Tag Archives: GTIN

Is A GS1 GTIN Really Usable As An NDC For DSCSA Compliance? Part 2

QuestionBottle.Part 2Part 1 of this essay provided a wealth of hyperlinks into the Code of Federal Regulations (CFR) and FDA guidance documents with content related to placing the National Drug Code in human- and machine-readable form onto drug packages prior to November 27, 2017 (see “Is A GS1 GTIN Really Usable As An NDC For DSCSA Compliance?  Part 1”).  In Part 2, we will look at how the Drug Supply Chain Security Act (DSCSA) will change, or add-to, the requirements found in those earlier specifications.  And finally, we will be able to answer the question in the essay title.

HOW THE DSCSA CHANGES THE NDC AND BARCODE REQUIREMENTS FOR DRUG PACKAGES

First of all, the DSCSA does not change anything Continue reading Is A GS1 GTIN Really Usable As An NDC For DSCSA Compliance? Part 2

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

The DSCSA Product Identifier On Drug Packages

DSCSA Product IdentifierAccording to the Drug Supply Chain Security Act (DSCSA), manufacturers must apply a new “Product Identifier” on all of their prescription drug products by November 27, 2017 (Repackagers by that date in 2018).  The DSCSA Product Identifier is defined this way:

“PRODUCT IDENTIFIER.—

The term ‘product identifier’ means a standardized graphic that includes, in both human-readable form and on a machine-readable data carrier that conforms to the standards developed by a widely recognized international standards development organization, the standardized numerical identifier, lot number, and expiration date of the product.”  (Section 581[14])

Continue reading The DSCSA Product Identifier On Drug Packages

DSCSA “Serial Numbers”

????????????????I often write about the fact that drug manufacturers and repackagers that sell into the U.S. market must put “serial numbers”, or “serialize” their drug packages and homogeneous cases before November 27, 2017, but what exactly does that mean?

Let’s break it down.  The Drug Supply Chain Security Act (DSCSA) defines the term “Product identifier” this way:

PRODUCT IDENTIFIER.—

The term ‘product identifier’ means a standardized graphic that includes, in both human-readable form and on a machine-readable data carrier that conforms to the standards developed by a widely recognized international standards development organization, the standardized numerical identifier, lot number, and expiration date of the product.”  (Section 581[14])

Back in March of 2010—3 ½ years before Congress passed the DSCSA—the FDA published final guidance called “Guidance for Industry, Standards for Securing the Drug Supply Chain – Standardized Numerical Identification for Prescription Drug Packages”, which defined the term “standardized numerical identifier (SNI)” this way: Continue reading DSCSA “Serial Numbers”

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

The GS1 Healthcare US Guidance For DSCSA, Vsn 1.1

GS1 US logoA few weeks ago, GS1 Healthcare US published version 1.1 of their guidance for using the GS1 Electronic Product Code Information Services (EPCIS) standard to meet the U.S. Drug Supply Chain Security Act (DSCSA).  See “GS1 Healthcare US Publishes Updated Guidance For DSCSA”.  I was too busy at that time to review the document properly, but it is an important addition to the spectrum of information that companies can use to help them understand how to best meet the requirements of the DSCSA so I wanted to get back to it when I had time.  That time is now.

As long term readers of RxTrace know, I did not believe EPCIS would ever be usable to meet the now obsolete California Pedigree law (see “The California Pedigree Law Is Now Officially Inoperative”), or any other State pedigree laws, and I do not believe it will be widely used to meet the Federal DSCSA before maybe 2021 or 2022, but I do believe it will take center-stage for meeting the long-term requirements of the DSCSA.

In 2023 the DSCSA transitions into Continue reading The GS1 Healthcare US Guidance For DSCSA, Vsn 1.1

Pharma Serialization: Going Totally Global Soon

World map.iStock.smallerOne of the best sessions during last week’s LogiPharma conference held in Princeton, NJ was called “Staging Your Implementation To Meet The 2017 Deadline”.  The “deadline” refers to the November 27, 2017 deadline for drug manufacturers to apply unique serial numbers to all drug packages and cases shipped into the U.S. market as required in the Drug Supply Chain Security Act (DSCSA), but it can also refer to similar deadlines with similar requirements in a number of other regions of the world.  The panel included knowledgeable representatives from two of the largest global pharma manufacturers selling into the U.S. market.  Both manufacturers are facing serialization mandates in the E.U., Brazil, Turkey, South Korea, China, India, Argentina and a few countries in Africa as well as the U.S.

As they spoke about their respective programs for meeting the requirements, one of the speakers mentioned that roughly 90% Continue reading Pharma Serialization: Going Totally Global Soon

Randomization—An Interview with Ken Traub—Part 1: GS1 Serial Number Considerations

Ken Traub
Ken Traub

Over the next two weeks I have a very special treat for RxTrace readers.  It is an interview with Ken Traub, GS1 standards expert and independent consultant.  The subject is GS1 serial number randomization, something so important that I think pharma companies ought to give deep thought to it before they turn on their serial number applications.

Pharma manufacturer who sell into the E.U. and/or Brazil markets will be forced to randomize their serial numbers because of regulatory requirements, but even those who only sell into the U.S. market should strongly consider randomization.  I’ll have more to say about why in a follow-up essay after this series is over.

Because the interview with Ken covers the topic so thoroughly, it is long.  That’s good, because it provides readers with an easy to understand explanation of everything they need to know about randomizing.  But it also makes for a very long essay, so I have broken the interview down into five RxTrace essays.  Read sequentially, they contain the complete interview.  The subtopics covered by those essays include: Continue reading Randomization—An Interview with Ken Traub—Part 1: GS1 Serial Number Considerations