FDA registration under 21 CFR Part 1271 is national, but some states add their own tissue bank license, permit, certification, or registration. This guide lists the states verified for this article, explains what a state credential does and does not tell you, and answers a common question: does the state where the bank sits matter, or the state where you live?
TLDR Tissue bank licensing is a state layer on top of federal FDA registration, and only some states have it. New York, California, Florida, Maryland, Oregon, Illinois, Delaware, and Georgia each have a requirement verified for this article, and Maryland and New York expressly reach banks outside their borders. A state license speaks to establishment standards, not outcomes. 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 or condition. 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. A close cousin of that question is about the bank itself. Who licenses the place that holds your tissue, and does your own state have any say?
The answer has two parts. The federal part is 21 CFR Part 1271, and it is the same everywhere. The state part is tissue bank licensing, and it changes at the border. This post covers the states verified for this article, not all fifty. It is not legal advice.
Why Some States Add Tissue Bank Licensing on Top of FDA Registration
States license tissue banks under their own public health laws, and the statutes verified below operate alongside Part 1271, not instead of it. Under section 1271.1, an establishment that manufactures 361 HCT/Ps must register and list with FDA and comply with the part “whether or not the HCT/P enters into interstate commerce.” Federal registration does not depend on state lines.
A state credential sits on top of that. A state health agency issues it under a state statute or rule, with its own application, fee, or renewal cycle. A bank in a licensing state needs both. This site covers the federal side in a guide to FDA establishment registration.
Which States Require a Tissue Bank License or Registration
Of the states verified for this article, New York, California, Florida, Maryland, Oregon, Illinois, Delaware, and Georgia each require some form of license, permit, certification, or registration. Louisiana and New Jersey turned up no requirement, and that absence was not confirmed. The table is not a fifty-state survey; it covers only the states verified here, and each citation links to the primary source.
| State | Citation | Agency | Type | Reaches out-of-state banks |
|---|---|---|---|---|
| California | HSC 1635.1 | Department of Public Health | License | Not stated |
| Delaware | Del. C. 2801 | Department of Health and Social Services | Annual registration | Not stated |
| Florida | F.S. 765.542 | Agency for Health Care Administration | Certification | Not stated |
| Georgia | Rule 111-8-10 | Department of Community Health | License (clinical laboratory) | Not stated |
| Illinois | 20 ILCS 2310/2310-330 (text not read; registration form confirmed) | Department of Public Health | Registration | Not stated |
| Maryland | Health-General 17-305 | Secretary of Health | Permit | Yes |
| New York | PHL 4364 | Department of Health | License | Yes, under 10 NYCRR 52-2.1 |
| Oregon | ORS 441.082 | Oregon Health Authority | Registration | Not stated; trigger is “doing business in this state” |
| Louisiana | None found | None | Not found; absence not confirmed | Not applicable |
| New Jersey | None found | None | Not found; absence not confirmed | Not applicable |
“Not stated” means the text read for this article did not address out-of-state banks, not that the state excludes them. Confirm current status with the agency before relying on any row.
Florida bars tissue procurement in the state unless the operation is certified as a tissue bank by the Agency for Health Care Administration, and procurement includes processing, storage, and distribution. Oregon is lighter: a tissue bank may not do business in the state unless registered with the Oregon Health Authority, with a civil penalty of up to $1,000.
Delaware requires tissue banks operating in the state to register by May 1 each year, with a $5,000 fine for failure, and the section sets no standards of its own. Georgia folds tissue banks into its clinical laboratory rules, which require a license. Illinois is the one row with a gap: the registration form is confirmed, but the statute text could not be read.
New York requires a Department of Health license to own or operate a bank that conducts procurement activity in the state, and licensed banks may not sell tissue for valuable consideration. California requires every tissue bank operating in the state to hold a current Department of Public Health license, and the word “autologous” does not appear in that chapter, so there is no autologous exemption. Its physician exemption covers only the treating physician’s own collection and implantation, not processing or storage.
