The FDA said in a court filing that while it had made progress in reassessing if there is a tirzepatide shortage, it will now be issuing its decision by Dec. 19. For the time being, it is presumed that FDA will continue to take enforcement discretion at least through the now-extended review period in the case of pharmacies that sterile compound copies of tirzepatide injection pursuant to prescriptions.
In October, NCPA and the Alliance for Pharmacy compounding requested the FDA issue an emergency amendment to guidance permitting 503A compounding pharmacies to have at least a 60-day transition period for dispensing compounded copies of tirzepatide injection and asking for clarification on 503B outsourcing facilities’ distribution to 503A compounding pharmacies. You can read that letter here.
