Florida’s CS/CS/SB 1768, codified at Sections 458.3245 and 459.0127 of the Florida Statutes and enacted as Chapter 2025-185, took effect July 1, 2025. It authorizes licensed Florida physicians to perform certain stem cell therapies that are not approved by the U.S. Food and Drug Administration, but only inside a narrow set of conditions that govern scope, sourcing facilities, consent, advertising, and sourcing contracts. This checklist walks a Florida MD or DO through every category the statute imposes so that a practice can audit itself before offering any service that falls under the law.
TLDR: Florida SB 1768 (Chapter 2025-185, effective July 1, 2025) lets licensed MDs and DOs perform non-FDA-approved stem cell therapy only for orthopedics, wound care, or pain management within their scope of practice. The cells must come from an FDA-registered facility that is also accredited by one of four named bodies, must adhere to current good manufacturing practices, and must arrive with a post-thaw viability report. A signed consent form and a specified advertising notice are mandatory. Violations may trigger Board of Medicine discipline. Banking adipose tissue does not enroll a patient in any therapy and does not guarantee any future eligibility, access, or benefit.
Important Disclaimer: Save My Fat does not provide FDA-approved treatments or cures for any disease. Banking adipose tissue today does not guarantee eligibility, access, or clinical benefit from any future therapy, clinical trial, or medical program. No adipose-derived stem cell product currently holds FDA approval for the conditions discussed in this article. All content is for educational purposes only and does not constitute medical advice. Patients must consult their own licensed healthcare professionals regarding all medical decisions.
If you practice in Florida and you are weighing whether to add a regenerative service line, the statute is short, but the operational obligations behind it are not. A clean reading of the bill text matters more than a summary, because the penalties attach to specific failures: the wrong sourcing facility, a missing report, an advertisement without the right language. The sections below track the statute clause by clause.
Who Is Authorized
Section 458.3245 applies to physicians licensed under Chapter 458 (MDs) and Section 459.0127 mirrors it for physicians licensed under Chapter 459 (DOs). The statute defines “physician” as a person licensed under the relevant chapter acting within the course and scope of his or her employment. Physician assistants, nurse practitioners, and other mid-level providers are not granted independent authority by this law. If your model relies on a mid-level acting without physician oversight, that arrangement is outside the authorization this statute provides.
The authorized clinical scope is also narrow. A physician may perform non-FDA-approved stem cell therapy only when it is within that physician’s existing scope of practice and only for therapies related to orthopedics, wound care, or pain management. Any other indication, neurologic, cardiac, autoimmune, cosmetic, or otherwise, is outside the authorized scope of SB 1768. This is the most common place a practice oversteps: the statute does not authorize a general regenerative practice, only three condition categories.
This is a separate question from what adipose tissue banking itself involves. Banking is the harvest and preservation of a patient’s own tissue, not the administration of a therapy. If you are evaluating where banking fits in a physician practice, the background is covered in the overview of why physicians add adipose banking.
Facility and Sourcing Requirements
The statute is specific about where the stem cells used in therapy may come from. Any stem cells used by a physician under this section must be retrieved, manufactured, and stored in a facility that is registered and regulated by the FDA, and that facility must also be certified or accredited by one of the following four entities: the National Marrow Donor Program, the World Marrow Donor Association, the Association for the Advancement of Blood and Biotherapies, or the American Association of Tissue Banks.
A brief orientation to each. The National Marrow Donor Program operates the national registry for marrow and cord blood and sets standards for cellular therapy products. The World Marrow Donor Association is the international standards body for unrelated donor stem cell products. The Association for the Advancement of Blood and Biotherapies, formerly AABB, accredits cellular therapy and biotherapy facilities. The American Association of Tissue Banks accredits tissue establishments and sets voluntary standards for tissue recovery and processing. Accreditation matters here because the statute makes it a precondition: a facility without one of these credentials cannot lawfully supply cells for therapy under this section, regardless of how capable it may be.
