FDA Issues COVID-19 Guidance for Drug Manufacturing

By Miranda Greenberg -

June 25, 2020

The US Food and Drug Administration has issued final guidance that provides recommendations to pharmaceutical manufacturers on actions to take when an employee who has been directly involved in manufacturing drugs has a confirmed infection of COVID-19, symptoms of COVID-19, or has been exposed to an infected person.

The FDA’s recommendations are intended to help avoid negative effects on the safety and quality of drugs. FDA expects drug manufacturers to evaluate existing manufacturing controls to prevent drug safety or quality issues related to contamination from SARS-CoV-2, the virus that causes COVID-19.

The FDA is also advising drug manufacturers to review guidance from the Centers for Disease Control and Prevention regarding when employees may continue working following exposure or potential exposure to COVID-19 as well as procedures to minimize exposure and transmission in the workplace.

The FDA says is not aware of any drugs that have been contaminated with SARS-CoV-2 or of information indicating transmission of COVID-19 is associated with drugs.

Source: US Food and Drug Administration