Originally published by our sister publication Specialty Pharmacy Continuum

By Gina Shaw
As federal officials explore possible strategic solutions to the ongoing problem of drug shortages, they are looking to leverage both 503A and 503B drug compounding facilities as potential avenues for filling in the gaps when a drug is in short supply, said legal experts at the NASP 2024 Annual Meeting & Expo, in Nashville, Tenn. 

These compounder also should be allowed to produce products beyond the FDA’s current hard compounding cut-off, which kicks in when a drug immediately drops off the FDA’s drug shortages list, they noted. Such flexibility could be applied to weight-loss medications and other chronically in-demand medications. Plus, it offers at least a partial U.S.-based solution.

“Compounding can provide gap supply of domestically manufactured product, without the many regulatory and logistical considerations that relate to foreign-manufactured products,” said Marc Wagner, JD, an associate in the healthcare and life sciences practice at the law firm of BakerHostetler. “Congress is currently working up proposals for both 503A and 503B compounders, which so far have focused on expanding drug shortage compounding allowances.”

503A compounding facilities are allowed to make “essential copies” of FDA-approved drugs to fill valid prescriptions for individual patients when those drugs are on the FDA Drug Shortages list. However, as Mr. Wagner noted, the FDA’s list is much smaller than that of ASHP in partnership with the University of Utah Drug Information Service. As of Oct. 7, the FDA’s list contained 118 entries, while ASHP reported a total of 300 active drug shortages at the end of the second quarter of 2024.

“Expanding drug shortage compounding based on the ASHP drug shortage list, in theory, would allow compounders to make more drug products than they’re currently allowed to make based on the FDA’s list,” Mr. Wagner noted.

Another proposal focused on 503Bs would extend the “tail period”—the time after a shortage ends when a 503B outsourcing facility is permitted to continue to compound a drug. “Currently, the statute reads that the 503B compounder must stop immediately once a drug shortage is resolved,” Mr. Wagner said. “However, the FDA has issued guidance allowing a 503B compounder a period of 60 days to continue manufacturing those products, and there are talks ongoing that would extend that period to 120 or 180 days.”

Some industry stakeholders have suggested that “it would be potentially beneficial to extend the tail period to a full one year after a drug comes off the shortage list,” he added.

Effect on Weight-Loss Medications

That would certainly be of interest to the many pharmacies that have been producing compounded versions of the diabetes/weight-loss drug tirzepatide (Mounjaro/Zepbound, Eli Lilly), which as of Oct. 2 was officially declared by the FDA to no longer be on shortage. “Officially, the moment it came off the list, tirzepatide compounding would have had to stop that day,” said BakerHostetler partner Lee Rosebush, JD, PharmD.

The Alliance for Pharmacy Compounding (APC) issued a statement to its members saying that preparing and dispensing compounded copies of the drugs “must immediately cease,” although it noted that tirzepatide remains on ASHP’s drug shortage list and that supply issues will likely persist. “A 60-day period during which a patient could continue compounded GLP-1 [glucagon-like peptide-1] therapy while their prescriber transitioned them to the FDA-approved versions would have been helpful for assuring continuation of care for those patients,” said APC CEO Scott Brunner in the statement, noting that the agency hadn’t yet responded to its requests for an off-ramp.

“The FDA’s enforcement discretion does allow 503B compounding to extend to 60 days after the shortage ends,” Dr. Rosebush said. “Any purchase order they had prior to that 60 days, they could fulfill.”

He also suggested that 503As could still potentially compound tirzepatide for individual patients.

“What I want to make clear is that what happened when it got removed from the list is that you can’t make an essential copy. You still can compound with a component of an FDA-approved product under section 503A; you just can’t compound an essential copy of it, which is something that I feel is being missed.”

The sources reported no relevant financial disclosures beyond their stated employment.