Bill · S. 3794· Senate(119-S-3794)
SAFE Drugs Act of 2026
- Introduced
- 2/5/2026
- Last activity
- 7/27/2026 — Placed on Senate Legislative Calendar under General Orders. Calendar No. 524.
- Sponsored by
- Jim Banks
- Cosponsors
- - 0 - 1
- Introduced
- On Calendar
What this bill would do
This bill, known as the "SAFE Drugs Act of 2026," aims to amend the Federal Food, Drug, and Cosmetic Act to increase regulations on compounding pharmacies and outsourcing facilities. It introduces stricter definitions for drug products that are considered essentially copies of commercially available medications. The legislation implements new reporting requirements for pharmacists and physicians regarding serious adverse events and interstate drug shipments. It also mandates more frequent inspections for large-scale outsourcing facilities. Additionally, the bill requires specific labeling on compounded drug products to inform patients about FDA approval status and how to report adverse events.
Yes
Does this give the federal government more power?+4
The bill expands the Secretary's authority over drug establishment fees and inspection requirements for large-scale facilities.
Does this make what the government does easier for the public to see?+3
The bill implements new reporting requirements for adverse events and interstate drug shipments to increase oversight.
Does this make the government pay for what it commits to?+1
The bill allows the Secretary to set a base establishment fee deemed appropriate to fund safety activities.
The opposite
Does this make it easier to run a small business?-3
The bill imposes new reporting requirements and potential fee increases on pharmacists and compounding facilities.
Does this make health care easier to get in general?-2
The restrictions on compounding drug products that are essentially copies of commercial drugs may limit availability for certain patients.
Who it would affect, and how
Potential Positive Impacts for People
-
Increased Safety Oversight: Large-scale outsourcing facilities (those compounding more than 100 times in a calendar year) will undergo an inspection before compounding any drug product for the first time and a reinspection at least every two years (Section 4).
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Improved Adverse Event Tracking: Licensed pharmacists and physicians must report serious adverse events associated with compounded drugs to the Secretary, the State where compounding occurs, and each State to which the drugs are sent (Section 2).
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Enhanced Patient Information: Drug labels must now include a statement that the medication was compounded for an individual patient and has not been approved by the FDA, along with information to facilitate reporting adverse events (Section 3).
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Better Transparency for Interstate Sales: Pharmacists and physicians who send more than 5 percent of their total annual compounded products out of state must submit annual reports detailing the types and quantities of products sent (Section 2).
Potential Negative Impacts for People
-
Increased Regulatory Burdens for Practitioners: Licensed pharmacists and physicians are subject to new, specific reporting requirements for serious adverse events and interstate drug shipments (Section 2).
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Potential Cost Increases: The base establishment fee is changed from a set $15,000 to an amount deemed appropriate by the Secretary to fund safety activities (Section 5).
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New Restrictions on Compounding: Pharmacies are prohibited from compounding a drug product that is essentially a copy of a commercially available drug product more than 20 times in a single month (Section 2).
Groups and Interests Ranking
Every group the model scored this bill for, from -10 to +10. Hover a score for the reason it gave.
- Governance And Ideology
- Increases Federal Power+4Improves Government Transparency+3
- Economy And Finance
- Improves Fiscal Responsibility+1Improves Small Business Support-3
- Healthcare
- Improves Healthcare Access-2
- 7/27/2026
- Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.
- Placed on Senate Legislative Calendar under General Orders. Calendar No. 524.
- 7/22/2026
- Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
- 2/5/2026
- Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- 1 Cosponsor added.
- Introduced in Senate
One bill Congress.gov lists as related to this one — companions in the other chamber, earlier versions, and bills this one absorbed or was folded into.
Martin HeinrichDemocrat · New Mexico