FDA announces actions taken in response to COVID-19 pandemic

Editor's Note:

The Food & Drug Administration (FDA) on March 25 announced several actions it has taken in its response to the COVID-19 pandemic.

These include:

• In response to the demand for hand sanitizers and their active ingredient, alcohol, the FDA issued guidance to alcohol manufacturers on how to incorporate their alcohol into hand sanitizers for consumer and healthcare personnel use.
• The FDA added hydroxychloroquine sulfate to category 1 of its policy on drug compounding. The agency does not intend to object to registered outsourcing facilities using hydroxychloroquine (or chloroquine phosphate, which was already category 1) to compound human drugs. In addition, state-licensed pharmacies and federal facilities may compound drugs using hydroxychloroquine sulfate or chloroquine phosphate bulk drug substances because they are components of an FDA-approved drug.
• The FDA issued an emergency use authorization for ventilators, anesthesia gas machines modified for use as ventilators, positive pressure breathing devices modified for use as ventilators, ventilator tubing connectors, and ventilator accessories.
• The FDA has worked with more than 190 test developers who intend to submit applications for tests to detect the SARS-CoV-2 virus. The FDA also has been notified by more than 100 laboratories seeking to develop and perform diagnostic tests to detect the SARS-CoV-2 virus.