The FDA made an update to their final guidance, “Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements…
FDA Updates Guidance On Adverse Reporting During a Pandemic
The FDA made an update to their final guidance, “Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements…
May, Fri, 2020
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…
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…
May, Fri, 2020
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…
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…
May, Thu, 2020
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…
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…
May, Mon, 2020
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…
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…
Apr, Fri, 2020
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…
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…
Apr, Mon, 2020
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…
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…
Apr, Fri, 2020
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.
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.
Apr, Thu, 2020
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…
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…
Apr, Fri, 2020
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…
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…