Enacted by the FDA, the Drug Supply Chain Security Act (DSCSA) mandates tracking prescription drugs across the entire supply chain to ensure patient safety and secure a safe chain of custody.
If you’re reading this blog post, that’s probably no surprise. Yet there’s a slew of updates on the horizon. Pharmacies must keep up. Otherwise, they risk penalties, fines, legal sanctions and maybe even suspension.
Pharmacy professionals should consult the latest FDA announcements about DSCSA and their attorneys, but for now, here’s a high-level summary of the latest updates.
What Data Pharmacies Need to Store, and How They Should Store It
So, what’s changing? The key differences are how transaction information is stored, transmitted and even grouped together. DSCSA previously revolved around “T3” information, which referred to three forms of transaction data: transaction information, transaction history and transaction statements. What do they mean?
Transaction information is similar to an invoice. It contains the parties involved in the transaction— where the item came from and where it's going—along with the line item detail (i.e., what that item is). For an individual package, transaction information also has details related to traceability, such as lot and expiration.
Transaction history contains information similar to transaction information in a historical format. For example, while the transaction information might be from a wholesaler to a dispenser, transaction history could contain information from a previous step in the supply chain, like movement from the manufacturer to the wholesaler.
A transaction statement is a legal statement included in these documents that records the intent and acknowledgment that these trading partners are complying with the law.
Updates to DSCSA change how this information is stored and shared. The FDA now requires the Electronic Product Code Information Service (EPCIS) standard. It’s the largest adopted interoperable standard in the world for all these new requirements. Under this new historical standard, an auditor can look at a transaction record at any point in the supply chain and have enough information to follow the item up or down the supply chain in either direction.
With this new standard, transaction history is no longer a separate element; it’s part of transaction information. Transaction history effectively goes away because it's historical. T3, in a sense, becomes “T2.”
Note the first word in that acronym. Previously, keeping that information on paper invoices or some other manual record was fine. Not anymore! Pharmacies must now store DSCSA data electronically.
The other major change is that pharmacies must now receive information about products at the package level (while they were previously responsible for lot-level details). That means updating receiving procedures to check for suspicious products at that package level.
What’s not changing? You still need to store the data for a minimum of six years. You still have to quarantine and report any products that look suspect. You also still need to quarantine and report products if a trading partner informs you that there's potential for a product to be illegitimate. And you still need to be ready to respond to audit requests from any state or federal authority within 48 hours.
Potential Exemptions
The FDA has already postponed enforcement of these DSCSA updates to provide more time for troubleshooting electronic systems and processes between manufacturers, distributors, and pharmacies. Their goal was to avoid supply chain disruptions and ensure patients could still access drugs. They also wanted to ensure proper implementation of the program. Enforcement is set to begin on November 27, 2024.
Recently, the FDA issued a notice to small dispensers. These entities can file for an exemption. So, what’s a small dispenser? Any organization or corporation that owns pharmacies with a total of 25 or fewer full-time employees licensed as a pharmacist or a qualified pharmacy technician by the state board for that pharmacy’s location. If you think you’re in this category, you’ll need to file for an exemption, and the FDA must then grant it.
Do More Than Meet the Minimum
With all these updates, an already complex regulation just got more complicated. At a bare minimum, pharmacies must follow these procedures and technical specifications to maintain compliance. But, competitive pharmacies will ensure DSCSA compliance without adding additional steps or placing more stress on their staff.
To stay competitive, pharmacies need to:
- Unify data and streamline purchasing management
- Ensure accountability by aligning teams at all stages of procurement
- Stay ready to quarantine and respond to audits
- Maintain data integrity during internal transfers
Pharmacy professionals should read the official FDA announcement about exemptions and seek the advice of a licensed attorney for any legal questions or concerns.
Note
Any statements, advice or solutions presented in this letter are solely SureCost’s interpretation of the needs and requirements of our customers in regards to the law and should not be construed as legal advice or a substitute for it. We strongly recommend that you seek the advice of a licensed attorney for any legal questions or concerns. SureCost will not assume any legal liability for any action taken or omitted based on the information provided in this letter, whether written or spoken.
