There are quite a few people people in the industry who misunderstand how the Drug Supply Chain Security Act (DSCSA) was designed to protect the supply chain. The most common misunderstanding is that it is a full “track and trace” system where drugs are verified at each step. In fact, the DSCSA is mainly just a breadcrumb system that forces companies in the supply chain to retain standardized documentation of supply chain events, “just in case”. Very few drug packages will ever get “verified” at any point in their existence in the supply chain. And that’s by design.Continue reading How The DSCSA Is Designed To Work
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
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?
Happy New Year!
A few hours before the end of the comment period, I submitted my comments to FDA’s docket on Regulations.gov for the new NDC format. By the time your read this, the docket will be closed. The agency that operates that web site often takes a few days to post submissions, but because of the government shutdown, I doubt if anyone will be working on it until after the government re-opens (assuming the furloughed workers haven’t gotten a better job by then…In that case, it could be even longer).Continue reading My Comments Regarding The New NDC Format
Over the weekend I skimmed through the many responses the FDA has received for their ‘Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers’ draft guidance (see “FDA Posts Two Final DSCSA Guidances And A Draft Product Identifier Q&A Document” and “FDA’s Late Recommendation On Human Readable”). As usual, the most specific, most detailed and most interesting response comes from the Healthcare Distribution Alliance (HDA). In fact, a few of the other respondents refer to the HDA’s work in the areas covered by the Q&A. Many of the respondents—even those who did not credit HDA—agreed with the HDA’s positions they covered. There were a few different opinions, however. Let’s take a look. Continue reading FDA Gets Comments On Their Draft Q&A on DSCSA Product Identifiers
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
In case you didn’t see my note at the end of my essay a few weeks ago, I am publishing new, free-to-everyone, RxTrace essays, one per month, on the Center For Supply Chain Studies (C4SCS) community website under the “Tune In | Monthly Slice of RxTrace” heading. In fact, there are now two new essays there. I’m finding that they are getting little notice there, so I have decided to post short intro essays, like this one, here on RxTrace.com whenever I post a new essay on the C4SCS website. That way everyone here will get notified and can easily find them with a single click.
October’s essay is quite good. It discusses the differences between the SGTIN that drug manufacturers put on their packages and the SNI that the DSCSA requires them to put there, and the implications of those differences. It’s a very timely topic, I think you’ll agree. Continue reading DSCSA Uniqueness: SNI vs SGTIN