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

Blockchain Will Not Be Used For DSCSA Data Exchange

That’s right.  I have now concluded that Blockchain will never be used in the US supply chain to fulfill the DSCSA requirement for sellers to provide buyers with Transaction Information (TI) and Transaction Statements (TS) (see also “Could Blockchain Technology Be Used For DSCSA Compliance?”).  So if you are currently planning to do a pilot to test a proposed architecture to do that, I recommend that you adjust it to test something else (see also “What Should FDA Pilot?”).

In fact, the thing to test is whether or not it can be used to facilitate gathering the TIs for a given Standardized Numerical Identifier (SNI) going back to the original manufacturer, as needed after November 27, 2023 during a suspect product investigation or recall.  Those are rare events compared with the number of drug sales and shipments where the TI and TS will need to be exchanged.

How and why did I come to this conclusion?  Let me explain. Continue reading Blockchain Will Not Be Used For DSCSA Data Exchange

HDA Questions FDA’s Authority To Mandate A Centralized System For the EDDS

Man in camelhair business suit wearing Question Authority button on left lapelOnce again, the Healthcare Distribution Alliance (HDA) has submitted written comments to the FDA as a follow-up to the FDA’s most recent DSCSA Public Meeting held on December 5-6 (see “HDA Schools FDA On DSCSA”, and “FDA DSCSA Public Meeting #2, Still A Gulf”).  The comments cover seven “issues” HDA wanted to provide further comments on, beyond those already expressed in the public meeting itself and earlier written comments.  The seven issues include:

  1. HDA urges greater appreciation for and recognition of the ‘distributed model’…
  2. HDA recommends topics to address at the February 28 public meeting
  3. We expand upon certain data standard and exchange issues from the December public meeting
  4. …we offer suggestions for where ‘guardrails’ may be useful [to the industry]”
  5. We summarize our understanding of the aggregation and inference discussion at the public meeting…
  6. HDA urges FDA to begin undertaking the small business assessment mandated by the DSCSA
  7. …various other issues raised during the public meeting…

Continue reading HDA Questions FDA’s Authority To Mandate A Centralized System For the EDDS

Sponsored: Anti-counterfeiting Successes and Failures Around the World

Governments around the world recognize the problem that the World Health Organization (WHO) once called Substandard/Spurious/ Falsely-labelled/Falsified/ Counterfeit medical products, or SSFFC, but more recently calls Substandard and Falsified medical products.  These governments recognize the problem, and their citizens suffer from it, but some of them don’t seem to know what to do about it.  Nigeria, Kenya and other countries in Africa have been very assertive in attacking the problems, but other poorer countries without strong central governments can’t afford or don’t have the will necessary to take strong action.

Rich countries impose serialization and tracing requirements, but that only helps to keep the legitimate supply chain clean.  Many countries Continue reading Sponsored: Anti-counterfeiting Successes and Failures Around the World

3 DSCSA Requirements You Can Totally Ignore

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

DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of Dirk Rodgers. The material contained in RxTrace is not legal advice. Dirk Rodgers is not a lawyer.
The reader must make their own decisions about the accuracy of the opinions expressed in RxTrace. Readers are encouraged to consult their own legal counsel
and trading partners before taking any actions based on information found in RxTrace. RxTrace is not a vehicle for communicating
the positions of any company, organization or individual other than Dirk Rodgers.

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