You’ve probably heard about upcoming changes to the Drug Supply Chain Security Act (DSCSA). Pharmacies will now be responsible for enhanced security provisions for drug distribution starting next year.
For a busy pharmacy professional, “next year” may feel like the far future and then appear like it’s next week. It’s always best to be prepared. With these DSCSA updates pharmacies have greater responsibility (and by extension more potential liability).
If you’re unsure what these DSCSA updates mean for your pharmacy or where to begin, here is some guidance for finding the best tools for your pharmacy. Keep in mind, regulators and government criteria seem to keep evolving, and we’ll continue writing and publishing information as it comes out to keep our readers informed.
Enhanced Drug Security Requirements for Pharmacies
Effective November 27, 2023, pharmacies will be required to verify product identifier information at the package level for most prescription drugs in finished form when they’re involved in a transfer of ownership. There are exceptions to this; such as, 503b compounded medications and inventory transfers based on pharmacy acquisitions.
The relevant product identifiers include the NDC, serial number, lot number and expiration date. In addition to product identifiers, pharmacies must also track information about the transfer of ownership. Many pharmacists abbreviate this information as “T3” data because it includes three transaction pieces: history, information, and a transaction statement. All of this information is captured at the saleable unit level: the bottle, box, packet, or any “smallest individual saleable unit.”
The new regulation also requires “systems and processes for verification of product at the package level…to promptly respond…in the event of a recall or for the purposes of investigating a suspect product or an illegitimate product.” Pharmacies must not only check the data; they have to record it and be able to produce it on demand.
The law initially required only manufacturers to verify products based on product identifiers. That’s why packages have a unique serial number along with (as of 2018) a 2D barcode capturing the identifier information. Over the years, repackagers, wholesalers, and dispensers were added to the law. Now, this “enhanced product tracing” includes pharmacies.
Ensuring Compliance with Enhanced Product Tracing
For more detailed guidance on this update, you should consult the FDA’s guidance. However, from what we understand so far, essentially pharmacies will be required to ensure their products match all data received from trading partners in the chain of custody. They’re also required to record product identifier data and be able to respond to package-level audits by the FDA or other authorities.
In terms of compliance, manual processes are virtually impossible. Even a small pharmacy ordering minimal products on a regular basis would be overwhelmed by having to accurately and regularly input, verify, and store all the product identifiers and T3 data. Depending on the number of doses in a package, a single order might have multiple data points that increase the work by several orders of magnitude. And you’d have to store years of paperwork on file in case of an audit.
When it comes to selecting technology to help you manage DSCSA, I recommend considering a solution that allows you to maintain compliance without complicating your work. The best solutions can already scan, store and report using the 2D bar codes that contain product identifiers.
So, your software should enable you to scan the 2D barcode and T3 data right into your system at a desktop workstation or through your mobile device. You scan the package, the system matches it with the packing list and it flags any discrepancies. That way, you can immediately report back to your vendor and do your due diligence.
Reaching Optimal Compliance for Your Pharmacy
Keep in mind that this is about more than checking off a requirement. When you’re planning for the new DSCSA regulation, consider balancing compliance with productivity.
For example, will you have to add more steps for verification in light of this DSCSA update? Large wholesalers likely already confirm T3 data on their end (just keep in mind, the way the law is currently written, this doesn’t mean that the pharmacies necessarily have to confirm it). When ordering from other vendors or manufacturers, you’ll need to create your own verification protocols for all the product you receive that require traceability under DSCSA law.
Ideally, a solution will truly integrate with all of your vendors. It should accommodate all transactions with them: from comparing their catalogs through ordering products from them to receiving those goods and then verifying their supply chain data—all under one interface. That way, you save time and lower stress while also ensuring compliance.
Great solutions adapt to your existing systems and anticipate future needs. Take a pharmacy chain that uses a centralized warehouse to distribute across their organization. Under the current version of this new regulation, because there is no transfer of ownership outside of the pharmacy, that business is only responsible for verifying product identifiers and T3 data at the warehouse.
Even assuming the regulation will continue to function this way, a solution should still empower you to verify data between locations. Data transparency will always enhance your operations and strategy.
Whether you’re managing several stores while purchasing from multiple vendors or using a single wholesaler at a single location, you shouldn’t have to overhaul your processes or complicate your work.
The Bigger Picture for DSCSA and Your Pharmacy
The right technology with the right partners behind it will make a difference. You’ll be able to continue to comply with DSCSA. Keeping up with these changes will feel far less daunting. And you’ll know you’re contributing to a better pharmaceutical ecosystem.
Diversions in the chain of command and counterfeit drugs are an unfortunate part of our industry. A closed-loop system that ensures accuracy at each step helps shut down these problems.
DSCSA has always aimed at traceability and accountability for quality products. It starts with the product’s origin at the manufacturer level. Now, with this DSCSA update, pharmacies can help ensure safety right down to their patients.
Ready to learn how SureCost supports DSCSA requirements?