HR5316Referred to Committee
Drug Shortage Compounding Patient Access Act of 2025
Introduced
In Committee
3
Passed One Chamber4
Passed Both5
Signed into Law119th
Congress
2025-09-11
Introduced
3
Cosponsors
HR
ⓘType
Sponsor
Diana Harshbarger
Republican · TN · Representative
Votes with party: 92.5% (601 recorded votes)
Full profile: /officials/H001086
Source: Congress.gov · FEC
Cosponsors (3)
Members who have signed on to support this bill since introduction. Source: Congress.gov.
3 cosponsors on record at Congress.gov. The named list is syncing into Govwatch and will appear here shortly — view on Congress.gov in the meantime.
Latest Action
The most recent step in the bill's legislative path. Committee Activity below shows referrals and reports; the full action-by-action history including floor proceedings lives at Congress.gov →
Committee Activity
Currently in
- House Committee on Energy and CommerceReferred To · 2025-09-11
Plain-English Summary
Drug Shortage Compounding Patient Access Act of 2025 This bill relaxes certain requirements for the compounding of drugs facing shortages. 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 outsourcing facility compounds in bulk for use in medical facilities. 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. 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. The bill also requires the FDA to publish annual updates on its evaluation of substances for inclusion on the list of bulk drug substances (i.e., active pharmaceutical ingredients) that may be used in bulk compounding of drugs not on the shortage list. Finally, manufacturers of certain drugs, including life-supporting and life-sustaining drugs, must report to the FDA certain surges in demand for such drugs.
Plain-English rewrite of the Congressional Research Service summary published on Congress.gov. Cached and reviewed.
Subjects
Health
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