Regulatory context for Florida pain management practices
Florida Statutes section 459.0127 (SB 1768), effective July 1, 2025, permits MD and DO physicians to use certain non-FDA-approved stem cell therapies in pain management and related specialties under defined informed consent and disclosure requirements. This state statute sits alongside, not in place of, federal FDA regulation, which continues to apply to the products themselves. For exosome products specifically, FDA has stated there are no FDA-approved exosome products, and Precision Biologics does not provide clinical, dosing, or protocol advice; any use decision belongs to the treating physician and independent counsel.
Ocala
NPPES registry listings, primary taxonomy, retrieved 2026-10-27
48- Pain Medicine
- 24
- Physical Medicine & Rehabilitation
- 24
Logistics for this region
Practices should decide in advance which staff member receives and logs shipments, particularly for cryopreserved inventory that needs to move into ultra-low freezer storage promptly.
- Cryopreserved Wharton's jelly products ship overnight on dry ice
- Storage at -80 degrees Celsius on arrival
- Lyophilized exosome formats are shelf-stable and do not require cryogenic storage
- Each lot is tracked by a unique identifier
Documentation to request
Ask for the certificate of analysis and lot release record for a specific lot, along with the donor eligibility summary for Wharton's jelly products or the characterization data and full ingredient disclosure for exosome products. Registration and licensure documentation is also available for qualified buyers to verify on their own.
Account setup
New accounts require a National Provider Identifier, which can be confirmed through the NPPES NPI Registry, and practices should independently verify their own licensure with the Florida Board of Medicine or Board of Osteopathic Medicine. Once verified, a practice can schedule a peer-to-peer physician call to review documentation before placing its first order.
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 exosome products?+
SB 1768 addresses physician use of certain non-FDA-approved stem cell therapies under Florida law. It does not change the federal regulatory status of exosome products, which FDA states are not FDA-approved and are generally regulated as biologic drugs.
What's the difference in storage between product families for a pain management practice?+
Cryopreserved Wharton's jelly products require -80 degree Celsius storage and overnight dry-ice shipping. Lyophilized exosome products are shelf-stable and do not require the same cold-chain setup.
Who can set up an account in Ocala?+
Licensed pain management and physical medicine practices can set up an NPI-verified account by confirming their NPI through the NPPES NPI Registry.