6 dated regulatory items. Most recent: FDA proposes excluding semaglutide and tirzepatide from the 503B bulks list (2026-06-01).
Regulatory items decide what can lawfully be sold, not what is safe or what works. The two get conflated constantly in coverage of this category.
Why regulatory developments matter here
The distinction that matters most is between a proposal and a final rule. A proposed exclusion from a bulks list, a warning letter and a finalised regulation are three very different things, and only the third changes what is lawful.
Warning letters in particular are about claims rather than harm. A letter over labelling does not mean a programme is dangerous, and its absence does not mean one is careful. We record them as reported and say we have not independently verified them.
All regulatory items
FDA proposes excluding semaglutide and tirzepatide from the 503B bulks list
If finalised, outsourcing facilities would lose a pathway for compounding these molecules at…
Washington State acts against a telehealth company's own compounding pharmacy
When the platform and the pharmacy are the same business, a state action against one is an…
First oral GLP-1 for weight loss approved, priced from $149
An oral small-molecule agent reaches the market at a fraction of injectable brand pricing, with…
FDA issues warning letters to compounded GLP-1 telehealth marketers
MEDVi, Ivim Health and the operator of SkinnyRx were among those cited on 20 February 2026 over…
A year after the shortage was declared over, the compounded market has restructured
Scope narrowed, large platforms exited, and pricing moved — but patient-specific compounding…
Zepbound approved for obstructive sleep apnoea in adults with obesity
The first drug approved for moderate-to-severe OSA in this population — and a route to coverage…
Primary sources
Clinical, dosing and regulatory statements on this page rest on the documents below. Links go to the publisher, not to a summary of it. Prices are not sourced here — they carry a verification date instead, and the reason is set out in the source ledger.
- ZEPBOUND (tirzepatide) full prescribing information — DailyMed, US National Library of Medicine. Dose ladder, contraindications, warnings, storage.
- FDA’s concerns with unapproved GLP-1 drugs used for weight loss — US Food and Drug Administration. Compounded GLP-1 risks, API import alert, cold-chain complaints.
- FD&C Act provisions that apply to human drug compounding — US Food and Drug Administration. Why a compounded preparation is lawful without being FDA-approved.
- Tirzepatide once weekly for the treatment of obesity (SURMOUNT-1) — N Engl J Med 2022;387:205-216. Registration NCT04184622. The weight-reduction and adverse-event figures used across this site.
- The full source ledger — every primary source, what it supports, the date we read it, and the claims we deliberately do not source.