Documentation pain management groups typically request
Pain management and physical medicine practices evaluating a new biologics supplier generally ask for the same baseline documentation regardless of product type: a certificate of analysis for the specific lot, a donor eligibility summary, and a lot release record showing the product cleared internal release criteria after third-party sterility testing.
Precision Biologics makes this documentation available to verified accounts and can arrange a peer-to-peer conversation between a physician and Precision Biologics about the documentation itself; these conversations do not constitute clinical or legal advice.
Orlando
NPPES registry listings, primary taxonomy, retrieved 2026-10-27
169- Pain Medicine
- 62
- Physical Medicine & Rehabilitation
- 107
Confirming regulatory posture
Exosome products are generally regulated as biologic drugs under section 351 of the Public Health Service Act, and the FDA has stated there are no FDA-approved exosome products. Whether a Wharton's jelly product's intended use in a given practice qualifies under the section 361 criteria in 21 CFR 1271.10 — minimal manipulation, homologous use, no systemic effect — is a determination the practice and its counsel make, not something Precision Biologics certifies.
Florida enacted SB 1768, effective July 1, 2025, which addresses physician use of certain non-FDA-approved stem cell therapies in pain management, orthopedics, and wound care under informed consent and disclosure requirements. It does not change federal FDA requirements. Practices should confirm current applicability with the Florida Board of Medicine and their own counsel.
Opening a verified account
Account setup requires an NPI number, which is checked against the NPPES registry, along with practice contact information. Orders are restricted to licensed physicians and practice entities; Precision Biologics does not sell to individual patients.
Shipping and cold-chain receiving
Cryopreserved products are shipped overnight on dry ice in validated containers from -80 degree C storage. A practice receiving shipments should plan for someone to be available to accept and log the delivery, since prompt transfer to proper storage preserves cold-chain integrity. Lyophilized formats ship shelf-stable and do not require cryogenic handling on receipt.
These products are not FDA approved or licensed for any disease or condition. Information is for licensed healthcare professionals and is not medical or legal advice.
Frequently asked questions
Can a pain management practice in Orlando order both Wharton's jelly and exosome products from one supplier?+
Yes. Precision Biologics distributes both product families to the same verified account, with separate documentation provided for each.
Are exosome products FDA-approved for use in pain management clinics?+
No. The FDA has stated there are no FDA-approved exosome products. Purchase and clinical use decisions remain with the treating physician and their own regulatory counsel.
How does Florida SB 1768 affect a pain management practice's purchasing decision?+
SB 1768 addresses physician use of certain non-FDA-approved stem cell therapies under Florida law and does not change federal FDA requirements for the product. Confirm applicability with the Florida Board of Medicine and counsel before ordering.