(Originally posted 2/25/2025)

The FDA has confirmed that the shortage of semaglutide injection products has been resolved.

This shortage began in March 2022 for Wegovy and in August 2022 for Ozempic. The FDA will continue to monitor the supply and demand for these products.

For more details, see the FDA statement on the resolution of the shortage and the Declaratory Order.

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(Added 4/10/2025)

See page 9 of the Feb. 21, 2025, Declaratory Order for a statement on FDA's enforcement discretion for compounders that are not registered as outsourcing facilities for compounding, distributing, or dispensing semaglutide injection products (60 days), and for outsourcing facilities that compound, distribute, or dispense a drug product that appeared on FDA’s drug shortage list (90 days).

"To avoid unnecessary disruption to patient treatment and to help facilitate an orderly transition, FDA does not intend to take action against a compounder that is not registered as an outsourcing facility for compounding, distributing, or dispensing semaglutide injection products that are essentially a copy of a commercially available drug product within 60 days of this decision. In addition, FDA does not intend to take action against an outsourcing facility for use of the bulk drug substance semaglutide to compound, distribute, or dispense a drug product that appeared on FDA’s drug shortage list, or for compounding, distributing, or dispensing semaglutide injection products that are essentially a copy of an FDA‐approved drug product, within 90 days of this decision. This order does not prevent FDA from taking action for violations of any other statutory or regulatory requirements, such as to address findings that a product may be of substandard quality or otherwise unsafe." (footnotes removed)