The cells must also adhere to applicable current good manufacturing practices for collection, removal, processing, implantation, and transfer, consistent with the Federal Food, Drug, and Cosmetic Act and 21 CFR Part 1271, the federal rule governing human cells, tissues, and cellular and tissue-based products. The federal classification framework that sits underneath all of this is worth understanding separately, and the discussion of 21 CFR Part 1271 lays out why that rule governs tissue at the federal level.
The Post-Thaw Viability Report Requirement
Before the cells are used in any patient, the statute requires that they contain viable or live cells upon post-thaw analysis and that a post-thaw viability analysis report for the product lot be sent to the physician before use. In plain terms, a viability report documents what fraction of the cells in a given lot are alive and functional after the freeze-and-thaw cycle. It is a quality-control record, not a clinical outcome prediction.
For the treating physician, the obligation is twofold: the report must exist, and you must receive and review it before proceeding. Build this into your intake workflow as a hard gate. A lot without a current report attached cannot be used under the statute, and “we assumed it was fine” is not a defense the law contemplates. The science of how viability is measured after freezing is covered in the explainer on adipose tissue cryopreservation viability.
Informed Consent Requirements
The statute requires a signed consent form, obtained before the therapy is performed, signed by the patient or, if the patient is not legally competent, by the patient’s representative. The form must state all of the following in language the patient can reasonably be expected to understand:
- The nature and character of the proposed treatment.
- That the proposed stem cell therapy has not yet been approved by the FDA.
- The anticipated results of the proposed treatment.
- The recognized serious possible risks, complications, and anticipated benefits involved in the treatment and in the recognized possible alternative forms of treatment, including nontreatment.
- That the patient is encouraged to consult with his or her primary care provider before undergoing any stem cell therapy.
Two practical notes. First, the “anticipated results” disclosure is not an invitation to promise outcomes; it is a requirement to describe realistically what is expected, and overstatement here creates separate exposure under federal and state advertising law. Second, the consent must be retained in the medical record. What informed consent means specifically in this field is covered in the discussion of informed consent in regenerative medicine.
Advertising Requirements
A physician who conducts stem cell therapy under this section must include a specific notice in any form of advertisement. The statutory language is:
“THIS NOTICE MUST BE PROVIDED TO YOU UNDER FLORIDA LAW. This physician performs one or more stem cell therapies that have not yet been approved by the United States Food and Drug Administration. You are encouraged to consult with your primary care provider before undergoing any stem cell therapy.”
The statute specifies how prominent that notice must be: it must be clearly legible and in a type size no smaller than the largest type size used in the advertisement. Note what this is and is not. It is a relative size rule tied to the largest text in your own ad, not a fixed point size. If your headline is 60-point, the notice cannot be smaller than 60-point. This requirement applies across advertising media, including digital, print, and social formats. A physician who advertises stem cell services without this notice is out of compliance with the statute.
Sourcing Contracts
SB 1768 also reaches the contract between the physician and the supplying facility. A physician may not obtain cells from a facility unless that facility maintains valid certification or accreditation, and the contract must require the facility to provide its name and address, the certifying or accrediting organization, the type and scope of certification, the effective and expiration dates of the certification, and any limitations or conditions imposed. The contract must also require the facility to notify the physician within 30 days of any change in certification status, including renewal, suspension, revocation, or expiration. This turns accreditation from a one-time check into an ongoing contractual duty.
Consequences of Non-Compliance
A violation of this section may subject the physician to disciplinary action by the Board of Medicine. Under the broader Florida disciplinary framework in Chapter 458 and Section 456.072, disciplinary action can include reprimand, fines, restrictions on practice, and suspension or revocation of licensure. The statute also carries a separate and far more serious provision: a physician who willfully performs or actively participates in treatment or research using cells derived from an aborted fetus or embryo, or in the sale or manufacture of certain products made from human cellular material, commits a third-degree felony. That provision sits outside the orthopedic, wound care, and pain management service most practices are contemplating, but it is in the same statute and worth knowing.
