State ordering guide
Sourcing Exosomes in Tennessee
Tennessee is the first state in the country to write exosomes into statute. Public Chapter 1016, signed 26 May 2026 and effective 1 July 2026, defines regenerative medicine therapy partly by what the manufacturer documents, and it names particle counts for exosome-based regenerative products alongside a lot-specific sterility report and a certificate of analysis for every product before use on a patient.
For a practice sourcing Kimera material, that is unusually straightforward: the documentation Tennessee describes is the documentation that ships with every vial, and Kimera is a Wharton’s jelly derived product, which the statute also addresses by name.
At a glance
| Question | Answer |
|---|---|
| Does ExaVeyra ship to Tennessee? | 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 | HB 2246 (Public Chapter 1016) (2026) |
| Does that statute reach exosomes? | Yes |
| 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. Compounded preparations are not available in this state at this time |
| Last reviewed | 9 August 2026 |
Ordering from Tennessee
ExaVeyra ships to licensed practices in all 50 states, Tennessee 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 Tennessee regulates who performs the procedure.
What your practice provides
- An active Tennessee professional license in good standing, verifiable through the Department of Health.
- A valid NPI, which ExaVeyra verifies at account setup.
- A signed research-use acknowledgment on file for exosome material.
- A Tennessee resale certificate if the practice is purchasing for resale rather than for use in its own operations.
How the state permits wholesale distribution
Tennessee licenses wholesale distribution through the Board of Pharmacy. Every manufacturer, outsourcing facility, or wholesaler and distributor obtains board licensure before manufacturing, selling, or distributing prescription drugs or devices in Tennessee, and any distributor shipping prescription drugs or prescription devices into or out of the state is licensed accordingly. Devices are inside the definition, as in California, New York, Arizona, and Nevada. The license sits with the distributor, not with the purchasing practice.
T.C.A. §§ 63-10-306, 63-10-310; Tenn. Comp. R. & Regs. 1140-01-.08, 1140-09 · Tennessee Board of Pharmacy
Tennessee regenerative-medicine law
Tennessee enacted HB 2246 (Public Chapter 1016), codified at T.C.A. tit. 63 ch. 6 pt. 2; tit. 68, effective 1 July 2026.
Physicians licensed under chapter 6 or chapter 9 of title 63, performing stem cell therapy or regenerative medicine therapy that the FDA has not approved, within their scope of practice. Accepted accreditors include the American Academy of Stem Cell Medicine, the Association for the Advancement of Blood and Biotherapies, the Foundation for the Accreditation of Cellular Therapy, and the World Marrow Donor Program. The section does not apply to a physician operating under an FDA-approved investigational new drug or device, to a hospital or affiliated hospital outpatient clinic, or to therapy performed under the Phil Timp-Amanda Wilcox Right to Try Act. Therapy using cells or tissues derived from a fetus or embryo after an abortion is excluded.
- Supplier validation of isolation techniques
- Lot-specific sterility report and certificate of analysis
- FDA-registered or accredited manufacturing facility
- Advertising notice in prescribed language
- Written patient consent before therapy
- Adverse event reporting within 30 days
“validates its isolation techniques by including cell viability and surface marker reports for cellular products, a viscosity report for Wharton’s jelly, and particle counts for exosome-based regenerative products”
How this applies to exosomes
Tennessee is the exception. Every other state guide in this directory explains why a stem cell statute written around cells and tissues does not reach acellular vesicles. Tennessee does reach them, and does so by name. Public Chapter 1016 splits its subject in two: stem cell therapy carries cell-specific gates on facility registration, storage at or below minus eighty degrees centigrade, and pre-thaw and post-thaw viability, while regenerative medicine therapy is defined by what the manufacturer documents. That second limb requires particle counts for exosome-based regenerative products, a viscosity report for Wharton’s jelly, a lot-specific sterility report, and a certificate of analysis for each product before it is used on a patient, all from a facility registered with the FDA or accredited by a listed body. This is a state documentation standard, not an FDA approval. No exosome product has been approved by the FDA for administration to humans, and ExaVeyra supplies Kimera material for topical aesthetic use in clinics and for research applications.
