AATB Accreditation, Federal Compliance, and the State-by-State Legal Landscape for Stem Cell Biologics in 2026
Licensed practitioners ask two questions about regenerative biologics more than any others: what does AATB accreditation actually mean, and what does the law in my state say? This guide covers both. It walks through the federal baseline, what AATB accreditation requires, compliant versus non-compliant marketing language, and the state laws enacted, amended, or rejected through October 2026.
This is a regulatory reference, not legal advice. Consult qualified legal counsel about your practice, your jurisdiction, and the products you source or use.
Part 1: The Federal Regulatory Baseline
21 CFR Part 1271 — The HCT/P Framework
Human cells, tissues, and cellular and tissue-based products (HCT/Ps), including products derived from umbilical cord tissue, are regulated under 21 CFR Part 1271. Part 1271 governs establishment registration, donor eligibility, and current Good Tissue Practice (cGTP) for how these products are recovered, processed, stored, labeled, and distributed.
Part 1271 also decides which regulatory pathway a product falls into. An HCT/P is regulated solely under Section 361 of the PHS Act only if it meets all four criteria: it is minimally manipulated, intended for homologous use only, not combined with another article, and either has no systemic effect and does not depend on the metabolic activity of living cells, or meets a listed exception. Miss any one and the product is regulated as a drug or biologic under Section 351, which requires an Investigational New Drug (IND) application to study it in people and a Biologics License Application (BLA) to market it.
What Federal Law Requires from Tissue Establishments
- ✓FDA establishment registration — HCT/P establishments must register with FDA and list their products, and registered establishments are subject to FDA inspection
- ✓Current Good Tissue Practice (cGTP) — recovery, processing, storage, labeling, and distribution must comply with 21 CFR Part 1271, Subpart D
- ✓Donor eligibility determination — donor screening and infectious disease testing per 21 CFR Part 1271, Subpart C
- ✓Lot-level documentation and traceability — testing and tracking records that follow each lot from donor to distribution
- ✓Adverse reaction reporting — establishments must investigate and report adverse reactions involving communicable disease related to their HCT/Ps
Part 2: What AATB Accreditation Means
What AATB Is
The American Association of Tissue Banks (AATB) is a nonprofit professional organization that sets voluntary accreditation standards for tissue banks and tissue establishments. Its standards for donor screening, processing, packaging, labeling, storage, and distribution go beyond the federal minimum.
AATB accreditation is not a government certification. It is a voluntary quality standard that requires regular on-site inspection and demonstrated compliance with AATB's published standards. Accreditation is issued for specific tissue categories and activities, so always confirm that the tissue type you are sourcing is within the establishment's scope of accreditation.
What the Accreditation Process Requires
- ✓Donor screening and eligibility — review of donor medical and social history, physical assessment, and required laboratory testing
- ✓Infectious disease testing — testing for a defined panel of communicable disease agents per AATB standards
- ✓Processing controls — validated SOPs, environmental monitoring, equipment qualification, and process controls
- ✓Quality management system — documented deviation management, CAPA, and change control
- ✓Storage and distribution — validated cold-chain procedures, shipping qualification, and chain-of-custody records
- ✓Inspection and surveillance — on-site AATB inspections and continued compliance to keep accreditation
Part 3: Compliant vs. Non-Compliant Marketing Language
Regardless of state law, the language used to describe these products in patient-facing and marketing materials is scrutinized by FDA, the FTC, and state medical boards. This guidance applies in every state.
Exosome Products — Topical Cosmetic Use Only
❌ Never Use
- Treats inflammation / anti-inflammatory
- Regenerates tissue / promotes healing
- Activates stem cells
- Injectable-grade / for injection
- FDA compliant / FDA approved
- Proven to improve [condition]
- Repairs / restores / reverses
- Any disease or condition name (arthritis, hair loss, wound healing, neuropathy)
- Any description of how the product acts on cells or tissue
- Better outcomes / superior results
✅ Compliant Language
- For topical cosmetic use only
- Not for injection or therapeutic use
- Not FDA-approved
- Post-procedure topical cosmetic support
- The look of skin texture and radiance
- NTA-verified particle count
- 3D bioreactor–cultured source material
- Lot-specific Certificate of Analysis
- For use by licensed professionals only
UCT-MSC Products — Where State Law Allows Their Use
❌ Never Use
- FDA approved / FDA legal in this state
- Proven to treat [condition]
- Cures / heals / reverses disease
- Better outcomes than standard care
- Legal alternative to surgery
- Disease names in promotional materials
- Safe and effective (implies FDA approval)
✅ Compliant Language
- Not approved by the U.S. Food and Drug Administration
- Performed by a licensed physician subject to applicable state and federal requirements
- An individualized decision made with your clinician
- Patients should consult their primary care provider
- Your state's required notice, word for word, where one applies
- Wharton's jelly tissue source from AATB-accredited establishment with this tissue category within scope of accreditation
- cGTP-compliant (21 CFR Part 1271)
Part 4: State-by-State Legal Landscape
A growing number of states regulate the use of non-FDA-approved stem cell therapies, usually through notice, consent, sourcing, and advertising requirements. These laws govern the practice of medicine within the state. They do not override FDA's authority over the products themselves. This section reflects enacted, amended, and rejected legislation through October 2026.
