The FDA is temporarily relaxing drug compounding rules in response to a shortage of drugs needed to put COVID-19 patients on ventilators, STAT reported.
For as long as the pandemic lasts, the agency said it will not take action against compounding pharmacies that make a drug that is a copy of an approved drug, use bulk ingredients not on an approved list, or fail to meet good manufacturing requirements for stability.
"In light of unprecedented disruptions to, and demands on, the global pharmaceutical supply chain as a result of the COVID-19 pandemic, and in order to respond to evolving regional conditions, additional flexibility is temporarily needed to ensure that treatment options are available when hospitals are unable to obtain FDA-approved drugs used for hospitalized patients with COVID-19," the FDA wrote in its temporary guidance.
The guidance applies only to outsourcing facilities and not to smaller compounders that fill only individual prescriptions, STAT reported. Outsourcing facilities make and sell large batches of drugs without requiring prescriptions.
Hospitals have struggled with shortages of drugs needed to put patients on ventilators as orders of the drugs are being filled and shipped to hospitals just 53 percent of the time, down from 72 percent in March.
The FDA will now allow compounders to make five sedatives and anesthetics, including etomidate, dexmedetomidine, ketamine, lorazepam, and midazolam; two analgesics, fentanyl and hydromorphone; and two muscle relaxants, cisatracurium and vecuronium, STAT reported.
But Scott Brunner, CEO of the Alliance for Pharmacy Compounding, told STAT the guidance will have "little or no effect."
"I’ve talked with several [compounders] today. It’s sort of a 'rearranging the furniture' move by FDA, without substantive economic or regulatory relief that will [provide incentives] to switch gears and reconfigure their facilities to make a medication that will likely only be in shortage for the next 60-90 days. So the shortages will persist, and patients will remain at risk," Mr. Brunner told STAT.
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