119th Congress · introduced in the House · Sep 11, 2025
Drug Shortage Compounding Patient Access Act of 2025
Official title from Congress.gov
Latest action (Sep 11, 2025): Referred to the House Committee on Energy and Commerce.
View on Congress.govPolicy area: Health
Congressional Research Service summary, version: Introduced in House (Sep 11, 2025)
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.
Show the full summary (1 more paragraphs)Includes amendment, cloture, and procedural votes. Each is labeled with its exact question; only a passage question is a vote to pass the bill.
No recorded roll calls on this bill in coverage.
Referred to the House Committee on Energy and Commerce.
Introduced in House
Introduced in House
Actions from Congress.gov, newest first.
LD-2 reports whose issue descriptions explicitly cite this bill (bill type and number validated against Congress.gov records). A citation does not establish the client's position or any contact with a member.
Loading lobbying reportsCoverage: reports for 2025 onward, posted Jan 1, 2025 through Oct 23, 2026.
32 citations; showing the 25 most recently posted.
NATIONAL COMMUNITY PHARMACISTS ASSOCIATION · lobbying firm or registrant: NATIONAL COMMUNITY PHARMACISTS ASSOCIATION
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 21, 2026 · issue area: Pharmacy
$370,000
Spent on own lobbying
…Most-Favored-Nation Prescription Drug Pricing to American Patients"; Comments to CDC on "RE: June 25-26 Advisory Committee on Immunization Practices Meeting"; H.R.5316, the Drug Shortage Compounding and Patient Access Act; H.R.5256, the 340B ACCESS Act; Comments to FDA on "RE: Docket No. FDA-2025-N-2589, Comments on the Risks…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
PROFESSIONAL COMPOUNDING CENTERS OF AMERICA · lobbying firm or registrant: PROFESSIONAL COMPOUNDING CENTERS OF AMERICA
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Pharmacy
$190,000
Spent on own lobbying
…sues related to animal drug compounding, issues relating to opioid safety; issues related to the pharmaceutical supply chain; issues related to drug shortages; H.R. 5316, the Drug Shortage Compounding Patient Access Act of 2025; S. 3794 / H.R. 6509, The Safe Drugs Act; S. 3788/ H.R. 8269 The Clear Labels Act
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
ELI LILLY AND COMPANY FKA LILLY USA, LLC · lobbying firm or registrant: FORBES-TATE
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Health Issues
$50,000
Paid to lobbying firm
…sues related to insulin pricing; Issues related to the pricing of GLP-1 therapeutic products; Issues regarding the 340B Drug Pricing Program; Issues related to H.R. 5316 - Drug Shortage Compounding Patient Access Act of 2025; Issues related to H.R. 6509 - SAFE Drugs Act of 2025; Issues related to S. 3794 - SAFE Drugs Act of 202…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
ELI LILLY AND COMPANY FKA LILLY USA, LLC · lobbying firm or registrant: FORBES-TATE
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Medicare/Medicaid
$50,000
Paid to lobbying firm
…irected Against Amyloid for the Treatment of Alzheimer's Disease; Issues related to H.R. 4231/S. 1973 - Treat and Reduce Obesity Act of 2025; Issues related to H.R. 5316 - Drug Shortage Compounding Patient Access Act of 2025; Issues related to H.R. 6509 - SAFE Drugs Act of 2025; Issues related to S. 3794 - SAFE Drugs Act of 202…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
ALLIANCE FOR PHARMACY COMPOUNDING · lobbying firm or registrant: HANCE SCARBOROUGH
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 12, 2026 · issue area: Health Issues
$50,000
Paid to lobbying firm
