DSCSA 2023 Deadline Extension: What Does It Mean for LTC Pharmacies?
If you work in the pharmaceutical industry, then by now you’ve probably heard all about the Drug Supply Chain Security Act (DSCSA) and its recent deadline extension.
That said, there has been some confusion and anxiety around DSCSA compliance and what it means for long-term care (LTC) pharmacies. The transition will likely cause operational challenges for pharmacies that look to meet compliance requirements while minimizing disruption to their business.
Keep reading to learn more about the DSCSA deadline extension and how LTC pharmacies should respond.
What Is the Drug Supply Chain Security Act?
The Drug Supply Chain Security Act (DSCSA) introduces regulations around serialized electronic tracing mechanisms to track prescription drugs distributed across the country.
Designed to implement interoperable electronic tracing of prescription products at the package level, the DSCSA aims to improve the process of removing dangerous drugs from the supply chain. Tracing packages makes it easier to identify and remove risky prescription products, such as counterfeit, stolen, or contaminated medications.
The Food and Drug Administration (FDA) recently announced a one-year delay on the new electronic prescription tracking system, shifting the deadline from Nov. 27, 2023, to Nov. 27, 2024. The decision to move the deadline is based on the market’s transition from EDI 856 to EPICS file types, delaying enforcement on dispensers should their up-channel supply chain partners need time to stabilize their EPCIS data transmissions.
What Steps Should LTC Pharmacies Take?
Nervous about the DSCSA and unsure of what steps to take next? Here are four tips to help you navigate the process:
1. Know the guidance and what’s changing.
There has been some misunderstanding around the FDA guidance and what the deadline extension means. Other elements of DSCSA are still in place; what’s being delayed is enforcement at the dispenser level of the requirements around system interoperability.
Don’t just take our word for it: Understanding what’s changing is critical for ensuring compliance. Read the guidance, learn the specific regulations, and make a plan for what needs to be done so you can make a fully informed decision for your business.
2. Identify gaps in your own workflows.
What does your pharmacy need and where are you concerning achieving and maintaining that compliance? Asking the right questions will help you identify gaps in your LTC pharmacy’s workflow to ensure your pharmacy is as prepared as possible.
For example, LTC pharmacies will need to purchase a Global Location Number (GLN) from GS1 (or receive one for free from a wholesaler) to comply with DSCSA regulations. Despite the deadline extension, pharmacies should keep moving forward and avoid taking their foot off the gas to ensure compliance with DSCSA requirements like these.
3. Consider the total cost of implementation.
To prepare for the DSCSA transition, pharmacies need to take into account not only the cost and effectiveness of a solution but also the impact it has on daily operations. Take a holistic view of what that solution set will provide you: What’s executable day in and day out so you can staff appropriately to get the full value of the solution?
4. Work with a compliance partner like Advasur.
The right compliance partner will make it much easier for pharmacies to meet DSCSA guidelines. Advasur’s compliance solution—which was created for this specific federal law—was built by pharmacists for pharmacists to minimize compliance efforts.
Thanks to the new SoftWriters partnership with Advasur, FrameworkLTC users will be able to work with Advasur directly to implement and streamline the new DSCSA requirements.
Regulatory compliance can be a real headache for pharmacies—but with the right plan and the right partner, you can meet requirements with minimal disruption. Do you still have questions about the DSCSA deadline extension and what it means for LTC pharmacies? Listen to the Framework Focus episode on DSCSA for more information.