“The Drug Quality and Security Act (DQSA) was signed into law almost seven years ago on Nov. 27, 2013. Title II of this Act, known as the Drug Supply Chain Security Act (DSCSA), …
… initial requirements of the DSCSA, introduced in a phased manner, were deliberately structured and timed to allow industry to thoughtfully design and implement the required capabilities in preparation for the pinnacle requirement, which goes into effect on Nov. 27, 2023: the implementation of Enhanced Drug Distribution Security (EDDS) capabilities. EDDS will be enabled by the establishment of standards for the interoperable exchange of data, combined with the inclusion of individual serial numbers in the product shipment transaction information transmitted for the NDCs/Lot #s sold and distributed. …
There is little doubt that the prescription drug product traceability and reporting requirements at the individual, serialized unit-level will require considerable planning, assessment, decision-making, change control, and execution. Manufacturers need to proceed quickly but thoughtfully and should approach this upcoming era of serialized product traceability holistically by expanding their objectives beyond achieving and maintaining compliance.”
“Blockchain startup Mediledger has published the results of its FDA blockchain pilot for the pharmaceutical supply chain. Numerous separate groups applied to the FDA and ran pilots for the Drug Supply Chain Security Act (DSCSA) 2023 milestone for package-level tracing, with this being one of the largest groups. Mediledger’s participants included all three major U.S. wholesalers, seven out of ten of the world’s largest pharmaceutical companies, massive dispensers Walgreens and Walmart, as well as logistics firms such as FedEx.”
“The Trump Administration wants to start a drug-importation program from Canada for both small-molecule and biologic products. The program would be a “time-limited Section 804 importation program” (SIP), with the SIP program sponsored by “a pharmacist, a wholesaler, or another State or non-federal governmental entity” and subject to FDA review. Additional language in the notice of proposed rulemaking (NPRM) gives guidance on how manufacturers themselves could set up reimportation. The NPRM is available in draft form today (Dec. 18), and is expected to be published officially in the Federal Register on Dec. 23.”
“The US FDA published a compliance policy final guidance document on September 23, 2019, announcing a one-year enforcement discretion for the Wholesale Distributor Verification Requirement for Saleable Returned Drug Product.
If you’re a wholesaler or a manufacturer rushing to meet the November 2019 deadline, this guidance is significant. But before you breathe a sigh of relief, you need to read the entire guidance document and the entirety this LSPediA article.”