Does the State Where You Live Matter, or the State Where the Bank Sits?
The state where the bank operates always matters. The state where you live matters only when its law reaches banks outside its borders, and two verified examples do. Maryland’s permit statute requires a permit before a person may “Operate a tissue bank in this State” or “Represent or service in this State any tissue bank that is outside this State.”
New York goes further on shipping. Under the state’s Part 52 regulation, shipping any tissue from an out-of-state facility “shall constitute distribution and shall require a license,” subject to narrow exceptions. A bank elsewhere that ships tissue into those two states may need that state’s credential too.
For most other rows, the text read for this article does not say. Florida’s section says “in this state” and does not expressly address out-of-state banks. Oregon’s trigger is “doing business in this state,” and whether that reaches a bank elsewhere is a question for the agency or an attorney. The state law map on this site tracks how states differ on stem cell rules, and the 2026 state law update covers what changed this year.
What a State License Tells You, and What It Does Not
A state license tells you that a state health agency has reviewed the establishment against its own rules and issued a credential. It tells you nothing about whether banked tissue will ever have a use. Tissue bank licensing regulates the establishment: who may operate, what to file, what to pay, and when to renew. That is a real layer of accountability, and it is worth asking about.
It is not an outcome standard. Part 1271 addresses communicable disease, not clinical value, and the state statutes cited here work the same way. No state license changes the FDA regulatory status of adipose tissue or of any future use of it. None of the statutes or rules cited here names adipose tissue or fat, so a license is a general facility credential, not a fat-specific endorsement. Banking preserves a patient’s own tissue, and any future use depends on FDA regulatory status, physician guidance, and the availability of approved or investigational pathways at that time.
How to Check a Bank’s State License or Registration
Ask the bank for its license or registration number, the issuing state, and the name of the issuing agency, then confirm those details with the agency itself. How to check whether a bank is legitimate is one of the questions readers bring to this site most often.
A useful starting point is the AATB statutes database, which summarizes state permitting, licensing, certification, and registration provisions. Read its caveat first: it was “prepared as of October 15, 2018,” and it does not identify later amendments, repeals, or new provisions. Treat it as a map of where to look, not as current law. Then go to the agency, such as Florida’s tissue bank page or Maryland’s licensing page.
This article does not state which state licenses any laboratory holds, including the tissue bank Save My Fat works with, because those details were not verified for publication. Ask the bank directly, then ask the agency to confirm. This site has a longer checklist on how to verify a banking company before signing anything.
Frequently Asked Questions
Is a state tissue bank license the same as FDA registration?
No. FDA registration under Part 1271 is federal, applies whether or not tissue crosses state lines, and addresses communicable disease. A state credential comes from a state health agency under state law. A bank in a licensing state needs both.
Does a state license mean banked tissue is approved for any use?
No. A state license is an establishment credential. It does not approve any product or change the FDA regulatory status of adipose tissue. Banking does not guarantee eligibility, access, or clinical benefit from any future therapy. Patients should consult their own licensed healthcare professionals on any medical decision.
What if my state is not in the table?
It means the state was not verified for this article, not that it has no requirement. Start with the AATB database, then check the state health department, and ask an attorney if the answer affects a decision.
Key Takeaways
Tissue bank licensing is a state layer on top of federal Part 1271 registration, which applies whether or not tissue crosses state lines. Of the states verified here, New York, California, Florida, Maryland, Oregon, Illinois, Delaware, and Georgia each require a license, permit, certification, or registration. Maryland and New York expressly reach banks outside their borders; most other statutes are silent. A state credential speaks to establishment standards, not outcomes, and none of the statutes cited names adipose tissue. Ask any bank for its license number, state, and agency, then confirm with the agency. Banking adipose tissue does not guarantee any future use.
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.
Readers weighing adipose tissue banking for potential future use can compare options on the pricing page or ask a question 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.
