discussion. SB 535 adds the facility layer: a person may not operate an experimental treatment center without a license from the Department of Public Health and Human Services, which sets operational standards, inspections, and adverse event reporting by rule, and licensed centers owe the 2% health freedom and access allocation. None of this authorizes a product for general or aesthetic use.
- Patient access and facility licensure, not product approval: every treatment runs through a provider recommendation and informed consent
- Any patient who has evaluated FDA-approved options, with no terminal-illness requirement since SB 422 (2023)
- Treatments past phase 1 that remain in an FDA-approved trial or have a documented safety record from a qualified medical institution
- Experimental treatment centers licensed by the Department of Public Health and Human Services (50-5-250)
- A health freedom and access requirement: 2% of a licensed center’s net annual profits supports access for qualifying Montana residents
“"Experimental treatment" means the provision of a medical intervention by a health care provider involving an investigational drug, biological product, device, or other treatment that has successfully completed phase 1 of a clinical trial but has not yet been approved for general use by the United States food and drug administration and either: (a) remains under investigation in a clinical trial approved by the United States food and drug administration; or (b) has a demonstrated safety record through documented clinical evidence from a qualified medical institution as defined by department rule.”
How this applies to exosomes
Montana’s framework is the country’s broadest experimental treatment access law, and it still never mentions exosomes: the enrolled SB 535 text contains no reference to exosomes or extracellular vesicles, and its subject is who may access an experimental treatment and under what facility license, not which products are lawful to market. Exosomes are acellular extracellular vesicles, and a vialed exosome product supplied to a practice is not an experimental treatment delivered under the Right to Try Act’s recommendation and consent gates. Exosome products in Montana remain governed by federal law, under which no exosome product has been approved by the FDA for administration to humans. ExaVeyra supplies Kimera material for topical aesthetic use by licensed practitioners, with full COA and lot documentation.
Who can handle product in a Montana practice
Montana runs on two models. An APRN-led practice operates on the nurse’s own authority under 37-8-409, with no collaborating physician filing of the Mississippi or Georgia kind. A physician-led practice delegates conventionally under the Board of Medical Examiners’ oversight. Both boards sit within the Department of Labor and Industry, so license verification runs through a single agency, and the one Montana-specific layer above both models is SB 535: a practice holding itself out as an experimental treatment center needs a DPHHS license first.
| Role | Scope under state law |
|---|---|
| MD / DO | Physicians are licensed by the Montana Board of Medical Examiners under Title 37, chapter 3, perform medical acts within their scope, and are the source of delegation in a physician-led practice. |
| NP / APRN | Montana advanced practice registered nurses practice on a board-approved amendment to their license under 37-8-409, on verification of national certification, with no physician collaboration or supervision requirement in the chapter. Prescriptive authority is a separate board application. An APRN-led practice in Montana evaluates and orders within its own scope. |
| PA | Physician assistants are licensed by the Montana Board of Medical Examiners and practice within the collaborative framework the board administers under Title 37, within an agreed scope. |
| RN | Registered nurses practice under Title 37, chapter 8 and the Board of Nursing’s standards, carrying out treatments on the order of a provider with authority to issue one. Since SB 535, a registered nurse performing services at a licensed experimental treatment center is also a health care provider under the Right to Try Act. An RN does not evaluate the patient independently or set the treatment plan. |
Good faith examination
Montana expects a patient evaluation by a provider with authority to conduct it, and an order, before a delegated treatment is administered. Because advanced practice registered nurses hold independent authority, that provider can be the APRN in an APRN-led practice. The expectations sit in board standards rather than a named good faith examination statute, so confirm current requirements with the Board of Medical Examiners and the Board of Nursing.
Ownership and clinic licensing
Montana does not codify a corporate practice of medicine prohibition, and no primary source stating a bright-line ownership rule was found, so Montana is generally grouped with the permissive states. Professional entities and management arrangements are the usual structures, and SB 535 adds one entity-level rule of its own: operating an experimental treatment center requires a department license. Because the general position rests on the absence of a statute rather than the text of one, confirm entity structure with Montana counsel.
Cold chain into Montana
Shipments leave Florida frozen under validated temperature monitoring. A package in transit over a weekend waits in the carrier network, so practices in Montana order around weekend and holiday closures.
| Metro | County | Notes |
|---|---|---|
| Billings | Yellowstone | Largest Montana market and the state’s main medical hub. |
| Bozeman | Gallatin | Fastest-growing market, with a concentrated longevity and aesthetic segment. |
| Missoula | Missoula | Western Montana hub with a university medical presence. |
| Whitefish | Flathead | Resort market served alongside Kalispell. |
| Helena | Lewis and Clark | Capital market served on the I-15 corridor. |
| Great Falls | Cascade | North-central market with a large clinical base. |
- Montana orders of fifteen or more cold-chain units ship free nationwide; see the volume program for current thresholds.
- Each shipment arrives with the manufacturer’s handling instructions and the lot-specific Certificate of Analysis.
Wholesale exosome supply by city in Montana
Each city page covers local receiving conditions, delivery disruptions and business license rules for Montana practices in that area.
Practice types we supply in Montana
Montana licensing and verification
Montana Board of Medical Examiners
Licenses physicians and physician assistants within the Department of Labor and Industry.
Montana Board of Nursing
Licenses APRNs, who practice on their own authority with board-granted prescriptive authority.
Montana Board of Pharmacy
Licenses the wholesale drug distributors that ship into Montana.
Montana Department of Revenue
Confirms Montana has no general sales tax, so no resale certificate applies.
