Ocala
NPPES registry listings, primary taxonomy, retrieved 2026-10-27
39- Orthopaedic Surgery
- 39
How Florida orthopedic groups structure vendor review
Florida Statutes section 459.0127, enacted as SB 1768 and effective July 1, 2025, allows MD and DO physicians to use certain non-FDA-approved stem cell therapies in orthopedics, wound care, and pain management under specific informed consent and disclosure requirements, in addition to federal FDA rules that still apply to the product itself. An Ocala orthopedic practice reviewing a biologics vendor should confirm with its own counsel how, if at all, that statute applies to the specific products and intended use under consideration, since it does not override federal FDA regulation.
Documentation to request before ordering
Precision Biologics provides certificates of analysis, donor eligibility summaries, and lot release records for its Wharton's jelly products on request. Registration and licensure documentation is also available for qualified buyers to verify independently. Whether a specific intended use qualifies for section 361 treatment under 21 CFR 1271.10, covering minimal manipulation, homologous use, and no systemic effect, is a determination for the practice and its own legal counsel, not something Precision Biologics advises on.
Receiving cold-chain shipments
Cryopreserved products are shipped overnight on dry ice in validated containers following slow-rate freezing and storage at -80 degrees Celsius, and a practice should have staff ready to move incoming lots into appropriate storage on arrival. Each lot carries a unique identifier for tracking at the patient record level once received.
Setting up an account
A new account requires a National Provider Identifier, confirmed through the NPPES NPI Registry, and practices should also verify their own standing with the Florida Board of Medicine or Board of Osteopathic Medicine as part of standard compliance diligence. Once the NPI is confirmed, a practice can request documentation and schedule a peer-to-peer physician call before its first order.
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 Florida's SB 1768 mean these products are FDA approved?+
No. SB 1768 is a state statute governing physician use of certain non-FDA-approved therapies under specific conditions. It does not change FDA's federal regulation of the product itself, which still applies.
What documentation does Precision Biologics provide to Ocala practices?+
Certificates of analysis, donor eligibility summaries, lot release records, and registration and licensure documentation are available on request to verified accounts.
How do I set up an account from an Ocala practice?+
Confirm the practice's NPI through the NPPES NPI Registry, then request documentation for the products under consideration. Pricing becomes available once the account is verified.