FDA Updates Temporary Policy Regarding PPE for Compounders

by | May 14, 2020 | All Posts, COVID-19, FDA

The FDA has issued an update to its Temporary Policy Regarding Non-Standard PPE Practices for Pharmacy Compounders During the COVID-19 Pandemic. In the update, the FDA has clarified that drugs can be compounded under the policy in a segregated compounding area that is not a cleanroom when the following BUD’s are utilized:

  • Up to 12-hours for products stored at room temperature
  • Up to 24-hours for products stored refrigerated

You can find the new version of the guidance document by following the link below:

Temporary Policy Regarding Non-Standard PPE Practices for Pharmacy Compounders During the COVID-19 Public Health Emergency

Have questions? Our experts are here to help. Fill out “Fact Check Form” for answers to this or any other subject related to health & science including COVID-19. Our scientific experts are committed to providing answers to help you in navigating these challenging times.

Who We Are

Eagle consultants and scientists are helping compounding facilities implement successful quality systems. Our team has over 200 years of combined experience in the FDA-regulated pharmaceutical industry and can provide guidance in establishing the systems and processes that will help facilities producing compounded medications meet and exceed regulatory expectations. Follow the link below to learn more about our consulting services.

Eagle Analytical
Verified by MonsterInsights