Passage of Drug Supply Chain Security Act (DSCSA) resulted in the immediate preemption of all State drug pedigree laws. It creates a closed prescription drug distribution system to prevent harmful drugs from entering the supply chain and reaching patients. The law places a heavy burden on the purchasers of the drug to respond to any FDA inquiries on pharmaceutical sourcing in full within 48 hours, providing all product transactional information records for the past six years. MMCAP Infuse provides a solution to ensure that the purchasers within government healthcare facilities using the contract can comply with FDA regulations.
After a competitive solicitation, vendors were contracted to provide a “software as a service” solution to allow MMCAP Infuse members to (a) confirm vendors and business partners are Authorized Trading Partner under the DSCSA, (b) comply with the product transactional information requirements for pharmaceutical dispensers for the DSCSA as they relate to the storage of and access to the data required for pharmaceuticals covered under the DSCSA, and (c) confirm pedigree of received pharmaceuticals and producing reports on transactional data as required by the DSCSA.