…s related to preserving patient access to compounded medications. Drug Shortages SAFE Drugs Act HR 6509/S.3794 The Drug Shortage Compounding Patient Access Act HR 5316 FY27 Appropriations
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
ALLIANCE FOR PHARMACY COMPOUNDING · lobbying firm or registrant: HANCE SCARBOROUGH
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 12, 2026 · issue area: Pharmacy
$50,000
Paid to lobbying firm
…s related to preserving patient access to compounded medications. Drug Shortages SAFE Drugs Act HR 6509/S.3794 The Drug Shortage Compounding Patient Access Act HR 5316 FY27 Appropriations
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
ALLIANCE FOR PHARMACY COMPOUNDING · lobbying firm or registrant: HANCE SCARBOROUGH
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 12, 2026 · issue area: Budget/Appropriations
$50,000
Paid to lobbying firm
…pounding. Issues related to preserving patient access to compounded medications. SAFE Drugs Act HR 6509/S.3794 The Drug Shortage Compounding Patient Access Act HR 5316 FY27 Appropriations
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
INDEPENDENT PHARMACY COOPERATIVE · lobbying firm or registrant: INDEPENDENT PHARMACY COOPERATIVE
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 8, 2026 · issue area: Pharmacy
$30,000
Spent on own lobbying
…nitors HR 879/S.3794 Safe Drug Act of 2026 IPC is opposed to the HRSA 340B proposed rebate model IPC opposes HR 6509/S. 3794 Safe Drug Act of 2026. IPC opposes HR 5316 the "Drug Shortage Compounding Patient Access Act of 2025" IPC supports the Breakup Big Medicine Act S. 3822 IPC supports Protecting Pharmacies in Medicaid Act…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
ELI LILLY AND COMPANY FKA LILLY USA, LLC · lobbying firm or registrant: FORBES-TATE
2026 Q2 report (Apr 1, 2026 – Jun 30, 2026) · posted Jul 20, 2026 · issue area: Health Issues
$50,000
Paid to lobbying firm
…sues related to Insulin pricing; Issues related to the pricing of GLP-1 therapeutic products; Issues regarding the 340B Drug Pricing Program; Issues related to H.R. 5316 - Drug Shortage Compounding Patient Access Act of 2025; Issues related to H.R. 6509 - SAFE Drugs Act of 2025; Issues related to S. 3794 - SAFE Drugs Act of 202…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
ELI LILLY AND COMPANY FKA LILLY USA, LLC · lobbying firm or registrant: FORBES-TATE
2026 Q2 report (Apr 1, 2026 – Jun 30, 2026) · posted Jul 20, 2026 · issue area: Medicare/Medicaid
$50,000
Paid to lobbying firm
…irected Against Amyloid for the Treatment of Alzheimer's Disease; Issues related to H.R. 4231/S. 1973 - Treat and Reduce Obesity Act of 2025; Issues related to H.R. 5316 - Drug Shortage Compounding Patient Access Act of 2025; Issues related to H.R. 6509 - SAFE Drugs Act of 2025; Issues related to S. 3794 - SAFE Drugs Act of 202…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
PROFESSIONAL COMPOUNDING CENTERS OF AMERICA · lobbying firm or registrant: PROFESSIONAL COMPOUNDING CENTERS OF AMERICA
2026 Q2 report (Apr 1, 2026 – Jun 30, 2026) · posted Jul 20, 2026 · issue area: Pharmacy
$220,000
Spent on own lobbying
…sues related to animal drug compounding, issues relating to opioid safety; issues related to the pharmaceutical supply chain; issues related to drug shortages; H.R. 5316, the Drug Shortage Compounding Patient Access Act of 2025; S. 3794 / H.R. 6509, The Safe Drugs Act; S. 3788/ H.R. 8269 The Clear Labels Act
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
NATIONAL COMMUNITY PHARMACISTS ASSOCIATION · lobbying firm or registrant: NATIONAL COMMUNITY PHARMACISTS ASSOCIATION
2026 Q2 report (Apr 1, 2026 – Jun 30, 2026) · posted Jul 17, 2026 · issue area: Pharmacy
