Updates to FDA’s Policy for Compounding of Hand Sanitizer On April 15, FDA updated the Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products during the COVID-19 public health emergency. Of note are discussions of alternate sources of...
FDA Relaxes Restrictions on 503Bs for COVID-19 On April 16, 2020, the FDA issued the guidance document “Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency”. The guidance...
FDA Issues Temporary Policy on PPE for Compounders FDA has issued a guidance document that addresses the Sterile Compounding Industry’s concerns regarding PPE in light of current shortages during the COVID-19 pandemic. The document entitled “Temporary Policy Regarding...
FDA Issues Clarification on Compounding Policies In case you missed it, the FDA sent an email clarifying several compounding policies in response to questions from stakeholders. Of particular importance to compounding pharmacies and outsourcing facilities is the FDA’s...
More on FDA’s EUA for Hydroxychloroquine Sulfate and Chloroquine Phosphate Here’s what Eagle’s Chief Technical Officer and the current Chairman of the USP Microbiology Expert Committee, Dr. David Hussong says about the Emergency Use Authorization (EUA) of...
FDA Issues EUA for the Use of Hydroxychloroquine and Chloroquine On Sunday March 29, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to permit the emergency use of hydroxychloroquine sulfate and chloroquine phosphate. The drugs,...
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