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Wholesaler Question: Am I to able break down my package and sell individual vials without Serial numbers?

We recently received this question from a wholesaler. Their business relied in purchasing serialized products, removing each single unit vials from the box and selling each individual vials to physicians. The problem is that each vial does not have a serial number. Can they do that? Let's analyze.

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How YOU can Prepare for Interoperable Technology to meet the DSCSA requirements

Drug supply chain trading partners, including manufacturers, wholesalers, distributors, pharmacies, and other pharmaceutical related businesses have been adapting to the changes outlined in the DSCSA regarding how trading partners handle the serialization and traceability of pharmaceutical products. As we’ve said farewell to phase I of the DSCSA, it’s time to look ahead to phase II, which includes a focus on interoperability for the industry.

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Top Distributor issues VRS Letter, What Steps Should Other Wholesale Distributors Be Taking?

It’s hard to believe that more than a year has passed since manufacturers were in a mad rush to meet compliancy standards, but time marches on and now there’s a new deadline looming in the near future. 

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Do State Drug Importation Laws Align with the DSCSA

The Drug Supply Chain Security Act (DSCSA) is being implanted with the goal of securing our nation’s drug supply chain and ensuring the quality and purity of the pharmaceuticals that make their way into the patient’s hand. With the DSCSA, which was first adopted in 2013, the focus has been on track and trace solutions that enable trading partners to monitor each pharmaceutical as it makes it way through the drug supple chain. More than halfway through, the industry as a whole has made giant leaps toward this goal.

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How to Fill out your Wholesale Distributor/3PL Annual Report to the FDA

The Annual Reporting by Prescription Drug Wholesale Distributors and 4 Third-Party Logistics Providers is new reality for industry. This means that if you are pharmaceutical wholesaler and a 3PL you must submit your company information to the FDA. The actual FDA guidance:

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Will Negative Verifications Create Financial Strain for the Drug Supply Chain?

As we’re gearing up to face the DSCA deadlines this November brings, now is a good time to stop and reflect on some of the specific challenges the industry has faced up to this point. There has been a decent amount of challenges, some more impactful than others. Reflecting on these bumps in the road allows us to get a clearer picture of obstacles that may present themselves in the future, so that maybe we can better prepare for them today. 

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