$270,000
Spent on own lobbying
…Most-Favored-Nation Prescription Drug Pricing to American Patients"; Comments to CDC on "RE: June 25-26 Advisory Committee on Immunization Practices Meeting"; H.R.5316, the Drug Shortage Compounding and Patient Access Act; H.R.5256, the 340B ACCESS Act; Comments to FDA on "RE: Docket No. FDA-2025-N-2589, Comments on the Risks…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
ALLIANCE FOR PHARMACY COMPOUNDING · lobbying firm or registrant: HANCE SCARBOROUGH
2026 Q2 report (Apr 1, 2026 – Jun 30, 2026) · posted Jul 17, 2026 · issue area: Health Issues
$50,000
Paid to lobbying firm
…s related to preserving patient access to compounded medications. Drug Shortages SAFE Drugs Act HR 6509/S.3794 The Drug Shortage Compounding Patient Access Act HR 5316 FY27 Appropriations
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
ALLIANCE FOR PHARMACY COMPOUNDING · lobbying firm or registrant: HANCE SCARBOROUGH
2026 Q2 report (Apr 1, 2026 – Jun 30, 2026) · posted Jul 17, 2026 · issue area: Pharmacy
$50,000
Paid to lobbying firm
…s related to preserving patient access to compounded medications. Drug Shortages SAFE Drugs Act HR 6509/S.3794 The Drug Shortage Compounding Patient Access Act HR 5316 FY27 Appropriations
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
ALLIANCE FOR PHARMACY COMPOUNDING · lobbying firm or registrant: HANCE SCARBOROUGH
2026 Q2 report (Apr 1, 2026 – Jun 30, 2026) · posted Jul 17, 2026 · issue area: Budget/Appropriations
$50,000
Paid to lobbying firm
…pounding. Issues related to preserving patient access to compounded medications. SAFE Drugs Act HR 6509/S.3794 The Drug Shortage Compounding Patient Access Act HR 5316 FY27 Appropriations
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
INDEPENDENT PHARMACY COOPERATIVE · lobbying firm or registrant: INDEPENDENT PHARMACY COOPERATIVE
2026 Q2 report (Apr 1, 2026 – Jun 30, 2026) · posted Jul 14, 2026 · issue area: Pharmacy
$40,000
Spent on own lobbying
…) prescription drug distribution proposals IPC is opposed to the HRSA 340B proposed rebate model IPC opposes HR 6509/S. 3794 Safe Drug Act of 2026. IPC opposes HR 5316 the "Drug Shortage Compounding Patient Access Act of 2025" IPC supports the Breakup Big Medicine Act S. 3822 IPC supports Protecting Pharmacies in Medicaid Act…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
NATIONAL COMMUNITY PHARMACISTS ASSOCIATION · lobbying firm or registrant: NATIONAL COMMUNITY PHARMACISTS ASSOCIATION
2026 Q1 report (Jan 1, 2026 – Mar 31, 2026) · posted Apr 20, 2026 · issue area: Pharmacy
$320,000
Spent on own lobbying
…Most-Favored-Nation Prescription Drug Pricing to American Patients"; Comments to CDC on "RE: June 25-26 Advisory Committee on Immunization Practices Meeting"; H.R.5316, the Drug Shortage Compounding and Patient Access Act; H.R.5256, the 340B ACCESS Act; Comments to FDA on "RE: Docket No. FDA-2025-N-2589, Comments on the Risks…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
PROFESSIONAL COMPOUNDING CENTERS OF AMERICA · lobbying firm or registrant: PROFESSIONAL COMPOUNDING CENTERS OF AMERICA
2026 Q1 report (Jan 1, 2026 – Mar 31, 2026) · posted Apr 20, 2026 · issue area: Pharmacy
$220,000
Spent on own lobbying
…sues related to animal drug compounding, issues relating to opioid safety; issues related to the pharmaceutical supply chain; issues related to drug shortages; H.R. 5316, the Drug Shortage Compounding Patient Access Act of 2025; S. 3794 / H.R. 6509, The Safe Drugs Act; S. 3788, The Clear Labels Act
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
ALLIANCE FOR PHARMACY COMPOUNDING · lobbying firm or registrant: HANCE SCARBOROUGH
