Tag Archives: HIBCC

Is A GS1 GTIN Really Usable As An NDC For DSCSA Compliance? Part 1

QuestionBottleAfter 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

An Open Letter To The FDA, RE: Please Fix The National Drug Code Soon

Dear FriendDear FDA,

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 how you could do it for pharmaceuticals, let me explain why you should do it as clearly as I can. Continue reading An Open Letter To The FDA, RE: Please Fix The National Drug Code Soon

GS1 Publishes Version 16 Of Their General Specifications …And Why You Should Care

GS1_logoMedical device manufacturers have a choice of standards to use when identifying their products for the U.S. market.  The FDA’s Unique Device Identification (UDI) rule allows them to select from any identification standards organization (referred to as a “number issuing” agency) that is accredited by the Agency for that purpose.  So far, three organizations have been FDA-accredited:  HIBCC, ICCBBA and GS1.

ICCBBA has a lock on the identification of Continue reading GS1 Publishes Version 16 Of Their General Specifications …And Why You Should Care

The DSCSA, the NDC, Inventory Management, GS1 GTINs…and Turkeys

Thanksgiving is my favorite holiday!
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 Deadline For Class III Medical Devices Quickly Approaching

UDIexample.small.ucm368901There is a lot of angst in the pharma community right now about the fast approaching DSCSA first deadline for the exchange of transaction data, but the medical device community is dealing with an even earlier deadline:  the September 24, 2014 deadline for UDI on class III medical devices.

The FDA UDI web page lists the following requirements for the September deadline, now less than five months away:

Continue reading UDI Deadline For Class III Medical Devices Quickly Approaching

The Future of Healthcare Supply Chain Security

Businessman looking through binocularsLet’s take a brief pause from our in-the-moment work on meeting today’s healthcare supply chain security needs and consider what the supply chain will look like in the future.  Because of regulations and laws enacted in 2012 and 2013 in the U.S., and expected in 2014 in the E.U., we know more today about how healthcare supply chain security will work In 2024 than looking forward in any previous 10 year period.  In the last two years the U.S. and the E.U. have enacted legislation and introduced regulations that will have a profound impact on the security of these major supply chains in ten years.  These include:

Continue reading The Future of Healthcare Supply Chain Security

Will Use Of EPCIS Force Everyone To Use GS1 Identifiers?

EPCISOver the last five years the larger companies in the U.S. pharmaceutical supply chain have increasingly aligned around GS1’s Electronic Product Code Information Services (EPCIS) standard for holding and communicating serialization-based events.  The hope and expectation by many of these manufactures and others in the supply chain is that EPCIS will be the standard that ensures supply-chain-wide interoperability in any future track and trace or ePedigree system that the federal government might impose.  On its surface it appears that EPCIS is designed around GS1’s family of serialized identifiers, which are based on GS1’s GS1 Company Prefix (GCP) (see “Anatomy of a GTIN” and “Your GS1 Company Prefix: An Enterprise Resource“).  This includes Continue reading Will Use Of EPCIS Force Everyone To Use GS1 Identifiers?

UDI And The Approaching End Of The NDC

UDI Barcode Cake
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