Regulatory news
Every regulatory development we have covered, newest first.
12 dated regulatory items. Most recent: FDA proposes excluding semaglutide from the 503B bulks list (2026-04-30).
All-in monthly cost at 2.4 mg
Stories in this category
FDA proposes excluding semaglutide from the 503B bulks list
If finalised, outsourcing facilities would lose a pathway for compounding at scale.…
Wegovy HD adds a 7.2 mg dose at $399 a month direct
A higher-dose option for patients who plateau, priced through the manufacturer's direct channel.…
State action against a telehealth company's own compounding pharmacy
When the platform and the pharmacy are the same business, an action against one lands on patient…
FDA issues warning letters to compounded GLP-1 marketers
Several telehealth companies were cited over labelling and marketing claims rather than patient …
Oral Wegovy launches for chronic weight management
An FDA-approved semaglutide tablet for weight loss reaches the market, with reported cash pricin…
State boards tighten telehealth prescribing and non-resident pharmacy rules
Availability maps narrowed programme by programme, and the reasons were licensure rather than cl…
FDA issues more than 55 warning letters to online GLP-1 sellers
The agency targeted direct-to-consumer advertising by compounded semaglutide and tirzepatide mar…
The 503B deadline passes, closing large-scale semaglutide compounding
Outsourcing facilities lose the shortage exception a month after 503A pharmacies.…
Court declines to block the semaglutide compounding wind-down
A district court denied the preliminary injunction sought by an outsourcing-facility trade group…
The 503A deadline passes for compounded semaglutide
State-licensed pharmacies lose the shortage exception that permitted copies of Ozempic and Wegov…
FDA sets the wind-down clock for compounded semaglutide
The agency published transition deadlines: 60 days for state-licensed pharmacies and 90 days for…
FDA declares the semaglutide shortage resolved
The declaration narrowed lawful compounding to the patient-specific 503A pathway and set the dea…
Open these rather than taking our word for it. Every one is a regulator, a trial registry, a label, an accreditor or the manufacturer.