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Pharmacy News

Track-and-trace requirements go into effect on Friday

Starting Friday, November 27, 2020, pharmacies must buy and sell only products with a required “product identifier” on their packages. This requirement is part of the phased-in implementation of the Drug Supply Chain Security Act of 2013 (DSCSA), also known as the “track-and-trace” law. By Friday, dispensers should be familiar with this requirement and know what to do if a product identifier is not on the package when they receive products that require it. The product identifier is on most drug packages in both human-readable format and on a machine-readable 2D data matrix barcode.

HHS releases drug pricing announcements, fails to address harmful DIR fees

The U.S. Department of Health and Human Services (HHS) released three new drug pricing policies late last week. Two of the policies are based on executive orders President Trump signed in July; the last, a surprise revocation of guidances related to FDA’s Unapproved Drugs Initiative (UDI), was out of the blue. The policies’ release was announced on Friday, November 20, 2020, at a White House briefing.

FDA authorizes monoclonal antibodies for treatment of COVID-19

FDA issued an emergency use authorization (EUA) for casirivimab and imdevimab (Regeneron Pharmaceuticals) to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients aged 12 years or older weighing about 88 pounds with positive results of direct SARS-CoV-2 viral testing and who are at high risk for pr

FDA issues EUA for new COVID-19 treatment

On Saturday, FDA issued an emergency use authorization (EUA) for a combination monoclonal antibody treatment—casirivimab and imdevimab (Regeneron Pharmaceuticals)—to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients aged 12 years and older weighing 88 pounds with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19.

Pfizer to seek authorization of COVID-19 vaccine Friday

Pfizer announced that it plans to ask FDA on Friday for emergency use authorization of its COVID-19 vaccine. Pfizer and partner BioNTech reported this week the two-dose vaccine was 95% effective and well-tolerated.

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