Tag Archives: NCPA

Dispensers, DSCSA

Dispensers Make Last Minute Appeal for Delay in DSCSA Deadline

Less than a week before the July 1, 2015 Drug Supply Chain Security Act (DSCSA) deadline for dispensers to begin receiving, storing a being able to retrieve Transaction Information (TI),Transaction History (TH) and a Transaction Statement (TS) for every incoming shipment of prescription drugs, a group of pharmacy associations have asked the FDA for enforcement discretion for an unspecified time to avoid “…the possible outcome of disruptions to the supply chain”.  Continue reading Dispensers Make Last Minute Appeal for Delay in DSCSA Deadline →

Congress, Federal Pedigree

Federal Pedigree: Caught In A Web Of Politics

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spiderwebSeventeen months ago, the goal of the Pharmaceutical Distribution Security Alliance (PDSA) was to get a nationwide track & trace bill introduced into Congress and then get it attached to some “must-pass” legislation which would pull it through to certain passage.  They found sympathetic members of both houses of Congress and they worked together to produce a single bill.  Last summer the “must-pass” legislation was the Prescription Drug User Fee Act (PDUFA) which was combined with other bills and was enacted as the FDA Security and Innovation Act (FDASIA).  See “What If RxTEC Isn’t Adopted?”, “PDUFA Will Not Include RxTEC” and “The Supply Chain Provisions Of The FDA Safety & Innovation Act”.)

Unfortunately the track & trace Continue reading Federal Pedigree: Caught In A Web Of Politics →