This guide is currently available in English. A Spanish version is in progress.
Sourcing Exosomes in Maine
Licensed Maine 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. Maine buyers need their own professional license and NPI; the wholesaler license is the supplier’s obligation, not the purchaser’s.
Maine’s most practice-shaping rule is on the nursing side: a certified nurse practitioner completes a 24-month supervised transition and then practices on their own authority, which makes NP-led practices a workable structure here. On the statute side, Maine’s only law in this neighborhood is a 2016 Right To Try Act for terminally ill patients, which is narrower than readers usually assume.
At a glance
| Question | Answer |
|---|---|
| Does ExaVeyra ship to Maine? | 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 | None |
| 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 Maine
ExaVeyra ships to licensed practices in all 50 states, Maine 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 Maine professional license in good standing, verifiable through the Maine Board of Licensure in Medicine license verification service or the Maine State Board of Nursing.
- A valid NPI, which ExaVeyra verifies at account setup.
- A signed professional-use acknowledgment on file for exosome material.
- A Maine resale certificate from Maine Revenue Services if the practice is purchasing for resale rather than for use in its own operations.
How the state permits wholesale distribution
Maine licenses drug manufacturers and wholesalers through the Board of Pharmacy, which sits within the Office of Professional and Occupational Regulation. The statute is unusually blunt about reach: 32 M.R.S. 13758 requires that all manufacturers and wholesalers whose products are distributed in the State in any manner be licensed by the board, whether the firm sits inside or outside Maine, and 32 M.R.S. 13751 makes the license an annual establishment license. The board defines a wholesaler as a person who buys prescription drugs for resale and distribution to persons other than consumers. The license sits with the distributor, not with the purchasing practice.
32 M.R.S. §§ 13751, 13758 · Maine Board of Pharmacy (Office of Professional and Occupational Regulation)
Maine regenerative-medicine law
Maine has not enacted a statute specific to stem cell or regenerative therapies. Practice in this area is governed by the state's general medical practice and professional licensing rules, alongside federal law.
Maine has enacted no statute addressing unapproved regenerative therapy: no stem cell authorization law of the Florida, Texas, or Georgia kind, no disclosure law of the California kind, and no documentation statute of the Tennessee kind. The law most often mistaken for one is the Right To Try chapter enacted in 2016 as Public Law chapter 418 and codified at 22 M.R.S. chapter 602-A, Access to Investigational Treatments for Terminally Ill Patients. That chapter lets a manufacturer make an investigational drug, biological product, or device that has completed phase 1 of an FDA trial available to a terminally ill patient on a physician’s recommendation with written informed consent. It is a patient-access law for terminal illness, not a practice authorization. Practice in this area is otherwise governed by the Medical Practice Act, the Nurse Practice Act in 32 M.R.S. chapter 31, and the boards that administer them, alongside federal law, which is the only layer that addresses the products themselves.
How this applies to exosomes
Maine has no stem cell statute, so unlike Florida or Tennessee there is no state definition to ask whether exosomes fall inside. The nearest law, the Right To Try chapter at 22 M.R.S. chapter 602-A, concerns investigational products for terminally ill patients and says nothing about stem cells, extracellular vesicles, or aesthetic practice. Exosomes are acellular extracellular vesicles, and in Maine they are governed by federal law alone, 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 Maine practice
Maine runs on two models once the NP transition is complete. An established NP-led practice operates on the nurse practitioner’s own authority, with no collaborating physician filing of the Georgia kind. A physician-led practice delegates conventionally under the Board of Licensure in Medicine’s oversight. The transition period is the planning item: a newly certified NP needs a supervising physician or NP, or a qualifying employer, for the first 24 months.
| Role | Scope under state law |
|---|---|
| MD / DO | Physicians are licensed by the Maine Board of Licensure in Medicine, perform medical acts within their scope, and are the source of delegation in a physician-led practice. The board publishes license verification and complaint records on its site. |
| NP / APRN | A certified nurse practitioner completes a supervised transition, set by 32 M.R.S. 2102(2-A) at 24 months under a licensed physician or a supervising nurse practitioner, or through employment in a clinic or hospital with a physician medical director, with the Board of Nursing’s practice standards under 32 M.R.S. 2205-B layered on top. After the transition the NP practices on their own authority, evaluating patients and ordering within NP scope. |
| PA | Physician assistants are licensed by the Maine Board of Licensure in Medicine and practice within the collaboration framework the board administers, in the scope their practice agreement establishes. |
| RN | Registered nurses practice under the Nurse Practice Act in 32 M.R.S. chapter 31 and the Maine State Board of Nursing’s standards, carrying out treatments on the order of a provider with authority to issue one. An RN does not evaluate the patient independently or set the treatment plan. |
Good faith examination
Maine expects a patient evaluation by a provider with authority to conduct it, and an order, before a delegated treatment is administered. Once the supervised transition is complete, that provider can be the nurse practitioner in an NP-led practice. The expectations sit in board standards rather than a named good faith examination statute, so confirm current requirements with the Maine Board of Licensure in Medicine and the Maine State Board of Nursing.
