{"bill":{"id":"119-hr-5316","congress":119,"type":"HR","number":5316,"title":"Drug Shortage Compounding Patient Access Act of 2025","originChamber":"House","introducedDate":"2025-09-11","sponsors":[{"bioguideId":"H001086","fullName":"Rep. Harshbarger, Diana [R-TN-1]","party":"R","state":"TN","district":1}],"cosponsorsCount":3,"latestAction":{"actionDate":"2025-09-11","text":"Referred to the House Committee on Energy and Commerce."},"policyArea":"Health","subjects":[],"actions":[{"date":"2025-09-11","text":"Referred to the House Committee on Energy and Commerce.","type":"IntroReferral","chamber":"House floor actions","hasVote":false},{"date":"2025-09-11","text":"Introduced in House","type":"IntroReferral","chamber":"Library of Congress","hasVote":false},{"date":"2025-09-11","text":"Introduced in House","type":"IntroReferral","chamber":"Library of Congress","hasVote":false}],"summary":"<p><strong>Drug Shortage Compounding Patient Access Act of 2025</strong></p><p>This bill relaxes certain requirements for the compounding of drugs facing shortages.</p><p>Currently, subject to certain requirements, compounded drugs (i.e., drugs altered to meet patient needs) do not require Food and Drug Administration (FDA) approval. There are two general categories of compounding: (1) pharmacy compounding, wherein a licensed pharmacist or physician not registered with the FDA compounds in limited quantities for identified patients; and (2) bulk compounding, wherein an FDA-registered <em>outsourcing facility</em> compounds in bulk for use in medical facilities.</p><p>The bill permits pharmacy compounding in limited quantities for an urgent medical need not involving a specific patient if, among other requirements, the drug appeared on the FDA’s drug shortage list within a specified period. The bill also formally waives limits on pharmacy compounding of drugs that are essentially copies of commercially available drugs if the drug appeared on the shortage list within a specified period.</p><p>Separately, the bill extends the period during which an outsourcing facility may compound a drug that appeared on the shortage list to 180 days after the drug’s removal from the list.</p><p>The bill also requires the FDA to publish annual updates on its evaluation of substances for inclusion on the list of <em>bulk drug substances</em> (i.e., active pharmaceutical ingredients) that may be used in bulk compounding of drugs not on the shortage list.</p><p>Finally, manufacturers of certain drugs, including life-supporting and life-sustaining drugs, must report to the FDA certain surges in demand for such drugs.</p>","updateDate":"2026-07-06T20:10:06Z"},"markets":[],"stateBills":[],"meta":{"sources":["congress.gov"],"latencyMs":336,"ts":"2026-07-14T03:27:21.897Z"},"nextActions":{"inspect":[],"related":[{"description":"Search related legislation","method":"GET","url":"https://simplefunctions.dev/api/public/query-gov?q=Drug%20Shortage%20Compounding%20Patient%20Access%20Act%20of%202025"}]}}