[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"current-user-roles":3,"user-subscription":3,"bill:119-hr-5316":4},null,{"bill":5,"indexable":168,"summaries":169,"cosponsors":175,"cosponsorSlugs":191,"actions":195,"amendments":212,"amendmentSponsorSlugs":213,"linkages":214,"sponsorSlug":215},{"statusDate":6,"sponsor":7,"cboCostEstimates":15,"originChamber":16,"congress":17,"isByRequest":18,"title":19,"createdAt":20,"committeeReports":21,"cosponsorCount":22,"onBehalfOfSponsor":3,"adminOverride":3,"amendmentCount":23,"actionCount":22,"popularTitle":3,"laws":3,"billType":24,"subjects":25,"introducedDate":6,"congressGovUrl":26,"constitutionalAuthority":27,"policyArea":28,"deletedAt":3,"latestAction":29,"billNumber":31,"cosponsorCountIncludingWithdrawn":22,"status":32,"keyMilestoneCount":33,"policyAreaLower":34,"updateDate":35,"shortTitle":19,"officialTitle":36,"committees":37,"committeeCodes":47,"updatedAt":48,"searchTokens":49},"2025-09-11",{"firstName":8,"lastName":9,"district":10,"fullName":11,"state":12,"party":13,"bioguideId":14},"Diana","Harshbarger","1","Rep. Harshbarger, Diana [R-TN-1]","TN","R","H001086",[],"House",119,false,"Drug Shortage Compounding Patient Access Act of 2025","2026-05-13T22:12:21.020Z",[],3,0,"hr",[],"https:\u002F\u002Fwww.congress.gov\u002Fbill\u002F119th-congress\u002Fhouse-bill\u002F5316","\u003Cpre>\n[Congressional Record Volume 171, Number 149 (Thursday, September 11, 2025)]\n[House]\nFrom the Congressional Record Online through the Government Publishing Office [\u003Ca href=\"https:\u002F\u002Fwww.gpo.gov\">www.gpo.gov\u003C\u002Fa>]\nBy Mrs. HARSHBARGER:\nH.R. 5316.\nCongress has the power to enact this legislation pursuant\nto the following:\nArticle I; Section 8 of the United States Constitution\n[Page H4265]\n\u003C\u002Fpre>","Health",{"date":6,"text":30},"Referred to the House Committee on Energy and Commerce.",5316,"in_committee",2,"health","2026-07-06T20:10:06Z","To amend the Federal Food, Drug, and Cosmetic Act to ensure patients have access to certain shortage and urgent-use compounded medications, and for other purposes.",[38],{"name":39,"systemCode":40,"chamber":16,"activities":41,"subcommittees":45,"type":46},"Energy and Commerce Committee","hsif00",[42],{"name":43,"date":44},"Referred To","2025-09-11T13:05:15Z",[],"Standing",[40],"2026-07-07T06:30:22.675Z",[50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,146,147,148,149,150,151,152,153,154,155,156,157,158,159,160,161,162,163,164,165,166,167],"drug","dr","dru","shortage","sh","sho","shor","short","shorta","shortag","compounding","co","com","comp","compo","compou","compoun","compound","compoundi","compoundin","patient","pa","pat","pati","patie","patien","access","ac","acc","acce","acces","act","of","2025","20","202","to","amend","am","ame","amen","the","federal","fe","fed","fede","feder","federa","food","fo","foo","and","cosmetic","cos","cosm","cosme","cosmet","cosmeti","ensure","en","ens","ensu","ensur","patients","have","ha","hav","certain","ce","cer","cert","certa","certai","urgent","ur","urg","urge","urgen","use","compounded","compounde","medications","me","med","medi","medic","medica","medicat","medicati","medicatio","medication","for","other","ot","oth","othe","purposes","pu","pur","purp","purpo","purpos","purpose","rep","harshbarger","har","hars","harsh","harshb","harshba","harshbar","harshbarg","harshbarge","diana","di","dia","dian","tn",true,[170],{"versionCode":171,"actionDate":6,"actionDesc":172,"text":173,"updateDate":174},"00","Introduced in House","\u003Cp>\u003Cstrong>Drug Shortage Compounding Patient Access Act of 2025\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>This bill relaxes certain requirements for the compounding of drugs facing shortages.\u003C\u002Fp>\u003Cp>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 \u003Cem>outsourcing facility\u003C\u002Fem> compounds in bulk for use in medical facilities.\u003C\u002Fp>\u003Cp>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.\u003C\u002Fp>\u003Cp>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.\u003C\u002Fp>\u003Cp>The bill also requires the FDA to publish annual updates on its evaluation of substances for inclusion on the list of \u003Cem>bulk drug substances\u003C\u002Fem> (i.e., active pharmaceutical ingredients) that may be used in bulk compounding of drugs not on the shortage list.\u003C\u002Fp>\u003Cp>Finally, manufacturers of certain drugs, including life-supporting and life-sustaining drugs, must report to the FDA certain surges in demand for such drugs.\u003C\u002Fp>","2026-07-06T20:08:58Z",[176,181,187],{"bioguideId":177,"fullName":178,"party":13,"state":179,"district":10,"sponsorshipDate":180,"isOriginalCosponsor":18,"withdrawn":18,"sponsorshipWithdrawnDate":3},"H001052","Rep. Harris, Andy [R-MD-1]","MD","2025-10-24",{"bioguideId":182,"fullName":183,"party":13,"state":184,"district":185,"sponsorshipDate":186,"isOriginalCosponsor":18,"withdrawn":18,"sponsorshipWithdrawnDate":3},"O000086","Rep. Owens, Burgess [R-UT-4]","UT","4","2025-09-17",{"bioguideId":188,"fullName":189,"party":13,"state":190,"district":10,"sponsorshipDate":6,"isOriginalCosponsor":168,"withdrawn":18,"sponsorshipWithdrawnDate":3},"C001103","Rep. Carter, Earl L. \"Buddy\" [R-GA-1]","GA",{"H001052":192,"O000086":193,"C001103":194},"andy-harris","burgess-owens","earl-l-buddy-carter",[196,203,209],{"actionDate":6,"actionDateTime":3,"text":30,"type":197,"actionCode":198,"sourceSystem":199,"committees":201,"recordedVotes":3,"calendarNumber":3,"sequenceIndex":23,"isKeyMilestone":18},"IntroReferral","H11100",{"code":33,"name":200},"House floor actions",[202],{"name":39,"systemCode":40},{"actionDate":6,"actionDateTime":3,"text":172,"type":197,"actionCode":204,"sourceSystem":205,"committees":3,"recordedVotes":3,"calendarNumber":3,"sequenceIndex":208,"isKeyMilestone":168},"Intro-H",{"code":206,"name":207},9,"Library of Congress",1,{"actionDate":6,"actionDateTime":3,"text":172,"type":197,"actionCode":210,"sourceSystem":211,"committees":3,"recordedVotes":3,"calendarNumber":3,"sequenceIndex":33,"isKeyMilestone":168},"1000",{"code":206,"name":207},[],{},[],"diana-harshbarger"]