Drug Shortages Are a Boon to One Industry: Compounding Pharmacies

livemint.com:

Pfizer manufacturing plant that produced 8% of sterile injectable medicines used by U.S. hospitals. Lobbyists for compounders say they could do more to help with shortages if they had more regulatory flexibility.

Large compounders can duplicate drugs that are on the FDA’s shortage list, but predicting when drugs will make that list and how long they will stay on can be difficult. Compounders are sometimes reluctant to invest in ramping up production for drugs that could go either way. House Republicans last month proposed lengthening the amount of time bulk compounders could copy drugs—30 days to produce and six months to distribute—even after the drugs are no longer in shortage.

Data from Premier, a major group-purchaser for U.S. hospitals, shows that its 4,400 members purchased 41% more products from outsourcing facilities in 2022 than in 2021, compared with roughly 4% between 2020 and 2021. “More and more hospitals are inclined and interested to move to the outsourcing facilities," said Amish Vyas, who leads a compounding division started last year by generic drugmaker Hikma.

The FDA, too, sometimes taps compounders for help with drugs in shortage. In June, it asked generic manufacturer and compounder Nephron Pharmaceuticals to consider compounding cardioplegia, a solution used in open heart surgery, said Chris Fortier, president of the company’s compounding division. He said Nephron has distributed all2,000 cardioplegia bags produced.