DSCSA 2023: How Distributors Can Help Dispensers Prepare for Compliance
HDA is hosting a webinar series to discuss the upcoming Drug Supply Chain Security Act (DSCSA) requirements. These webinars, which focus on education specific to dispensers, will lead up to HDA’s annual Traceability Seminar on October 12-14 in Washington D.C.
HDA kicked off the 2022 Traceability Webinar Series: Just-in-Time Review for 2023 on August 11, with featured speakers from a variety of HDA distributor member companies. The webinar covered how distributors can help dispensers prepare to meet the 2023 deadline, what dispensers will need to do on their own, as well as other priorities for dispensers when complying with DSCSA.
In discussing what dispensers can expect distributors to help with, Brad Pine, Vice President, Brand Pharma & Regulatory, Smith Drug Corporation, Div. JM Smith Corporation said, “The biggest thing that we will be able to do for dispensers is to hold their transaction information and the transaction statement, as long as you maintain a written agreement with us available at your pharmacy.” He mentioned that HDA wholesalers will have products vetted against the seller’s Electronic Product Code Information Services (EPCIS) data events or will verify it via a verification routing system (VRS) after the November 2023 deadline. However, dispensers who purchase from multiple sources have the option to contract with an EPCIS service provider to aggregate this information and to reach agreement with their distributors in this regard.
Julie Malone, Regulatory Affairs Manager, Value Drug Company, spoke to what actions dispensers must take, the first of which is to obtain a Global Location Number (GLN). This identifier is used to gather location information and master data. “Obtaining a GLN is central to maintaining transaction information, and really important for EPCIS interoperability standards,” said Malone. She also mentioned that dispensers should maintain standard operating procedures, for instance, in terms of identifying, reviewing and recording suspicions of counterfeit product.
Outlining other considerations for dispensers, Matt Sample, Senior Vice President, Manufacturer Operations, AmerisourceBergen Corporation, underscored the importance of verifying sourcing partners: “As we get to 2023, make sure that you have processes, policies, procedures … in place to make sure that you are purchasing human prescription drugs from somebody that should be selling them to you.” In speaking more specifically to processes dispensers need to have for 2023, Scott Mooney, Vice President, Distribution Operations at McKesson Corporation said that dispensers will only be able to accept product after they have received the transaction information as well as the transaction statement from the seller. “In 2023, this process is required to only be electronically implemented—through portals or an EPCIS file push from the supplier to a dispenser repository,” he said.
In the Q&A following their presentation, panelists discussed how EPCIS requirements meet the demands of trading partners across the board, whether distributors will aggregate information for dispensers, how purchase orders can be placed, and how to determine if a product is subject to the DSCSA. To learn more, watch the August 11 webinar recording.
More resources for dispensers are located at DSCSA.pharmacy, including a Checklist for Dispenser Compliance and one-pager “How Can Your Wholesale Distributor Help Prepare for DSCSA 2023?” developed by HDA.
Those interested in continuing their DSCSA preparation and learning should consider registering for HDA’s upcoming Traceability Seminar.
For more information, contact Jaidalyn Rand, Director, Industry Relations.