FDA updates certain COVID-19 drug compounding guidance

The Food and Drug Administration yesterday updated two guidances for the temporary compounding of certain drugs used to treat COVID-19 patients.

The guidance for temporary compounding of certain drugs for outsourcing facilities now includes information to help hospitals determine which facilities are covered by the policy, and clarifies policies for testing both container-closures and product stability. It also says FDA will not take action against outsourcing facilities for filling drug orders for copies of FDA-approved products.

In addition, FDA updated guidance for temporary compounding of certain drugs by pharmacy compounders to include reporting to FDA any adverse events associated with drugs they compounded.