FDA recently granted the pharmacies an additional four months to comply with federal track and trace requirements under the Drug Supply Chain Security Act (DSCSA). The DSCSA was enacted in 2013 to prevent and deter drug counterfeiting through the establishment of a nationwide pharmaceutical “track and trace” system. Each drug package would be given a unique number to allow federal officials to trace its path through the supply chain. However, many pharmacies were unable to meet compliance standards by the statutory deadline on July 1, 2015, and requested a temporary reprieve from the FDA’s transactional requirements. Regulatory Affairs Professionals Society (RAPS) has the full story here.
Last Updated on May 7, 2020 by Aimed Alliance
