119th Congress · introduced in the House · Dec 9, 2025
SAFE Drugs Act of 2025
Official title from Congress.gov
Latest action (Dec 9, 2025): Referred to the House Committee on Energy and Commerce.
View on Congress.govPolicy area: Health
Congressional Research Service summary, version: Introduced in House (Dec 9, 2025)
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.
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
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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.
34 citations; showing the 25 most recently posted.
NOVO NORDISK INC. · lobbying firm or registrant: WILLIAMS AND JENSEN, PLLC
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Health Issues
$60,000
Paid to lobbying firm
Medication affordability and access; general diabetes prevention, 340B, monitoring FDA reform, changes and new programs. SAFE Drugs Act (HR6509/S3794). FDA actions on drug compounding and illicit drugs. Issues related to TrumpRX.
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
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · lobbying firm or registrant: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Health Issues
$7,040,000
Spent on own lobbying
…Program H.R. 2214: DRUG Act H.R. 3521: Clinical Trial Modernization Act H.R. 4317: PBM Reform Act of 2025 H.R. 5256: 340B ACCESS Act H.R. 6423: HELP Copays Act H.R. 6509: SAFE Drugs Act of 2025 H.R. 6610: Pharmacists Fight Back [in Federal Employee Health Benefit Plans Act] H.R. 7837: Most Favored Patients Act H.R. 7953: FAIR A…
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 & COMPANY · lobbying firm or registrant: WILLIAMS AND JENSEN, PLLC
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Health Issues
$50,000
Paid to lobbying firm
340B Drug Pricing program, pharmaceutical supply chain, drug compounding and counterfeiting issues, PBM reform policies. SAFE Drugs Act (HR6509/S3794). FDA actions on drug compounding and illicit drugs. Issues related to TrumpRX. Alzheimer's Screening and Prevention (ASAP) Act (H.R. 6130 / S. 3267).
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
GSK (FKA GLAXOSMITHKLINE INC.) · lobbying firm or registrant: GSK (FKA GLAXOSMITHKLINE INC.)
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Health Issues
$1,530,000
Spent on own lobbying
…Program H.R. 2214: DRUG Act H.R. 3521: Clinical Trial Modernization Act H.R. 4317: PBM Reform Act of 2025 H.R. 5256: 340B ACCESS Act H.R. 6423: HELP Copays Act H.R. 6509: SAFE Drugs Act of 2025 H.R. 6610: Pharmacists Fight Back [in Federal Employee Health Benefit Plans Act] H.R. 7837: Most Favored Patients Act H.R. 7953: FAIR A…
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.
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Health Issues
$270,000
Spent on own lobbying
S.3794 SAFE Drugs Act H.R.6509 SAFE Drugs Act Drug Enforcement Administration's special registrations for telemedicine and limited state telemedicine registrations Matters related to compoun…
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
AMERICAN DIABETES ASSOCIATION · lobbying firm or registrant: AMERICAN DIABETES ASSOCIATION
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Health Issues
$100,000
Spent on own lobbying
SAFE Drugs Act (H.R.6509/ S.3794); Diabetes Act (S. 4037) and competitive bidding program; INSULIN Act (H.R. 10227/ S. 4189); Diabetes foot health (H.R. 7905/H.R. 1616/S. 4070/ S. 1805…
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
…es 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
ALLIANCE FOR SAFE ONLINE PHARMACIES (ASOP GLOBAL) · lobbying firm or registrant: FAEGRE DRINKER BIDDLE & REATH LLP
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Health Issues
$70,000
Paid to lobbying firm
…n on patient safety; Domain name system accountability; Social media and online marketplace platform accountability; FDA Destruction Authority; SAFE Drugs Act (H.R. 6509, S. 3794).
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 SAFE ONLINE PHARMACIES (ASOP GLOBAL) · lobbying firm or registrant: FAEGRE DRINKER BIDDLE & REATH LLP
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Pharmacy
$70,000
Paid to lobbying firm
…n on patient safety; Domain name system accountability; Social media and online marketplace platform accountability; FDA Destruction Authority; SAFE Drugs Act (H.R. 6509, S. 3794).
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 SAFE ONLINE PHARMACIES (ASOP GLOBAL) · lobbying firm or registrant: FAEGRE DRINKER BIDDLE & REATH LLP
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Telecommunications
$70,000
Paid to lobbying firm
…n on patient safety; Domain name system accountability; Social media and online marketplace platform accountability; FDA Destruction Authority; SAFE Drugs Act (H.R. 6509, S. 3794).
