I attended the FDA’s New NDC Format Public Meeting last Monday where I presented my open letter that was last Monday’s RxTrace essay (see “An Open Letter To The FDA: New NDC Format Public Meeting”). After a welcome from Dr. Janet Woodcock, Director, FDA, Center For Drug Evaluation and Research (CDER) and a brief overview of the purpose of the meeting by Paul Loebach of FDA CDER, there were nine presentations from stakeholders and the public. After each presentation, the FDA panel Continue reading FDA New NDC Format Public Meeting
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
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
RxTrace readers are well aware that the deadline is this November 27 for applying unique serial numbers within GS1 DataMatrix 2D barcodes to prescription drugs distributed in the United States under the Drug Supply Chain Security Act (DSCSA). Once that happens, most prescription drugs entering the U.S. supply chain will be identified by 14-digit GS1 Global Trade Item Numbers (GTIN-14) for the first time (see “Anatomy of a GTIN”). That’s because, you can’t fit the drug’s National Drug Code (NDC) along with the serial number, lot number and expiration date into a data matrix barcode, as required by the law, without first encoding it into a GTIN-14 (see “Anatomy Of The National Drug Code”, and “Depicting An NDC Within A GTIN”). This fact forces companies to encode their NDCs into GTIN-14s, many for the first time. Continue reading Sponsored: How To Properly Define GTINs For Your NDCs
Heart Failure is a human condition that is characterized by several easily identifiable symptoms, including fatigue, difficulty breathing and in its later stages, gurgled breathing. My mother and my mother-in-law both suffered from heart failure during their decline. Analogous to heart failure in humans is a condition of an identifier system that is near the end of its useful life that we can call “identifier failure”. At the end of November, a new FDA final guidance called “Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs” went into effect. Buried deep within this 200+ page document is the official announcement that signaled the National Drug Code (NDC) identifier system is now afflicted with this end-stage condition. The NDC won’t last long now, and there is no longer any excuse for inaction. The need for a replacement is now urgent. Continue reading NDC Nearing Its End, Afflicted by ‘Identifier Failure’
Part 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
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 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