Does Interoperability Change In 2023?

There are many terms specifically defined within the Drug Supply Chain Security Act (DSCSA) text (see “Don’t Skip The DQSA Definition of Terms Section”).  One of the words you should expect to be defined there is “interoperability”, because it plays such a big role in the system(s) that must be used by everyone in the supply chain after November 27, 2023.  That is, the “…interoperable, electronic tracing of product at the package level…” that is at the core of the Enhanced Drug Distribution Security (EDDS) phase that is defined in Section 582(g).  But surprisingly, the term not defined in the text.

In fact, it appears to be left up to Continue reading Does Interoperability Change In 2023?

Sponsored: Don’t Miss These Back-To-Back Pharma Serialization and Tracing Events

There is a rare alignment of events that will happen in the first week of December that is so special that you need to put it on your calendar.  There are two important pharma serialization events that will occur in the Washington DC area and anyone with a serious interest in that subject should attend both.  These events line up perfectly to allow you to travel once, and spend four days that will solidify your understanding of the issues and opportunities embedded within the Drug Supply Chain Security Act (DSCSA) in particular, and pharma serialization in general. Continue reading Sponsored: Don’t Miss These Back-To-Back Pharma Serialization and Tracing Events

The FMD Product Code

Under the Falsified Medicines Directive (FMD), starting on February 9, 2019 drug manufacturers must begin affixing a new Unique Identifier and an anti-tamper device to all consumer packages of prescription drugs (see “The E.C. Officially Published The Pharma Safety Feature Delegated Act This Morning”).  The Unique Identifier must be composed of a Product Code, Serial Number, Batch Number, Expiration Date and, where required, a National Reimbursement Code (see “The ‘Unique Identifier’ in the EU Delegated Act”).  This data must be uploaded to the E.U. Hub prior to shipment into the supply chain.  All of the details are spelled out in the Delegated Regulation (EUDR).

One of the more interesting aspects of the FMD/EUDR is the Product Code. Continue reading The FMD Product Code

DSCSA: The U.S. Pharma Supply Chain Must Organize, Or Risk Failure, Again

iStock_000021010135XSmallA couple of days before President Obama signed the DQSA legislation back in 2013 I published an RxTrace essay that looked at what was going to be necessary in the next year from the FDA and the industry (see “DQSA: The U.S. Pharma Supply Chain Must Organize, Or Risk Failure“).  The initial standards necessary at that time were for data exchange, and the FDA had one year to come up with them.  My essay was about the need for the industry to work with the FDA to come up with the standards that would work.  The FDA didn’t have the expertise or the knowledge of how the supply chain operated and so I felt it was imperative for the industry to help them out.

Fast forward to today.  Rather than data exchange standards, the FDA is facing Continue reading DSCSA: The U.S. Pharma Supply Chain Must Organize, Or Risk Failure, Again

FDA DSCSA Public Meeting #1 Exposes Gulf In Goals

The FDA held the first of three scheduled DSCSA public meetings last week.  This one focused on:

  • The vision for 2023; and,
  • The enhanced drug distribution security (EDDS) needs related to tracing prescription drugs at the package level.

The meeting started off with short presentations by representatives from:

In the short time they were each given, these speakers Continue reading FDA DSCSA Public Meeting #1 Exposes Gulf In Goals

Identifying Trading Partners Under the DSCSA

The FDA published a new draft guidance yesterday with explanations intended to dispel various kinds of confusion over the five kinds of trading partners defined in the Drug Supply Chain Security Act (DSCSA) text.  They are clearly on a roll, with the combination of the recent draft compliance policy, pilot and public meeting announcements, and now this draft guidance exceeding all of the DSCSA-specific communications they produced last year.  We’ll know for sure that the logjam has been cleared when we finally see one of the four mandated guidance documents that were originally due on November 27, 2015 (see “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?“).  But what about this new one? Continue reading Identifying Trading Partners Under the DSCSA

Sponsored: How Long Until You Are Fully Serialized?

This week, IQPC released the final report of a very interesting survey they conducted in April through June this year.  The results are fresh and they paint a picture with good news, and not so good news about the readiness of pharmaceutical manufacturers facing serialization deadlines in the United States, the European Union and elsewhere.  The survey focused on serialization planning, implementation progress, traceability in operation and benefits beyond compliance.  You can download the full report here, but let’s take a look at the responses to just one of the questions they asked. Continue reading Sponsored: How Long Until You Are Fully Serialized?

DSCSA Verification and Suspect Product

Last week I wrote about the debate over the number of possible responses to verification requests in any potential solution the industry might adopt to meet the Drug Supply Chain Security Act (DSCSA) (see “DSCSA Red Light Green Light: Verification Responses”).  Today I want to take a closer look at a related issue:  the relationship between verification and suspect product.  Most specifically, does a failed verification automatically force a product into the suspect product category?  The answer might surprise you. Continue reading DSCSA Verification and Suspect Product