As I mentioned last week, the FDA published two new draft DSCSA guidance documents on the day of the recent FDA DSCSA Public Meeting (see “FDA DSCSA Public Meeting #3: A Difference?”). Let’s take a closer look at what’s in them and their significance to companies facing the Drug Supply Chain Security Act (DSCSA). I’ll cover one of the two in this essay and cover the other document in the next essay. Continue reading DSCSA Guidance: Definitions of Suspect and Illegitimate Product for Verification Obligations
FDA DSCSA Public Meeting #3: A Difference?
Last Wednesday the FDA held the third in a series of three Drug Supply Chain Security Act (DSCSA) public meetings (see “FDA Announces New DSCSA Pilot Program and Public Meeting Series”). I noticed a few important differences at this meeting compared with the two previous meetings (see “FDA DSCSA Public Meeting #1 Exposes Gulf In Goals”, and “FDA DSCSA Public Meeting #2, Still A Gulf”).
Overall, these differences indicate that the FDA may be beginning to recognize how much ground they and the industry must cover between now and November of 2023, and it appears that has led them to get a little more rational. One meeting is not enough to establish a change in pattern, but if it eventually proves true, then this meeting would be the beginning of that change. A big injection of rationality is what happened in Brazil back in late 2016 (see “Brazil Gets Rational With Their New Pharma Traceability Law”) and that seems to have put them on a course for success. Could something similar be happening here? Continue reading FDA DSCSA Public Meeting #3: A Difference?
The Most Head-Scratching Section Of The FMD
Just after I posted my last FMD essay on RxTrace (see “FMD, One Year Out”) I found out that the European Commission had published version 9 of their “Safety Features for Medicinal Products for Human Use, Questions and Answers”. This is must reading for anyone with questions about how to interpret the most confusing provisions of the Falsified Medicines Directive (FMD) (also known as EU Directive 2011/62 and which amends Directive 2001/83) and the Delegated Regulation (EUDR) (also known as EU Regulation No 2016/161) (see “The E.C. Officially Published The Pharma Safety Feature Delegated Act This Morning“).
With each major revision this Q&A document grows. This time it grew substantially with the addition of 21 new questions and answers and updates to four previously posted answers.
But there is one provision of the FMD that defies explanation, even though the Q&A document burns two Q&As to attempt it. That provision in the FMD is Section 1 of Article 45a, which basically says, in part, that you cannot put an anti-tamper device on non-prescription drugs unless the EC or a Member State specifically says you can. What’s going on here? Continue reading The Most Head-Scratching Section Of The FMD
Human Readable Text Controversy
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
FMD, One Year Out
Last Friday marked one year to go for the start of the Falsified Medicines Directive (FMD) and the Delegated Regulation (EUDR) in the European Union (EU) (see “More Concerns With The FMD/EUDR Big Bang Start”). With the one year delay in the serialization and verification requirement of the Drug Supply Chain Security Act (DSCSA) in the US, the deadlines for these two markets are only about 10 weeks apart, assuming there won’t be any more delays. I don’t expect another delay in the manufacturer’s serialization and verification deadline in the US, and I haven’t talked with anyone who expects Continue reading FMD, One Year Out
Sponsored: Unique Device Identification Questions Answered Here
If you have anything to do with Unique Device Identification (UDI) in your company and you’ve never been to one of the UDI Conferences put on by the Clarion Group, then you don’t know what you are missing. Those who have been to one know that these are the best possible events to attend for UDI.
Why? Easy. I’ve never been to a conference where the experts from the regulatory body itself—the FDA in this case—dominate the speaker list as they do here. If you have Continue reading Sponsored: Unique Device Identification Questions Answered Here
Sponsored: Dispenser Perspectives On The DSCSA: An IQPC Interview
Many RxTrace readers have a fairly good understanding of the perspective of drug manufacturers and wholesale distributors regarding the Drug Supply Chain Security Act (DSCSA) and its implementation, but dispenser perspectives are not so well understood. Enter IQPC who interviewed Brian Files, Principal Consultant with Healthcare Strategies Consulting Group and former Director, Inventory and Compliance with CVS Health, one of the largest chain pharmacies in the US, to find out his perspectives on the DSCSA.
Continue reading Sponsored: Dispenser Perspectives On The DSCSA: An IQPC Interview
Wholesalers Find Troubling Results In DSCSA Barcode Assessment
Last month GS1 US published the results of an assessment of the implementation progress by drug manufacturers of the Drug Supply Chain Security Act (DSCSA) serialization requirements. It contains troubling indications of the next problem the industry will face in its quest for DSCSA compliance: too many unusable barcodes.
Big deal, you say? That kind of complacency could come back to haunt you later this year. Now is the time to look at your own packages and address any deficiencies. Here is a look at what GS1 US found in their assessment. Continue reading Wholesalers Find Troubling Results In DSCSA Barcode Assessment
