Industry & Regulation
How regulatory and business changes ripple down to patients — FDA proposals, warning letters, advisory committee reviews, and what major telehealth pivots tell us about access and cost.
5 articles
Industry & Regulation
What the FDA's 503B removal proposal means for compounded GLP-1 patients
The FDA proposed removing semaglutide, tirzepatide, and liraglutide from the 503B compounding list on April 30, 2026. Here's what that actually means — and what it doesn't.
4 min · Updated 2026-05-27
Industry & Regulation
The ProRx FDA warning letter: what compounded GLP-1 patients need to understand
The FDA issued warning letter WL #723704 to ProRx LLC on April 7, 2026, citing illegal tirzepatide compounding and serious sterility failures. Here's what it means.
5 min · Updated 2026-05-27
Industry & Regulation
The FDA is reviewing 7 peptides for the compounding list. Here's what that actually means.
The FDA's Pharmacy Compounding Advisory Committee meets July 23–24, 2026 to review BPC-157, TB-500, and 5 other peptides for the 503A Bulks List. Here's what that process actually involves — and what it doesn't.
4 min · Updated 2026-05-27
Industry & Regulation
FDA's April 2026 GLP-1 compounding clarification: what it says and what it means
The FDA's April 1, 2026 clarification restricts compounded semaglutide+B12 combinations and limits 503A pharmacies to 4 prescriptions per month of such products. Here's what the policy actually says.
4 min · Updated 2026-05-27
Industry & Regulation
What the Hims & Hers GLP-1 pivot tells patients about access and cost
Hims & Hers posted a $92M Q1 2026 loss as it wound down its compounded GLP-1 supply chain and pivoted to branded Wegovy and Zepbound. Here's what the shift means for patients who relied on lower-cost compounded options.
4 min · Updated 2026-05-27