USA – FDA updates COVID-19 compounding guidance with reporting clarification

Two guidance documents related to compounding drugs during the coronavirus pandemic were updated by the US Food and Drug Administration (FDA) on Thursday. Among other updates, a requirement for weekly reporting will allow hospitals to identify which compounders are making what quantities of drugs currently in shortage during the public health emergency of the COVID-19 pandemic.
 
The FDA updated two separate guidance documents regarding compounding of fifteen drugs that are currently in shortage; most of them are medicines that treat patients who require intubation and mechanical ventilation. The first applies to outsourcing facilities, while the second applies to smaller pharmacy compounders.
 
(RELATED: FDA allows compounding of needed hospital drugs for COVID-19Regulatory Focus 16 April 2020; FDA expands COVID-19 drug compounding policy to smaller pharmaciesRegulatory Focus 21 April 2020; Epinephrine and morphine added to FDA’s COVID-19 compounding listsRegulatory Focus 20 May 2020)…