Drug Shortage Compounding Patient Access Act of 2025
Sponsored By: Representative Harshbarger, Diana [R-TN-1]
Introduced
Summary
Would allow urgent-use compounding of shortage drugs by pharmacists and physicians for limited distribution to hospitals and clinical settings. It would also tighten shortage reporting, labeling, and adverse event tracking to improve patient safety and monitor supply surges.
Show full summary
- Hospitals and clinicians: Enables receipt of limited quantities of compounded drugs for urgent administration when a product appeared on the drug shortage list during the prior 60-day period. Orders must include a prescriber certification that a manufacturer or outsourcing-produced drug could not be obtained.
- Pharmacists and outsourcing facilities: Creates new documentation and labeling duties. Compounded products must carry a beyond-use date, a clear label that they are not FDA approved, and pharmacists must link patient records within 7 days and report adverse events to FDA MedWatch within 15 days of awareness.
- Supply chain and regulators: Expands reporting to cover discontinuances, interruptions, and surges in demand, requires at least 6 months' notice of planned stoppages when possible, and calls for annual public updates on bulk drug substance evaluations used by outsourcing facilities.
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Bill Overview
Analyzed Economic Effects
4 provisions identified: 3 benefits, 0 costs, 1 mixed.
Earlier alerts on drug demand surges
Drug makers and outsourcing facilities would need to alert FDA about big demand surges as soon as practicable. They would give at least 6 months’ notice for planned stoppages or interruptions, or report as soon as possible if 6 months is not feasible. The bill updates what “drug shortage” means and defines a “surge” as demand the maker likely cannot meet without meaningful shortfall or delay.
Hospitals could get urgent compounded drugs
If enacted, hospitals and clinics could receive small amounts of compounded drugs for urgent care during shortages. The drug must have been on FDA’s shortage list within the past 60 days, and the prescriber must certify they tried and could not get an outsourcing‑facility version. The compounder would add a USP beyond‑use date, mark the package for urgent use, request patient records within 7 days, link those records to the order, and report bad reactions to FDA within 15 days. The bill also says some compounded drugs would not count as “copies” of a commercial drug: when a prescriber makes a patient‑specific change that is a significant difference, or when a shortage drug is labeled and documented for urgent use as above.
Clear labels on compounded drugs
Certain compounded prescriptions would need a clear label: “This medication has been compounded for dispensing to an individual patient and has not been approved by the Food and Drug Administration.” The bill also updates a reference so pharmacies use the National Formulary drug or dietary supplement monograph.
Wider 180-day window for compounding list
For outsourcing‑facility compounding, a drug would count as shortage‑listed if it appeared at any time in the 180 days before the action. The Health Secretary would also publish yearly updates on how bulk drug substances are evaluated for the outsourcing list.
Sponsors & CoSponsors
Sponsor
Harshbarger, Diana [R-TN-1]
TN • R
Cosponsors
Rep. Carter, Earl L. "Buddy" [R-GA-1]
GA • R
Sponsored 9/11/2025
Rep. Owens, Burgess [R-UT-4]
UT • R
Sponsored 9/17/2025
Rep. Harris, Andy [R-MD-1]
MD • R
Sponsored 10/24/2025
Roll Call Votes
No roll call votes available for this bill.
View on Congress.gov