FDA issues delay for upcoming DSCSA compliance
Great news for pharmacies! FDA announced they will issue a one-year delay until November 27, 2024, for the requirements under the Drug Supply Chain Security Act (DSCSA) set to go into effect this year.
DSCSA was passed in 2013 and created a stepwise approach for implementing requirements for supply chain security. The goal was to create an electronic, interoperable exchange of information that identifies and traces certain prescription drugs down to the package level as they move through the supply chain to protect consumers from counterfeit, stolen, contaminated, or otherwise harmful drugs. DSCSA requires pharmacies, referred to as “dispensers,” to have systems and processes to comply with the law’s requirements.
FDA is strongly urging all members of the supply chain to continue their efforts to implement necessary measures to satisfy these enhanced drug distribution security requirements despite this one-year delay. Dispensers and other trading partners must still comply with other provisions of DSCSA that have been in place since its enactment including, among other things, the exchange of transaction information that has been required prior to November 27, 2023, as well as the verification requirements related to suspect and illegitimate products.