2026 Q1 report (Jan 1, 2026 – Mar 31, 2026) · posted Apr 18, 2026 · issue area: Health Issues
$50,000
Paid to lobbying firm
…ccess to compounded medications. Fiscal Year 2026 Appropriations. Drug Shortages SAFE Drugs Act HR 6509/S.3794 The Drug Shortage Compounding Patient Access Act HR 5316 FY27 Appropriations
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
ALLIANCE FOR PHARMACY COMPOUNDING · lobbying firm or registrant: HANCE SCARBOROUGH
2026 Q1 report (Jan 1, 2026 – Mar 31, 2026) · posted Apr 18, 2026 · issue area: Pharmacy
$50,000
Paid to lobbying firm
…ccess to compounded medications. Fiscal Year 2026 Appropriations. Drug Shortages SAFE Drugs Act HR 6509/S.3794 The Drug Shortage Compounding Patient Access Act HR 5316 FY27 Appropriations
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
ALLIANCE FOR PHARMACY COMPOUNDING · lobbying firm or registrant: HANCE SCARBOROUGH
2026 Q1 report (Jan 1, 2026 – Mar 31, 2026) · posted Apr 18, 2026 · issue area: Budget/Appropriations
$50,000
Paid to lobbying firm
…rving patient access to compounded medications. Fiscal Year 2026 Appropriations. SAFE Drugs Act HR 6509/S.3794 The Drug Shortage Compounding Patient Access Act HR 5316 FY27 Appropriations
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
ELI LILLY AND COMPANY FKA LILLY USA, LLC · lobbying firm or registrant: FORBES-TATE
2026 Q1 report (Jan 1, 2026 – Mar 31, 2026) · posted Apr 18, 2026 · issue area: Health Issues
$50,000
Paid to lobbying firm
…sues related to Insulin pricing; Issues related to the pricing of GLP-1 therapeutic products; Issues regarding the 340B Drug Pricing Program; Issues related to H.R. 5316 - Drug Shortage Compounding Patient Access Act of 2025; Issues related to H.R. 6509 - SAFE Drugs Act of 2025; Issues related to S. 3794 - SAFE Drugs Act of 202…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
ELI LILLY AND COMPANY FKA LILLY USA, LLC · lobbying firm or registrant: FORBES-TATE
2026 Q1 report (Jan 1, 2026 – Mar 31, 2026) · posted Apr 18, 2026 · issue area: Medicare/Medicaid
$50,000
Paid to lobbying firm
…irected Against Amyloid for the Treatment of Alzheimer's Disease; Issues related to H.R. 4231/S. 1973 - Treat and Reduce Obesity Act of 2025; Issues related to H.R. 5316 - Drug Shortage Compounding Patient Access Act of 2025; Issues related to H.R. 6509 - SAFE Drugs Act of 2025; Issues related to S. 3794 - SAFE Drugs Act of 202…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
HIMS & HERS HEALTH, INC. · lobbying firm or registrant: HIMS & HERS HEALTH, INC.
2025 Q3 report (Jul 1, 2025 – Sep 30, 2025) · amended · posted Jan 23, 2026 · issue area: Health Issues
$330,000
Spent on own lobbying
…ncerning Telemedicine Prescribing of Controlled Substances Discussions concerning proposed legislation related to access to compounded drugs and drug shortages H.R.5316 - Drug Shortage Compounding Patient Access Act of 2025 H.R.4605 - End Prescription Drug Ads Now Act H.R.238 - Healthy Technology Act of 2025 S.5040 - Protectin…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
NATIONAL COMMUNITY PHARMACISTS ASSOCIATION · lobbying firm or registrant: NATIONAL COMMUNITY PHARMACISTS ASSOCIATION
2025 Q4 report (Oct 1, 2025 – Dec 31, 2025) · posted Jan 21, 2026 · issue area: Pharmacy
$230,000
Spent on own lobbying
…Most-Favored-Nation Prescription Drug Pricing to American Patients"; Comments to CDC on "RE: June 25-26 Advisory Committee on Immunization Practices Meeting"; H.R.5316, the Drug Shortage Compounding and Patient Access Act; H.R.5256, the 340B ACCESS Act; Comments to FDA on "RE: Docket No. FDA-2025-N-2589, Comments on the Risks…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing