--- title: "Expanded Access Requests: A Clear 2026 Step By Step" description: "The expanded access request process step by step for 2026: who submits, what FDA reviews, the 30 day rule, and the emergency phone pathway." url: "https://savemyfat.com/expanded-access-program-request-process/" --- # The Process for an Expanded Access Program Request, Step by Step #### Table of Contents - [Oscar Tellez](https://savemyfat.com/author/oscartellez/) - September 23, 2026 - 10:00 am ![Cold storage dewar and racks of labeled vials in a lab, the setting behind an expanded access request](https://savemyfat.com/wp-content/uploads/2026/08/expanded-access-program-request-process.png)The process for an expanded access program request, step by step 2 Expanded access is the federal pathway that lets a patient receive an investigational drug outside a clinical trial. The request moves through a licensed physician, the company holding the drug, an institutional review board, and FDA. This article walks that sequence and names who performs each step. **TLDR A patient cannot file an expanded access request. A licensed physician confirms eligibility, obtains the company’s agreement to supply the drug, collects informed consent, and submits Form FDA 3926. An IRB reviews, and FDA determines whether treatment may proceed. The pathway reaches investigational drugs held under an active IND by a sponsor. Banking adipose tissue does not guarantee eligibility, access, or clinical 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 has FDA approval for any condition, and Save My Fat does not file these applications and cannot obtain investigational products for anyone. 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. --- Families usually meet this pathway at the worst possible moment, and the first thing they get wrong is who files it. FDA states it plainly on its [patient page](https://www.fda.gov/news-events/expanded-access/expanded-access-information-patients): “A licensed physician requests the investigational medical product under the expanded access program for you.” The steps below come from 21 CFR Part 312, [Subpart I](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-312/subpart-I), and FDA’s instructions to physicians, review boards, and patients. They lead to an investigational drug held under an active investigational new drug application, or IND, by a sponsor, not to a product a clinic sells for cash. ## Who files an expanded access request, the patient or the physician A licensed physician files it. A patient cannot apply directly, and the regulation never lists patients among the parties who may submit. The rule at [312.310](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-312/subpart-I/section-312.310) lets FDA permit use “for the treatment of an individual patient by a licensed physician.” Section 312.310(b)(1) says the submission “may be made by the sponsor or by a licensed physician.” --- ## The eight steps, and who performs each one Eight steps, four parties. The physician performs five, the company one, an IRB one, and FDA one. **Step one, the physician** confirms that no clinical trial is available and that the patient meets the criteria, following FDA’s [physician guidance](https://www.fda.gov/news-events/expanded-access/expanded-access-information-physicians). Our guide to [clinical trial enrollment](https://savemyfat.com/how-clinical-trial-enrollment-works/) covers that route. **Step two, the physician** contacts the company or sponsor holding the drug and obtains its agreement to supply it. **Step three, the company or sponsor** either sponsors the expanded access itself, issues a Letter of Authorization giving FDA a right of reference to its IND under 312.310(b)(3), or supplies the underlying data. **Step four, the physician** obtains informed consent under 21 CFR Part 50. **Step five, the physician** submits the request to FDA, using Form FDA 3926 for an individual patient. **Step six, an IRB** reviews. For individual patient requests FDA permits a waiver of full board review, so the IRB chair or a designee may concur instead. FDA treats a Form 3926 with Field 10.b checked as that waiver request, per its [IRB guidance](https://www.fda.gov/news-events/expanded-access/expanded-access-information-institutional-review-boards-irbs). **Step seven, FDA** reviews the submission and determines whether the treatment use may proceed. **Step eight, the physician** administers the drug and reports. Under 312.310(c)(2), “At the conclusion of treatment, the licensed physician or sponsor must provide FDA with a written summary of the results of the expanded access use, including adverse effects.” --- ## What FDA must determine before