State ordering guide
Sourcing Exosomes in New York
Licensed New York practices order Kimera exosome material from ExaVeyra as research-grade product, shipped cold-chain from Miami Beach with a Certificate of Analysis and lot traceability on every vial. New York buyers need their own professional license and NPI; the nonresident wholesaler registration is the supplier’s obligation, not the purchaser’s.
New York is structured differently from most states in two ways worth knowing early. It has no stem cell or regenerative-medicine statute, so federal law and general practice rules govern instead. And medicine, nursing, and pharmacy all sit under a single regulator, the State Education Department’s Office of the Professions, rather than under separate boards.
At a glance
| Question | Answer |
|---|---|
| Does ExaVeyra ship to New York? | Yes. Cold-chain from Miami Beach, as we do to all 50 states |
| Cold-chain transit from Miami | 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 | Yes |
| Who holds the wholesale distribution permit | The supplier, not the purchasing practice |
| What ExaVeyra supplies here | Kimera exosome material and 503A compounded preparations |
| Last reviewed | 9 August 2026 |
Ordering from New York
ExaVeyra ships to licensed practices in all 50 states, New York included. Distribution-side licensing is handled by us, so your practice orders against its own professional license and NPI. What varies state to state is not whether product can reach you, but the indications it may be used for under federal law and how New York regulates who performs the procedure.
What your practice provides
- An active New York professional license in good standing, verifiable through the Office of the Professions.
- A valid NPI, which ExaVeyra verifies at account setup.
- A signed research-use acknowledgment on file for exosome material.
- A New York resale certificate (form ST-120) if the practice is purchasing for resale rather than for use in its own operations. Using it requires a Certificate of Authority from the Department of Taxation and Finance first.
How the state permits wholesale distribution
New York uses a registration model rather than a permit. Section 6808 prohibits holding or selling drugs for wholesale purposes without registering with the department, and section 6808-b, in effect since March 2003, extends that to nonresident establishments. Any manufacturer, repacker, or wholesaler physically located outside New York that ships, mails, delivers, invoices, or provides samples of prescription drugs or prescription devices into the state must register, and each establishment registers separately. Devices are inside the definition here, as in California. The registration sits with the distributor, not with the purchasing practice.
N.Y. Educ. Law art. 137 §§ 6808, 6808-b · New York State Education Department, Office of the Professions, State Board of Pharmacy
New York regenerative-medicine law
New York 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.
That absence does not mean the area is unpoliced. Conduct is reached through the Education Law provisions governing professional practice and misconduct, and through general consumer-protection law: the Attorney General has brought action against stem cell clinics under Executive Law section 63(12) and General Business Law sections 349 and 350, which address deceptive acts and false advertising. In practice, how a New York practice describes a service carries as much regulatory weight as how it performs it.
How this applies to exosomes
New York has not enacted a stem cell authorization law like Florida or Texas, nor a disclosure law like California, so there is no state statute to read exosomes into or out of. Exosome products are governed by federal law, under which no exosome product has been approved by the FDA for administration to humans. The practical consequence for a New York practice is that marketing language is the exposed surface, since the Attorney General’s consumer-protection authority reaches advertising claims directly. ExaVeyra supplies Kimera material for topical aesthetic use in clinics and for research applications, with full COA and lot documentation.
Who can handle product in a New York practice
New York runs on patient-specific orders rather than broad standing delegation. A physician or nurse practitioner evaluates the individual patient and issues an order for that patient, and only then may a registered nurse administer within their own scope. A multi-agency inspection sweep in January 2026 focused on exactly this documentation, so keeping the per-patient order on file is the practical discipline.
| Role | Scope under state law |
|---|---|
| MD / DO | Physicians licensed through the Office of the Professions may perform medical acts within their scope and are the source of any delegation. They also hold the clinical entity under the corporate practice rules. |
| NP / APRN | Nurse practitioners practice under a collaborative arrangement, and under Education Law section 6910 an NP with at least 3,600 hours of qualifying practice may work without a written collaborative agreement. That relief operates within the nursing scope; it does not authorize practicing medicine and does not change who may own the clinical entity. |
| PA | Physician assistants practice under physician supervision within the scope their supervising physician delegates. |
| RN | Registered nurses may administer injections and perform non-ablative device treatments and superficial peels, but only under a patient-specific order from a physician or nurse practitioner. The order is per patient rather than a general standing protocol. |
Good faith examination
New York does not use the phrase “good faith examination” as a statutory term. The functional requirement is that a physician or nurse practitioner evaluates the patient and issues a patient-specific order before a delegated treatment is administered. A registered nurse may carry out the order but does not perform the evaluation or set the plan.
Ownership and clinic licensing
New York reserves ownership and control of medical practice to licensed physicians under Education Law section 6521, operating through a professional corporation or professional limited liability company. Physicians are the only professionals who may own the clinical entity of a practice offering medical procedures. Nurse practitioners and registered nurses commonly participate through a management services organization that runs the business side under a management services agreement alongside a physician-owned clinical entity. Structure this with New York counsel before opening.
Cold chain into New York
Shipments dispatch from our Miami Beach facility under validated temperature monitoring, and delivery into New York is scheduled to avoid a weekend hold at the carrier hub.
| Metro | County | Notes |
|---|---|---|
| Manhattan | New York | Highest density of aesthetic and dermatology practices in the state. |
| Brooklyn | Kings | Fast-growing med spa market across the borough. |
| Long Island | Nassau and Suffolk | Established aesthetic and concierge corridor east of the city. |
| Westchester | Westchester | Suburban concierge and longevity practices north of the city. |
| Buffalo | Erie | Western New York hub with a broad clinical mix. |
| Rochester | Monroe | Finger Lakes market with dermatology and orthopedic coverage. |
- New York orders of fifteen or more cold-chain units ship free nationwide; see the volume program for current thresholds.