Montana sourcing questions
- What did Montana SB 535 (2025) actually create?
- SB 535 made Montana the first state to license experimental treatment centers. Codified at 50-5-250 to 50-5-252, it requires a license from the Department of Public Health and Human Services before operating such a center, with a $10,000 application fee and $5,000 annual renewal, department rules on standards, inspections, and adverse event reporting, and a health freedom and access requirement allocating 2% of a center’s net annual profits to treatment access for qualifying Montana residents. It also rewrote the Right to Try Act definitions it operates under.
- Does Montana’s Right to Try Act still require a terminal illness?
- No. SB 422 (2023) removed the restriction on which patients are eligible, and the current patient requirements in 50-12-104 ask only that the patient has evaluated FDA-approved treatment options, received a recommendation from their treating health care provider, given informed consent, and received documentation of eligibility. Montana is the only state whose right-to-try framework carries no illness threshold at all.
- Do Montana’s experimental treatment laws cover exosomes?
- No. The enrolled SB 535 text never mentions exosomes or extracellular vesicles. The framework governs who may access an experimental treatment, under a provider’s recommendation and informed consent, and which facilities may hold themselves out as experimental treatment centers. It does not approve any product or authorize any product for general or aesthetic use. No exosome product is FDA approved for administration to humans.
- Can a nurse practitioner run a practice in Montana without a physician?
- Yes, within APRN scope. Montana APRNs practice on a board-approved license amendment under 37-8-409, on verification of national certification, with no physician collaboration or supervision requirement in the nursing chapter, and prescriptive authority is applied for through the Board of Nursing. An APRN-led practice evaluates and orders within its own scope.
- Does my Montana clinic need a wholesale distributor license to buy exosomes?
- No. The wholesale drug distributor license under Mont. Code Ann. 37-7-604 and 37-7-605 is held by the distributor shipping into Montana, not by the practice buying. Your practice orders against its own professional license and NPI. Licensure for shipping into the state is held by the entities that ship: our 503A pharmacy partner for compounded preparations, and a registered tissue bank licensed to ship to all 50 states and Puerto Rico for exosome material.
- Does a Montana practice need a resale certificate to order?
- No. The Montana Department of Revenue states plainly that Montana does not have a general-use sales tax, so the resale certificate item that appears on most states’ ordering checklists has no Montana equivalent. ExaVeyra’s account setup for Montana practices asks only for the professional license, the NPI, and the signed professional-use acknowledgment.
- How long does cold-chain shipping take to Montana?
- Ships from Florida by overnight shipping, and arrival can take one to three business days. All exosome shipments travel cold-chain with validated temperature monitoring. A shipment in transit over a weekend waits in the carrier network, so a practice that will be closed orders around the closure.
Sources
Last reviewed 16 October 2026 by ExaVeyra Sciences editorial team. Every claim above links to a primary source.
- Mont. Code Ann. 50-12-102 (2025), Right to Try Act definitions, including experimental treatment (accessed 16 October 2026)
- Mont. Code Ann. 50-12-104 (2025), patient requirements, with no terminal-illness restriction (accessed 16 October 2026)
- Mont. Code Ann. 50-5-250 (2025), licensure of experimental treatment centers (accessed 16 October 2026)
- Mont. Code Ann. 37-7-605 (2025), out-of-state wholesale distributor licensing requirements (accessed 16 October 2026)
- Montana Board of Pharmacy, facility licensing including wholesale drug distributors (accessed 16 October 2026)
- Mont. Code Ann. 37-8-409 (2025), advanced practice registered nursing (accessed 16 October 2026)
- Montana Department of Revenue, sales tax guidance (no general-use sales tax) (accessed 16 October 2026)
- FDA Public Safety Notification on Exosome Products (accessed 16 October 2026)
Scientific literature
Peer-reviewed references, each with its study design and, for human studies, the number of participants, so a reader can judge the weight of a citation without opening it. None is a claim about any product.
- Théry C, Witwer KW, Aikawa E, et al. Minimal information for studies of extracellular vesicles 2018 (MISEV2018): a position statement of the International Society for Extracellular Vesicles and update of the MISEV2014 guidelines. Journal of Extracellular Vesicles, 2018. doi:10.1080/20013078.2018.1535750 PMID:30637094Clinical guidelinesupports: The landmark characterization standard for extracellular vesicles, the baseline this page assumes when it describes what a defensible exosome COA documents for a Montana practice.
- Welsh JA, Goberdhan DCI, O’Driscoll L, et al. Minimal information for studies of extracellular vesicles (MISEV2023): From basic to advanced approaches. Journal of Extracellular Vesicles, 2024. doi:10.1002/jev2.12404 PMID:38326288Clinical guidelinesupports: The current revision of the MISEV standard, supporting this page’s point that EV characterization expectations come from the field’s consensus guidelines rather than from Montana’s access statutes.
- Lener T, Gimona M, Aigner L, et al. Applying extracellular vesicles based therapeutics in clinical trials - an ISEV position paper. Journal of Extracellular Vesicles, 2015. doi:10.3402/jev.v4.30087 PMID:26725829Consensus statementsupports: The ISEV position on manufacturing, safety, and regulatory expectations for EV-based products, the context for this page’s statement that no exosome product holds FDA approval.
These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease. There are no FDA-approved exosome products. Biomolecular signaling vesicle products distributed by ExaVeyra Sciences are supplied for topical aesthetic use by licensed practitioners and for laboratory and IND-authorized clinical research, and are not tissue products as defined by FDA guidelines.