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
The 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 … Read more
The 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 … Read more
The 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 … Read more
The FDA determined that the shortage of semaglutide injection products, in place since 2022, was resolved, after confirming with the manufacturer that stated availability and manufacturing capacity could meet present and projected national demand. Because the legal basis for compounding these products rested on their presence on the shortage list, the announcement set two deadlines: … Read more