Legis Daily

SAFE Drugs Act of 2026

USA119th CongressS-3794| Senate 
| Updated: 2/5/2026
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.
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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.
  • 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.

Health

Related Bills

  • HR 119-6509: SAFE Drugs Act of 2025

SAFE Drugs Act of 2026

USA119th CongressS-3794| Senate 
| Updated: 2/5/2026
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.
View Full Text

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.
  • 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.
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