Protect Access to
Compounded GLP-1
Medications
The FDA has proposed excluding semaglutide, tirzepatide, and liraglutide from the 503B compounding bulks list — a move that would end access to affordable, compounded GLP-1 medications for millions of Americans. Physicians and patients have until June 30, 2026 to submit public comments.
The FDA Wants to End Large-Scale Compounding of GLP-1 Drugs
On April 30, 2026, the FDA proposed to exclude semaglutide (Ozempic/Wegovy), tirzepatide (Mounjaro/Zepbound), and liraglutide (Victoza/Saxenda) from the 503B Bulks List. This list determines which drugs can be compounded in large quantities by outsourcing facilities.
The FDA's stated rationale is that these drugs are no longer in shortage. However, this ignores the critical role that compounding pharmacies play in providing affordable, accessible, and customized doses to patients who cannot afford or tolerate brand-name formulations.
If this proposal is finalized, millions of patients who rely on compounded GLP-1 medications for obesity, type 2 diabetes, and cardiovascular disease management could lose access to affordable treatment.
Affordability Crisis
Brand-name GLP-1 medications cost $900–$1,400/month. Compounded versions are often 80–90% less expensive, making them accessible to patients without insurance coverage.
Customization Eliminated
Compounding pharmacies provide customized doses and formulations for patients with specific medical needs that commercial products cannot address.
Proven Safety Record
503B outsourcing facilities operate under strict FDA oversight and Current Good Manufacturing Practice (CGMP) standards, with an established safety record.
Your Comment Matters
The FDA is legally required to consider all public comments. A well-reasoned comment from a physician or patient carries significant weight in the regulatory process.
How Would You Like to Take Action?
We've prepared tailored letter templates for both physicians and patients. Select your role to get started with a personalized FDA public comment and congressional outreach.
For Physicians
Share your clinical experience with GLP-1 medications, document patient outcomes, and advocate for continued access to compounded formulations. Your medical expertise carries particular weight with the FDA.
- Pre-filled FDA public comment template
- Personalize with your clinical experience
- One-click copy to Regulations.gov
- Contact your senators & representatives
For Patients
Share your personal experience with compounded GLP-1 medications, the health benefits you've seen, and why continued access is essential for you and others in your community.
- Personal story FDA comment template
- Add your own health journey details
- One-click copy to Regulations.gov
- Find and email your representatives
Contact Your Representatives
Enter your ZIP code to find your senators and representative, and send them a pre-written email about protecting GLP-1 access.
Three Steps to Make Your Voice Heard
Choose Your Template
Select whether you're a physician or patient. We'll provide a tailored letter template based on your role, pre-filled with the key arguments and regulatory details.
Personalize Your Letter
Add your name, credentials, and personal experience. The most effective comments include specific details about patient outcomes or your own health journey.
Submit & Contact Congress
Copy your letter and submit it to the FDA docket on Regulations.gov. Then enter your ZIP code to contact your senators and representative with a separate template.
The Case for Compounded GLP-1 Medications
Average cost of brand-name GLP-1 medications without insurance
FDA-regulated outsourcing facilities with CGMP standards and federal oversight
2026 deadline to submit public comments to FDA docket FDA-2018-N-3240-0377
Semaglutide, tirzepatide, and liraglutide proposed for exclusion from 503B list