New York regulates tissue banks under its own state law, Public Health Law Article 43-B, on top of the federal rules in 21 CFR Part 1271. A New York resident weighing adipose tissue banking needs to know what an NY Tissue Bank License is, who must hold one, and how to check. This guide explains the statute, the rule behind it, and how the state layer fits with federal registration.
TLDR New York requires a Department of Health license to own or operate a tissue bank that conducts procurement activity in the state. The rule treats shipping tissue into New York from another state as distribution, and it places autologous storage inside the definition of a tissue bank. That state license sits on top of federal registration under 21 CFR Part 1271. Banking adipose tissue does not guarantee any future use, which depends on FDA regulatory status at that time.
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. 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.
Whether stem cell therapy is legal, and where, is the question readers bring to this site more than any other. For New Yorkers, part of the answer sits in a state law most people have never read. New York has licensed tissue banks under Article 43-B since 1990, according to the Department of Health’s Wadsworth Center Tissue Resources Program page.
That matters because federal law is not the only rulebook. FDA’s Part 1271 applies across the country. New York adds a state license with its own definitions, its own form, and its own penalties. This post describes the licensing rule only. It does not say whether any particular bank holds a license, and it does not say that New York permits or bans adipose banking.
What Is Article 43-B and Who Issues an NY Tissue Bank License?
Article 43-B is the part of New York’s Public Health Law that licenses tissue banks, and the state Department of Health issues the NY Tissue Bank License. Under section 4364, no person may own or operate a bank or storage facility that conducts procurement activity in New York “unless a license has been issued pursuant to this article.”
The definitions live in section 4360. A “bank” or “storage facility” is any person or facility that procures, stores, or arranges for the storage of tissue for transplantation, therapy, education, research, or fertilization purposes, “including autologous procedures.” In plain words, storing tissue counts, and storing it for the same person counts.
The statute’s definition of “tissue” is a closed list. It names a human eye, skin, bone, bone marrow, heart valve, spermatozoon, ova, artery, vein, tendon, ligament, pituitary gland, or a fluid other than blood or a blood derivative. Adipose tissue is not on that list. The rule and the application form, covered below, use broader words. A reader should not stop at the statute.
Section 4364 also bars a bank from selling or transferring tissue “for valuable consideration,” with reasonable costs excluded. Enforcement sits in section 4366. The commissioner may revoke, suspend, limit, or annul a license, or fine the holder. The statute states no dollar amount.
Why an Out-of-State Bank Can Still Need a New York License
A bank located outside New York can still need a New York license because the state rule treats shipping tissue into New York as distribution. Under 10 NYCRR 52-2.1, anyone who plans to operate a tissue bank or distribute tissue in New York State must submit a signed application to the department and obtain a license first.
Subdivision (f) closes the geographic gap. It states that “Shipping of any tissue from an out-of-state facility shall constitute distribution and shall require a license,” unless a narrow exception applies. The named exceptions cover certain eye tissue and hematopoietic progenitor cells, and virally inactivated or extensively processed tissue under a written exception.
For a New York resident, the practical point is movement, not address. A bank in another state that ships tissue into New York is distributing tissue in New York. That is a state question that federal establishment registration does not answer.
Is Autologous Tissue Exempt in New York?
No, autologous tissue is not exempt from New York’s tissue bank definition. The rule uses the word “autogeneic” rather than “autologous,” and it puts autogeneic procedures inside the definition. 10 NYCRR 52-1.1 defines a tissue bank as any person or facility that retrieves, preserves, transports, processes, stores, or arranges for the storage of human tissues, among other listed activities, “including autogeneic procedures.”
The same section defines “autogeneic tissue collection” as “the retrieval of tissue from a donor for subsequent reimplantation into that same donor.” The one carve-out is narrow: a transplantation facility whose autogeneic tissue never leaves the operating room. Tissue that is preserved, transported, or stored somewhere else falls outside it.
What Does the License Cover and How Can a New Yorker Check?
The license covers all tissue banking activities in New York, and a New Yorker can start checking a bank’s status from the Department of Health’s Wadsworth Center program page. That page states: “Licensure is required for all tissue banking activities in New York, including collection, processing, storage, and distribution.” The same page says the application is Form DOH-2973 and that the license list is published on Health Data NY.
