The US Food and Drug Administration (FDA) has determined the shortage of glucagon-like peptide 1 (GLP-1) medication, semaglutide, is resolved. Semaglutide injection products have been on the FDA shortage list since 2022. The FDA has confirmed with the drug’s manufacturer, Novo Nordisk, that their product availability and manufacturing capacity can meet the present and projected demand. To avoid patient disruption, the FDA does not intend to take immediate action against compounders for violations of the FD&C Act, which prohibits the compounding of commercially available medications.
For a state-licensed pharmacy or physician compounding under section 503A of the FD&C Act: compounding, distributing or dispensing semaglutide injection products that are essentially a copy of an FDA-approved product within 60 calendar days from the announcement, until April 22, 2025. For outsourcing facilities under section 503B of the FD&C Act: compounding, distributing or dispensing semaglutide injection products that are essentially a copy of an FDA-approved drug product within 90 calendar days from the announcement, until May 22, 2025.
