This New Bill Could Effectively End Compounded GLP-1 Access for Hundreds of Thousands

Original posted at obesity.news/ on Dec 10, 2025

With the introduction of the Safeguarding Americans from Fraudulent and Experimental (SAFE) Drugs Act of 2025, Congress is revisiting the balance between pharmaceutical manufacturing and compounding. And to be fair, this balance is worth revisiting as the landscape has changed dramatically with the advent of GLP-1 medications. Patients deserve safe medication. They also deserve transparency about what they are taking. They deserve confidence that their prescription was made in a facility that meets basic standards. These goals matter.

But patients also deserve access. They deserve affordability. They deserve continuity of treatment in a healthcare system that routinely forces them to choose between what is ideal and what is possible. And if we are going to talk honestly about the SAFE Drugs Act of 2025, we have to hold both truths at once.

This bill arrives at a moment when demand for GLP-1 therapies has far outpaced the structure we built to support them. It arrives in a moment when patients are navigating insurance exclusions, denials, and price points that many in need simply cannot reach. It arrives in a moment when compounding became a bridge, not because patients wanted a workaround, but because that bridge was the literally the only path forward.

The stated goal of the SAFE Drugs Act attempts to address real safety concerns. But it’s real world impact will fall most heavily on the people who have the least margin for error.

What the bill actually does

The language leaves much open to interpretation, which is part of the issue.

It does limit 503A pharmacies to just 20 compounded prescriptions per month for any drug that

contains an active ingredient found in a commercially available product. It creates a reporting mechanism for those compounding more than 20. Currently, 503A are serving thousands. It severely tightens the definition of what counts as “essentially a copy,” which in my estimation, closes the door on many personalized versions, or at least leaves that open to a judge’s own interpretation. It places new reporting requirements on pharmacies dispensing out of state. It essentially creates a new category for large scale 503B facilities, placing them under more frequent inspections, inspections that they’ll essentially be required to pay for.

In a perfect world, none of this would feel controversial. Patients would be fully covered. Supply would always be steady. Branded GLP-1 drugs would be affordable to the average household. Safety and access would be the same path.

But we do not live in that world. It’s getting better. But we’re are not there yet.

The bill reads as if we are.

The safety goals are valid, but the reality is more complicated

There have been real concerns about variable quality among compounded products, mislabeled vials, dosing discrepancies, and contamination risks. Especially with 503A pharmacies, which lack federal oversight. Those concerns deserve attention. When a medication is injected vs swallowed, the consequences of error grow vastly more significant.

But safety and access are not, and do not need to be opposing forces. They rise and fall together.

When regulation restricts access without providing a clear alternative, patients are the ones who absorb the cost.

The result is more patients losing continuity and falling back into the very health struggles these medications were helping them escape.

Taking away a bridge without building a suitable replacement is not patient protection. It is patient abandonment.

Telehealth compounding could contract sharply, even though telehealth care itself has now been shown to be safe and effective

Many patients turned to telehealth because traditional access points failed them. Shortages, waitlists, insurance denials, rural barriers, and a lack of clinicians trained in obesity medicine pushed people toward virtual care that could meet them where they were.

Under the SAFE Drugs Act, any pharmacy filling more than 20 compounded GLP-1 prescriptions per month for patients who live out of state must submit detailed reports to federal regulators. That level of scrutiny could shrink these operations quickly, even when the underlying care is strong.

And now we have peer-reviewed data that shows how strong that data can be.

Today, Ro published a peer reviewed outcomes study in the journal Obesity, co authored with leading obesity clinicians, showing that patients treated with semaglutide through a telehealth platform achieved weight loss and safety outcomes that match what was seen in clinical trials. Over 68 weeks, patients lost an average of 16.6% of their body weight, with roughly 33% losing 20% or more. Women in the study lost an average of 18.1%, compared to 13.4% for men. Sex was the only factor significantly associated with greater weight loss.

Side effects were consistent with what was already known. No new safety signals were observed.

This reinforces a truth that often gets lost in policy debates. Telehealth is not the weak link. Telehealth is not a shortcut. Telehealth is not where the danger lies. In many cases, telehealth has been the only channel patients could rely on.

But the bill does not distinguish between responsible care and irresponsible care. It restricts access to compounded GLP-1s based solely on monthly volume. It closes channels while alternatives have not expanded enough to keep pace. And the people who will feel that contraction first are the ones who rely on telehealth because the offline system has not made room for them.

Patients deserve better than a choice between stability and affordability

Every patient currently using compounded GLP-1 medication is there for a specific reason. Maybe their insurance categorically excludes obesity treatment. Maybe their copay is more than their mortgage. Maybe the branded drug has been out of stock at their pharmacy for months. Maybe their provider cannot get them into a covered clinic for several weeks.

The SAFE Drugs Act does not appear to solve any of these barriers. Instead, it looks more like a christmas present for big pharma, wrapped in a patient safety bow.

It limits one pathway without opening another for the most vulnerable. That is not balance. If we want safety and consistency, we must also want affordability and access. Patients deserve all of it, not pieces of it.

A patient centric policy would include three commitments. A commitment to safety through strong oversight. A commitment to access through insurance reform and affordability measures. And a commitment to continuity so patients already stabilized on treatment are not forced into metabolic whiplash when policy changes.

The SAFE Drugs Act raises real safety questions. Those questions matter. But the answers cannot leave patients behind. They cannot assume access that does not exist. They cannot move faster than the system is able to support.

Safety matters. Access matters. Patients deserve both, and any policy that forgets that will fail the people who need these medications the most.

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