Regulatory news
Every regulatory development we have covered, newest first.
7 dated regulatory items. Most recent: FDA proposes excluding tirzepatide from the 503B bulks list (2026-06-01).
All-in monthly cost at 10 mg
What this beat covers
Rule changes that decide what may lawfully be compounded, by whom, and under what conditions. This beat drives more of the compounded market than pricing does, because a regulatory change can remove a programme's supply route entirely rather than adjusting what it charges.
The two structural facts underpinning current coverage: the tirzepatide shortage was resolved, which closed the shortage-based pathway that let outsourcing facilities compound at scale, and 503A pharmacies may still compound against individual patient prescriptions. Proposals to restrict that further are proposals, not rules, and we say which is which.
Stories in this category
FDA proposes excluding tirzepatide from the 503B bulks list
If finalised, outsourcing facilities would lose a pathway for compounding at scale.…
State action against a telehealth company's own compounding pharmacy
When the platform and the pharmacy are the same business, a regulatory action lands directly on …
First oral GLP-1 for weight loss approved, priced from $149
A daily tablet reaches the market at a fraction of injectable brand pricing, with a smaller effe…
FDA issues warning letters to compounded GLP-1 marketers
Several telehealth companies were cited over labelling and marketing claims, not over patient ha…
A year after the shortage was declared over, the market has restructured
Scope narrowed and large platforms exited, but patient-specific compounding continues.…
Semaglutide approved for MASH with moderate to advanced fibrosis
The first GLP-1 with an FDA liver indication — and a coverage route that weight management is no…
Zepbound approved for obstructive sleep apnoea
A discrete diagnosis with an approved indication is a stronger prior-authorisation argument than…
How to read a dated item
Every story carries the date we recorded it and links to what we read. Nothing here is undated, because an undated claim about a market that reprices this often is not usable. Where an item concerns a price, the figure is repeated with its dose and its fee basis attached rather than left to be inferred from the headline.
If an item is wrong, it gets a correction with a date rather than a silent edit. The full log is at corrections, and it includes errors we found in our own work.
Open these rather than taking our word for it. Every one is a regulator, a trial registry, a label, an accreditor or the manufacturer.