Semaglutide shortage is over, FDA says; grants discretion for compounding pharmacies

NCPA February 25, 2025

The Food and Drug Administration has determined the shortage of semaglutide injection products is resolved, and that it does not intend to take action against:

  • Pharmacies compounding, distributing or dispensing semaglutide injection products that are essentially a copy of an FDA-approved product until April 22, 2025; and

  • Outsourcing facilities compounding, distributing or dispensing semaglutide injection products that are essentially a copy of an FDA-approved drug product until May 22, 2025.

FDA stated that it may still take action regarding violations of any other statutory or regulatory requirements, such as to address findings that a product may be of substandard quality or otherwise unsafe.

NCPA will keep its members appraised of developments.

NCPA