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the FDA has received for their ‘Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers’ draft guidance (see “FDA Posts Two Final DSCSA Guidances And A Draft Product Identifier Q&A Document” and “FDA’s Late Recommendation On Human Readable”).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
Just ten weeks before the Drug Supply Chain Security Act (DSCSA) requires drug manufacturers to begin applying a serialized product identifier in barcode and human readable form to drug packages and homogeneous cases, the FDA has recommended a human readable format that differs from what the majority of manufacturers have already chosen. What’s going on here? What options do manufacturers have? Continue reading FDA’s Late Recommendation On Human Readable
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
I was a little surprised at how heated the discussion was at the breakfast table back during last year’s Healthcare Distribution Alliance (HDA) Traceability Seminar. I chose an open seat at a table with people from multiple drug manufacturers and someone from GS1 US. Our conversation at the table started out typically—the weather, the previous day’s speakers—the usual. I had recently been thinking about the human readable portion of the Product Identifier mandated by the Drug Supply Chain Security Act (DSCSA) (see “The DSCSA Product Identifier On Drug Packages”), so I asked everyone what their company was planning to do? Continue reading Human Readable Text Controversy
The Drug Quality and Security Act (DQSA) was constructed back in 2013 by Congressional staff, with input from the FDA, members of the industry and who knows who else. There was one bill in the House of Representatives and a different bill in the Senate. Once these bills passed their respective houses, they formed a conference committee who merged the two bills into the final text that we know today as the DQSA (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law”). Chapter 2 of that act is the Drug Supply Chain Security Act (DSCSA). Most readers of RxTrace haven’t forgotten that history but it is important to look back at that history to explain why most companies can ignore certain requirements in the law. That’s right. There are requirements in the law that you can ignore because they will not be enforced by anyone. They are the result of the disjoint way the DQSA was written. Let me explain. Continue reading 3 DSCSA Requirements You Can Totally Ignore