- Inspect the temperature indicator on arrival and contact us before use if the shipment reads outside range.
- Storage and handling conditions for each product are stated on its Certificate of Analysis.
Practice types we supply in New York
New York licensing and verification
NYSED Office of the Professions, Medicine
New York regulates medicine through the Education Department rather than a separate medical board.
NYSED Office of the Professions, Nursing
NYSED Office of the Professions, Pharmacy Establishments
Registers the nonresident establishments that ship into New York.
New York State Department of Taxation and Finance
Issues the Certificate of Authority required before using form ST-120.
New York sourcing questions
- Does New York have a stem cell law that covers exosomes?
- New York has no stem cell or regenerative-medicine statute, neither an authorization law like Florida or Texas nor a disclosure law like California. Exosome products are governed by federal law, under which no exosome product is FDA-approved for administration to humans. Conduct is reached through the Education Law professional practice provisions and through the Attorney General’s consumer-protection authority under Executive Law section 63(12) and General Business Law sections 349 and 350.
- Who regulates my license in New York?
- The State Education Department’s Office of the Professions regulates medicine, nursing, and pharmacy together, rather than the separate boards most states use. Practices relocating from other states are often surprised by this, since license verification and establishment registration both run through the same body.
- Can a nurse practitioner own a med spa in New York?
- Not the clinical entity. Education Law section 6521 reserves ownership and control of medical practice to licensed physicians, operating through a professional corporation or PLLC. The common structure pairs a physician-owned clinical entity with a management services organization owned by the non-physician operator. The 3,600-hour relief under section 6910 removes the written collaborative agreement requirement within nursing scope but does not change ownership.
- Can a registered nurse administer treatment in New York?
- Yes, under a patient-specific order from a physician or nurse practitioner, and within the RN scope. New York works on per-patient orders rather than broad standing protocols, so the order is written for the individual patient rather than for the service generally.
- Does my New York clinic need a wholesaler registration to buy exosomes?
- No. The nonresident establishment registration under Education Law section 6808-b is held by the out-of-state distributor shipping into New York, not by the practice buying. Your practice orders against its own professional license and NPI. ExaVeyra handles distribution-side registration.
- How long does cold-chain shipping take to New York?
- Overnight from our Miami Beach facility once prepared, with preparation taking one to two business days. All exosome shipments travel cold-chain with validated temperature monitoring, and deliveries are scheduled to avoid a weekend hold at the carrier hub.
Material available to licensed New York practices
Kimera Labs preparations distributed by ExaVeyra, characterised on the certificate of analysis supplied with every lot. Research-grade material for licensed practices; the practitioner determines clinical use.
- Luxir
1 Trillion Microvesicles · 5 Trillion Microvesicles
Available formats: 1.0 mL, 5.0 mL
- Luxir+
3 Trillion Microvesicles · 15 Trillion Microvesicles
Available formats: 1.0 mL, 5.0 mL
- Kiara
3 mg secretome · 15 mg secretome
Available formats: 1.0 mL, 5.0 mL
- Vive
2 Trillion Microvesicles
Available formats: 5.0 mL
Sources
Last reviewed 9 August 2026 by ExaVeyra Sciences editorial team. Every claim above links to a primary source.
- N.Y. Educ. Law art. 137, Pharmacy (accessed 8 August 2026)
- NYSED, Article 137 as published by the Board of Pharmacy (accessed 8 August 2026)
- NYSED Office of the Professions, out-of-state establishment requirements (accessed 8 August 2026)
- N.Y. Educ. Law art. 131, Medicine (incl. § 6521) (accessed 8 August 2026)
- N.Y. Educ. Law art. 139, Nursing (incl. § 6910) (accessed 8 August 2026)
- New York State Department of Taxation and Finance (accessed 8 August 2026)
- FDA Public Safety Notification on Exosome Products (accessed 8 August 2026)
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 treatments in clinics and for medical, molecular biology, and biochemistry research applications, and are not tissue products as defined by FDA guidelines.
Reference only. Not legal or medical advice.
The content of these guides is provided for general informational purposes only. It does not constitute legal, medical, or regulatory advice, and does not establish that any particular product or practice is compliant. Regulatory requirements vary by state and depend on the circumstances of each practice. Each practitioner should consult their own legal counsel and the applicable state licensing boards before acting on anything stated here.
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ExaVeyra Sciences publishes these guides as a reference for licensed practitioners. They summarize publicly available federal and state requirements as those requirements read on the review date shown above. The content is provided for general informational purposes only and does not constitute legal, medical, or regulatory advice, and it does not establish that any particular product or practice is compliant.
No attorney-client relationship, and no professional or clinical relationship of any kind, is created by accessing these materials. ExaVeyra Sciences is a supplier of research-use materials. It is not a law firm, it is not a regulatory consultant, and it takes no part in any diagnosis, treatment decision, or plan of care. Each practitioner is responsible for retaining their own legal counsel and for determining, with that counsel and the applicable state licensing boards, how the requirements described here apply to the services, staffing, and structure of their own practice.
Statutes, regulations, board rules, and agency positions are subject to amendment, supersession, and reinterpretation. ExaVeyra Sciences makes no representation or warranty as to the accuracy, completeness, timeliness, or applicability of this content to any particular practice. Citations and links to third-party sources are provided for convenience only and do not constitute an endorsement of their content.
The practitioner and the practice are solely responsible for compliance with all applicable licensing, scope of practice, supervision, ownership, facility, recordkeeping, and tax requirements, and for all clinical decisions, including the suitability of any material for a given patient. To the fullest extent permitted by law, ExaVeyra Sciences disclaims all liability for any action taken or not taken in reliance on this content.