Regulatory Tracker
FDA warning letters, enforcement actions, court rulings, and vendor status changes across the peptide and GLP-1 market — logged as they are published, each with a primary source. See also GLP-1 medications, the provider comparison, and what these actions mean for compounded semaglutide.
- Warning letters
- Enforcement actions
- Vendor status changes
-
FDA proposes to bar semaglutide, tirzepatide and liraglutide from the 503B bulks list
Read more: FDA proposes to bar semaglutide, tirzepatide and liraglutide from the 503B bulks listThe 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…
-
FDA says adding B12 does not stop a compounded semaglutide product being a copy
Read more: FDA says adding B12 does not stop a compounded semaglutide product being a copyThe 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…
-
FDA warns five online peptide sellers over unapproved GLP-1 drugs
Read more: FDA warns five online peptide sellers over unapproved GLP-1 drugsOn 31 March 2026 the FDA’s Center for Drug Evaluation and Research issued warning letters to five websites selling injectable peptides to US buyers: Lovega LLC dba Pink Pony Peptides, Gram Peptides, Prime Sciences, Mile High Compounds and PekCura Labs. Each cites unapproved new drugs sold over the internet under sections 301(d) and 505(a) of…
-
FDA warns 30 telehealth companies over compounded GLP-1 marketing
Read more: FDA warns 30 telehealth companies over compounded GLP-1 marketingThe 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…
-
More than 50 warning letters to GLP-1 compounders and manufacturers
Read more: More than 50 warning letters to GLP-1 compounders and manufacturersThe 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
-
FDA launches a “green list” import alert for GLP-1 ingredients
Read more: FDA launches a “green list” import alert for GLP-1 ingredientsThe 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.…
-
Outsourcing facilities lose the shortage exemption for semaglutide
Read more: Outsourcing facilities lose the shortage exemption for semaglutideThe 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…
-
Enforcement discretion ends for pharmacies compounding semaglutide
Read more: Enforcement discretion ends for pharmacies compounding semaglutideThe 60-day period during which the FDA said it did not intend to act against state-licensed pharmacies and physicians compounding semaglutide under section 503A expired. Two days later, on 24 April 2025, a district court declined to disturb the agency’s determination that the shortage was over, removing the remaining legal argument for continuing. Outsourcing facilities…
-
Court declines to force tirzepatide back onto the shortage list
Read more: Court declines to force tirzepatide back onto the shortage listThe US District Court for the Northern District of Texas denied the Outsourcing Facilities Association’s motion for a preliminary injunction, which had sought to prevent the FDA from keeping tirzepatide off the drug shortage list. Consequential for the compounding market: shortage status is the legal basis for much large-scale compounding of a drug, so the…
-
FDA warning letter to USA Peptide over semaglutide and tirzepatide
Read more: FDA warning letter to USA Peptide over semaglutide and tirzepatideThe FDA issued a warning letter to USApeptide.com for introducing unapproved and misbranded semaglutide and tirzepatide into interstate commerce. The agency cited inadequate directions for use and pointed to evidence that the products were intended for human applications including weight loss and diabetes management — despite research-use-only labeling. An early instance of the argument the…