Liquid Gold. That's how Interpol has described organized crime's view of vaccine demand. The more in demand a product is, the more it will be counterfeited. We can count on an absolute tidal wave of COVID vaccine and treatment counterfeiting to flood the markets now that the vaccine is available.
It is one thing to mandate the printing of serialized barcodes on pharmaceutical packaging, and quite another to properly print these barcodes on said packaging to meet compliance.
Earlier this year, the FDA called on the life sciences and healthcare industry to design and deliver pilot projects for an electronic, interoperable system that can identify and trace prescription drugs as they are distributed across the United States in support of the DSCSA. Systech partnered with several industry innovators to respond to the FDA’s proposal including RxTransparent, T-Systems, FarmaTrust, CryptoWerk and CalQLogic.
The US pharmaceutical industry has been all abuzz about the upcoming VRS Mandate on November 27, 2019. If this is news to you, you may want to start here.
On March 25, 2019 the Prescription Drug Security Alliance (PDSA) published the first of three white papers that describe their proposal for establishing a new, non-profit governance organization that would be responsible for ensuring interoperability of the Drug Supply Chain Security Act (DSCSA) solutions. This first paper is called “A Proposal: Governance for DSCSA Phase II Interoperability”. In addition, PDSA also published another paper called “An Overview: PDSA Vision for Phase II...
From now through November 2020, the deadlines for meeting the Drug Supply Chain Security Act (DSCSA) happen every year. The pace of change has accelerated and companies need to remain vigilant to stay compliant. Fortunately, there are three important new DSCSA resources that became available in the last two weeks.
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 products in those geographies.
It’s difficult to keep up to date on all the milestones and requirements of the Drug Supply Chain Security Act (DSCSA). Because the law contains 10 years’ worth of deadlines and detailed requirements for every segment of the supply chain, it’s easy to get lost and miss what your company should be working on now. Fortunately, most companies need only focus on what is coming up next, while keeping an eye on the long-term requirements. Toward that end, Systech has just introduced the first in a...
The Healthcare Distribution Alliance (HDA) Traceability Seminar is always a great event to find out about the current industry response to the Drug Supply Chain Security Act (DSCSA), and ideas for where it is headed in the future. This year was particularly valuable for those who attended. Sessions included a DSCSA update from the FDA, HDA perspectives on DSCSA guidance, manufacturer perspectives on serialization, an update on HDA’s Verification Router Service (VRS) and other technology...