treatment may proceed Three cumulative findings apply to every category of this pathway, and they sit at [312.305(a)](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-312/subpart-I/section-312.305). The patient must have “a serious or immediately life-threatening disease or condition, and there is no comparable or satisfactory alternative therapy.” The benefit must justify “the potential risks of the treatment use.” Supply must not “interfere with the initiation, conduct, or completion of clinical investigations” that could support approval. Section 312.310(a) adds two. The physician must find that drug risk “is not greater than the probable risk from the disease or condition.” FDA must find that “the patient cannot obtain the drug under another IND or protocol.” --- ## Form FDA 3926 and the documentation FDA requires Form FDA 3926 is the Individual Patient Expanded Access Investigational New Drug Application. A licensed physician submits it, and it replaces the two older application forms for individual patient requests, as FDA explains on its page for [submission forms](https://www.fda.gov/news-events/expanded-access/expanded-access-how-submit-request-forms). The [form itself](https://www.fda.gov/media/98616/download) has published [FDA instructions](https://www.fda.gov/media/98627/download) and dedicated [3926 guidance](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/individual-patient-expanded-access-applications-form-fda-3926). Physicians can file through the electronic [eRequest system](https://erequest.navigator.reaganudall.org/). Two requirements sit underneath the form. Every request needs an IND or a protocol under an existing IND, at 312.305(b)(1), and manufacturing and preclinical information, at 312.305(b)(2). No physician can produce another party’s manufacturing data alone, so company cooperation is structural. --- ## The 30 day rule is a ceiling, not a required wait Thirty days is the outside limit, not a waiting period. Section 312.305(d)(1) reads: “An expanded access IND goes into effect 30 days after FDA receives the IND or on earlier notification by FDA that the expanded access use may begin.” Read the second clause. Use may begin at day 30 unless FDA notifies the submitter earlier, or places the IND on clinical hold under 312.305(d)(3), “as described in 312.42.” In practice FDA often authorizes sooner. Any timeline describing a mandatory 30 day pause has the rule backwards. The clock is a deadline on the agency, not a wait on the patient. --- ## How an emergency request works An emergency request can start with a telephone call. Section 312.310(d) states: “If there is an emergency that requires the patient to be treated before a written submission can be made, FDA may authorize the expanded access use to begin without a written submission. The FDA reviewing official may authorize the emergency use by telephone.” Two deadlines follow. Under 312.310(d)(2), the physician or sponsor “must agree to submit an expanded access submission within 15 working days of FDA’s authorization of the use.” Separately, [21 CFR 56.104](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-56/subpart-A/section-56.104) permits emergency use of a test article “provided that such emergency use is reported to the IRB within 5 working days,” and any later use “is subject to IRB review.” Physicians should reach the agency through FDA’s [contact information](https://www.fda.gov/news-events/expanded-access/fdas-expanded-access-contact-information) page, which lists current business hours and the after hours line. Numbers printed inside the regulation have not kept pace. --- ## What happens after FDA reviews the request Authorization is permission, not delivery. FDA can allow a use to proceed and the patient still receives nothing, because the company has to hand over the drug. FDA’s [patient guidance](https://www.fda.gov/news-events/expanded-access/expanded-access-information-patients) says so directly: “There is no law or policy that requires a company to provide access to investigational medical products outside of the clinical trial.” Companies may decline for reasons including insufficient supply, and some use lotteries. Manufacturer policies sit in a [company directory](https://navigator.reaganudall.org/company-directory) kept by the Reagan-Udall Foundation, an independent nonprofit partner of FDA, not an FDA website. The other outcome is a hold. Section 312.305(d)(3) lets FDA place any expanded access IND or protocol on clinical hold, and treatment does not begin while that hold stands. Limits apply even when the answer is yes. Under 312.310(c)(1), “Treatment is generally limited to a single course of therapy for a specified