FDA Ends Domperidone Access Supply; New IND Import Path Open

The sole supplier of domperidone tablets for expanded access IND use has exited the market, leaving physician-sponsors without a distribution pathway and placing the compliance burden of sourcing squarely on individual healthcare providers. FDA confirmed in August 2025 that supply exhaustion is now in effect following a September 2025 cutoff, closing a program that served patients with refractory gastrointestinal motility disorders including gastroparesis, gastroesophageal reflux disease with upper GI symptoms, and chronic constipation.

The supplier's exit traces to a late-2022 ownership transfer that FDA was notified of at that time. Interim efforts to identify an alternative domestic source proved unsuccessful. For regulatory affairs teams, the timeline illustrates a structural vulnerability in sole-source investigational drug programs: a three-year gap between notification and supply exhaustion still yielded no qualified replacement, underscoring the difficulty of standing up compliant alternatives for unapproved agents under compressed timelines.

A path forward does exist, though it carries significant regulatory overhead. Physician-sponsors who identify a new supplier may submit a fresh expanded access IND. Where that supplier operates outside the United States, the physician-sponsor must satisfy 21 CFR 312.110(a) importation requirements before any investigational drug crosses the border. FDA has indicated it will assist sponsors upon identification of a qualifying supplier, but the agency has not named any candidate sources.

The regulatory backdrop adds further complexity. Domperidone is not approved for human use in the U.S., and a 2004 FDA warning established that distributing domperidone-containing products outside the IND framework is illegal. Compounding is not a permissible workaround: domperidone does not meet the conditions for compounding under sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act. Quality assurance for illegally imported or compounded product cannot be guaranteed, a concern that carries direct GMP implications for any facility or sponsor tempted to bridge supply through informal channels.

Safety documentation attached to the closure notice reinforces why informal sourcing carries unacceptable risk. FDA's 2004 cardiac risk warning remains in force, citing arrhythmias, cardiac arrest, and sudden death as dose-dependent risks. A 2023 FDA case review also identified a potential association between neuropsychiatric adverse events, including suicidal ideation and homicidal ideation, and abrupt or tapered discontinuation of domperidone used for lactation, adding a pharmacovigilance dimension that any new IND sponsor would need to address in their safety reporting plan.

Sponsors currently holding an active expanded access IND for domperidone should document their contingency assessment now, as FDA's willingness to engage on new submissions is contingent on a supplier being identified first.

Source: FDA Office of Drug Information via FDA.gov Drugs RSS Feed, October 1, 2026; original notifications dated August 4, 2025 and December 11, 2024.