Florida's statute authorizes licensed physicians to perform stem cell therapies that are not FDA-approved, within defined limits.
- Who may perform: Licensed MDs (Chapter 458) and DOs (Chapter 459)
- Covered fields: Orthopedics, wound care, and pain management
- Prohibited sources: Cells or tissues derived from a fetus or embryo after an abortion
- Sourcing: Products must be retrieved, manufactured, and stored in an FDA-registered facility certified or accredited by the National Marrow Donor Program, the World Marrow Donor Association, AABB, or AATB, and must be produced under the applicable manufacturing practices of 21 CFR Part 1271
- Viability: Products must contain viable cells on post-thaw analysis and be included in a post-thaw viability analysis report
- Advertising notice (physician obligation): "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."
- Consent: Signed consent covering the nature of the treatment, its non-FDA-approved status, anticipated results, serious risks, and encouragement to consult a primary care provider
- Exosomes: Not explicitly covered. Consult counsel before relying on the statute for any exosome use.
SNN relevance: Our 25M hUCT-MSC product comes from a Wharton's jelly tissue source from AATB-accredited establishment with this tissue category within scope of accreditation. It is produced in an FDA-registered tissue establishment, cGTP-compliant (21 CFR Part 1271), and each lot ships with post-thaw viability documentation. Whether a specific use qualifies under § 458.3245 is the physician's determination, made with counsel. The statute does not change a product's federal regulatory status.
Georgia's 2026 law, signed May 11, 2026, creates a state framework for non-FDA-approved stem cell therapy.
- Who may perform: Physicians, with defined involvement of physician assistants and nurse practitioners
- Sourcing: FDA-registered facilities, or sources certified by recognized bodies including WMDA, AABB, and AATB
- Consent: Signed consent stating the therapy is not FDA-approved
- Advertising: A required notice in type no smaller than the largest type used in the ad
Tennessee's law, signed May 19, 2026, allows licensed physicians to provide qualifying stem cell and regenerative medicine therapies within their scope of practice.
- Product standards: Numeric viability thresholds (reported as greater than 90% pre-thaw and at least 80% post-thaw), storage at −80 °C or colder for donor products, and FDA-registered facility documentation for allogeneic products
- Prohibited sources: Cells or tissues derived from embryos or fetuses after an abortion
- Advertising: Materials must state the therapy is not FDA-approved and encourage consultation with a primary care provider
- Consent: Written consent covering non-approval status, risks, expected benefits, alternatives, and costs
- Exosomes: The statute's definition of regenerative medicine therapy reaches certain exosome-based products that meet its criteria. Stem Nova Network's exosome products remain positioned for topical cosmetic use only.
Utah Code § 58-1-512 allows health care providers whose scope includes stem cell therapy to use afterbirth placental perinatal stem cells or HCT/Ps that are not FDA-approved, subject to notice and consent.
- Notice: "THIS NOTICE MUST BE PROVIDED TO YOU UNDER UTAH LAW. This health care practitioner performs one or more stem cell therapies that have not yet been approved by the United States Food and Drug Administration." Posted at the office entrance and in patient areas (8.5" × 11", 40-point type), given in writing, and included in all advertising
- Consent: Signed consent covering the treatment, its non-approval status, anticipated results, alternatives, and serious risks
- New supplier duty (SB 55): Suppliers may provide covered products only after receiving the provider's written confirmation that patients will receive the required notice
- Prohibited sources: Fetal or embryonic tissue after an abortion
Wyoming's act authorizes physicians to provide stem cell therapy and limits board discipline for doing so in compliance with the act.
