Sourcing and compliance
Exosome sourcing for licensed practices
ExaVeyra Sciences ships Kimera exosome material to NPI-verified licensed practices in all 50 states, cold-chain from Miami Beach with a Certificate of Analysis and lot traceability on every vial. Distribution-side licensing is ours to hold, so your practice orders against its own professional license and NPI.
What changes from state to state is not whether product can reach you. It is the indications the material may be used for under federal law, and how your state regulates who performs the procedure. These guides cover both, state by state.
One thing worth stating up front, because it is the most common misconception we hear: most state stem cell laws do not reach exosomes at all. Those statutes are written around cells and tissues, and exosomes are acellular. That is not a restriction, it simply means federal law is what governs.
Tennessee is the exception, and it is worth knowing about. Its Public Chapter 1016, effective 1 July 2026, is the first US statute to name exosome-based regenerative products, and it does so by setting a supplier documentation standard rather than by approving anything. Each state guide sets out where its state actually lands.
Guides by state
10 of 50 state guides published. The remainder are in review and will appear as they are completed.
South
West
- Alaska
- Arizona
- California
- Colorado
- Hawaii
- Idaho
- Montana
- Nevada
- New Mexico
- Oregon
- Utah
- Washington
- Wyoming
Midwest
- Illinois
- Indiana
- Iowa
- Kansas
- Michigan
- Minnesota
- Missouri
- Nebraska
- North Dakota
- Ohio
- South Dakota
- Wisconsin
Northeast
- Connecticut
- Maine
- Massachusetts
- New Hampshire
- New Jersey
- New York
- Pennsylvania
- Rhode Island
- Vermont
Common sourcing questions
- Do state stem cell laws cover exosomes?
- Almost never. Laws such as Florida SB 1768 and Texas HB 810 are written around stem cells and human cells, tissues, or cellular or tissue-based products, and California defines its subject as therapies involving HCT/Ps. Exosomes are acellular extracellular vesicles and fall outside those definitions, so those statutes neither permit nor restrict them. Two states are worth separating out. Tennessee is the first in the country to name exosome-based regenerative products in statute, in Public Chapter 1016 effective 1 July 2026, which sets supplier documentation requirements rather than approving anything. Nevada reaches biological products more broadly, but its statute turns on a treatment produced exclusively for one patient from that patient’s genetic profile, which an off-the-shelf preparation is not. In every case exosome products remain governed federally, and no exosome product has been approved by the FDA for administration to humans.
- Does my practice need a wholesale distributor license to buy exosomes?
- No. State wholesale distribution permits are held by the distributor selling into the state, not by the practice purchasing. Your practice orders against its own professional license and NPI. ExaVeyra handles distribution-side licensing.
- What does ExaVeyra verify before opening an account?
- An active professional license in the practice’s state, a valid NPI, and a signed research-use acknowledgment for exosome material. Practices purchasing for resale also provide their state resale certificate.
- What documentation ships with each vial?
- Every Kimera vial ships with a Certificate of Analysis and lot number. COAs include particle characterization and sterility panel data, and are available for review before ordering.
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.
These guides summarize publicly available state requirements for licensed practitioner education and are not legal advice. Requirements change. Confirm current federal and state obligations with qualified counsel before offering any regenerative service line.