Like most readers of this blog, I tend to take my work home with me, on vacation, and pretty much wherever I go. Visiting my neighborhood pharmacy to pick up a prescription for my darling son, I naturally asked my pharmacist what she knew about DSCSA serialization and the 2D barcode.
“I don’t think I’ve ever heard of it,” Hannah told me.
Undaunted, I pulled out an LSPediA sample bottle with one of our serialized 2D barcode labels, because of course I carry product demos around with me all day.
“I’ve seen those,” Hannah said, “but I didn’t know what they’re for.”
Pharmacists left in the dark
I can’t blame Hannah one bit. Reaching out to independent pharmacies and small business has been a challenge for the industry, including the FDA. It’s not uncommon for FDA officers conducting an in-store audit to face a pharmacist who is oblivious to the looming DSCSA requirements. Unless Hannah surfs the FDA website, googles “DSCSA,” or
attends as many conferences as I do, how would she know anything about DSCSA? The FDA has launched outreach efforts to educate pharmacists, including web pages, flyers, and webinars. But that doesn’t seem to be enough.Patients depend on their neighborhood pharmacies for their daily medicine, and adherence by the pharmacies to DSCSA rules is the last mile to patient safety. The FDA is inspecting pharmacies and wholesale distributors, and is issuing Form 483 warning letters for DSCSA violations. Dispensers need to understand the DSCSA and meet each of the time-phased compliance requirements.
Think you’re ready? Take this test
To help cope with the challenge, 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.
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.
Deadline: 21 months and counting
Think about it: Every dispenser in the country has just 21 months to put all of this in place – or face the wrath of the FDA. Besides our new Dispenser Checklist, LSPediA also publishes this handy Guide To DSCSA Compliance For Dispensers for you to download. Trust me, this is much easier to read than wading through the entire text of the Drug Quality and Security Act to figure out what dispensers need to do now. And much cheaper than an FDA fine.
And the work doesn’t end there. By November 2023, dispenser must be able to handle FDA requests, saleable returns and verify all serialized products through a secure electronic network.
What can we all do? If you’re a dispenser, check with your distributors to find out what they’re doing to meet DSCSA regulations, what that means for you, and how they expect you to interact with their solutions. If you’re a distributor, it’s time to start having this conversation with every dispensary in your network – so feel free to share our checklist and readiness test with them. And if you need help, contact me at LSPediA, where we’ve built turnkey systems that handle all your DSCSA requirements at every level.
We’re all investing a lot of time, effort, and money into making sure that we not only comply with DSCSA regulations but that we also maximize the return on our investment through lower costs, improved efficiency and greater patient safety. To make that work, we need to help Hannah and all her fellow pharmacists work with us.
LSPediA is a leading supply chain software provider for the pharmaceutical industry. LSPediA’s serialization solutions RxChain,® RxChain™ Mobile, and Saleable® 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, and verify the validity of the drug product. To learn more, please call (248) 973-2008, email [email protected] or visit www.lspedia.com.