Regulation · Tirzepatide

Which compounded tirzepatide programs still have a lawful lane

The compounded GLP-1 market that exists in 2026 is not the one that existed in 2024. The shortage-era lane closed; what continues is narrower, and the programs operating in it look different from the ones that filled the gap during the shortage.

What actually changed

The FDA declared the tirzepatide shortage resolved in December 2024 and the semaglutide shortage resolved in February 2025. During a declared shortage, compounders may make copies of an approved drug; once it is resolved, that permission winds down. The wind-down ran through early 2025 on staggered dates for 503A pharmacies and 503B outsourcing facilities.

One correction worth making, because it is widely misreported: semaglutide and tirzepatide were never on the FDA's 503B bulk drug substances list. Subsequent regulatory action to keep them off it forecloses a pathway rather than closing an open one. The distinction matters if you are trying to predict what happens next.

What remains

503A compounding against documented, patient-specific clinical need. That is a narrower activity than the shortage-era market: it requires an individual prescription, a documented reason the approved product will not serve that particular patient, and a pharmacy willing to operate on that basis.

In this database, 17 of the 37 programs describe a 503A arrangement explicitly, and 8 name the pharmacy at all. The rest use language like "partner pharmacies", which tells you nothing about which lane they are in.

Reading a program's lane from what it publishes

Three signals are worth more than marketing copy. Does it name the pharmacy? Does it describe a patient-specific prescribing process, or does it read like an e-commerce checkout? And does its pricing look like a compliant operation — a price far below the field's floor is worth understanding rather than celebrating, because compounded sterile injectables have a real cost structure.

The current floor in this database is $169 a month for tirzepatide and $129 for semaglutide, all-in. Programs advertising materially below that are flagged on their record pages.

What would change this page

Regulatory decisions in this area are still moving. If the 503B pathway is permanently foreclosed for these molecules, programs relying on outsourcing facilities lose their supply and the ones operating patient-specific 503A arrangements do not. That is the fault line to watch, and it is why this site records pharmacy type per program rather than treating "compounded" as one category.

Questions

Are compounded GLP-1s banned?

No. 503A compounding against documented patient-specific clinical need continues. What ended was the shortage-era discretion that permitted large-scale compounding of copies, which wound down through early 2025 after both shortages were declared resolved.

Were semaglutide and tirzepatide removed from the 503B bulks list?

They were never on it. Regulatory action in this area forecloses a pathway rather than closing one that was open, which is a distinction most coverage gets wrong.

How can I tell which lane a program is in?

Whether it names its compounding pharmacy, whether its intake describes patient-specific prescribing, and whether its pricing is consistent with the cost structure of compounded sterile injectables.