It’s been eleven months since the FDA held their public hearing to collect ideas for fixing the National Drug Code (NDC) system (see “FDA Seeks Input On The Future Format of the National Drug Code” and “FDA New NDC Format Public Meeting”). The FDA, themselves, estimated that they may have as little as 10 years before they run out of Labeler Codes, and that was over a year ago. So now we have less than nine years? My friends, it’s almost time to panic because the FDA seems to have dropped the ball after hearing from the industry that they would need at least ten years to prepare for any changes that the FDA may make (see “FDA New NDC Format Public Meeting”).Continue reading FDA Inaction On Fixing The NDC Indicates Why They Should Get Out Of The Numbering Business
It was fairly easy to predict the FDA would invoke enforcement discretion for the wholesale distributor’s saleable returns requirement of the Drug Supply Chain Security Act (DSCSA), as they announced last Tuesday (see “Is The FDA About To Delay Enforcement Of The Wholesaler’s 2019 Mandate?”). The deadline for the mandate was originally this November 27, but with the announcement, will not be enforced until November 27, 2020.Continue reading No Surprise: DSCSA Verification Delay
What is a counterfeiter to do today? Governments around the world are moving toward standardized serialization and track & trace requirements aimed directly at their bottom line. It’s getting harder to fake your way past supply chain workers who are increasingly educated on what to look for and how to raise their suspicions to the authorities. Or is it? Let’s take a closer look.Continue reading Pharma Counterfeiter Strategies In a Track & Trace World
Earlier this month the Russian Federation finally amended Decree #1556 to cut the length of the Signature portion of the crypto-code element of their pharmaceutical unique identifier in half. Will that solve the problems the industry uncovered, like the barcode taking up so much space and slow read performance? Let’s take a closer look at it, but first, a review.Continue reading Russia Officially Cuts Length of Crypto-code in Half
Last week GS1 US announced that they have published a new implementation guideline to help companies in the US pharma supply chain make use of the new GS1 lightweight messaging standard for verification of product identifiers to meet the saleable returned drug verification requirement of the Drug Supply Chain Security Act (DSCSA). The messaging standard itself was ratified by GS1 in January and it can be used to implement a wide range of product verification schemes in any industry. The new GS1 US guideline is a valuable resource for companies wanting to apply that standard to the problem of verifying drugs that fall under the DSCSA, so it contains a wealth of information needed to ensure interoperability of Verification Router Service (VRS) solutions.Continue reading GS1 US Publishes New DSCSA VRS Implementation Guide
Ahh, summer. Some years it seems like everyone is on vacation except me. I usually only take a few days off here and there in the summer, preferring to do longer vacations in other parts of the year. So next weekend I’m going to take an extra day off, and so there will be no RxTrace essay published next Monday (the Labor Day holiday here in the US), and I’m going to link to one of my favorite essays from the last year this week as the summer winds down. This essay was posted on October 7, 2018 under the “A Monthly Slice of RxTrace” on the Center For Supply Chain Studies (C4SCS) website. Unfortunately I haven’t been able to keep up with the “Monthly” part of that title due to time pressures, but there is some great content out there from the last 12 months (see “A Monthly Slice of RxTrace”). Other than my diverted attention, nothing has changed so I may post more new content on the C4SCS site in the future if I can make some time.Continue reading DSCSA Uniqueness: SNI vs SGTIN…Again
Some countries mandate the use of GS1 standards for drug product identification and package and case barcodes. The European Commission seems to tolerate GS1 standards, leaving it up to each member state to decide. Most use them, a few held onto their own national codes as long as they could. China is taking their time warming up to the GS1 Global Trade Item Number (GTIN) but it seems to be happening. That is, I think it’s happening. The United States has always had its own national numbering system for identifying drugs, known as the National Drug Code (NDC) (see “Anatomy Of The National Drug Code”). Because they are running out of numbers to identify new manufacturers (labelers), they are considering changes to the NDC that could break the ability to encode an NDC within a GTIN (see “How To Properly Define GTINs For Your NDCs”, “FDA New NDC Format Public Meeting” and “An Open Letter To The FDA: New NDC Format Public Meeting”). The USA is not the only country to be considering a break with GS1 standards. Indonesia will allow QR Codes on drug packages, and now there is a movement in the India government to move away from GS1 standards. What’s going on here? Can GS1 hold onto drug identification around the world? Let’s take a look.Continue reading Can GS1 Hold Onto Drug Identification Worldwide?
Last week the Pharmaceutical Distribution Security Alliance (PDSA) released a prospectus for the, as yet, unnamed non-profit organization that they are trying to kickstart to help govern supply chain interoperability of the Drug Supply Chain Security Act (DSCSA) solutions targeting the Enhance Drug Distribution Security (EDDS) phase that will go into effect in November of 2023 (see “PDSA’s Proposal for Governance of DSCSA Phase II Interoperability” and “PDSA Brainstorms Vision For DSCSA Governance Organization With Stakeholders”). You can download the prospectus here.Continue reading PDSA Releases Prospectus To Prospective Governance Group Members