The US FDA published a compliance policy guidance document on September 23, 2019, announcing a one-year enforcement discretion for the Wholesale Distributor Verification Requirement for Saleable Returned Drug Product. Despite…
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The HDA held their annual forum on serialization last week in Washington DC—and LSPediA was proud to be a sponsor of the event. As anticipated, the HDA did another outstanding…
In the FDA compliance policy final guidance document published on September 23, 2019 , FDA specifically called out that “manufacturer[‘s] verification obligations” will be enforced. Here, we take you for…
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....
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“We had a two-year span where we didn’t have any shipping discrepancies. That’s huge. In the years before we implemented RxChain for serialization it was common to have one a...
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Meet Mark Rumble! Mark is the VP of Operations at Auburn Pharmaceutical and is responsible for warehouse and regulatory operations and DSCSA compliance. “Auburn’s biggest challenge has been getting ready for…
Wholesalers: you need to be ready now. The DSCSA mandates all wholesale distributors to verify saleable returns by November 2019. That’s only 55 working days away. Still unclear about the November…
The November saleable returns deadline requires wholesale distributors to verify every saleable return package before restocking and the manufacturers must respond to a wholesalers’ request within 24 hours. The wholesalers,…
Meet Robert Urben! Robert is the Solutions Engineer at LSPediA and works closely with our customers to ensure a smooth onboarding process with our Verification Router Service (VRS) solution. He…