Pharmaceutical serialization has been looked upon as a panacea for the rampant global issue of counterfeiting. Now that enforcement data has become available on the US Drug Supply Chain Security Act (DSCSA) and EU Falsified Medicines Directive (FMD), it’s time analyze the results. Has serialization put an end to counterfeiting?
Spoiler alert. According to the EU IP Office, pharmaceutical counterfeiting has not slowed down, but is a growing threat.
Drug repackagers face unique challenges under the Drug Quality and Security Act (DQSA), driven by their distinctive position in the pharmaceutical supply chain. One major US drug repackager needed a solution with a wide breadth of features and comprehensive configurability to get in compliance with DQSA so they reached out to Systech for assistance.
A few months ago, the government of the Russian Federation adopted Order Number 791-r, which appears to have significance for pharma serialization there. The primary deviation from the pharma serialization specification that has dictated the government pilot in Russia since early 2017 is the addition of two new data elements to the datamatrix barcode on secondary packaging. For the pilot, the datamatrix barcode contained:
Last month, GS1 US published a report on a DSCSA barcode assessment they conducted last year with two of the largest wholesale distributors in the US, AmerisourceBergen and McKesson. The goal of the assessment was to take a “snapshot” of pharmaceutical manufacturer progress toward meeting the serialization requirement of the Drug Supply Chain Security Act (DSCSA) by analyzing drug packages actually in the market.
Pharmaceutical manufacturers are working non-stop to get the serialization systems in place necessary to meet the USA DSCSA mandate going live this November, and the EU FMD mandate going live the following February of 2019. If serialization projects aren’t in full flight at this time, there is a significant chance that a manufacturer will not meet the deadline, not be compliant and not be able to distribute product in those geographies.
President of the Russian Federation, Vladimir Putin, signed a new law the last week of December 2017 that is important for pharmaceutical manufacturers distributing products to or manufacturing in Russia. It establishes January 1, 2020 as
Last week, Systech participated in the FDA DSCSA Pubic Meeting, held in Silver Spring, MD at FDA headquarters. The meeting was two days long and was aimed at discussing the possible characteristics of the Enhanced Drug Distribution Security (EDDS) phase under the Drug Supply Chain Security Act (DSCSA) beginning in November of 2023. The meeting was broken down into four primary topics:
Systech is a member and strong supporter of GS1 Healthcare, the global group that promotes standardization in healthcare product and entity identification. On October 17, 2017 in Chicago, GS1 Healthcare held their fall Global Healthcare Conference.
Drug manufacturers who market drugs in Europe will need to begin applying unique identifiers and an anti-tampering device to their packaging by February 9, 2019. Most companies are already aware of these well-publicized requirements of the Falsified Medicines Directive (FMD) and the E.U. Delegated Regulation (EUDR). Systech offers packaging line management and serialization solutions that will allow you to easily meet these requirements. But you might not be aware of the other big...