Who can handle product in a Tennessee practice
A Tennessee practice runs on written protocols and standing orders approved by the medical director, a good faith examination before treatment, and delegation only to qualified authorised providers. Where a service falls under Public Chapter 1016, the statute layers its own duties on top: a signed written consent form, a prescribed advertising notice in type no smaller than the largest used in the advertisement, and adverse event reporting to the manufacturer, any applicable accrediting organisation, and the licensing authority within thirty days.
| Role | Scope under state law |
|---|---|
| MD / DO | Physicians licensed under title 63 chapter 6, and osteopathic physicians under chapter 9, may perform medical acts within their scope and are the source of any delegation. Under Public Chapter 1016 the physician also carries the consent, advertising notice, and adverse event reporting duties. |
| NP / APRN | Nurse practitioners practice under a supervisory or collaborative arrangement with a physician and may perform delegated procedures within it. They do not independently supervise or direct a medical practice. |
| PA | Physician assistants practice under physician supervision within the delegated scope. |
| RN | Registered nurses may perform treatments such as injectables or intravenous therapy when properly trained and where the service has been formally delegated, and are supervised by a physician or by a physician assistant, nurse practitioner, or registered nurse with authority to do so. |
Good faith examination
Tennessee expects a good faith examination before treatment, with the medical director responsible for writing and approving treatment protocols and standing orders for every procedure offered and for delegating only to qualified, authorised providers.
Ownership and clinic licensing
Tennessee bars the corporate practice of medicine. An entity providing medical services is owned by licensed physicians, or by physicians together with licensed chiropractors or podiatrists, and non-physicians including nurse practitioners cannot directly own the medical practice. Business operations are commonly separated into a management services organisation. Structure this with Tennessee counsel before opening.
Cold chain into Tennessee
Shipments dispatch from our Miami Beach facility under validated temperature monitoring, and delivery into Tennessee is scheduled to avoid a weekend hold at the carrier hub.
| Metro | County | Notes |
|---|---|---|
| Nashville | Davidson | Largest Tennessee market and a national centre of gravity for healthcare operators. |
| Memphis | Shelby | Strong physician-led regenerative and orthopedic presence. |
| Knoxville | Knox | East Tennessee hub with a growing aesthetic segment. |
| Chattanooga | Hamilton | Regional market serving the Georgia border corridor. |
| Franklin | Williamson | Affluent Nashville suburb with dense med spa coverage. |
| Brentwood | Williamson | Concierge and longevity practices south of Nashville. |
- Tennessee 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, which is also the document Public Chapter 1016 asks a supplier to provide per lot.
Practice types we supply in Tennessee
Tennessee licensing and verification
Tennessee Board of Medical Examiners
Licenses medical spas and office-based surgery centers directly, and may promulgate rules to effectuate Public Chapter 1016.
Tennessee Board of Nursing
Tennessee Board of Pharmacy
Licenses the wholesale distributors that ship into Tennessee.
Tennessee Department of Revenue
Where a practice registers before issuing a resale certificate.
Tennessee sourcing questions
- Does Tennessee law mention exosomes?
- Yes, and it is the first state statute in the country to do so. Public Chapter 1016, effective 1 July 2026, defines regenerative medicine therapy partly by manufacturer documentation, and requires that a supplier validate its isolation techniques by including particle counts for exosome-based regenerative products, alongside cell viability and surface marker reports for cellular products and a viscosity report for Wharton’s jelly.
- Does that mean exosomes are FDA approved in Tennessee?
- No. A state documentation standard is not a federal approval. No exosome product has been approved by the FDA for administration to humans, and Public Chapter 1016 addresses therapies the FDA has not approved rather than changing their federal status. ExaVeyra supplies Kimera material for topical aesthetic use in clinics and for research applications.
- What documentation does Tennessee expect from a supplier?
- A lot-specific sterility report and a certificate of analysis for each product before it is used on a patient, validation of isolation techniques including particle counts for exosome-based products and a viscosity report for Wharton’s jelly, and manufacture and storage in a facility registered with the FDA or accredited by a listed body such as the Association for the Advancement of Blood and Biotherapies or the Foundation for the Accreditation of Cellular Therapy. Every Kimera vial ships with a COA and lot number, and COAs include particle characterization and sterility panel data.
- What does Public Chapter 1016 require of the physician?
- A written consent form signed by the patient or their representative before therapy, a prescribed notice in each advertisement stating the therapy is not FDA approved and encouraging consultation with a primary care provider, in type no smaller than the largest used in the advertisement, and reporting of adverse events to the manufacturer, any applicable accrediting organisation, and the physician’s licensing authority within thirty days.
- Who is outside the statute?
- A physician performing therapy under an FDA-approved investigational new drug or device, a hospital or affiliated hospital outpatient clinic, and therapy performed under the Phil Timp-Amanda Wilcox Right to Try Act. Therapy using cells or tissues derived from a fetus or embryo after an abortion is excluded from the definitions.
- How long does cold-chain shipping take to Tennessee?
- 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 Tennessee 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.
- Tennessee Public Chapter 1016 (2026), enacted text (accessed 8 August 2026)
- Tennessee HB 2246, bill history and status (accessed 8 August 2026)
- Tenn. Comp. R. & Regs. 1140-01, Board of Pharmacy licensing rules (accessed 8 August 2026)
- Tennessee Board of Pharmacy (accessed 8 August 2026)
- Tennessee Board of Medical Examiners (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.
Read the full disclaimer
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.