Ownership and clinic licensing
Maine does not codify a corporate practice of medicine prohibition in the way Texas, New York, or Oregon now do, and no primary source stating a bright-line ownership rule was found. Professional entities and management services arrangements are the usual structures, and because the position rests on general licensing law rather than a single statute, ownership structure here is a question for Maine counsel and the licensing boards rather than one a guide should answer with a percentage.
Cold chain into Maine
Shipments leave Florida frozen under validated temperature monitoring. A package in transit over a weekend waits in the carrier network, so practices in Maine order around weekend and holiday closures.
| Metro | County | Notes |
|---|---|---|
| Portland | Cumberland | Largest Maine market, with most of the state’s aesthetic coverage. |
| Scarborough | Cumberland | South-of-Portland corridor with growing med spa coverage. |
| Kennebunk | York | Coastal York County market with a seasonal resort clientele. |
| Lewiston | Androscoggin | Second-largest urban area, with a substantial clinical presence. |
| Augusta | Kennebec | Capital market serving central Maine. |
| Bangor | Penobscot | Regional hub for northern and eastern Maine. |
- Maine 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.
Practice types we supply in Maine
Maine licensing and verification
Maine Board of Licensure in Medicine
Licenses physicians and physician assistants and runs license verification.
Maine State Board of Nursing
Licenses nurse practitioners, who practice independently after a 24-month supervised transition.
Maine Board of Pharmacy (OPOR)
Issues the annual wholesaler establishment licenses that cover distribution into Maine.
Maine Revenue Services
Sales tax registration and resale certificates.
Maine sourcing questions
- Does Maine have a stem cell law?
- No. Maine has enacted no stem cell authorization law, disclosure law, or documentation statute. The law most often mistaken for one is the 2016 Right To Try chapter at 22 M.R.S. chapter 602-A, which concerns investigational products for terminally ill patients and says nothing about stem cells or exosomes. The products are governed by federal law, under which no exosome product is FDA approved for administration to humans.
- Can a nurse practitioner run a practice in Maine without a physician?
- After the transition, yes, within NP scope. Maine law at 32 M.R.S. 2102(2-A) requires a certified nurse practitioner to practice for at least 24 months under a licensed physician or a supervising nurse practitioner, or through employment in a clinic or hospital with a physician medical director, with practice standards set by Board of Nursing rule under 32 M.R.S. 2205-B. An NP who has completed the transition practices on their own authority.
- Does my Maine clinic need a wholesaler license to buy exosomes?
- No. The wholesaler license under 32 M.R.S. 13758 is held by the manufacturer or wholesaler whose products are distributed in the state, 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.
- What is Maine’s Right To Try law, and does it matter for an aesthetic practice?
- Maine’s Right To Try chapter, 22 M.R.S. chapter 602-A, lets a manufacturer make an investigational product that has completed phase 1 of an FDA trial available to a terminally ill patient on a physician’s recommendation with written informed consent. It is a patient-access law for terminal illness. It does not authorize, restrict, or address aesthetic practice or any product category an aesthetic practice orders.
- Are exosomes FDA approved?
- No exosome product has been approved by the FDA for administration to humans, and the FDA has issued a public safety notification about exosome products marketed outside that framework. ExaVeyra supplies Kimera material for topical aesthetic use by licensed practitioners, with a Certificate of Analysis and lot traceability on every vial.
- How long does cold-chain shipping take to Maine?
- 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.
- 32 M.R.S. § 13758, licensure of manufacturers and wholesalers in or out of Maine (accessed 16 October 2026)
- 32 M.R.S. § 13751, annual establishment licenses under the Maine Pharmacy Act (accessed 16 October 2026)
- Maine Board of Pharmacy, establishment licensing, including the wholesaler license (accessed 16 October 2026)
- 22 M.R.S. ch. 602-A, Access to Investigational Treatments for Terminally Ill Patients (accessed 16 October 2026)
- 32 M.R.S. § 2102, nursing definitions and nurse practitioner supervised practice (accessed 16 October 2026)
- Maine Board of Licensure in Medicine (accessed 16 October 2026)
- Maine Revenue Services (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 Maine 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 any Maine statute.
- Witwer KW, Van Balkom BWM, Bruno S, et al. Defining mesenchymal stromal cell (MSC)-derived small extracellular vesicles for therapeutic applications. Journal of Extracellular Vesicles, 2019. doi:10.1080/20013078.2019.1609206 PMID:31069028Consensus statementsupports: The ISEV and ISCT position defining MSC-derived small extracellular vesicles, the framework behind this page’s description of perinatal MSC-EV source material and its documentation.
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.