YourVoice.Now Summary
Transparency & AccountabilityCompounding pharmacies shipping across state lines would report serious side effects, and labels must say the drug isn't FDA-approved.
Transparency & Accountability
- Reporting requirements — Serious adverse events must go to the FDA and to every state a drug was shipped to
- Reporting requirements — Annual interstate volume report required above a 5 percent out-of-state threshold
- Labeling disclosure — Labels must state the drug is compounded and not FDA-approved
- Labeling disclosure — Labels must carry the MedWatch website and phone line for reporting problems
- State reporting authority — Expressly preserved, so states may require more than federal law
The details
Pharmacies that mix custom drugs and ship them across state lines would face new reporting duties. Compounded drugs are made to order for a specific patient and are not reviewed or approved by the FDA. Under the bill, a pharmacist or physician who compounds and sends drugs out of state must pass along any serious side-effect report they receive. It goes to the FDA, to their own state, and to every state the drug was shipped to. A second report covers volume. Anyone sending more than 5 percent of their yearly compounded output out of state files an annual report each January 15. It lists their name, license number, and how many units of each product went to each state. Hospital pharmacies compounding for their own patients are exempt, and states remain free to require more. Labels would also change. Every compounded drug would have to carry a statement that it was compounded for one patient and is not FDA-approved, along with the MedWatch website and phone number for reporting problems. The reported version is much narrower than the bill as introduced. The committee dropped a cap on how often a pharmacy could copy a commercially available drug, mandatory inspections of large-scale outsourcing facilities, and a change to the FDA establishment fee.
Congressional Summary
Safeguarding Americans from Fraudulent and Experimental Drugs Act of 2026 or the SAFE Drugs Act of 2026This 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.
Details
- Congress
- 119th
- Chamber
- Senate
- Status
- summarized
- Action
- Introduced in Senate
- Action Date
- 2026-02-05
- Date Added
- 2026-06-30
- Source
- Congress.gov →
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