Compounding pharmacies want to make FDA pandemic changes permanent
FDA's temporary policy changes intended to ease COVID-19 drug shortages should be made permanent, say compounding pharmacies.
FDA's temporary policy changes intended to ease COVID-19 drug shortages should be made permanent, say compounding pharmacies. These policies include allowing small compounding pharmacies to supply hospitals that are unable to purchase 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 determines that COVID-19 is no longer a pandemic. Compounders say that easing current restrictions has facilitated their ability to respond to the pandemic, reveals how essential their industry is, and highlights what the industry is capable of. However, public health experts are concerned that permanently easing restrictions could lead to an increase risk of patients receiving substandard drugs. Patti Zettler, an assistant professor of law at Ohio State University, says: "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."