Peter Pitts
RCHealth | January 16, 2026
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.