While a lot of the industry is focused on the November deadline for wholesale drug distributors to verify saleable returned drugs, drug dispensers already are operating under DSCSA rules – and have another deadline coming up next year, too.
The FDA has launched outreach efforts to educate pharmacists, including web pages, flyers, and webinars. But that doesn’t seem to be enough, but it’s not uncommon for FDA officers conducting an in-store audit to face a pharmacist who is oblivious to the looming DSCSA requirements.
To promote awareness, LSPediA created our own Dispensers DSCSA Checklist, which outlines the current and future compliance rules dispensers face. This simple web form takes just 30 seconds to complete: Do you know what a 2D barcode matrix is? Are you able to send electronic purchase verifications? Do you think a “serialized product” is something in the breakfast aisle at the grocery store? The results will show dispensers just where they stand and what they need to do to comply.
Need more information? Check out our comprehensive DSCSA guide for distributors.
The DSCSA already requires that dispensers use secure electronic databases to verify suspect or illegitimate products, and to put systems in place to quarantine those drugs. Dispensers also must now maintain a system to send, receive, capture and maintain the vital 3Ts – transaction history, transaction information, and a transaction statement for each sale or purchase. All that has been in place since 2015; after November 2017 dispensers also were required to get and receive their 3Ts electronically.
Soon, dispensers will face the real test – by November 2020 they won’t be able to buy or sell any product that lacks the 2D data matrix barcode and human readable text format. They’ll also be required to verify any suspect products using that serialized data. All of us at LSPEDIA are alarmed when we hear that most individual pharmacies lack any capability to scan those 2D barcodes.
LSPediA is a leading supply chain software provider for the pharmaceutical industry. LSPediA’s serialization solution RxChain®, RxChain™ Mobile, and Verifier® VRS protect pharma companies against regulatory risks and improve supply chain efficiency. Pharmaceutical manufacturers, wholesale distributors, dispensers, and healthcare providers partner with LSPediA to manage serial data, distribute serialized drug products, verify the validity of the drug product. To learn more, please call (248) 973-2008, mailto:firstname.lastname@example.org, or visit www.lspedia.com.