Dear FDA:
Thank you for inviting interested parties like me to provide our thoughts on the new NDC format that you think will be necessary in 10 to 15 years (see “FDA Seeks Input On The Future Format of the National Drug Code”). I hope you can make it that long, but regardless, now is certainly the time to begin working on a replacement. Continue reading An Open Letter To The FDA: New NDC Format Public Meeting
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DSCSA Uniqueness: SNI vs SGTIN
In case you didn’t see my note at the end of my essay a few weeks ago, I am publishing new, free-to-everyone, RxTrace essays, one per month, on the Center For Supply Chain Studies (C4SCS) community website under the “Tune In | Monthly Slice of RxTrace” heading. In fact, there are now two new essays there. I’m finding that they are getting little notice there, so I have decided to post short intro essays, like this one, here on RxTrace.com whenever I post a new essay on the C4SCS website. That way everyone here will get notified and can easily find them with a single click.
October’s essay is quite good. It discusses the differences between the SGTIN that drug manufacturers put on their packages and the SNI that the DSCSA requires them to put there, and the implications of those differences. It’s a very timely topic, I think you’ll agree. Continue reading DSCSA Uniqueness: SNI vs SGTIN
FDA’s Late Recommendation On Human Readable
Just ten weeks before the Drug Supply Chain Security Act (DSCSA) requires drug manufacturers to begin applying a serialized product identifier in barcode and human readable form to drug packages and homogeneous cases, the FDA has recommended a human readable format that differs from what the majority of manufacturers have already chosen. What’s going on here? What options do manufacturers have? Continue reading FDA’s Late Recommendation On Human Readable
Sponsored: From Serialization to Full Traceability: 2018 Outlook On Compliance
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
Sponsored: IQPC: The Biggest Challenges Preparing For The DSCSA
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
Does the DSCSA Have A ‘Spirit’
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’
Aggregation: The Achilles’ Heel of Pharma Supply Chain Operation Under A Serialization Regulation
Neither the Drug Supply Chain Security Act (DSCSA) in the United States, nor the Falsified Medicines Directive (FMD) in the European Union explicitly mandates the capture or use of aggregation data (see “Aggregation –> Chargeback Accuracy –> ROI” and “EU FMD: Aggregation Is Not Mandated, But It Will Be Necessary“). In this instance, “aggregation data” is data that documents the serialized packaging containment hierarchy of drug products—also known as “parent-child relationships”. It is well established that companies are not required by law to capture it, but for the smooth operation of pharma supply chains under a serialization, tracing and/or verification regulation, high quality aggregation data will be necessary. But there are warning signs that a significant percentage of drug manufacturers are not going to meet that bar by the deadlines. Continue reading Aggregation: The Achilles’ Heel of Pharma Supply Chain Operation Under A Serialization Regulation
Newly Published Material From HDA and C4SCS
I was on vacation last week and only arrived home Sunday evening so I didn’t have time to write an essay for Monday, but this is Tuesday! Near the end of last month there was a spike in the number of things that need to be covered in RxTrace. Two of them are important things from HDA and the Center For Supply Chain Studies. I’ve been waiting for both for months, and here they are. Continue reading Newly Published Material From HDA and C4SCS
