Compounding pharmacies are pushing the FDA to make temporary policy changes made to ease COVID-19 drug shortages permanent, but public health officials warn the changes could pose greater risks to patients, STAT reported.
Throughout the pandemic, the FDA has updated policies related to compounding pharmacies, easing restrictions to get drugs needed to treat COVID-19 patients to hospitals faster. Those policies include allowing small compounding pharmacies to supply hospitals that aren't able to buy drugs from their usual manufacturers and allowing pharmacists to use nonstandard personal protective equipment while compounding drugs.
All of the policy changes are set to expire when HHS declares that COVID-19 is no longer a pandemic, but the compounding industry is pushing for the changes to remain in place permanently, according to STAT.
Compounders say that loosening the restrictions has helped them respond to the pandemic and shown how important their industry is and how much it's capable of, according to STAT.
Public health experts warned that permanently easing restrictions could hike the risk of patients receiving substandard drugs.
"I worry that in the rush to get patients access to needed drugs for [COVID-19], we will forget why it is [that] we have a lot of the regulatory requirements that we have," Patti Zettler, an assistant professor of law at Ohio State University, told STAT.
Read the full article here.