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 SAFE ONLINE PHARMACIES (ASOP GLOBAL) · lobbying firm or registrant: FAEGRE DRINKER BIDDLE & REATH LLP
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Consumer Issues/Safety/Products
$70,000
Paid to lobbying firm
…n on patient safety; Domain name system accountability; Social media and online marketplace platform accountability; FDA Destruction Authority; SAFE Drugs Act (H.R. 6509, S. 3794).
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
TIBER CREEK HEALTH STRATEGIES, INC. (ON BEHALF OF ELI LILLY AND COMPANY) · lobbying firm or registrant: TIBER CREEK GROUP
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Health Issues
$80,000
Paid to lobbying firm
…g pricing; Issues related to reimbursement of insulin products; Issues related to the One Big Beautiful Bill Act (PL 119-21); Issues related to compounding and H.R. 6509/S. 3794 - Safeguarding Americans from Fraudulent and Experimental (SAFE) Drugs Act of 2025.
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
…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 2026.
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
…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 2026.
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
…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 2026.
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
…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 2026.
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
NOVO NORDISK INC. · lobbying firm or registrant: WILLIAMS AND JENSEN, PLLC
2026 Q2 report (Apr 1, 2026 – Jun 30, 2026) · posted Jul 20, 2026 · issue area: Health Issues
$60,000
Paid to lobbying firm
Medication affordability and access; general diabetes prevention, 340B, monitoring FDA reform, changes and new programs. SAFE Drugs Act (HR6509/S3794).
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 & COMPANY · lobbying firm or registrant: WILLIAMS AND JENSEN, PLLC
2026 Q2 report (Apr 1, 2026 – Jun 30, 2026) · posted Jul 20, 2026 · issue area: Health Issues
$50,000
Paid to lobbying firm
340B Drug Pricing program, pharmaceutical supply chain, drug compounding and counterfeiting issues, PBM reform policies. SAFE Drugs Act (HR6509/S3794).
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
…es 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
ALLIANCE FOR SAFE ONLINE PHARMACIES (ASOP GLOBAL) · lobbying firm or registrant: FAEGRE DRINKER BIDDLE & REATH LLP
2026 Q2 report (Apr 1, 2026 – Jun 30, 2026) · posted Jul 20, 2026 · issue area: Health Issues
$60,000
Paid to lobbying firm
…n on patient safety; Domain name system accountability; Social media and online marketplace platform accountability; FDA Destruction Authority; SAFE Drugs Act (H.R. 6509, S. 3794).
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 SAFE ONLINE PHARMACIES (ASOP GLOBAL) · lobbying firm or registrant: FAEGRE DRINKER BIDDLE & REATH LLP
2026 Q2 report (Apr 1, 2026 – Jun 30, 2026) · posted Jul 20, 2026 · issue area: Pharmacy
$60,000
Paid to lobbying firm
…n on patient safety; Domain name system accountability; Social media and online marketplace platform accountability; FDA Destruction Authority; SAFE Drugs Act (H.R. 6509, S. 3794).
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 SAFE ONLINE PHARMACIES (ASOP GLOBAL) · lobbying firm or registrant: FAEGRE DRINKER BIDDLE & REATH LLP
2026 Q2 report (Apr 1, 2026 – Jun 30, 2026) · posted Jul 20, 2026 · issue area: Telecommunications
$60,000
Paid to lobbying firm
…n on patient safety; Domain name system accountability; Social media and online marketplace platform accountability; FDA Destruction Authority; SAFE Drugs Act (H.R. 6509, S. 3794).
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 SAFE ONLINE PHARMACIES (ASOP GLOBAL) · lobbying firm or registrant: FAEGRE DRINKER BIDDLE & REATH LLP
2026 Q2 report (Apr 1, 2026 – Jun 30, 2026) · posted Jul 20, 2026 · issue area: Consumer Issues/Safety/Products
$60,000
Paid to lobbying firm
…n on patient safety; Domain name system accountability; Social media and online marketplace platform accountability; FDA Destruction Authority; SAFE Drugs Act (H.R. 6509, S. 3794).
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
TIBER CREEK HEALTH STRATEGIES, INC. (ON BEHALF OF ELI LILLY AND COMPANY) · lobbying firm or registrant: TIBER CREEK GROUP
2026 Q2 report (Apr 1, 2026 – Jun 30, 2026) · posted Jul 19, 2026 · issue area: Health Issues
$80,000
Paid to lobbying firm
…g pricing; Issues related to reimbursement of insulin products; Issues related to the One Big Beautiful Bill Act (PL 119-21); Issues related to compounding and H.R. 6509 - Safeguarding Americans from Fraudulent and Experimental (SAFE) Drugs Act of 2025.
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
…es 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