All things DSCSA and Serialization.

Time Is Running Out – Where Wholesalers Should Be In Regard to the Upcoming DSCSA Deadline

A look at the calendar tells us that summer is drawing to a close, and while that means trying to sneak in those last few bits of summer fun and recreation, wholesalers in the pharmaceutical industry are focused on something a bit more serious.

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Which Elements of the DSCSA Are Keeping Health Execs Up at Night?

At this point in 2019, we’ve long since passed the official midway point to complete DSCSA implementation and compliance in 2023. As each phase of the drug supply chain act has moved along, we’ve had a front row seat in witnessing the benefits of the process, along with a few growing pains along the way.

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FDA Violation issued! Form 483 Letter to one of Country's Largest Wholesale Distributor

2018 was a pretty significant year for the Drug Supply Chain Security Act (DSCSA) with a major deadline occurring last November. With this, there have been some rumblings in the industry as to when we were going to see the FDA issue its first sanction for a violation of the DSCSA.

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What’s Next for the DSCSA in 2019?

Members of the drug supply chain in the United States breathed a collective sigh of relief as the serialization deadline that had been extended to November 2018 finally passed. For many, the process took several years to fully implement with plenty of challenges along the way.

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7 Important Questions Answered About the DSCSA and Product Identifiers

Members of the drug supply chain, specifically wholesalers and manufacturers, have been working furiously towards meeting product identifier requirements for a fast approaching deadline. The deadline requires that pharmaceutical manufacturers adhere product identifiers to every package or homogenous case.

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FDA Issues Last Minute Draft Guidance to Address Human Readable Identifiers

As the November deadline for the DSCSA serialization quickly approaches, pharmaceutical manufacturers and other stakeholders within the drug supply chain have been working hard to ensure that they meet compliancy standards, especially considering that the approaching deadline is the cumulation of a year long extension granted by the FDA.

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