Last week the FDA posted final versions of two DSCSA guidance documents, and, a new draft Product Identifier Q&A document. The two final guidance documents include the grandfathering policy and the product identifier compliance policy that delayed enforcement of the product identifier and verification requirements until November 27, 2018. These documents are companions to each other, which is to say that they are pretty tightly related, and that’s why FDA Continue reading FDA Posts Two Final DSCSA Guidances And A Draft Product Identifier Q&A Document
In just two months, pharmaceuticals entering the US pharma supply chain through drug manufacturers will be serialized according to the Drug Supply Chain Security Act (DSCSA). It’s already been a long journey, but this is only the beginning. Companies can’t even take a break. In just one year the wholesale distributor saleable returns requirement will force manufacturers to either capture aggregation data or connect to a Verification Router Service (VRS)—or both! The year after that, Continue reading Sponsored: From Serialization to Full Traceability: 2018 Outlook On Compliance
Kevan MacKenzie, Director of Serialization Technology at McKesson, is arguably the leading expert on the Drug Supply Chain Security Act (DSCSA) requirements for wholesale distributors, and interactions with their trading partners. IQPC recently interviewed Mr. MacKenzie to get his perspectives on the biggest challenges companies face when preparing for the DSCSA.
MacKenzie’s insights will Continue reading Sponsored: IQPC: The Biggest Challenges Preparing For The DSCSA
I was on an industry call a few weeks ago when someone from a technology vendor suggested that the industry should take some particular action because, it was aligned with “the spirit of the Drug Supply Chain Security Act (DSCSA)”. That got me to thinking… Continue reading Does the DSCSA Have A ‘Spirit’