duration unless FDA expressly authorizes multiple courses or chronic therapy.” --- ## Where adipose tissue banking fits in this process, and where it does not It does not fit. This pathway reaches investigational drugs held under an active IND by a sponsor, and stored adipose tissue is not such a drug. Each link closes the same door. A request needs an IND or a protocol under an existing IND, plus manufacturing and preclinical data. A sponsor must agree to supply and grant a right of reference. FDA must find no satisfactory alternative therapy. An operation selling an unapproved product for cash, with no IND and no sponsor, meets none of those conditions, as our overview of [expanded access programs](https://savemyfat.com/expanded-access-programs-how-patients-can-legally/) explains. FDA’s [consumer information](https://www.fda.gov/vaccines-blood-biologics/consumers-biologics/important-patient-and-consumer-information-about-regenerative-medicine-therapies) page is blunt: “If you are being charged for these products or offered these products outside of a clinical trial, you are likely being deceived and offered a product illegally.” Adipose-derived material remains investigational and early stage, and FDA’s roster of [approved cellular therapies](https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products) lists none for any disease. Save My Fat preserves a patient’s own tissue, and any future use depends on FDA regulatory status, physician guidance, and available pathways then. Those decisions belong with a licensed provider. --- ## Frequently Asked Questions ### Can a patient submit the request without a physician? No. FDA says a licensed physician requests the product for the patient, and the regulation allows submission only by a sponsor or a licensed physician. A patient’s role is to bring the question to a treating physician willing to carry those duties. ### What documentation does FDA require? Form FDA 3926, an IND or a protocol under an existing IND, manufacturing and preclinical information, and informed consent under 21 CFR Part 50. The IRB waiver request travels on the form through Field 10.b. ### How long does the review process take? An expanded access IND goes into effect 30 days after FDA receives it, or on earlier notification that the use may begin. That is a ceiling, not a required wait, and emergencies can be authorized by telephone before any written submission exists. ### Does any of this apply to banked adipose tissue? No. Nothing here converts stored tissue into an investigational drug, and no adipose-derived product is FDA approved for any disease. Banking today does not guarantee eligibility, access, or clinical benefit from any future therapy, trial, or program. --- ## Key Takeaways A licensed physician drives this pathway, not the patient. The physician screens for a trial, secures the company’s agreement, obtains consent, and files Form FDA 3926. An IRB concurs, FDA decides, and the physician administers and reports. Thirty days is a ceiling, not a required wait. Emergencies can be authorized by telephone, with a written submission due within 15 working days and an IRB report within 5 working days. FDA’s authorization is still not access, because no law compels a company to supply, and none of this reaches stored adipose tissue. 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. Readers weighing adipose tissue banking for potential future use can review [current pricing](https://savemyfat.com/pricing/) or raise a question through the [contact page](https://savemyfat.com/contact-us/). --- *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 adipose tissue banking 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 more than 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:** [adipose stem cell trials](https://savemyfat.com/adipose-stem-cell-clinical-trials/). Follow Save My Fat on Google Set us as a preferred source and Google will show our latest updates more often in your results. [PrevPreviousExpanded Access Program Services: What They Cover and What They Don’t](https://savemyfat.com/expanded-access-program-services/) [NextAdipose Stem Cell Hair Restoration: What the Research Actually ShowsNext](https://savemyfat.com/adipose-cell-therapy-hair-restoration-research/) Clinical Trials ### [Phase 1 Trial Services: What They Are and Who Provides Them](https://savemyfat.com/phase-1-clinical-trial-services/) [Read More »](https://savemyfat.com/phase-1-clinical-trial-services/) Oscar Tellez 09/26/2026 10:00 AM Clinical Trials ### [Adipose-Derived Stem Cells: A Clinical Trials Landscape Overview](https://savemyfat.com/adipose-clinical-trials-landscape-2026/) [Read More »](https://savemyfat.com/adipose-clinical-trials-landscape-2026/) Oscar Tellez 09/25/2026 10:00 AM Clinical Trials ### [Adipose Stem Cell Hair Restoration: What the Research Actually Shows](https://savemyfat.com/adipose-cell-therapy-hair-restoration-research/) [Read More »](https://savemyfat.com/adipose-cell-therapy-hair-restoration-research/) Oscar Tellez 09/24/2026 10:00 AM [![Cold storage dewar and racks of labeled vials in a lab, the setting behind an expanded access request](https://savemyfat.com/wp-content/uploads/2026/08/expanded-access-program-request-process-768x768.png)](https://savemyfat.com/expanded-access-program-request-process/) Clinical Trials ### [The Process for an Expanded Access Program Request, Step by Step](https://savemyfat.com/expanded-access-program-request-process/) [Read More »](https://savemyfat.com/expanded-access-program-request-process/) Oscar Tellez 09/23/2026 10:00 AM Clinical Trials ### [Expanded Access Program Services: What They Cover and What They Don’t](https://savemyfat.com/expanded-access-program-services/) [Read More »](https://savemyfat.com/expanded-access-program-services/) Oscar Tellez 09/22/2026 10:00 AM Adipose Banking ### [Autologous vs Allogeneic: What the Difference Means for Banked Tissue](https://savemyfat.com/adipose-banking-autologous-vs-allogeneic/) [Read More »](https://savemyfat.com/adipose-banking-autologous-vs-allogeneic/) Oscar Tellez 09/21/2026 10:00 AM ```json [{"@context":"https:\/\/schema.org","@graph":[{"@type":"BreadcrumbList","@id":"https:\/\/savemyfat.com\/expanded-access-program-request-process\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":"1","item":{"@id":"https:\/\/savemyfat.com","name":"Home"}},{"@type":"ListItem","position":"2","item":{"@id":"https:\/\/savemyfat.com\/our-blog\/","name":"Our Blog"}},{"@type":"ListItem","position":"3","item":{"@id":"https:\/\/savemyfat.com\/category\/clinical-trials\/","name":"Clinical Trials"}},{"@type":"ListItem","position":"4","item":{"@id":"https:\/\/savemyfat.com\/expanded-access-program-request-process\/","name":"The Process for an Expanded Access Program Request, Step by Step"}}]}]},{"@context":"https:\/\/schema.org","@graph":[{"@type":"Person","@id":"https:\/\/savemyfat.com\/oscar-tellez\/#person","name":"Oscar Tellez","jobTitle":"Founder","description":"Oscar Tellez is the Founder of SaveMyFat, a company that connects patients and physicians with a U.S. tissue bank for adipose tissue banking, so a person's own tissue can be preserved for potential future use in FDA-regulated pathways. He is not a physician.","url":"https:\/\/savemyfat.com\/oscar-tellez","email":"info@savemyfat.com","image":{"@type":"ImageObject","url":"https:\/\/savemyfat.com\/wp-content\/uploads\/2026\/05\/Oscar-Headshot-Rounded-1.png","width":"200","height":"200"},"worksFor":{"@type":"Organization","@id":"https:\/\/savemyfat.com\/#organization","name":"SaveMyFat","url":"https:\/\/savemyfat.com"},"knowsAbout":["Adipose Tissue Banking","Cryopreservation","Regenerative Medicine Regulation","Adipose-Derived Cells","Expanded Access Pathways"],"sameAs":["https:\/\/savemyfat.com\/oscar-tellez","https:\/\/www.linkedin.com\/in\/o-tellez\/","https:\/\/www.facebook.com\/savemyfat\/","https:\/\/www.instagram.com\/savemyfat\/"]},{"@type":"Article","@id":"https:\/\/savemyfat.com\/expanded-access-program-request-process\/#article","headline":"The Process for an Expanded Access Program Request, Step by Step","url":"https:\/\/savemyfat.com\/expanded-access-program-request-process\/","mainEntityOfPage":{"@type":"WebPage","@id":"https:\/\/savemyfat.com\/expanded-access-program-request-process\/"},"datePublished":"2026-09-23T10:00:00-04:00","dateModified":"2026-08-26T17:25:06-04:00","description":"The expanded access request process step by step for 2026: who submits, what FDA reviews, the 30 day rule, and the emergency phone pathway.","inLanguage":"en-US","articleSection":"Expanded Access Program Request Process","author":{"@type":"Person","@id":"https:\/\/savemyfat.com\/oscar-tellez\/#person","name":"Oscar Tellez","jobTitle":"Founder","url":"https:\/\/savemyfat.com\/oscar-tellez"},"publisher":{"@type":"Organization","@id":"https:\/\/savemyfat.com\/#organization","name":"SaveMyFat","url":"https:\/\/savemyfat.com"},"image":"https:\/\/savemyfat.com\/wp-content\/uploads\/2026\/08\/expanded-access-program-request-process.png"}]},{"@context":"https:\/\/schema.org","@type":"WebPage","@id":"https:\/\/savemyfat.com\/expanded-access-program-request-process\/#webpage","url":"https:\/\/savemyfat.com\/expanded-access-program-request-process\/","name":"Expanded Access Requests: A Clear 2026 Step by Step","speakable":{"@type":"SpeakableSpecification","cssSelector":[".smf-speakable"]}}] ```