- On April 30, 2026, the U.S. FDA announced it is considering removing GLP-1 medications from the 503B bulks list.
- FDA’s 503B bulks list identifies drug substances that outsourcing facilities can use to compound medications.
- Experts agree removing GLP-1s from the 503B bulks list will significantly lower the availability of compounded GLP-1s drugs.
- Patients may still be able to receive compounded GLP-1s through 503A compounding pharmacies, and consider legitimate alternatives for weight loss.
According to the FDA’s announcement, the organization is asking for submitted comments for or against this decision by the end of June 2026 before making their final determination.
Medical News Today spoke with 4 obesity experts to find out more about what the FDA’s 503B bulks list is, the potential future availability of compounded GLP-1 medications, and what alternatives may be available for users who may not be able to afford the brand name drugs.
According to Douglas Ewing, MD, FACS, DABOM, a board-certified bariatric surgeon and medical director of the Center for Weight Loss and Metabolic Health at Hackensack University Medical Center, and associate professor of surgery at Hackensack Meridian School of Medicine in New Jersey, the FDA’s 503B bulks list identifies bulk drug substances that outsourcing facilities can use to compound medications.
“These outsourcing facilities, regulated under section 503B of the Federal Food, Drug, and Cosmetic Act, can produce larger batches of compounded drugs than traditional
“The critical difference between a drug on the 503B list and an FDA-approved medication is the level of scrutiny,” he continued.
“FDA-approved drugs undergo a long and rigorous process of clinical trials to prove their safety, effectiveness, and quality before they can be marketed to the public.”
“Compounded drugs, even from 503B facilities, do not go through this same pre-market approval process. While 503B facilities are required to follow current Good Manufacturing Practices (cGMP), the compounded drugs themselves are not FDA-approved.”
If semaglutide and tirzepatide are removed from the 503B bulks list, the availability of compounded GLP-1s would drop significantly, Michael Snyder, MD, FACS, FASMBS, DABOM, medical director of the Bariatric Surgery Center at Rose Medical Center, founder and director of the Denver Center for Bariatric Surgery Foundation, and in-house obesity specialist at FuturHealth, told MNT.
“Most current compounded supply is produced through 503B outsourcing facilities, which would no longer be able to compound them in bulk,” Snyder said.
“There may still be limited use under 503A compounding rules, where a medication is prepared for an individual patient based on a specific clinical indication, but that pathway is much more restricted and not designed for widespread use.”
Jen Manne-Goehler, MD, ScD,assistant professor of medicine at Harvard Medical School, agreed.
“There may be some forms of compounded GLP-1 drugs still available despite this decision,” Manne-Goehler told MNT.
”Specifically, the FDA’s decision not to include these GLP-1s on the bulk compounding list would not be expected to affect their use by 503A pharmacies. 503A compounding pharmacies compound according to specific patient prescriptions and are required by state boards of pharmacy to comply with standards.”
Because of the popularity and high demand of GLP-1 medications, Mir Ali, MD, bariatric surgeon and medical director of MemorialCare Surgical Weight Loss Center at Orange Coast Medical Center in Fountain Valley, CA, worried this may drive some people to purchase their medication through a potentially unsafe option.
“What I think will happen is people will try to get the medications from other sources outside the U.S., and that is a little riskier,” Ali told MNT.
“You could not be getting the medication you are buying, you may be getting something different or something maybe even unsafe. So it may increase some risk if people are going to go to sources outside of the U.S. to try to get these medications.”
When asked about the safety of compounded GLP-1 drugs, Ewing said that is a complex question without a simple “yes” or “no” answer. “The safety of compounded GLP-1s can vary significantly depending on the source,” he explained.
“There are legitimate compounding pharmacies that adhere to high-quality standards. However, the lack of FDA approval and oversight for the final compounded products introduces inherent risks.”
– Douglas Ewing, MD, FACS, DABOM
“Concerns have been raised about the potential for contamination, impurities, and incorrect dosages in some compounded products,” Ewing continued.
“There have also been instances of pharmacies using different salt forms of semaglutide, which have not been approved by the FDA and whose safety and efficacy are unknown.”
Manne-Goehler said that many reports have suggested that the current compounded GLP-1s have a higher number of severe side effects.
“For instance,
“This may be because lower quality compounding practices can result in issues with drug quality, contamination or differences in the amount of active ingredient. Several medical societies have recommended against the use of compounded GLP-1 therapies.”
If compounded GLP-1s become less available, Snyder said there are still legitimate, evidence-based options for weight loss.
“That includes other FDA-approved medications for weight management, as well as structured
“We also expect that over time these medications will become more affordable and coverage should expand over time. But, clearly, not soon.”
Ali said there are other medications available that are maybe available in generic form because they have been around longer, but they do not work quite the same, or maybe not even quite as well as the GLP-1 medications.
“So there are other options available, but they may be less effective,” he added.
For those who may be worried about affording the name-brand GLP-1 medications, Ewing said it is always worthwhile to check with your insurance provider about their coverage for weight-loss medications, as formularies can change, and what was not covered before might be now.
“Many pharmaceutical companies offer copay cards and patient assistance programs that can significantly reduce the out-of-pocket cost of brand-name GLP-1s for eligible individuals,” he detailed. “Services like GoodRx can offer significant savings on brand-name GLP-1 medications for those paying out-of-pocket.”
“It is essential for patients currently using compounded GLP-1s to have an open conversation with their healthcare provider to explore these alternatives and develop a safe and effective treatment plan moving forward,” Ewing added.
