Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency - Immediately in Effect Guidance for Clinical Labor

Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency - Immediately in Effect Guidance for Clinical Labor

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

Today, the FDA issued an update to its guidance for pharmacy compounders that experience shortages, due to the COVID-19 public health emergency, of the personal protective equipment (PPE) they typically use to compound human drugs that are intended or expected to be sterile. In the update, FDA has clarified that drugs can be compounded under the policy in a segregated compounding area that is not in a cleanroom, when the following beyond-use dates are utilized: up to 12-hours for product stored at room temperature, and up to 24 hours for products stored refrigerated. These beyond use dates aim to reduce the risk of contamination. FDA adopted this policy to help assure patient access to needed medicines and to reduce the risks of compounding when standard PPE are not available. FDA wants to ensure that health care professionals are aware of this guidance and the potential for greater contamination risk when compounded drugs are prepared without standard PPE or within segregated compounding areas. FDA encourages health care professionals who purchase compounded drugs to engage with compounders to balance these risks and the need for compounded products for patient care.