News

Regulatory and market developments

Explainers, not wire copy: each piece below reconstructs a development from primary sources in our evidence ledger — Federal Register notices, FDA statements, agency records — and labels anything that reached us only through trade press. Event dates are the events'; our pages carry data-snapshot dates, not simulated publication dates.

• Proposed April 30, 2026 · comment period closed July 30, 2026

  FDA moves to exclude GLP-1s from the 503B bulks list

  The agency proposed finding no clinical need for bulk compounding of semaglutide, tirzepatide, and liraglutide at outsourcing facilities — the single decision with the most leverage over the compounded-GLP-1 market.

• Seizures April 2025 and December 2025

  Counterfeit Ozempic reached licensed U.S. pharmacies twice

  Both confirmed counterfeit incidents involved product inside the legitimate supply chain — with authentic lot numbers — which changes what "buy from a licensed pharmacy" can and cannot protect against.

• Warning-letter rounds September 2025 – June 2026, as reported

  FDA's enforcement wave against compounded GLP-1 marketing

  Over a hundred warning letters to telehealth companies and online sellers in three reported rounds, plus an announced move against compounded GLP-1 ingredients — much of it reaching us through trade press, and labeled accordingly.

How these explainers work

We separate event reporting from analysis. Every dated fact cites an evidence-ledger record whose source you can open; claims we could only source to trade press are markedthird-party reported in the text, not silently blended with agency records. Where a development's outcome is not yet public — a pending decision, an unpublished docket result — the page says "unknown" rather than predicting.