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
How Will They Delay The FMD?
There is now little doubt that the Falsified Medicines Directive (FMD) will need to be delayed. The only question is, how will they do it? Let’s look at some facts and try to come up with a possible answer. Continue reading How Will They Delay The FMD?
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’
China Posts New Draft Pharma Serialization Guidelines
As I was preparing today’s RxTrace essay on Friday I received notice from GS1 Healthcare that China had posted draft guidance for comment for a new pharmaceutical traceability system. I dropped everything and translated the three documents into English for RxTrace subscribers and GS1 Healthcare members to use.
The explanation provided by the China Office of the State Drug Administration for the drafts translates to: Continue reading China Posts New Draft Pharma Serialization Guidelines
EMVO Admits, ‘Insufficient Randomisation’ Warnings Can Be Ignored
The EU Delegated Regulation (EUDR) of the Falsified Medicines Directive (FMD) mandates that all serial numbers placed on non-exempt drugs entering the EU supply chain after February 9, 2019 must be ‘sufficiently randomised’. What is sufficient randomisation? The regulation says one thing, and the European Medicines Verification Organization (EMVO), the operator of the EU Hub, says something beyond that. What should drug manufacturers do? The EMVO recently updated their messaging. Let’s take another look at this important topic. Continue reading EMVO Admits, ‘Insufficient Randomisation’ Warnings Can Be Ignored
FDA Seeks Input On The Future Format of the National Drug Code
Last week the FDA published a notice of a public hearing and request for comments regarding the impact of any future changes made to the length and format of the National Drug Code (NDC). The current format of the NDC has been around since the early 1970s (see “Anatomy Of The National Drug Code”). It has served the FDA, healthcare professionals and patients well since that time, but it is showing its age. I call its affliction, “Identifier Failure” and I point out all of the symptoms for the aging NDC system in my essay “NDC Nearing Its End, Afflicted by ‘Identifier Failure’”.
It appears that the FDA recognizes these problems Continue reading FDA Seeks Input On The Future Format of the National Drug Code
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
