BREAKING: Congress Moves to Address GLP-1 + Drug Shortages!
- Dave Knapp
- Oct 8
- 3 min read
Original posted at obesity.news/ on Sep 15, 2025
Where it gets it right, and where it falls short
This morning brought a rare glimmer of hope in the ongoing fight to protect patients from drug shortages. A new bill, the Drug Shortage Compounding Patient Access Act of 2025 (H.R. 5316), was introduced by Representatives Diana Harshbarger (R-TN) and Buddy Carter (R-GA), the only two pharmacists in Congress. The Alliance for Pharmacy Compounding (APC), along with the American Pharmacists Association and the National Community Pharmacists Association, is advocating for and backing the measure.
WATCH THE VIDEO:
What the Legislation Would Do
If passed, H.R. 5316 would give both 503A pharmacies and 503B outsourcing facilities the regulatory clarity to step in when drugs are on the FDA shortage list. That means when shelves go empty, patients and providers have somewhere to turn.
Key provisions include:
Drug shortage mitigation: Authorizes 503A pharmacies to compound drugs for urgent use in hospitals or clinics, with certification and recordkeeping, plus a 60-day transition window when a drug comes off the shortage list.
Improved shortage reporting: Requires manufacturers to report anticipated disruptions and surges in demand, and directs FDA to consider data from hospitals, clinicians, and patients when updating the shortage list.
Stronger role for 503Bs: Mandates annual updates to the FDA’s bulk substances list, provides a 180-day transition period when shortages end, and eases outdated labeling restrictions.
Regulatory cleanup: Removes obsolete language from the Food, Drug, and Cosmetic Act and ensures compounded medications are clearly labeled.
As APC’s CEO Scott Brunner put it: “This legislation is common-sense reform. It ensures that when shortages happen, and they will, patients can count on compounding pharmacies and outsourcing facilities to be there with rapid solutions.”
Likelihood of Passage and Timeline
If the APC is able to pick up some Democrat co-sponsors to add to the republican sponsors of the bill, add support from additional major pharmacy associations, and maintain clear patient-access framing, this bill will have a decent chance of moving forward. But Congress doesn’t move fast. Realistically, the earliest we’d see progress is in committee hearings this fall, with any floor vote likely slipping into 2026 unless there’s strong public and industry pressure to act sooner. Contact your legislature today and let them know you’d like to see it supported. I’ve added a stock letter and links to find your rep below:
I am writing to urge you to support H.R. 5316, the Drug Shortage Compounding Patient Access Act of 2025. This bipartisan legislation takes meaningful steps to protect patients when critical medications are in shortage by empowering compounding pharmacies and outsourcing facilities to act quickly, while also improving manufacturer reporting requirements.
As a patient, I have personally struggled to access medications during shortages, and I know how devastating it can be to miss doses of a therapy that my health depends on. Drug shortages are not abstract policy — they are life-or-death realities for people living with obesity, diabetes, cancer, and many other conditions.
This bill is a common-sense measure that ensures patients are not left without access to the medications they rely on. I strongly encourage you to co-sponsor and support swift passage of H.R. 5316.
Where It Falls Short
I’ve been advocating for stronger measures for the last year, and while this bill is a win, it leaves out one core item we’ve advocated for: buffer stock requirements.
The legislation asks manufacturers to report anticipated shortages, but reporting alone doesn’t solve the problem. What patients need is proof that manufacturers are maintaining enough supply to withstand surges in demand. In our petition, we called for a six-month buffer stock, verified and publicly disclosed, so that shortages never spiral into the chaos we’ve all lived through with GLP-1s.
That remains a missing piece, in my humble opinion. Reporting is reactive. Buffer stock is proactive. Without it, we are still too dependent on a fragile supply chain, and the fierce tug of war between big pharma and little pharma.
Why I Support It
Even with its gaps, I support this legislation. It gives compounding pharmacies the certainty they need to step in during shortages, and it creates more accountability for manufacturers than we’ve seen before. It’s not everything we asked for, but it’s a start and it’s proof that the advocacy we’ve been pushing for over the past year is finally gaining traction, thanks in large part to APC’s work on the Hill.
👉 Share this with anyone who’s been affected by the GLP-1 shortages. The fight for buffer stock isn’t over, but for the first time, Congress is acknowledging the reality patients face when shelves go empty.
On The Pen relies your generosity to keep our
advocacy efforts going. Please consider
subscribing, only if you truly believe in what we’re doing.
Comments