If the SAFE Drugs Act of 2025 makes you nervous, you should ask yourself why.
Earlier this year, the Center for Medicine in the Public Interest (CMPI) published a report warning that large-scale, copycat drug compounding—particularly involving high-demand medicines like GLP-1s—had drifted far from its lawful, patient-centric roots and into something far more dangerous: a loosely regulated shadow market operating at industrial scale, often with little regard for patient safety or FDA rules.
Representatives Rudy Yakym and André Carson’s SAFE Drugs Act of 2025 is a direct response to those concerns. And despite the predictable outcry from some compounders, the facts are simple: this legislation doesn’t threaten legitimate pharmacy practice. It only threatens lawbreakers.
Compounding has an important, long-standing role in American medicine. When a patient cannot tolerate an FDA-approved drug because of an allergy to an inactive ingredient or needs a patient-specific IV drip that’s not commercially available while in the hospital, pharmacists can step in to meet that narrow, individualized need. That’s what compounding was designed to do.
But it was never meant to be a way for companies looking to cash-in on demand for innovative new drugs to mass-produce unapproved knockoffs without doing the hard, expensive work of obtaining FDA approval.
Yet today, that is exactly what’s happening.
The U.S. market is flooded with compounded products aggressively marketed online and on social media: topicals and sprays for hair-loss, erectile dysfunction gummies, hormone cocktails, even controlled substances like compounded ketamine—supposedly for anxiety or depression but seemingly available to anyone who pays. And, of course, so-called ‘personalized’ GLP-1s. These products are almost always compounded, meaning they have never been reviewed or approved by FDA for safety or effectiveness. The FDA itself has been clear: compounded drugs pose a higher risk to patients than FDA-approved medicines.
For consumers, the danger is not theoretical. They often have no idea what they’re actually putting into their body as “medicine.”
Nowhere is this more alarming than with compounded GLP-1 knockoffs. Publicly available customs and import data show that over the past fiscal year, FDA failed to intercept more than a hundred shipments of semaglutide and tirzepatide from illicit, unregistered foreign manufacturers. Those were disclosed shipments—that’s just what’s hiding in plain sight. Many more shipments are fraudulent smuggled into the country, often by Chinese entities with no business sending anything here. Indeed, a Brookings Institution analysis found that nearly half of all imported semaglutide over an 18-month period came from just three Chinese suppliers—each previously cited by FDA for failing to meet U.S. safety standards.
The SAFE Drugs Act addresses these risks head-on by taking aim at one of the industry’s most cynical tactics: fake personalization. Adding vitamin B12 or slightly tweaking a dose without any clinical justification doesn’t magically transform a mass-produced copy into a patient-specific therapy. It’s a regulatory dodge that compounders use to mass produce unapproved drugs—nothing more.
Yakym and Carson’s bill restores common sense by requiring compounders to demonstrate that a modification is clinically meaningful and tied to a real patient need. That’s not anti-compounding. That’s pro-patient.
In addition, by requiring initial and biannual reinspection of large-scale compounding facilities, the bill strengthens FDA’s ability to identify unsafe practices before patients are harmed.
Critics claim that “reputable” compounders don’t use unregistered ingredients or cut corners. But FDA warning letters, state enforcement actions, and repeated large-scale recalls tell a very different story—one involving sterility failures, contaminated products, and facilities that repeatedly fail inspections while continuing to operate.
If you’re doing everything right, inspections aren’t scary. If you’re a shadow drugmaker flouting the law, inspections are terrifying. Again, none of this is anti-compounding; it’s pro-patient.
Let’s be clear about what this debate is—and isn’t—about. The SAFE Drugs Act does not eliminate compounding. It does not punish pharmacists acting in good faith. It does not restrict access to legitimate therapies.
What it does do is close loopholes that bad actors have exploited to sell unapproved drugs at scale, often using overseas ingredients of questionable quality, while advertising them as safe, effective alternatives to FDA-approved medicines.
If your business model depends on avoiding inspections, obscuring ingredient sources, and pretending mass production is “personalization,” then yes—the SAFE Drugs Act should worry you.
For everyone else, it should be a relief.
Patients deserve medicines that are manufactured transparently, regulated rigorously, and held to clear safety standards. Congress has an obligation to uphold the integrity of the drug supply and the FDA’s gold-standard approval system.
The SAFE Drugs Act of 2025 is an important step toward doing exactly that.
Peter J. Pitts, a former FDA Associate Commissioner, is President of the Center for Medicine in the Public Interest and a Visiting Professor at the University of Paris School of Medicine.
