What Florida's SB 1768 does and does not cover
Florida Statutes 459.0127 (SB 1768, effective July 1, 2025) permits physicians to use certain non-FDA-approved stem cell therapies in pain management, along with orthopedics and wound care, provided informed consent and disclosure requirements under the statute are met. The statute governs physician conduct under Florida law; it does not change how the FDA regulates a tissue allograft or exosome product federally.
Whether a specific pain management use fits the statute, and separately whether it fits the federal framework in 21 CFR 1271.10, are determinations for the practice and its own counsel.
Lakeland
NPPES registry listings, primary taxonomy, retrieved 2026-10-27
48- Pain Medicine
- 23
- Physical Medicine & Rehabilitation
- 25
Documentation before your first order
Pain management and physical medicine practices typically request a certificate of analysis, donor eligibility summary, and third-party sterility testing confirmation for the specific lot under consideration, before placing an order rather than after.
- Certificate of analysis
- Donor eligibility summary
- Lot release record
- Sterility testing confirmation
Account setup and shipping to Central Florida
Account verification requires a valid National Provider Identifier, after which pricing becomes visible to the account. Cryopreserved products ship overnight on dry ice in validated containers for -80 degree Celsius storage; practices should document receipt and lot numbers as part of a standard intake step.
Precision Biologics supports account setup and documentation delivery, and offers peer-to-peer calls on product paperwork. We do not advise on dosing or procedure. Confirm your regulatory posture with the Florida medical board and your own counsel.
FDA has stated there are no FDA-approved exosome products. Exosome products are generally regulated as biologic drugs under section 351 of the Public Health Service Act, not as 361 HCT/Ps. Purchase and clinical use decisions belong to the physician with their own regulatory counsel.
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
Does SB 1768 apply to every pain management use of these products?+
SB 1768 sets informed consent and disclosure conditions for physicians using certain non-FDA-approved stem cell therapies in pain management, among other specialties, under Florida law. Whether a specific product and use qualifies is a determination for your practice and counsel, not something we assess for you.
What is the first document a pain management practice in Lakeland should request?+
Most practices start with the certificate of analysis for the lot they are considering, followed by the donor eligibility summary and sterility testing confirmation.
How is product tracked once it reaches our clinic?+
Lot-level traceability at the patient record level is maintained on the clinic side; we provide the lot release record to support that tracking.