Search Results for: "enforcement discretion"

Dispensers, DSCSA

FDA Limits Ongoing Dispenser Enforcement Discretion To First Responders

Back in October the FDA announced the extended use of enforcement discretion to temporarily set aside the data exchange provisions of the Drug Supply Chain Security Act (DSCSA) for dispensers until March 1, 2016 (see “FDA Extends Dispenser Delay in DSCSA Enforcement“).  That was itself an additional four month extension to the four month enforcement … Continue reading FDA Limits Ongoing Dispenser Enforcement Discretion To First Responders →

DSCSA, HDA, PDG

2 Organizations You Need to Join to Get Ready for the DSCSA Phase II

If you are a pharmaceutical company serious about meeting the requirements of Phase II of the DSCSA, there are two organizations you must join.  The first is the Partnership for DSCSA Governance, or the PDG. It is an organization formed by manufacturers, wholesalers, dispensers, and solution providers that are working to solve the interoperability requirements … Continue reading 2 Organizations You Need to Join to Get Ready for the DSCSA Phase II →

COVID-19, DSCSA, FDA

Impact of COVID-19 on DSCSA Implementation

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Before the pandemic struck, the pharma industry was working feverishly to implement and enforce all the requirements of the DSCSA, especially the Phase II requirements scheduled for November of 2023. When COVID-19 dramatically changed the business landscape, the implementation became even more of an uphill battle, with both time and the pandemic acting as a … Continue reading Impact of COVID-19 on DSCSA Implementation →