H.R. 5316 · 119th Congress

Drug Shortage Compounding Patient Access Act of 2025

Introduced on Sep 11, 2025 by Diana Harshbarger (R-TN-1). 3 cosponsors, all from the sponsor's party. Latest action (Sep 11, 2025): Referred to the House Committee on Energy and Commerce.

Stage
Introduced
Introduced
Sep 11, 2025
Cosponsors
3
0 from the other party
Policy area
Health
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Progress

The furthest stage the measure reached. Simple and concurrent resolutions do not go to the President.

  1. Introduced
  2. 2Reported by committee
  3. 3Passed one chamber
  4. 4Passed both chambers
  5. 5Sent to the President
  6. 6Became law

Official title

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.

Summary

By the Congressional Research Service (Introduced in House, Sep 11, 2025). Public domain.

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.

Sponsor and cosponsors

Cosponsors by party as of the day they signed on. Original cosponsors signed on the day of introduction.

Diana HarshbargerR-TN-1Sponsor

Republicans · 3

Roll calls

Recorded votes on the measure. Most measures move by voice vote or unanimous consent, which record no individual positions.

No recorded roll call on this measure: it moved by voice vote or unanimous consent, or has not reached the floor.

History

Every action as published, oldest first. Roll calls link to how each member voted.

  1. Sep 11, 2025Introduced in House
  2. Sep 11, 2025Introduced in House
  3. Sep 11, 2025 · HouseReferred to the House Committee on Energy and Commerce.

Committees

Committees and subcommittees the measure was referred to.

Agencies in its committees' jurisdiction

Analisa's mapping of committee jurisdiction to federal agencies; the bill may touch others, or none of these.

Who lobbied on it

Organizations whose lobbying reports (LD-2) name this measure. Spending is what they reported for those quarters on all issues, not on this measure alone.

  1. NATIONAL COMMUNITY PHARMACISTS ASSOCIATION4 reports
    $1.2M reported (all issues)Federal contractor: NATIONAL COMMUNITY PHARMACISTS ASSOCIATIONAI match · 100%
  2. PROFESSIONAL COMPOUNDING CENTERS OF AMERICA4 reports
    $720K reported (all issues)
  3. ALLIANCE FOR PHARMACY COMPOUNDING2 reports
    $100K reported (all issues)
  4. Eli Lilly and Company fka Lilly USA, LLC2 reports
    $100K reported (all issues)
  5. INDEPENDENT PHARMACY COOPERATIVE2 reports
    $70K reported (all issues)Federal contractor: INDEPENDENT PHARMACY COOPERATIVEAI match · 99%
  6. Lilly USA, LLC2 reports
    $100K reported (all issues)Federal contractor: THE LILLY COMPANYAI match · 97%
  7. HIMS & HERS HEALTH, INC.1 report
    $330K reported (all issues)

Reports filed in 2025, 2026.

Sources and method

Every figure on this page traces to these records.

  • Bill status: bills and resolutions, sponsors, actions, subjects and CRS summaries (U.S. Government Publishing Office (GovInfo), from Congress.gov (Library of Congress))GovInfo Bill Status bulk data (Congress.gov; summaries by the Congressional Research Service) · data current to Oct 10, 2026 · loaded Oct 10, 2026 · license: Public domain (U.S. Government work, 17 U.S.C. § 105)
  • Members of Congress, their terms, committees and identifiers (The @unitedstates project (from the Biographical Directory of the U.S. Congress, the House and the Senate))unitedstates/congress-legislators: legislators, committees and current committee membership · data current to Oct 3, 2026 · loaded Oct 3, 2026 · license: CC0 1.0 (public domain dedication)
  • House roll-call votes (Office of the Clerk, U.S. House of Representatives)Office of the Clerk, U.S. House of Representatives, roll-call vote records · data current to Oct 3, 2026 · loaded Oct 3, 2026 · license: Public domain (U.S. Government work, 17 U.S.C. § 105)
  • Senate roll-call votes and DW-NOMINATE scores (Voteview (UCLA Department of Political Science))Lewis, Jeffrey B., Keith Poole, Howard Rosenthal, Adam Boche, Aaron Rudkin, and Luke Sonnet (2026). Voteview: Congressional Roll-Call Votes Database. https://voteview.com/ · data current to Oct 3, 2026 · loaded Oct 3, 2026 · license: Free to use with the required citation
  • Lobbying disclosures (LD-1 registrations, LD-2 quarterly reports, LD-203 contribution reports) (Clerk of the U.S. House of Representatives)Clerk of the House, Lobbying Disclosure Act filings (organizations only; lobbyists' names are not loaded) · data current to Oct 10, 2026 · loaded Oct 10, 2026 · license: Public domain (U.S. Government work, 17 U.S.C. § 105)
  • Positions are shown only where a roll call recorded them; voice votes and unanimous consent record none.
  • Money and votes are shown side by side; neither explains the other.