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.
Kimera material is a perinatal MSC-derived preparation. Tennessee’s statute names exosome-based products in its documentation standard, and whether a given service falls inside the statute is a question for the practice and its counsel. The certificate of analysis and lot number that accompany every vial are the starting point for the documentation the statute describes.
At a glance
| Question | Answer |
|---|---|
| Does ExaVeyra ship to Tennessee? | 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 | HB 2246 (Public Chapter 1016) (2026) |
| Does that statute reach exosomes? | Yes |
| Physician delegation required to hand off medical acts | Yes |
| 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 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. 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 Tennessee professional license in good standing, verifiable through the Department of Health.
- A valid NPI, which ExaVeyra verifies at account setup.
- A signed professional-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 only state whose statute names exosome-based products expressly. Most other state guides in this directory explain why a stem cell statute written around cells and tissues does not reach acellular vesicles; Vermont’s disclosure law sweeps in extracellular components and vesicles without naming exosomes, and its guide covers that nuance. Tennessee names them outright in its documentation standard. 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 by licensed practitioners.
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 authorized 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 organization, 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, authorized 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 organization. Structure this with Tennessee counsel before opening.
Cold chain into Tennessee
Shipments leave Florida frozen under validated temperature monitoring. A package in transit over a weekend waits in the carrier network, so practices in Tennessee order around weekend and holiday closures.
| Metro | County | Notes |
|---|---|---|
| Nashville | Davidson | Largest Tennessee market and a national center 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.
- Storage and handling conditions follow the manufacturer's handling instructions, which ship with each order; the Certificate of Analysis is the document Public Chapter 1016 asks a supplier to provide per lot.
Wholesale exosome supply by city in Tennessee
Each city page covers local receiving conditions, delivery disruptions and business license rules for Tennessee practices in that area.
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 by licensed practitioners.
- 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 organization, 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?
- 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 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 use by licensed practitioners and for laboratory and IND-authorized clinical research, and are not tissue products as defined by FDA guidelines.