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HR 6509 - 119

SAFE Drugs Act of 2025

Referred to the House Committee on Energy and Commerce.

Bill highlights

Votes, text signals, source context, and latest movement from this record.

Bill Text Stats

11
Analyzed sections
$15,000
Detected dollar total
0
Tax signals
1
Deadlines

Signal counts

Tax density 0.0%
Spending density 9.1%
Statutory Reference 5
Amendments 3
Deadline 1
Spending 1

Top agencies

N/A

Statutory references

21 U.S.C. 353a 1
21 U.S.C. 353a 1
21 U.S.C. 353b 1
21 U.S.C. 360 1
21 U.S.C. 379j-62 1

House Votes

No House roll call votes have been linked to this bill yet.

Timeline

Dec 9, 2025

Introduced in House

Dec 9, 2025

Introduced in House

Dec 9, 2025

Referred to the House Committee on Energy and Commerce.

Affected Sectors

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Healthcare
12 evidence matches
Impact 100% Confidence 90%

Health

Health

SAFE Drugs Act of 2025 Referred to the House Committee on Energy and Commerce. Health

Energy
2 evidence matches
Impact 94% Confidence 85%

Energy and Commerce Committee Standing House

SAFE Drugs Act of 2025 Referred to the House Committee on Energy and Commerce. Health

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Summary

00 Introduced in House Jun 16, 2026

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.

Sponsors

Yakym, Rudy
Sponsor

Yakym, Rudy

Republican · IN-2 · Y000067

Joined Dec 9, 2025
Website
N/A
Office
349 Cannon House Office Building
Kelly, Mike
Cosponsor

Kelly, Mike

Republican · PA-16 · K000376

Joined Mar 18, 2026
Website
N/A
Office
1707 Longworth House Office Building
Houchin, Erin
Cosponsor

Houchin, Erin

Republican · IN-9 · H001093

Joined Apr 15, 2026
Website
N/A
Office
342 Cannon House Office Building

Amendments

No amendment records are currently available for this bill.
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