Peptide Review Desk Editorial 
The FDA extended the comment period on its 1 May proposal to exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list. Comments were originally due 30 June 2026; the deadline moved to 30 July 2026. Sources: Federal Register 2026-12937
The FDA issued a further round of warning letters on 8 June 2026, including to Altru Telehealth, Medica Weight Loss and FITISH, continuing the enforcement line it opened in September 2025 and widened in March 2026. Sources: Altru Telehealth · Medica Weight Loss · FITISH
The FDA proposed not to include semaglutide, tirzepatide and liraglutide on the 503B bulks list — the roster of substances outsourcing facilities may legally compound from bulk. The agency stated it had reviewed the nominations it received and did not find sufficient evidence of a clinical need for any of the three. If finalised, the … Read more
The FDA restated the conditions a compounded drug must meet to qualify for the section 503A and 503B exemptions, and addressed a practice common in compounded GLP-1 products directly. It said a product combining semaglutide with another active ingredient, giving vitamin B12 (cyanocobalamin) as its example, may still be considered essentially a copy of a … Read more
The FDA issued warning letters to 30 telehealth companies over false or misleading claims made about compounded GLP-1 products sold on their websites. It was the second wave of letters aimed at telehealth firms since the agency opened a broader campaign against misleading direct-to-consumer drug advertising in September 2025, and the largest single action against … Read more
The FDA issued over 50 warning letters to US and international companies compounding or manufacturing semaglutide and tirzepatide. The cited conduct centered on marketing compounded GLP-1s as “generic versions” of the approved drugs, or making direct comparative claims against them. Sources: FDA warning letter database · Wilson Sonsini analysis
The FDA established a “green list” import alert covering GLP-1 active pharmaceutical ingredients, intended to stop unverified foreign-sourced APIs from entering the US market. Ingredients from facilities the agency has inspected or evaluated, and which appear to meet its manufacturing standards, are listed; APIs from any other source become subject to detention without physical examination. … Read more
The 90-day period for outsourcing facilities compounding semaglutide under section 503B expired, one month after the equivalent deadline for state-licensed pharmacies. With both periods closed, the shortage-based justification for compounding semaglutide no longer applied to either category of compounder. The FDA noted throughout that it could still act on other grounds, including findings that a … Read more