California licenses tissue banks through the California Department of Public Health under Health and Safety Code section 1635 and the sections after it. This guide explains what the statute covers, who must hold a California tissue bank license, what it costs, how to check a bank, and how it differs from the state’s disclosure law for stem cell clinics.
TLDR California requires every tissue bank operating in the state to hold a current license from the California Department of Public Health under Health and Safety Code 1635.1. The statute contains no autologous exemption, and CDPH lists autologous tissue stored overnight or longer among the facility types it licenses. A license addresses the establishment, not any outcome. Banking adipose tissue does not guarantee eligibility for, access to, or benefit from any future therapy.
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 has FDA approval for any condition. 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.
You live in California and you are weighing whether to bank your own adipose tissue. You know FDA registration is required under federal rules. Then you see a line on a bank’s website about a state license, and you wonder what that layer adds.
How to check whether a bank is legitimate is one of the questions readers bring to this site most often. This post answers the California part of that question from the statute text and the CDPH program page. It does not say whether any particular bank, including our laboratory partner, holds a California license. One point frames everything below: a license is about the establishment, not any outcome.
What Does Health and Safety Code 1635 Define as a Tissue Bank?
Section 1635 defines a tissue bank as “a place, establishment, or institution that collects, processes, stores, or distributes tissue for transplantation into human beings.” That definition is subdivision (f) of section 1635, which opens Chapter 4.1 of the Health and Safety Code, sections 1635 to 1643.2, added in 1991.
Two neighboring definitions matter. “Tissue” means a human cell or group of cells and “any other portion of a human body,” with organs recovered for transplant excluded. “Transplantation,” in subdivision (g), “means the act or process of transferring tissue, including by ingestion, from a donor to the body of the donor or another human being.” The words “to the body of the donor” are why storing your own tissue for your own possible future use sits inside the definition.
The statute does not name adipose tissue or any other tissue type. It works by function, as does the federal HCT/P definition in our guide to 21 CFR Part 1271.
Who Must Hold a California Tissue Bank License?
Every tissue bank operating in California must hold a current license from CDPH. Section 1635.1 states that “every tissue bank operating in California on or after July 1, 1992, shall have a current and valid tissue bank license issued or renewed by the department pursuant to Section 1639.2 or 1639.3.”
There is no autologous exemption. The word “autologous” does not appear anywhere in sections 1635 to 1643.2. The statute exempts a treating physician’s own collection and implantation of tissue, then limits even that: “This exemption shall not be interpreted to apply to any processing or storage of the tissue.” A facility that processes and stores fat afterward is a tissue bank under the statute.
CDPH makes the point concrete. Among the facility types it licenses and surveys, the CDPH program page lists “Autologous tissue stored overnight or longer” and “Any facility described above which is located in California or is located outside of California and wants to operate in California.” An out-of-state bank serving California patients therefore falls within the program’s scope.
The federal layer runs alongside. Under section 1271.1, an establishment that manufactures a 361 HCT/P must register and list with FDA and comply with Part 1271 “whether or not the HCT/P enters into interstate commerce.” Neither the state license nor FDA registration replaces the other.
What Does the License Cost and How Often Does It Renew?
The application fee and the annual renewal fee are each $950, and a license expires 12 months after issuance. Section 1639.5 states that “the application and annual renewal fee for a tissue bank license shall be nine hundred fifty dollars ($950).” Under section 1639.2, a license may be “renewed for one- or two-year periods, at the option of the licensee.”
Operating without a license carries a criminal penalty. Under section 1641, a violation is a misdemeanor punishable by a fine of up to $1,000, up to 180 days in county jail, or both.
How Do You Check Whether a Bank Holds a California Tissue Bank License?
Start with the CDPH tissue bank page, then ask the bank directly, in writing. The CDPH page describes the facility types the program licenses and surveys and cites the statute along with Title 17 of the California Code of Regulations, sections 1235 to 1237.
Ask the bank three things. Does the establishment that will hold your tissue hold a current California tissue bank license, under what legal name, and when does it expire? Which activities does it cover: collection, processing, storage, or distribution? Can it show its FDA registration record as well? Our post on how to verify a bank lists the other documents to request.
Save My Fat connects patients and providers with a U.S. tissue bank. It does not collect, process, store, or treat tissue, so it is not itself a tissue bank under section 1635. A license belongs to the establishment that holds the tissue, and this post does not state whether our laboratory partner holds one.
How Does HSC 1635 Differ From the California Disclosure Law for Stem Cell Clinics?
Health and Safety Code 1635 governs the establishment that handles tissue, while California’s separate disclosure law governs providers who offer stem cell services to patients. They are different layers aimed at different parties. Our post on the California disclosure law explains the provider side.
The table puts the two laws side by side, using only the statute and the CDPH page for the bank law and the linked post for the disclosure law.
| Question | HSC 1635 tissue bank license | California disclosure law for stem cell clinics |
|---|---|---|
| Who it addresses | An establishment that collects, processes, stores, or distributes tissue | Providers who offer stem cell services to patients |
| What it requires | A current CDPH license, $950 application and annual renewal fee | Disclosures to patients, explained in the linked post |
| Autologous carve out | None; “autologous” does not appear in the chapter | See the linked post |
| What it says about outcomes | Nothing; it is about the establishment | Nothing; it is about what the patient is told |
Neither law approves any product or tells you whether banked adipose tissue will ever have a use. Readers outside California can use our state law map to see which states have a licensing layer at all.
Frequently Asked Questions
Does a California tissue bank license mean stored fat will work in a future therapy?
No. The license means CDPH has licensed the establishment. It says nothing about whether any future therapy using stored adipose tissue will exist or whether you would qualify. No adipose-derived stem cell product has FDA approval for any condition, research remains early stage, and banking does not guarantee eligibility for any trial or program. Any future use depends on FDA status at that time and your own licensed healthcare professionals.
Does the license requirement reach a bank located outside California?
CDPH’s page lists, among the facilities it licenses, any described facility that “is located outside of California and wants to operate in California.” Ask an out-of-state bank whether it holds a California license and, if not, why it believes one is not required.
Is a California tissue bank license the same as FDA registration?
No. FDA registration under Part 1271 is federal and applies whether or not the HCT/P enters interstate commerce. The California license is a state requirement under section 1635.1 with its own fee, renewal cycle, and penalty. A bank serving California patients may need both, and neither is an approval of any product.
Key Takeaways
Health and Safety Code 1635 defines a tissue bank by function: an establishment that collects, processes, stores, or distributes tissue for transplantation, including transfer back to the donor’s own body. Section 1635.1 requires every tissue bank operating in California to hold a current CDPH license, with no autologous exemption. The fee is $950, the license expires after 12 months, and operating without one is a misdemeanor. Check the CDPH page, then ask the bank in writing. A license is about the establishment, not any outcome, and it sits alongside FDA registration rather than replacing it.
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.
Californians weighing adipose tissue banking for potential future use can review current pricing or bring their licensing questions to 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.
