H.R. 6509 · 119th Congress

SAFE Drugs Act of 2025

Introduced on Dec 9, 2025 by Rudy Yakym III (R-IN-2). 20 cosponsors, 5 of them from another party. Latest action (Dec 9, 2025): Referred to the House Committee on Energy and Commerce.

Stage
Introduced
Introduced
Dec 9, 2025
Cosponsors
20
5 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 further regulate compounding pharmacies and outsourcing facilities, and for other purposes.

Subjects

  • Administrative law and regulatory procedures
  • Department of Health and Human Services
  • Drug safety, medical device, and laboratory regulation
  • Food and Drug Administration (FDA)
  • Government information and archives
  • Health personnel
  • Licensing and registrations
  • User charges and fees

Summary

By the Congressional Research Service (Introduced in House, Dec 9, 2025). Public domain.

Safeguarding Americans from Fraudulent and Experimental Drugs Act of 2025 or the SAFE Drugs Act of 2025

This bill provides for increased oversight of drug compounding and imposes statutory limits on compounded drugs that are essentially copies of commercially available drugs.

Currently, subject to certain requirements, compounded drugs (i.e., drugs that are mixed or altered to meet patient needs) do not require Food and Drug Administration (FDA) approval. Additional limits apply to the compounding of drugs that are essentially copies of commercially available drug products.

Under the bill, a compounded drug is essentially a copy of a commercially available drug product if (1) the compounded drug contains any active ingredient found in a commercially available drug product, and (2) there is no change made for an individual patient that results in a significant difference between the compounded drug and the commercially available drug. (The FDA’s current definition of the term also addresses dosage strength and route of administration.)

The bill increases the frequency at which a licensed pharmacist or physician may compound a drug that is essentially a copy of a commercially available drug to 20 times per month. Current FDA policy allows four such prescriptions per month.

The bill also imposes annual reporting requirements on physicians, facilities, and pharmacies (except hospital-based pharmacies) that compound certain drug products for out-of-state patients more than 20 times per month. Further, the bill subjects certain large-scale outsourcing facilities (i.e., FDA-registered facilities that compound in bulk) to regular inspection and reporting requirements.

Sponsor and cosponsors

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

Rudy Yakym IIIR-IN-2Sponsor

Democrats · 5

Republicans · 15

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. Dec 9, 2025Introduced in House
  2. Dec 9, 2025Introduced in House
  3. Dec 9, 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. ELI LILLY AND COMPANY4 reports
    Federal contractor: ELI LILLY AND COMPANY$286.4K in contracts, FY2026AI match · 100%
  2. ALLIANCE FOR PHARMACY COMPOUNDING2 reports
    $100K reported (all issues)
  3. Alliance for Safe Online Pharmacies (ASOP Global)2 reports
    $110K 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. PROFESSIONAL COMPOUNDING CENTERS OF AMERICA2 reports
    $440K reported (all issues)
  7. Lilly USA, LLC1 report
    $50K reported (all issues)Federal contractor: THE LILLY COMPANYAI match · 97%
  8. NATIONAL COMMUNITY PHARMACISTS ASSOCIATION1 report
    $270K reported (all issues)Federal contractor: NATIONAL COMMUNITY PHARMACISTS ASSOCIATIONAI match · 100%
  9. NOVO NORDISK INC.1 report

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.