Updates to FDA’s Purple Book: Database of Licensed Biological Products This week the FDA updated the Purple Book: Database of FDA-Licensed Biological Products. The update is part of a multi-phase enhancement of the database, intended to ultimately improve...
FDA Announces Update on MOU for Compounding Pharmacies On May 13, a standard memorandum of understanding, also known as a MOU, between the FDA and the states was made available for public viewing as part of the regulatory process. The article states that this marks a...
FDA Updates Temporary Policy Regarding PPE for Compounders 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...
Morphine Sulfate & Epinephrine added to COVID-19 Compounding List FDA has updated two guidance documents that describe temporary policies for the compounding of certain human drugs during the COVID-19 public health emergency. The updates add morphine sulfate and...
FDA’s Guidance for 503A Compounding of COVID-19 Following our previous posts on FDA’s guidance released this week, Dr. David Hussong discusses the terms stipulated by the temporary policy which allows 503A pharmacies to compound certain drugs for COVID-19 without...
503A’s Can Temporarily Compound Certain Drugs The FDA has issued a temporary guidance which enables 503A compounding pharmacies to compound certain medications without the requirement of a patient-specific prescription during the COVID-19 public health...
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