The Alliance for Pharmacy Compounding (APC) wants clarity around the FDA’s decision to reconsider tirzepatide’s removal from its national shortage list.
Compounders are allowed to distribute their own versions of a drug in very specific circumstances, including during certain shortage situations. The FDA removed Eli Lilly’s blockbuster weight loss and diabetes drug tirzepatide from its national shortage list earlier this month, noting that a nearly two-year shortage had been resolved.
But the agency said last week that it would reconsider its decision, following a legal challenge from a trade group representing large compounding pharmacies. While the move could reopen the door for some compounders to continue selling their own copies of tirzepatide, APC said the situation remains unclear.
The FDA said in court documents that it would not take enforcement action against certain pharmacies for compounding tirzepatide while it reassesses, but APC noted that the announcement doesn’t protect pharmacies from state actions or challenges from Eli Lilly. While APC said those situations are unlikely, it added, “that’s what we think, not what we know.”
APC is also seeking clarity around which pharmacies are safe from FDA enforcement during this time.
“APC is working this weekend with our lawyers to submit a formal request for clarification to the FDA,” it said in a Tuesday announcement. “Our aim is to get in writing that FDA will take enforcement discretion related to all pharmacies compounding copies of tirzepatide injection at this time.”
For now, APC recommends 503A pharmacies — which tend to provide patient-specific compounds as opposed to large batches — “continue to stand down on compounding tirzepatide copies.”
When asked for an update on its decision, the FDA told Endpoints News on Wednesday that it “generally does not comment on litigation.”
APC maintains that tirzepatide is “not commercially available in quantities needed to meet the demand” and should be added back to the shortage list.
Tirzeptide is still listed as “resolved” in the FDA’s drug shortage database. The agency published information on Tuesday about drug shortage management, including how it determines whether a shortage has been resolved. A shortage is considered resolved when “all the manufacturers combined are able to meet total national pre-shortage supplies as seen with market data, or what meets current market needs, as supply amounts level out,” regulators said.
The FDA emphasized that information on shortages can change daily. And according to the agency, patients may experience variability in supply at particular pharmacies even when a medicine is considered available.
Editor’s Note: This story has been updated to include comment from the FDA.