A lot has been written about the concept of “verification”, here in RxTrace and elsewhere. It’s all good, but I still don’t think the critical point has been made yet by anyone—including me (see “What’s So Hard About Unique Identifier Verification?”)—and until it is, companies are going to do it wrong. Less than an hour after I posted my essay last Wednesday (see “GS1’s Messaging Standard For Verification Of Product Identifiers”) I received an email from a subscriber who had questions about it, the essay was referenced in a post on LinkedIn by a reader in Europe, and I found a great link to a brand new essay about verification by Scott Pugh that had just been posted about the same time. So here is my new take on why most companies are going to get it wrong.Continue reading Most Companies Will Do DSCSA Verification Wrong
For companies in the US pharma supply chain, 2019 is going to be the year of an important milestone of the Drug Supply Chain Security Act (DSCSA). In November, wholesale distributors will be required to begin issuing verification requests to manufacturers, at the Standardized Numerical Identifier (SNI) level, for any returned drug that is still saleable, before they resell it. I’ve written a lot about this change in the past.Continue reading GS1’s Messaging Standard For Verification Of Product Identifiers
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the FDA has received for their ‘Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers’ draft guidance (see “FDA Posts Two Final DSCSA Guidances And A Draft Product Identifier Q&A Document” and “FDA’s Late Recommendation On Human Readable”).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
Most regulations dictating the application of unique identifiers on drug packages also dictate specific data be encoded into a machine-readable barcode, and human readable text. The purpose of the machine-readable unique identifiers is obvious–to allow computers to read the product’s unique identifier quickly and accurately. The purpose of the human-readable unique identifier is less well-understood. Many believe it is to allow manual entry of the barcode contents when the barcode is unreadable for any reason. Others believe it is Continue reading How To Accept Manual Entry Of Drug Unique Identifiers
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