Current status (as of August 2026): H.R. 6509 was referred to the House Committee on Energy and Commerce on December 9, 2025, and remains there. Its action record shows no hearing, no markup, no committee report and no floor vote, and it has not become law. Its latest recorded action reads, verbatim: "Referred to the House Committee on Energy and Commerce." The related Senate bill has moved instead: the Senate Committee on Health, Education, Labor, and Pensions ordered S. 3794 reported with a substitute on July 22, 2026, and that bill has been on the Senate Legislative Calendar since July 27, 2026.

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 a commercially available drug product. 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. LegislationPatch's full section-by-section analysis of the bill is at H.R. 6509: plain-English summary.

Where H.R. 6509 Stands

The bill is at the earliest legislative stage: referral to committee. H.R. 6509 was assigned to the House Committee on Energy and Commerce, whose jurisdiction under House Rule X covers "Health and health facilities" and "Public health and quarantine," and the referral is the only committee activity Congress.gov records for it. As of this update it has 19 cosponsors — 14 Republicans and 5 Democrats. One of them, Rep. Andre Carson (D-IN-7), is an original cosponsor who joined on the day of introduction.

The steps that would put the bill on the House floor — a hearing, a markup, and a committee report — do not appear in its record as of August 2026. For how committee referral works, see our explainer on what a congressional committee is and why bills die there.

The related Senate bill has gone further. S. 3794, the SAFE Drugs Act of 2026, was introduced by Sen. Jim Banks (R-IN) on February 5, 2026 and referred to the Senate Committee on Health, Education, Labor, and Pensions. That committee ordered it reported favorably with an amendment in the nature of a substitute on July 22, 2026; it was reported by Sen. Cassidy without a written report on July 27, 2026 and placed on the Senate Legislative Calendar under General Orders as Calendar No. 524. Congress.gov lists S. 3794 as the only bill related to H.R. 6509. The substitute text as reported is published; this page describes H.R. 6509 as introduced, the only text version the House bill has.

What the Bill Would Change

Compounded drugs are, in the words of the bill's official summary, "drugs that are mixed or altered to meet patient needs." Under current law, compounded drugs generally do not require FDA approval, subject to certain requirements, and additional limits apply to the compounding of drugs that are essentially copies of commercially available drug products. The limit in force today is written as a standard rather than a number: 21 U.S.C. 353a(b)(1)(D) requires that a pharmacist or physician "does not compound regularly or in inordinate amounts (as defined by the Secretary) any drug products that are essentially copies of a commercially available drug product." According to the bill's official summary, H.R. 6509 would make several changes to that framework:

  • Redefine "essentially a copy." Current law states the term negatively: it "does not include a drug product in which there is a change, made for an identified individual patient, which produces for that patient a significant difference, as determined by the prescribing practitioner." The bill turns that carve-out into an affirmative two-part test — a compounded drug is essentially a copy if it contains any active ingredient found in a commercially available drug product and there is no such change producing a significant difference. The prescribing practitioner keeps that judgment; the bill does not change who makes it. The summary says the FDA's current definition of the term also addresses dosage strength and route of administration.
  • Replace the "inordinate amounts" standard with a number: 20 per month. The bill sets the frequency at which a licensed pharmacist or physician may compound a drug that is essentially a copy at 20 times in a single 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. The bill text defines a large-scale outsourcing facility as one that compounds any drug product more than 100 times in a single calendar year, and would require an inspection before such a facility compounds a product for the first time and a reinspection at least every two years.

Four further changes are in the bill text but not in the official summary. Section 2 adds a definition of "commercially available drug product" — a product "sold in the commercial marketplace in the United States", manufactured at a facility required to comply with section 501(a)(2)(B), and not in the discontinued section of the list at section 505(j)(7)(A) — a term current law leaves undefined. Section 4(b) strips outsourcing facilities of a registration exemption in 21 U.S.C. 360(g)(1). Section 4(c) delays both Section 4 amendments until "6 months after the date of enactment of this Act". And Section 5 would strike the $15,000 base establishment fee set by 21 U.S.C. 379j-62(c)(1)(A)(i), replacing that figure with "a base amount deemed appropriate by the Secretary to fund activities to ensure the safety of compounded drug products."

What Happens Next

Because H.R. 6509 sits in committee, the next procedural step for it 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. But Congress.gov lists one related bill, S. 3794, and that one is already past its committee and on the Senate calendar — so the House bill's own action record is not the only place to watch.

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

H.R. 6509 has no recorded vote, but named organizations have published positions for and against the SAFE Drugs Act, 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). Their joint announcement says the bill would protect patients from "untested, unapproved, and potentially dangerous mass compounded drugs," and that it codifies the definition of "essentially a copy" so as "to prevent illegal mass compounding of unapproved versions of FDA-approved drugs."

The same announcement carries a statement from Rita Kalyani, chief scientific and medical officer with the American Diabetes Association, who says "While compounded medications play a critical role in our health care system, concerns have emerged regarding the widespread availability and promotion of non-FDA approved compounded GLP-1 and dual GIP/GLP-1 RA medication classes to treat obesity directly to patients," and that "Additional FDA oversight is needed regarding these compounding practices for these medication classes and entities manufacturing them to protect patients with diabetes and obesity."

The Alliance for Safe Biologic Medicines (ASBM) supports the Senate bill and, in its own words, "the bipartisan companion bill (H.R. 6509)." ASBM argues that "recent years have seen the expansion of large-scale production and interstate distribution of compounded drugs that closely replicate commercially available, FDA-approved products, but often do so without the rigorous FDA review and inspection standards that safeguard public health," and says it supports "reforms that preserve access to legitimate, patient-specific compounding while closing loopholes that allow the mass production of unapproved drugs outside the FDA approval framework."

Why do opponents object?

The Alliance for Pharmacy Compounding (APC) has campaigned against the bill. In a post dated July 10, 2026 it called an emergency town-hall briefing for members, asked member pharmacies to submit shortage-compounding data through its survey portal, and told them to expect instructions for messaging the Senate HELP Committee — because, it wrote, "We need Senate HELP Committee members to hear clearly that gutting shortage drug compounding will not make patients safer — it will leave them with fewer options when commercial drugs are in shortage."

APC says that if the bill passes, "state-licensed pharmacies would be severely restricted in preparing compounded medications for patients," and that the restriction would bite even for drugs the FDA lists as being in shortage. It puts the practical effect at "a limit of 20 prescriptions per pharmacy per month for each drug in shortage."

APC argues the bill would do nothing to protect patients from fraudulent or experimental drugs and would, "by design, cripple legitimate pharmacies and outsourcing facilities that serve critical patient needs." It illustrates the point with a sick child who needs a "pediatric amoxycillin suspension" while that drug is in shortage and who is "patient number 21."

Primary Sources

Drafted from primary source documents by LegislationPatch's automated research pipeline, then reviewed, verified, and edited by , Editor. Every figure and citation is checked against the official text before publication. See our editorial standards and AI disclosure.