“I am taking compounded semaglutide that I ordered online, but I don’t know how long I will have access to it.”
That was what one anonymous patient told Pharmaceutical Technology on an online compounded semaglutide forum on Reddit with over 10,000 members. The forum is one of many that exist online to discuss compounded GLP-1RAs — a pharma subsector that has grown significantly as the interest in GLP-1RAs has skyrocketed in the last few years.
Semaglutide, manufactured by Novo Nordisk and sold under the brands Ozempic and Wegovy, as treatment for type 2 diabetes (T2D) and obesity, respectively, was one of the catalysts behind the growth of the GLP-1RA market. Eli Lilly then spurred it on further with tirzepatide — a GLP-1RA and gastric inhibitory polypeptide (GIP) agonist. Tirzepatide is sold under the brand names Mounjaro and Zepbound for T2D treatment and weight loss, respectively.
Compounded drugs are custom-made and unbranded medications that contain the same active ingredient as a marketed drug, such as semaglutide or tirzepatide, pursuant to a prescription. A shortage of a commercially available drug is one of the criteria that allows compounded production, as per FDA legislation.
“The number of people served by the compounded drug is extraordinary. I can't think of another time in history when as many patients were served by a particular compounded therapy,” says Scott Brunner, CEO of the Alliance for Pharmacy Compounding.
With both GLP-1RAs being in short supply for most of the last two years, thousands of patients turned to compounding pharmacies to fill the gap. This practice shifted when the agency first declared that the tirzepatide shortage was over, followed soon by a similar announcement signalling the end of the semaglutide shortage in February 2025. Now, there are deadlines for pharmacies and outsourcing facilities in April and May, respectively, to cease production, while the provided off-ramp gives patients and providers time for medication transition.
Though the never-seen-before demand for GLP-1RAs thrust compounders into the spotlight, compounding drugs is not a new concept. Pharmacies have long dispensed compounded medication to individual patients under a prescription. 503As are traditional retail pharmacies that compound medications and focus on patient-specific prescriptions, while 503Bs are outsourcing facilities that can distribute larger batches.
“503As can now source drugs from 503Bs and dispense them based on an individual prescription. But that's not a line of business that they had been in before this GLP-1RA phenomenon,” says Brunner.
Among the numerous compounding pharmacies, new companies cropped up, looking to cash in on the GLP-1RA shortage. While most compounding pharmacies exist to deliver tailored medication not commercially available to patients and fill limitations in the supply chain, some have emerged whose main revenue stream comes from opportunities in the GLP-1RA age.
Despite the FDA highlighting safety issues with compounded GLP-1RAs, this type of medication’s use has skyrocketed.
“There is absolutely opportunism in compounding right now, and I'm concerned about it because of the implication for many other compounded therapies on which Americans rely,” Brunner says.
Since the semaglutide and tirzepatide shortage has been declared over, a pharmacy’s ability to prepare copies of GLP-1RAs has gotten trickier. And for recently emerged telehealth weight loss platforms, whose revenue relies on these drugs, so has their ability to manage 2025 revenue expectations.
Despite the FDA mandate, pharmacies have some legislative leeway based on dose and formulation tailoring, and certain companies are betting on this to stay active. California-based Mochi Health is one of the many platforms providing compounded semaglutide to individuals. More than 10,000 patients use the company to access compounded medication.
In an email to Pharmaceutical Technology, Mochi Health’s CEO Dr Myra Ahmad said: “[We] will continue to provide compounded GLP-1RAs, even after the FDA has resolved the semaglutide shortage. Mochi can maintain these under personalised treatment plans because the medication prescribed to the patient is not a replica of the well-known brand-name medications.”
Hims & Hers Health, an online telehealth platform that gained notable attention courtesy of its advertisement aired during the 2025 Super Bowl, said it will stop selling commercially available doses of semaglutide by the end of the FDA off-ramp. However, customers who have a personalised dosing regimen via their platform will still have access to the medication, the company confirmed. Despite the shortage ending, Hims & Hers predicts potential revenues of $2.4bn this year.
Dr Jamil Alkhaddo, medical director of WeightWatchers, a company that offers compounded semaglutide among its weight loss services, said it will closely monitor regulatory changes surrounding weight loss medication.
“The recent news does not signal any near-term changes to existing treatment plans,” Alkhaddo told Pharmaceutical Technology.
“We are prepared to support members with alternative options, including FDA-approved, branded GLP-1RAs and other compounded medications for those who qualify.”
Other platforms such as California-based EllieMD advertise their GLP1-RAs that are mixed with vitamin B12. But simply joining two drugs together, without any tailoring to the patient, could lead to legal trouble, Brunner explains.
“Formulations or dosage strengths that aren’t commercially available aren’t considered a copy. However, simply combining two commercially available drugs into one, without a prescriber’s adjustment of dosage form or strength, would be considered a copy under a strict reading of US Food and Drug Administration (FDA) guidance,” Brunner says.
A clue to the future of compounded semaglutide can be garnered from the tirzepatide experience. Eli Lilly’s GLP-1RA was taken off the FDA shortage list in December 2024. Despite pharmacies largely having to stop making the drug in mid-March, it is still being offered on many platforms, including Mochi Health.
At the root of the question on the future of compounded GLP-1RAs is whether widespread shortages will occur again. Even after the shortages for both drugs ended as per the FDA, the American Society of Health-System Pharmacists (ASHP), for example, only declared them resolved in a 5 March update. Patients on online weight loss forums are still describing issues with receiving GLP-1RAs. Some describe stockpiling the medication to protect against future disruption to their orders.
“We do firmly believe that the FDA was premature on both [tirzepatide and semaglutide] shortages. We believe the information they relied on was considerably incomplete,” Brunner says.
Brunner remarks that pharmacies are still facing difficulties in acquiring tirzepatide in sufficient quantities. Those challenges also extend to semaglutide, where orders fall significantly short of patient waiting lists.
The FDA states Novo Nordisk has provided assurances that it can cope with demand going forward. However, not everyone agrees. The tirzepatide shortage was the subject of a court case initiated by the Outsourcing Facilities Association (OFA). While the injunction sought by OFA was blocked by a US judge, the trade body has also sued the FDA over ending the semaglutide shortage.
Both Eli Lilly and Novo Nordisk have spent billions of US dollars to meet the growing demand for their blockbuster drugs. Not only have they scaled manufacturing and reinforced drug supply chains, but also launched their own direct online pharmacies selling products at reduced costs to match the compounded price tags.
Given that GLP-1RAs are demonstrating efficacy in diseases beyond weight loss and diabetes, their use is only going to increase. Zepbound, Eli Lilly’s branded tirzepatide for weight loss, is forecast to make $28.2bn by 2031 while Wegovy is slated to see sales of $26bna, according to analysis by GlobalData’s Pharma Intelligence Center.
GlobalData is the parent company of Pharmaceutical Technology.
“Seeing that the population needing GLP-1RAs is going to increase in the future, either companies will have to keep expanding their facilities, or there will be a shortage again,” says GlobalData pharma analyst Costanza Alciati.
“It’s definitely possible that with the opening up of more indications, there’s going to be a higher demand and subsequent future shortages.”
With fallout from the tirzepatide shortage still ongoing and the compounded semaglutide deadlines fast approaching, it remains to be seen how, and indeed if, the FDA will enforce its legislation.
Correction: An earlier version of the story incorrectly stated that semaglutide and tirzepatide are still in short supply as per the ASHP. This paragraph (number 22) has been updated to include the information from a March ASHP update, and other individual reports on these drug shortages.
"The GLP-1 drug shortage is over. What’s next for the compounders?" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand.
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