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 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 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 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