Tag Archives: FMD

What’s So Hard About Unique Identifier Verification?

Both, the Drug Supply Chain Security Act (DSCSA) in the US and the Falsified Medicines Directive (FMD) in the EU make use of unique identifier verification in one way or another.  Under the FMD, verification is the centerpiece of patient protection.  Under the DSCSA, verification is used as a tool to help resolve higher risk use cases, like saleable returns to wholesale distributors, and anytime someone becomes “suspicious” about a collection of drug packages.  On the surface, verification of unique identifiers seems simple, but there are some sticky problems that make it complex in some circumstances (see also “Drug Verification: EU Vs US”). Continue reading What’s So Hard About Unique Identifier Verification?

The Most Head-Scratching Section Of The FMD

I found this sealed OTC product in my own closet. Note the round clear adhesive seal between the four yellow arrows. Would this anti-tamper seal render this product illegal in the EU after next February?

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

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

A US Medicines Verification Organization (USMVO)? Again

If you’re like me, you are doing at least some work this week.  I usually do some work work during this quiet time when I am not interrupted.  It’s usually things I need to do to wrap up the year, but also includes planning for the new year.  In case you are working this week but you need a little diversion, here is something to think about for 2018.

It has become increasingly clear that what the US pharma supply chain needs is for some organization to step up and take responsibility for the decisions and actions that are needed to ensure successful development and operation of the Enhanced Drug Distribution Security phase of the Drug Supply Chain Security Act (DSCSA).  There are less than six years before that phase is supposed to begin.  But with no one clearly specified as the organization responsible, odds are, it isn’t going to happen.  This was the topic I covered two months ago when I originally published “A US Medicines Verification Organization (USMVO)?”.  With the end of the year and the holidays coming up, I’ve been too busy to write a new essay this week, so take another look at this idea. Continue reading A US Medicines Verification Organization (USMVO)? Again

Sponsored: Bio/Pharma Serialization and Traceability Summit 2017

Back on June 30, 2017, the U.S. FDA extended the product identifier requirements under the Drug Supply Chain Security Act (DSCSA) to November 26, 2018 due to insufficient industry readiness.  This gives the industry an extra full year to make sure their solutions are fully integrated and tested.  Are you ready?  Are you done?  Even those who would have been ready this November are likely to have more to do to make sure their start-ups go smoothly.  What about your European Falsified Medicines Directive (FMD) strategy?  That’s right around the corner too. Continue reading Sponsored: Bio/Pharma Serialization and Traceability Summit 2017

A US Medicines Verification Organization (USMVO)?

The Drug Supply Chain Security Act (DSCSA) makes it clear that the FDA must work with industry stakeholders to figure out exactly how the US pharma supply chain should meet its requirements after November 27, 2023–see DSCSA Section 582(g).  That section specifies “The transaction information and the transaction statements shall be exchanged in a secure, interoperable, electronic manner…”.  There is no mention of the creation of an independent third-party to design or coordinate that exchange, and Continue reading A US Medicines Verification Organization (USMVO)?

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

Is Your Drug Too Small For The Mandated 2D Barcode?

Is your Drug Too Small?  Sample vial and syringe with barcode attached.
As an experiment, I taped the smallest DSCSA-compliant 2D barcode I could define to these sample vial and syringe from CCL Label. Notice that neither sample includes the required human readable text of the data encoded in the barcode, which means that these examples may not comply in some markets. The barcode on the vial is readable, but the one on the syringe is not readable because of the short radius of the barrel (about 5mm).

RxTrace readers are already well aware that multiple new laws around the world will require prescription drug manufacturers to put a new 2D barcode on their products in the next few years.  But what if your drug package is too small to fit the new mandated 2D barcode and human readable information on the label?  Let’s take a look at what the regulations say in the E.U., Brazil and the United States.  From that, we can come up with some strategies. Continue reading Is Your Drug Too Small For The Mandated 2D Barcode?