"#DSCSA enhanced security requirement will become effective in 2023 and will be here to stay after 2023," said Dr. Connie Jung, RPh, PhD. Senior Advisor for Policy, Office of Drug. Security, Integrity, and Response (ODSIR), Office at HDA’s Traceability Seminar October 2022. (LSPedia | LinkedIn)
A question we hear often is whether dispensers can expect the FDA to grant discretion to enforce DSCSA on November 27, 2023. We don’t hear the same questions from manufacturers and wholesalers anymore; we see them heads-down, implementing processes and technologies to meet the upcoming interoperability and Enhanced Supply Chain Security (ESCS) requirement.
For every three dispensers we talk to, one asks if the FDA plans to grant enforcement discretion — followed by, “What is the penalty for non-compliance?" Faced with such soul-searching questions, our response is: How important is your business to you?
Simply put, at this point — with a bit over nine months left — it’s much easier and safer to comply with DSCSA than to wait, especially since help is now readily available. Further, as it’s now clear that trading partners across the industry have the information and resources available to adopt DSCSA, there’s no regulatory rationale to accommodate businesses that don’t take these steps.
At the start of 2023, we noticed that the EPCIS exchange volume skyrocketed 15 times in December in the Test Environment, where manufacturers test their EPCIS exchange with wholesale customers (aka EPCIS onboarding). LSPedia’s Investigator platform tracks the industry EPCIS data exchange volume and exceptions status. Throughout most of 2022, testing files were steady, at around 1,000 files a month. In December alone, LSPedia processed 15,000 test files.
As recently as December 2022, the FDA indicated that it intends to follow through with the enforcement deadline, in line with its previous statements and its summer draft guidance releases. Businesses who have not moved to comply will be facing steep costs and enforcement actions – all when they could have taken simple steps that, in the long term, protect their patients, their partners, and themselves.
“It’s a matter of risk management -- when you look at the costs concerned, you realize it’s not worth the stress of waiting,” said LSPedia’s Chris Smith, Manager, Dispensers and Health Systems. “A small pharmacy can get on the path to easy, automated DSCSA compliance at just $2 a day, less than a cup of coffee.”
It’s unfathomable to risk a pharmacy business when affordable, convenient help is here. In addition, LSPedia uses serialization data for expiry management and store transfer to get rid of dead stock costs.
LSPedia's OneScan Pharmacy Solution is the industry's leading DSCSA compliance solution for dispensers. With an easy-to-use interface, quick implementation time of 1-3 days, and our compliance guarantee, you can focus your time on what you do best: patient care. Click here to start using LSPedia’s DSCSA Pharmacy Solution today.
There’s no reason to wait and see – complying with DSCSA is the best path forward, and it can happen quickly and without any disruption. Get in touch with us today to find out more, or write to DSCSA@lspedia.com.