On April 30, 2020, the Food and Drug Administration (FDA) issued new guidance relaxing certain requirements under the Drug Supply Chain Security Act (DSCSA) for COVID-19 related drug products. In the guidance, FDA explained that under the DSCSA... Read More
On April 30, 2020, the Food and Drug Administration (FDA) issued new guidance relaxing certain requirements under the Drug Supply Chain Security Act (DSCSA) for COVID-19 related drug products. In the guidance, FDA explained that under the DSCSA... Read More
Wholesale drug distributors need to maintain adequate track and trace documents, especially when acquiring and distributing COVID-19 therapies. The COVID-19 epidemic has sparked a demand for various drug products including, hydroxychloroquine. To... Read More
Recently, Pharmacy Benefit Managers (PBMs) have been requesting pharmacies to provide documentation in compliance with Drug Supply Chain and Security Act (DSCSA), better known as “track-and-trace." DSCSA was enacted as part of the Drug Quality... Read More
The Drug Supply Chain Security Act (DSCSA) signed into law November 2013 requires dispensers, including pharmacies, to comply with certain requirements related to product tracing. Although these requirements took effect on July 1, 2015, the FDA had... Read More