# 2025-20658: FDA Hosts Workshop to Improve Community Access to Life-Saving Epinephrine 2025-20658, Improving Anaphylaxis Outcomes: Approaches for Enhancing Access to Epinephrine; Public Workshop; Request for Comments, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2025-11-24, effective 2025-12-16 (as of 2026-06-08). - Canonical: https://policyrisk.com/federal-register/2025-20658 - As of: 2026-06-08 - Plain-text twin of the page above; the HTML and this file carry the same facts. ## Facts - Document number: 2025-20658 - Title: Improving Anaphylaxis Outcomes: Approaches for Enhancing Access to Epinephrine; Public Workshop; Request for Comments - Type: Notice - Agencies: Health and Human Services Department; Food and Drug Administration - Citation: 90 FR 52958 - Published: 2025-11-24 - Effective: 2025-12-16 - Comments close: 2026-01-16 - Significant: no - Touches household money: no - Regulation identifier numbers: none - Last updated: 2026-06-08 ## In one line FDA Hosts Workshop to Improve Community Access to Life-Saving Epinephrine ## Summary The FDA is hosting a workshop on December 16, 2025, to talk about making epinephrine easier to get for people who might have severe allergic reactions (anaphylaxis). This effort aims to save lives by getting epinephrine into more hands, especially in community places. Everyone can join online or in person and share their thoughts by January 16, 2026, helping shape future access and safety improvements. ## Abstract The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled "Improving Anaphylaxis Outcomes: Approaches for Enhancing Access to Epinephrine." The purpose of the public workshop is to initiate a discussion on expanding epinephrine accessibility and use, including in community settings, to reduce anaphylaxis-related morbidity and mortality. This public workshop will be convened and supported by a cooperative agreement between FDA and the Duke-Margolis Institute for Health Policy. ## Effects PRIA read - Many at-risk patients lack or avoid epinephrine: cost, high. Anaphylaxis can progress within 15 to 30 minutes and epinephrine is the only effective first-line treatment. The document says up to 5 percent lifetime prevalence in the U.S. and about 200 deaths annually, and it notes patients prescribed epinephrine may not have it available during an event or may… - Community sites often lack epinephrine policies: cost, medium. Schools, workplaces, restaurants, sports facilities, transportation vehicles, and public venues may lack policies for epinephrine storage, staff training, and emergency administration. That institutional lack of preparedness can reduce access to epinephrine where anaphylaxis commonly happens. - State liability rules discourage stocking epinephrine: cost, medium. State laws vary regarding Good Samaritan protections for lay administration of epinephrine, and these liability concerns can discourage institutions from maintaining emergency epinephrine supplies. - Cost of epinephrine limits community availability: cost, medium. The document identifies economic obstacles from the cost of epinephrine products as a barrier to having community‑use epinephrine available in public settings, which can limit access during emergencies. - Rural disparities reduce timely epinephrine access: cost, medium. The document notes geographic disparities, especially in rural communities where pharmacies may be spread out and emergency medical services can have longer response times, which can limit timely access to epinephrine. - Prescription and provider authorization create access hurdles: cost, low. The notice identifies procedural barriers such as obtaining healthcare provider authorization and maintaining a current prescription for epinephrine as factors that can limit access to this life‑saving medication. ## Related documents - [2026-16296](https://policyrisk.com/federal-register/2026-16296): Substances Generally Recognized as Safe, 2026-08-11 - [2026-14073](https://policyrisk.com/federal-register/2026-14073): Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign E…, 2026-07-13 - [2026-13047](https://policyrisk.com/federal-register/2026-13047): Establishment Registration and Product Listing for Tobacco Products, 2026-06-29 - [2025-04978](https://policyrisk.com/federal-register/2025-04978): Nonprescription Drug Product With an Additional Condition for Nonprescription Use, 2025-03-25 - [2025-01840](https://policyrisk.com/federal-register/2025-01840): Nonprescription Drug Product With an Additional Condition for Nonprescription Use, 2025-01-27 - [2026-20727](https://policyrisk.com/federal-register/2026-20727): Medical Devices; Immunology and Microbiology Devices; Classification of the System for Detection of Nucleic Acid From Non-Viral Microorgani…, 2026-10-09 ## Sources - [2025-20658 on federalregister.gov](https://www.federalregister.gov/documents/2025/11/24/2025-20658/improving-anaphylaxis-outcomes-approaches-for-enhancing-access-to-epinephrine-public-workshop) - [2025-20658 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2025-11-24/pdf/2025-20658.pdf) ## Related - [Previous: 2025-20657, Carroll County Energy LLC; Notice of Institution of Section 206 Proceeding And…](https://policyrisk.com/federal-register/2025-20657) - [Next: 2025-20659, Agency Information Collection Activities; Proposed eCollection eComments Reques…](https://policyrisk.com/federal-register/2025-20659) - [All Federal Register documents](https://policyrisk.com/federal-register) Source: PRIA, https://policyrisk.com/federal-register/2025-20658 (as of 2026-06-08).