How to check whether a bank is legitimate is one of the questions readers bring to this site most often. The state’s application instructions, revised in February 2026, sort tissue into license categories. Two matter here: “Other Tissues means any other human tissue,” and “Tissue Derived Products means any products or cells derived from human tissue.” Those catch-all categories are why the statute’s closed list is not the end of the story.
This article does not state whether any particular laboratory holds an NY tissue bank license. Ask the bank directly whether it holds one, which category it covers, and whether it appears on the Health Data NY list. Ask the same about its federal registration. A bank that cannot answer in writing has not cleared the first bar. Our guide on how to verify a bank walks through the rest.
How the New York Layer Sits With 21 CFR Part 1271
The New York license is additional to federal registration, not a substitute for it. Under 21 CFR 1271.1(b), an establishment that manufactures HCT/Ps must register and list them with FDA’s Center for Biologics Evaluation and Research and comply with Part 1271 “whether or not the HCT/P enters into interstate commerce.” The state license applies on top of that federal duty.
The two systems ask different questions. Part 1271 addresses communicable disease risk. Article 43-B and Part 52 decide who may operate or distribute tissue in New York at all. The table below sets the two side by side.
| Question | Federal, 21 CFR Part 1271 | New York, Article 43-B and 10 NYCRR Part 52 |
|---|---|---|
| Who administers it | FDA, Center for Biologics Evaluation and Research | New York State Department of Health |
| What the establishment must do | Register and list its HCT/Ps and comply with Part 1271 | Hold a license to own or operate a bank that conducts procurement activity |
| Applies inside one state only | Yes, whether or not the HCT/P enters interstate commerce | Yes, for any bank operating or distributing tissue in New York |
| Reach across state lines | Applies regardless of interstate commerce | Shipping tissue in from out of state is distribution and needs a license, with narrow exceptions |
| What the text addresses | Manufacturing of HCT/Ps, aimed at communicable disease risk | Collection, processing, storage, and distribution |
Read the two columns together. A bank that serves a New York resident answers to both. For the federal side in depth, see our guide to 21 CFR Part 1271. For how New York compares with other states, start with the state law map.
Frequently Asked Questions
Does New York’s tissue bank law name adipose tissue?
No. Public Health Law 4360 defines “tissue” as a closed list, and adipose is not on it. The rule speaks of “human tissues” generally, and the application form adds “Other Tissues” and “Tissue Derived Products” categories. None of these texts carves fat out either. Ask the bank, and if needed the Department of Health, how it classifies adipose tissue.
Does storing tissue for the same person require an NY tissue bank license?
Yes, as the definitions read. Autologous, or “autogeneic,” procedures sit inside the definition of a tissue bank. The only carve-out in 10 NYCRR 52-1.1 is a transplantation facility whose autogeneic tissue never leaves the operating room.
Does a New York license replace FDA registration?
No. 21 CFR 1271.1(b) requires registration with FDA whether or not the tissue enters interstate commerce. The New York license is an added state requirement, so ask for evidence of both.
Key Takeaways
New York licenses tissue banks under Public Health Law Article 43-B, in place since 1990, and the state Department of Health issues the license. The definition of a bank includes autologous procedures. The rule treats shipping tissue into New York from another state as distribution that requires a license. The statute’s closed list does not name adipose, while the rule and the application form use broader words, so ask a bank how it classifies the tissue. The state license sits on top of federal registration under 21 CFR Part 1271. Ask any bank for evidence of both in writing.
Save My Fat connects patients and providers with a U.S.-based tissue bank. It is not a tissue bank, a laboratory, a medical practice, or a treatment provider. Stem cell and regenerative medicine regulations vary by state, including specific informed-consent and disclosure requirements in Florida, Utah, California, Georgia, and Tennessee 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.
New Yorkers weighing adipose tissue banking for potential future use can review current pricing or ask their licensing questions through the contact page.
Save My Fat works with a U.S.-based tissue bank for laboratory processing and storage.
This article is for educational purposes only and does not constitute medical or legal advice. Please consult your own licensed healthcare provider before making any decisions about treatment or research participation.
About the author: Oscar Tellez is the founder and CEO of Save My Fat. He holds a Bachelor of Science in Exercise Science and Health Promotion from Florida Atlantic University. He has spent a decade in the regenerative medicine industry across product distribution, laboratory and vendor relationships, and provider training. He is not a licensed clinician, and this article is educational, not medical advice.
Related guide: state stem cell laws.