This article is a compliance orientation, not legal advice. The interpretation of “anticipated results,” the precise contract language, and the boundaries of “scope of practice” are exactly the kind of questions a Florida healthcare attorney should review against your specific practice before launch.
The Pre-Launch Compliance Checklist
A practice or compliance manager can use the following as a pre-launch audit. Each item maps to a statutory requirement above.
- Confirm the sourcing facility is registered and regulated by the FDA, and obtain documentation.
- Verify the facility holds current accreditation from NMDP, WMDA, the Association for the Advancement of Blood and Biotherapies, or AATB, and document the type, scope, and expiration dates.
- Confirm cGMP adherence for collection, processing, and transfer is documented.
- Establish a post-thaw viability report intake step that gates use of any lot.
- Put the required sourcing-contract clauses in place, including the 30-day status-change notice.
- Draft a consent form that contains all five statutory disclosures, and have counsel review it.
- Confirm every advertisement, in every medium, carries the statutory notice at the required type size.
- Train clinical and front-office staff on the consent, notice, and documentation workflow.
Frequently Asked Questions
Does SB 1768 let a Florida physician treat any condition with stem cell therapy?
No. The authorization is limited to therapies related to orthopedics, wound care, or pain management, and only within the physician’s existing scope of practice. The statute does not authorize stem cell therapy for other conditions.
Does the law require a specific font size for advertisements?
The statute does not set a fixed point size. It requires the notice to be clearly legible and no smaller than the largest type size used in that same advertisement. The required size therefore depends on the largest text in your own ad.
Does banking adipose tissue qualify a patient for therapy under SB 1768?
No. Banking is the preservation of a patient’s own tissue. It is separate from the therapeutic use of stem cells, and it does not create eligibility for, or access to, any therapy. Any future use would depend on FDA regulatory status, physician judgment, and the pathways available at that time.
Are there exemptions to this section?
Yes. The section does not apply to a physician who has obtained FDA approval for an investigational new drug or device for the relevant use, or to a physician performing stem cell therapy under contract on behalf of an institution accredited by the Foundation for the Accreditation of Cellular Therapy, the Blood and Marrow Transplant Clinical Trials Network, the Association for the Advancement of Blood and Biotherapies, or an entity with expertise as determined by the department.
Key Takeaways
Florida SB 1768 is best read as a permission with conditions attached, not a green light. It opens a narrow lane for orthopedic, wound care, and pain management therapy using non-FDA-approved cells, but only when the sourcing facility is both FDA-registered and accredited by one of four named bodies, only when a post-thaw viability report reaches the physician before use, and only when consent and advertising follow the statutory script. The Board of Medicine penalty for getting any of these wrong is real, and the felony provision in the same statute underscores how seriously Florida treats the sourcing question. For a physician evaluating a regenerative service line, the practical move is to treat accreditation, the viability report, the five consent disclosures, and the advertising notice as four independent gates, each of which must be cleared before a patient is ever scheduled. None of this changes the underlying reality that no adipose-derived product is FDA-approved for these uses, and that banking tissue is a preservation decision, not a treatment decision.
Save My Fat operates as a tissue preservation service, not a medical practice or treatment provider. Stem cell and regenerative medicine regulations vary by state, including specific informed-consent and disclosure requirements in Florida, Utah, and Nevada governing tissue and stem cell services. Banking adipose tissue does not connect patients to any treatment pathway, and any future use depends on FDA regulatory status, physician guidance, and the availability of approved or investigational pathways at that time.
Physicians evaluating whether adipose banking fits their practice can contact Save My Fat to discuss how tissue preservation works alongside a compliant service model. Service and processing details are available at https://savemyfat.com/pricing/.
Save My Fat partners with L2 Bio for laboratory processing and storage.
This article is for educational purposes only and does not constitute medical or legal advice. Legal and medical review including neurology and neurosurgery input is required before publication. Please consult your neurologist or neurosurgeon before making any decisions about neurologic treatment or research participation.
