April 16, 2020

FDA Issues Temporary Policy Regarding Non-Standard PPE Practices for Sterile Compounding

On April 10, the FDA issued guidance on a temporary policy to address shortages of PPE for pharmacies engaged in sterile compounding.  Under the policy, the FDA provides limited regulatory flexibility for pharmacies (but not outsourcing facilities) that are unable to procure adequate supplies of PPE for sterile compounding as a result of supply chain disruptions caused by the COVID-19 pandemic. The FDA directs pharmacies to safely preserve available PPE.  However, if those measures are not sufficient to address the need for PPE, the FDA states that it does not intend to take enforcement action against noncompliance with the insanitary conditions provision of the FD&C Act, so long as certain conditions are met.