After November 27, 2017 the U.S. Drug Supply Chain Security Act (DSCSA) requires drug manufacturers (2018 for repackagers) to affix a DSCSA “product identifier” to all drug packages entering the supply chain (see “ The DSCSA Product Identifier On Drug Packages”). According to the DSCSA, that product identifier must be present in both human-readable and 2D Data Matrix barcode forms. Part of that product identifier is what is known as a Standardized Numerical Identifier (SNI). The SNI is composed of the drug’s National Drug Code (NDC) and a serial number (see “ DSCSA ‘Serial Numbers’”) that is unique on every individual package of that drug (see “ FDA Aligns with GS1 SGTIN For SNDC” and “ Anatomy Of An FDA SNI”).
Lately, I’ve heard people in the industry claim that it is acceptable to use a GS1
Global Trade Item Number (GTIN) that encapsulates an NDC (see “ Depicting An NDC Within A GTIN”) to satisfy the NDC part of this DSCSA requirement to affix the product identifier on a drug package. I’m not so sure about that. Let me explain. Continue reading Is A GS1 GTIN Really Usable As An NDC For DSCSA Compliance? Part 1
Thanks for inviting me to your
DSCSA Pilot Party this week. I look forward to visiting you at your Silver Spring home so we can catch up on what’s been happing in our lives recently. I’m glad you are thinking more about the Drug Supply Chain Security Act (DSCSA) lately. I am too.
In fact, I’ve been thinking about how nice it would be if you would fix the broken
National Drug Code (NDC) as part of the implementation of the DSCSA. It’s really not very hard to do. You already laid out and tested the path that needs to be followed when you implemented the Unique Device Identification (UDI) numbering system for medical devices a few years ago.
Remember how happy that made me? Remember, I called it “revolutionary” (see “
FDA Proposed UDI: A Revolution In Number Assignment”), and it was! But before I get to for pharmaceuticals, let me explain how you could do it as clearly as I can. why you should do it Continue reading An Open Letter To The FDA, RE: Please Fix The National Drug Code Soon
Giving thanks! It is my favorite holiday and I have a lot to be thankful for.
Until the Drug Supply Chain Security Act (DSCSA) was passed as part of the Drug Quality and Security Act (DQSA) last year (see “
It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law”), companies could use whatever code they wanted to refer to the prescription drug products in supply chain operations and for their own inventory management. Some probably chose the 10-digit National Drug Code (NDC), some probably chose the 11-digit reimbursement code that is based on the 10-digit NDC, and some probably chose to use a 12- or 14-digit GS1 Global Trade Item Number (GTIN) as a reference code for their inventory data. But now that the DSCSA mandates the use of the 10-digit NDC when exchanging transaction data on January 1, companies using the other codes that are based on the NDC might need to Continue reading The DSCSA, the NDC, Inventory Management, GS1 GTINs…and Turkeys
UDI Barcode Cake from last week’s UDI Conference
To be honest, I was somewhat surprised when Jay Crowley announced during last week’s
UDI Conference that the U.S. FDA had published the final rules for Unique Device Identification (UDI). Its publication starts the clock on a host of new requirements designed to identify most medical devices in the U.S. market with the same standard approach. That is expected to result in the reduction of errors made by medical professionals and also increase the accuracy and efficiency of the supply chain. I’ve become a little jaded about healthcare Automatic Identification and Data Capture (AIDC) deadlines lately and so the fact that one actually happened caught me slightly off-guard. Of course, UDI was Continue reading UDI And The Approaching End Of The NDC
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