Tag Archives: pharmaceutical supply chain

EU FMD, EUDR

More Concerns With The FMD/EUDR Big Bang Start

iStock.Licensed.criminalThe key part of Article 50 of the European Union Delegated Regulation (EUDR) says:  “This Regulation…shall apply from 9 February 2019.”  That’s the date of the “big bang”—the date everything takes effect.  On that date, all drugs entering E.U. markets (except in Italy, Belgium and Greece) must contain the two safety features called out by the regulation on their packaging, including an anti-tamper device and a compliant Unique Identifier (see “The ‘Unique Identifier’ in the EU Delegated Act”).  It is the date by which “National Competent Authorities” in each of the EU member states (except the three listed above) must offer a data repository for the covered drug products that are targeted at their local market.  And it is the date on which dispensers (called “persons authorised or entitled to supply medicinal products to the public” in the text) must begin using the system of repositories to “…verify the safety features and decommission the unique identifier of any medicinal product bearing the safety features they supply to the public…”.  All on the same day.  The day of the “big bang”.

This “big bang” start will result in some problems. Continue reading More Concerns With The FMD/EUDR Big Bang Start →

GTIN, NDC

Is A GS1 GTIN Really Usable As An NDC For DSCSA Compliance? Part 1

QuestionBottleAfter November 27, 2017 the U.S. Drug Supply Chain Security Act (DSCSA) requires drug manufacturers (2018 for repackagers) to affix a DSCSA “product identifier” to all drug packages entering the supply chain (see “The DSCSA Product Identifier On Drug Packages”).  According to the DSCSA, that product identifier must be present in both human-readable and 2D Data Matrix barcode forms.  Part of that product identifier is what is known as a Standardized Numerical Identifier (SNI).  The SNI is composed of the drug’s National Drug Code (NDC) and a serial number (see “DSCSA ‘Serial Numbers’”) that is unique on every individual package of that drug (see “FDA Aligns with GS1 SGTIN For SNDC” and “Anatomy Of An FDA SNI”).

Lately, I’ve heard people in the industry claim that it is acceptable to use a GS1 Global Trade Item Number (GTIN) that encapsulates an NDC (see “Depicting An NDC Within A GTIN”) to satisfy the NDC part of this DSCSA requirement to affix the product identifier on a drug package.  I’m not so sure about that.  Let me explain. Continue reading Is A GS1 GTIN Really Usable As An NDC For DSCSA Compliance? Part 1 →

GLN

GLN: The Lowly Identifier That Could Kill The Use Of EPCIS For Pharma Regulatory Compliance

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iStock_000085320577_SmallerAlmost everyone agrees that GS1’s Electronic Product Code Information Services (EPCIS) standard will be used by drug manufacturers and the large wholesale distributors in the United States for compliance with the serialization requirement of the Drug Supply Chain Security Act (DSCSA).  Even I think that (see “Will EPCIS Event Exchange Replace EDI ASNs for DSCSA Someday?”).  But there is a problem that could kill its use beyond the internal uses of today, keeping it from being used for data exchange or the data repositories that will eventually become the way data is “exchanged” in 2023 as part of the Enhanced Drug Distribution Security (EDDS) phase of the DSCSA.

The problem is, EPCIS defaults to the use of a single location identifier, the GS1 Global Location Number (GLN).  So what?  Why is that a problem?  Let me explain. Continue reading GLN: The Lowly Identifier That Could Kill The Use Of EPCIS For Pharma Regulatory Compliance →

EU FMD

EU FMD: Aggregation Is Not Mandated, But It Will Be Necessary

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iStock_000016455220_SmallerEver since the E.U. Falsified Medicines Directive (FMD) was passed in 2011 my European friends have touted the fact that their government mandated solution would take a “bookend” approach.  The implication was always that it would be much less complex than the ePedigree approaches that were being planned by various U.S. states, and then by the U.S. federal government with the passage in 2013 of the Drug Supply Chain Security Act (DSCSA).

My friends always liked to point out how simple Continue reading EU FMD: Aggregation Is Not Mandated, But It Will Be Necessary →

DSCSA, EUDR

Meeting U.S. and E.U. Drug Serialization Requirements With A Single Solution

As serialization mandates sweep the world you would think that drug manufacturers and repackagers would just deploy one generic “serialization application” and simply turn it on for any drugs that requires it, and turn it off for any that do not.  That’s probably what the legislatures and regulators who create the requirements think.  RxTrace readers know it’s not nearly that easy.

The problem is that every regulation requires something different.  The only common thread is that there is always a “serial number” requirement in there somewhere (thus the name).  But the serial number itself is usually defined differently and everything else that surrounds the serial number is often not the same.  It’s not a matter of just turning it on and off, it’s a matter of changing a bunch of parameters, which result in significantly more complexity in the setup, testing and validation of the system for each market. Continue reading Meeting U.S. and E.U. Drug Serialization Requirements With A Single Solution →

EUDA

The E.C. Officially Published The Pharma Safety Feature Delegated Act This Morning

EC logoWith the official publication of the European Union Delegated Act (EUDA), the clock starts for pharmaceutical manufacturers who supply drugs for the E. U. market to include two safety features on their drug packages.  One safety feature is some type of tamper evident seal, and the other is a “unique identifier”, also known as “serialisation” (see “The ‘Unique Identifier’ in the EU Delegated Act“). Continue reading The E.C. Officially Published The Pharma Safety Feature Delegated Act This Morning →

wholesaler

U.S. Drug Wholesale Distributors Provide Direction To Manufacturers

Providing "direction"Over the next few years, the U.S. drug wholesale distributors are going to start dictating their specific requirements related to the Drug Supply Chain Security Act (DSCSA) to their suppliers.  For the “Big 3” U.S. wholesale distributors, those suppliers happen to be nearly every drug manufacturer who markets drugs in the United States.  The “Big 3” include McKesson, AmerisourceBergen and Cardinal Health, which together distribute about 85% of all drugs that pass through the domestic supply chain.

Of course, each segment has Continue reading U.S. Drug Wholesale Distributors Provide Direction To Manufacturers →

FDA Guidance

FDA Announces OMB Approval Of One DSCSA Draft Guidance

omb-logoIt’s funny.  Here we are waiting for the FDA to publish four new Drug Supply Chain Security Act (DSCSA) guidance documents (see “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?“), when an unexpected notice is published about an older draft DSCSA guidance document.  When I first looked at the title of the notice I had to read it four times before I could get myself to believe what I was seeing.

That’s right, this morning the FDA Continue reading FDA Announces OMB Approval Of One DSCSA Draft Guidance →