FDA updates PPE policies for pharmacy compounders during COVID-19

NCPA May 15, 2020

On May 14, the FDA updated its guidance for pharmacy compounders who experience shortages, due to the COVID-19 public health emergency, of the personal protective equipment they use to compound sterile drugs. FDA clarified that these drugs can be compounded in a segregated compounding area that is not in a cleanroom, when the following beyond-use dates are utilized: up to 12 hours for product stored at room temperature, and up to 24 hours for products stored refrigerated. These BUDs aim to reduce the risk of contamination.