DSCSA: A Fast-Approaching Deadline

Come Nov. 27 of this year, via the Drug Supply Chain Security Act (DSCSA), the FDA is requiring that all members of the pharma supply chain be prepared with an electronic data system that will enable the full interoperable, electronic tracking of medications at the package level. The concepts of the legislation date back a decade ago to Nov. 27, 2013, with DSCSA being considered Title II of the Drug Quality and Security Act (DQSA). 

Alongside the traceability portion, FDA is also requiring third-party logistics providers (3PLs) and wholesaler distributors to report licensure to the organization annually.

As Nick Basta, Pharma Commerce’s editor emeritus previously reported in his April feature, the aforementioned pharma supply chain is not impervious to counterfeits, and there are current cirumstances that could expose that via “dark corners” of the supply chain.

“With the disruptions brought on by the pandemic, the urgent needs for COVID-19 therapies and other medications around the world, the readiness of counterfeiters to step in, and now the Russia-Ukraine war, the pharma supply chain has become a Wild West,” Greg Cathcart, CEO of Excellis Health Solutions, a Drug Supply Chain Security Act (DSCSA) and supply chain consulting firm (a part of NNIT, a global information technology company) tells Basta. “These disruptions have given drug diverters plenty of room to operate in.”

The various links of the supply chain have been doing their part to prep for the November implementation, including TraceLink Inc., a digital network platform company, partnering with PharmaLink, a pharmaceutical reverse distributor. Through the agreement, the parties note, TraceLink will provide DSCSA capabilities for PharmaLink customers, allowing pharmacy dispensers to meet upcoming regulatory requirements by connecting them with trading partners for compliance data exchange quicker and arguably more financially affordable than traditional point-to-point methods.

In other news, LSPedia, a software-as-a-service (SaaS) provider that specializes in product traceability solutions for the pharma industry, is collaborating with MatchRX, a provider of DSCSA compliance and SaaS solutions, to offer OneScan Pharmacy Pro, DSCSA software, at a discount for MatchRX members. LSPedia's branded solution receives, tracks, manages, verifies, and investigates EPCIS data, and automates expiry management, partner licenses, data retention, FDA reporting, and more. The software supports efficient, accurate operations, while protecting pharmacies from slowdowns, disruptions, and audits.

Given the timeliness of this issue, on a recent episode of the PC Podcast, I recently sat down with Gregg Gorniak, AmerisourceBergen’s senior director of manufacturer operations & data services, to learn more about the following focus points:

• A history and overview of DSCSA, along with what exactly members of the pharma supply chain are expected to comply with come November
• Pharma supply chain members’ mindsets at in terms of being prepared for its implementation
• What an ideal implementation of DSCSA look like, and the barriers that are standing in the way? (HDA has recommended that FDA allows more time before enforcement actions are taken.)
• How Gorniak envisions the future of track-and-trace shaping out over the next decade

Readers can catch the rest of Pharma Commerce’s DSCSA coverage here.