Current status (as of July 2026): H.R. 6509 was referred to the House Committee on Energy and Commerce on December 9, 2025, and remains in committee. It has not received a hearing, a markup, or a floor vote, and it has not become law. Its latest recorded action reads, verbatim: "Referred to the House Committee on Energy and Commerce."

H.R. 6509, the SAFE Drugs Act of 2025 — formally the Safeguarding Americans from Fraudulent and Experimental Drugs Act of 2025 — is a House bill that would increase federal oversight of drug compounding and place new statutory limits on compounded drugs that are "essentially a copy" of commercially available, FDA-approved products. It was introduced by Rep. Rudy Yakym (R-IN-2) on December 9, 2025, and referred to the House Committee on Energy and Commerce. This page tracks where the bill stands; when LegislationPatch publishes a full section-by-section analysis of H.R. 6509, it will be linked here.

Where H.R. 6509 Stands

The bill is at the earliest legislative stage: referral to committee. In the House, most bills are referred to a committee of jurisdiction, and the large majority never advance beyond that point. H.R. 6509 was assigned to the House Committee on Energy and Commerce, which handles most federal health and drug legislation. As of this update it has 18 cosponsors — 14 Republicans and 4 Democrats.

For a bill at this stage to move, the committee would generally need to hold a hearing, mark the bill up (amend and vote on it), and report it before it could be scheduled for a floor vote. None of those steps had occurred as of July 2026. For more on why most bills stop here, see our explainer on what a congressional committee is and why bills die there.

What the Bill Would Change

Drug compounding is the practice of combining, mixing, or altering ingredients to create a medication tailored to an individual patient. Under current law, compounded drugs generally do not require FDA approval, subject to certain conditions, and additional limits apply specifically to compounding drugs that are "essentially a copy" of a commercially available product. According to the bill's official summary, H.R. 6509 would make several changes to that framework:

  • Redefine "essentially a copy." Under the bill, a compounded drug would be treated as essentially a copy of a commercially available product if it contains any active ingredient found in that product and there is no change made for an individual patient that produces a significant difference between the two. The summary notes that the FDA's current definition also addresses dosage strength and route of administration.
  • Raise the monthly threshold to 20. The bill would set the frequency at which a licensed pharmacist or physician may compound a drug that is essentially a copy at 20 times per month. The summary states that current FDA policy allows four such prescriptions per month.
  • Add reporting requirements. Physicians, facilities, and pharmacies (other than hospital-based pharmacies) that compound certain drug products for out-of-state patients more than 20 times per month would face annual reporting requirements.
  • Increase oversight of large outsourcing facilities. Certain large-scale outsourcing facilities — FDA-registered facilities that compound in bulk — would be subject to regular inspection and reporting requirements.

What Happens Next

Because the bill sits in committee, the next procedural step would be action by the House Committee on Energy and Commerce — a subcommittee or full-committee hearing, followed by a markup. If the committee reported the bill, it could then be scheduled for House floor consideration, after which it would need to pass the House, pass the Senate, and be signed by the President to become law. See how a bill becomes law for the full path.

Who Supports the SAFE Drugs Act, Who Opposes It, and Why

H.R. 6509 is at the committee-referral stage with no recorded vote, but named organizations have already lined up on both sides, so the debate is on the record even though no vote has tested it.

Why do supporters back the bill?

The bill was introduced on a bipartisan basis by Rep. Rudy Yakym (R-IN-2) and Rep. Andre Carson (D-IN-7), who argue it would protect patients from untested, mass-produced compounded drugs marketed as copies of FDA-approved products. The Alliance for Safe Biologic Medicines has voiced support for the SAFE Drugs Act and its Senate companion, and patient-advocacy groups including the American Diabetes Association have argued that the wide availability of compounded GLP-1 and dual GIP/GLP-1 medications used for diabetes and obesity raises safety concerns. Supporters contend that large-scale compounding of near-copies of approved drugs operates with less oversight than manufactured drugs, and that the bill would narrow that gap.

Why do opponents object?

Compounding-sector organizations — including the Alliance for Pharmacy Compounding (APC) and the National Community Pharmacists Association (NCPA) — have urged Congress to oppose the bill, arguing it would restrict lawful compounding that patients rely on. They argue the bill's cap of 20 per month on compounding a drug that is "essentially a copy" would limit 503A pharmacies even when a needed drug is on the FDA shortage list, and that the new reporting requirements on out-of-state prescriptions would burden small pharmacies. As an alternative, the APC has asked lawmakers to back a separate measure it favors, the Drug Shortage Compounding Patient Access Act. Because the bill sits in committee, neither side's case has been tested in a vote.

Primary Sources