Some compounding pharmacies are sidestepping the FDA’s ban on copying approved GLP-1s by adding a vitamin or supplement to their formulations, according to a report published July 17 in JAMA Health Forum. The finding is a sign that the legal window that let pharmacies mass-produce cheaper copies of Ozempic, Wegovy, Mounjaro and Zepbound is closing on multiple fronts at once — but not without workarounds. Here’s a rundown of where things stand today.
1. The shortage exception that started it all is gone
Compounding pharmacies were only ever allowed to make patient-specific copies of brand-name drugs under a narrow exception: when the FDA’s drug shortage list shows the branded product is unavailable. That’s what fueled the boom in compounded semaglutide and tirzepatide starting in 2022 and 2023, when Novo Nordisk and Eli Lilly couldn’t keep up with demand.
That exception no longer applies. The FDA declared the tirzepatide shortage resolved in December 2024 and did the same for semaglutide in February 2025. Once a drug comes off the shortage list, the legal basis for compounding an “essentially a copy” version of it expires, though compounding pharmacies pushed back at the time, arguing separate provisions still let them alter formulations for individual patients.
2. The FDA wants to close the door for good
In an April 30 notice, the FDA proposed excluding semaglutide, tirzepatide and liraglutide from its 503B bulks list — the list of active ingredients outsourcing facilities are allowed to compound from in bulk. The agency said it found no clinical need to justify keeping them on it, even if a future shortage pops up. The move follows Novo Nordisk’s own petition to exclude liraglutide from the same list, filed more than a year earlier.
If finalized, the move would permanently cut off the pathway 503B outsourcing facilities used for large-scale compounding, regardless of shortage status down the road. The FDA opened a public comment period on the proposal and, after stakeholders asked for more time, extended the deadline to July 30.
3. A narrow lane for compounding still exists
Patient-specific compounding by state-licensed 503A pharmacies hasn’t disappeared. A prescriber can still order a compounded GLP-1 for an individual patient, but only if they document a genuine clinical reason — not cost or convenience — for why that patient needs a formulation different from the FDA-approved version.
The FDA’s “essentially a copy” test looks at whether the compound has the same active ingredient, a similar strength (within 10%) and the same route of administration as the approved drug. If it checks all three boxes without a documented clinical difference, it doesn’t qualify.
4. Enforcement has escalated fast
The FDA has leaned hard on telehealth marketing this year, issuing rounds of warning letters to 30 companies in early March, then updated guidance in April telling pharmacies to stop compounding once branded versions leave the shortage list, followed by another 25 warning letters in mid-June. Novo Nordisk has also gone to court, suing telehealth company Hims & Hers over marketing claims and citing its own testing showing high impurity levels in some compounded semaglutide products — an escalation that traces back to Hims’ launch of a $99 compounded Wegovy pill in February.
Hims later struck a deal with Novo to sell branded Wegovy and Ozempic and step back from marketing compounds. Eli Lilly has pursued similar legal action against compounders and telehealth platforms over its products.
5. What to watch next
The FDA’s final call on the 503B bulks list won’t come until after the July 30 comment deadline closes and the agency reviews the responses filed. Separately, the agency has an advisory panel scheduled July 24 to weigh enforcement discretion on a handful of other compounded peptides, which will be a useful gauge of how much appetite the agency has right now for expanding, rather than narrowing, compounding access.
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