FDA · DEA · state legislation · enforcement actions · clinical trial readouts · shortage designations. Every event links to a public source (fda.gov, federalregister.gov, clinicaltrials.gov).
The FDA updated its drug shortage database to reflect that the semaglutide injection shortage has been resolved. Under Section 503A and 503B of the FD&C Act, compounding pharmacies must wind down production of compounded semaglutide once the reference product is no longer on the shortage list.
FDA Drug Shortages databaseFDA published its final determinations on which bulk drug substances may be used in 503A compounding. The action updates the list of substances that may or may not be compounded, directly affecting which peptides licensed pharmacies can legally produce.
Federal RegisterFDA re-evaluated the tirzepatide shortage status and confirmed it as resolved, triggering the wind-down clock for compounded tirzepatide under 503A and 503B compounding rules.
FDA Drug Shortages databaseFDA and Novo Nordisk confirmed counterfeit units of Ozempic 1 mg pens seized from the US drug supply chain. Consumers and pharmacies were advised to inspect packaging and serial numbers.
FDA safety alertEli Lilly issued an open letter to healthcare providers and telehealth companies warning against dispensing compounded tirzepatide and other GLP-1-like products, citing safety and provenance concerns.
Eli Lilly open letterEli Lilly's Phase 3 TRIUMPH-1 trial of retatrutide in adults with obesity continues to enroll. Retatrutide is an investigational triple agonist (GLP-1, GIP, glucagon) with readouts expected in subsequent Phase 3 studies.
ClinicalTrials.gov — NCT05882045