FDA shortage delisting

FORT WORTH, Texas — A federal court in Texas ruled that the FDA did not abuse its authority when it declared that a shortage of the diabetes drug Mounjaro and the weight-loss drug Zepbound is over. During the shortage, pharmacies were allowed to dispense non-FDA-approved copycat versions of the drugs through compounding, and now they may not. The delisting decision was an informal adjudication, not a substantive rule, so the FDA was not required to go through a formal notice-and-comment process or publish a rule in the federal registry.