After a series of high-profile failures in the early 2010s, the compounding pharmacy industry took its share of body blows from an FDA looking to impose its will.
Now, after years of lockdown, the FDA is turning to its old nemesis to help ease the burden COVID-19 has placed on hard-hit hospitals.
The FDA will temporarily allow hospitals to source hard-to-find drugs from compounding pharmacies to treat certain patients hospitalized with severe COVID-19, the agency said Monday.
The regulation, meant to last as long as hospitals continue to encounter shortages of key drugs, applies to compounding pharmacies that aren't already sanctioned by the FDA as "outsourcing facilities." To qualify, the copycat drugs must be listed on the FDA's shortages list, and hospitals must have exhausted all other options to access a commercial version of the drug.
The FDA emphasized that its extraordinary step was designed to be temporary as the pharmaceutical supply chain faces "unprecedented disruptions" amid the novel coronavirus pandemic to provide drugs used for patients placed on respirators.
"(The) FDA generally tries to address potential and actual drug shortages by working through the global pharmaceutical supply chain, rather than relying on compounded drugs, and focuses on restoring supplies of FDA-approved drugs," the FDA said in a release.
"However, in light of unprecedented disruptions," the agency added, "additional flexibility is temporarily needed to help ensure that treatment options are available when hospitals are unable to obtain FDA-approved drugs used for hospitalized patients with COVID-19."
The immense strain the novel coronavirus has put on the global supply chain has made strange bedfellows of the FDA and compounding pharmacies, long pitted against one another in regulatory battles.