- Scope: Autologous (the patient's own) mesenchymal stem cells. Allogeneic donor products, such as UCT-MSCs, are outside its scope.
- Requirements: Physician registration with the Wyoming Board of Medicine (which keeps a public registry), IRB approval, and an existing physician-patient relationship
Texas created an investigational stem cell pathway for patients with severe chronic disease or terminal illness.
- Setting and oversight: Physicians in hospitals, ambulatory surgical centers, or medical schools, with institutional review board (IRB) oversight
- Evidence requirement: The treatment must have been used in a human clinical trial
- Consent: Informed consent, including disclosure of non-approval status
- 2025 update: HB 5147, which would have expanded the program to outpatient settings, passed the House but died in Senate committee. The 2017 framework remains current.
California's SB 512 is a consumer protection and disclosure law, not a treatment authorization. The Medical Board of California has warned licensees against offering unapproved regenerative products.
- Required notice: "THIS NOTICE MUST BE PROVIDED TO YOU UNDER CALIFORNIA LAW. This health care practitioner 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 physician prior to undergoing a stem cell therapy."
- Where it must appear: Posted prominently at the office entrance and in patient areas, and provided in writing before the first treatment
- Practical guidance: SB 512 governs how practitioners communicate. It is not a green light to administer unapproved products.
Washington (RCW 18.130.420, 2018) and Vermont (Act 61, 2021) require notice and consent for stem cell therapies that are not FDA-approved. Vermont requires posted notices, notice in advertising, and a signed disclosure retained in the medical record. Neither law authorizes treatment.
North Carolina (HB 934, 2019) and Mississippi (SB 2830, 2020) set consent requirements for certain investigational stem cell use. Mississippi's law sits within its Right to Try framework and covers adult autologous MSCs. Confirm current requirements with counsel.
Montana's SB 535 expanded the state's Right to Try framework to allow licensed experimental treatment centers to offer investigational drugs and therapies that have completed Phase I safety trials. It is a general Right to Try expansion, not a stem-cell-specific statute.
SB 1214 would have authorized stem cell and birth tissue therapies with continuing education, advertising disclosure, consent, accredited sourcing, and adverse event reporting requirements. Governor Hobbs vetoed it on June 19, 2026. It is not law in Arizona.
Nevada: SB 128 (2025), which would have encouraged providers to discuss stem cell options with patients, was vetoed on June 10, 2025. Nevada has no stem-cell-specific disclosure or consent statute. New Hampshire: HB 1292 (2026), a proposed Right to Try and regenerative therapy framework, was sent to interim study and did not become law.
Part 5: State Comparison at a Glance
Updated October 2026. Not legal advice. Verify current law with qualified counsel before making clinical or sourcing decisions.
| State | Law | Status | Type | Accredited sourcing |
|---|---|---|---|---|
| Florida | SB 1768 (§ 458.3245) | Active July 2025 | Authorization: ortho, wound, pain | Yes — AATB among four named bodies |
| Georgia | HB 1275 | Active July 2026 | Authorization + notice + consent | Yes — AATB listed |
| Tennessee | HB 2246 (Pub. Ch. 1016) | Active July 2026 | Authorization + product standards | FDA-registered facility; viability thresholds |
| Utah | SB 199 + SB 55 | Updated May 2026 | Notice + consent + supplier confirmation | Not specified |
| Wyoming | SF0048 | Signed Mar 2026 | Autologous only; board registry | N/A (autologous) |
| Texas | HB 810 | Active 2017 | Investigational, IRB oversight | Not specified |
| California | SB 512 | Active | Disclosure only | N/A |
| Washington | RCW 18.130.420 | Active | Disclosure only | N/A |
| Vermont | Act 61 | Active | Disclosure only | N/A |
| North Carolina | HB 934 | Active | Consent-based | Not specified |
| Mississippi | SB 2830 | Active | Consent-based (Right to Try) | Not specified |
| Montana | SB 535 | Active | General Right to Try expansion | Not specified |
| Arizona | SB 1214 | Vetoed June 2026 | Not law | — |
| Nevada | SB 128 | Vetoed June 2025 | Not law | — |
Request Full Supplier Documentation
Tissue-source accreditation confirmation for our 25M hUCT-MSC product, FDA establishment registration, lot-specific CoAs, and cGTP documentation, available after credential verification.
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