Exosome sourcing for licensed practices

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 only for a patient diagnosed with a life-threatening or severely debilitating disease or condition, and only for a treatment produced exclusively for that patient from their genetic profile or a product already in an FDA-approved clinical trial. An off-the-shelf preparation for topical aesthetic use meets neither condition. 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?

Your practice orders against its own professional license and NPI and needs no wholesale permit to purchase. Licensure for shipping into each 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.

What does ExaVeyra verify before opening an account?

An active professional license in the practice’s state, a valid NPI, and a signed professional-use acknowledgment for exosome material. Practices purchasing for resale also provide their state resale certificate.

What documentation ships with each vial?

A Certificate of Analysis is issued for every Kimera lot and provided on request, and every vial carries its lot number. COAs include particle characterization and sterility panel data, and are available for review before ordering.

How many state sourcing guides has ExaVeyra published?

50 of 50 state guides are published. The remaining 0 are listed on the coverage page without a link and appear as each is researched and reviewed.

Which states have a published exosome sourcing guide?

Guides are published for Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin and Wyoming. Each one is linked from the coverage table.

What does a state sourcing guide cover?

Each guide reads the state's regenerative-medicine statute for what it does and does not reach, who in a practice may handle product under the state's delegation rules, which boards are involved, and cold-chain transit for the state's metros, with every regulatory statement cited to a primary source. The most recent review date across the published guides is 2026-10-16.