Legis Daily

SAFE Drugs Act of 2026

USA119th CongressS-3794| Senate 
| Updated: 7/27/2026
Jim Banks

Jim Banks

Republican Senator

Indiana

Cosponsors (1)
Martin Heinrich (Democratic)

Health, Education, Labor, and Pensions Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
The "Safeguarding Americans from Fraudulent and Experimental Drugs Act of 2026" aims to enhance the regulation of drug compounding to improve patient safety. It amends the Federal Food, Drug, and Cosmetic Act by placing new restrictions on compounding pharmacies. Specifically, the bill limits pharmacies to compounding a drug product that is "essentially a copy of a commercially available drug product" no more than 20 times in a single month. It also introduces a new reporting requirement for pharmacies, facilities, or physicians that compound such drug products more than 20 times monthly for out-of-state patients, requiring them to identify the drug types and compounding frequency to the Secretary. Furthermore, the legislation increases oversight for outsourcing facilities , particularly those deemed "large-scale" for compounding over 100 times annually. These facilities will now require an inspection prior to their first compounding activity and subsequent biennial reinspections. The bill also removes the general registration exemption for all outsourcing facilities and allows the Secretary to determine an appropriate base establishment fee to fund activities ensuring the safety of compounded drug products.

Bill Text Versions

View Text
2 versions available

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Timeline

Bill from Previous Congress

S 116-4492
Safe Drugs Act
Dec 9, 2025

Latest Companion Bill Action

HR 119-6509
Introduced in House
Feb 5, 2026
Introduced in Senate
Feb 5, 2026
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Jul 22, 2026
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
Jul 27, 2026
Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.
Jul 27, 2026
Placed on Senate Legislative Calendar under General Orders. Calendar No. 524.
  • Bill from Previous Congress

    S 116-4492
    Safe Drugs Act


  • December 9, 2025

    Latest Companion Bill Action

    HR 119-6509
    Introduced in House


  • February 5, 2026
    Introduced in Senate


  • February 5, 2026
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.


  • July 22, 2026
    Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.


  • July 27, 2026
    Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.


  • July 27, 2026
    Placed on Senate Legislative Calendar under General Orders. Calendar No. 524.

Health

Related Bills

  • HR 119-6509: SAFE Drugs Act of 2025
Administrative law and regulatory proceduresDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationFood and Drug Administration (FDA)Government information and archivesHealth personnelLicensing and registrationsUser charges and fees

SAFE Drugs Act of 2026

USA119th CongressS-3794| Senate 
| Updated: 7/27/2026
The "Safeguarding Americans from Fraudulent and Experimental Drugs Act of 2026" aims to enhance the regulation of drug compounding to improve patient safety. It amends the Federal Food, Drug, and Cosmetic Act by placing new restrictions on compounding pharmacies. Specifically, the bill limits pharmacies to compounding a drug product that is "essentially a copy of a commercially available drug product" no more than 20 times in a single month. It also introduces a new reporting requirement for pharmacies, facilities, or physicians that compound such drug products more than 20 times monthly for out-of-state patients, requiring them to identify the drug types and compounding frequency to the Secretary. Furthermore, the legislation increases oversight for outsourcing facilities , particularly those deemed "large-scale" for compounding over 100 times annually. These facilities will now require an inspection prior to their first compounding activity and subsequent biennial reinspections. The bill also removes the general registration exemption for all outsourcing facilities and allows the Secretary to determine an appropriate base establishment fee to fund activities ensuring the safety of compounded drug products.

Bill Text Versions

View Text
2 versions available

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline

Bill from Previous Congress

S 116-4492
Safe Drugs Act
Dec 9, 2025

Latest Companion Bill Action

HR 119-6509
Introduced in House
Feb 5, 2026
Introduced in Senate
Feb 5, 2026
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Jul 22, 2026
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
Jul 27, 2026
Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.
Jul 27, 2026
Placed on Senate Legislative Calendar under General Orders. Calendar No. 524.
  • Bill from Previous Congress

    S 116-4492
    Safe Drugs Act


  • December 9, 2025

    Latest Companion Bill Action

    HR 119-6509
    Introduced in House


  • February 5, 2026
    Introduced in Senate


  • February 5, 2026
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.


  • July 22, 2026
    Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.


  • July 27, 2026
    Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.


  • July 27, 2026
    Placed on Senate Legislative Calendar under General Orders. Calendar No. 524.
Jim Banks

Jim Banks

Republican Senator

Indiana

Cosponsors (1)
Martin Heinrich (Democratic)

Health, Education, Labor, and Pensions Committee

Health

Related Bills

  • HR 119-6509: SAFE Drugs Act of 2025
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Administrative law and regulatory proceduresDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationFood and Drug Administration (FDA)Government information and archivesHealth personnelLicensing and registrationsUser charges and fees