Pharmacy requirements under the Drug Supply Chain Security Act were already complex. The FDA’s planned changes further complicated matters. Postponements and some recent exemption deadlines added another layer of intricacy.
Although it may be confusing or even frustrating, DSCSA compliance is mandatory, and non-compliance is risky.
This blog post summarizes the requirements, updates, postponements and exemptions. We’ll also share best practices and solutions to ease the burden on your pharmacy and team. First, let’s understand how we got here and what you need to do.
DSCSA: Then and Now
DSCSA was first instituted in 2013, mandating the chain of custody for prescription drug products from drug manufacturers to pharmacy dispensers to patients. Over ten years later, the FDA announced new requirements to take effect in November 2023.
Here’s a brief rundown of the DSCSA requirements pharmacies will be responsible for:
- Package-level T2 product-tracing data
- EPCIS standard
- Six years of data in electronic format
- Updated procedures checking for suspicious products at the package level
- Ability to quarantine and report suspect product within 24 hours
- Respond to audit requests within 48 hours
Pharmacies should consult the latest regulations and requirements, as well as the advice of a licensed attorney, to understand the full scope of their responsibilities under DSCSA. The takeaway is that pharmacies must now have systems and processes for product verification at the package level and store that data using the historical interoperable EPCIS for six years. The requirements for quarantining and reporting suspect products and responding to audits remain in place.
The FDA postponed enforcement of these new regulations to 2024. Then, in October, the agency also added exemption deadlines for DSCSA based on their licensed employee count as of November 27, 2024:
- Dispensers with 25 or fewer full-time licensed employees: until November 27, 2026
- Dispensers with 26 or more full-time licensed employees: until November 27, 2025
- Manufacturers and repackagers: until May 27, 2025
- Wholesale distributors: until August 27, 2025
Pharmacies should read the official FDA announcement about exemptions and seek the advice of a licensed attorney for any legal questions or concerns. In a nutshell, trading partners who have made documented efforts or successfully established data connections with immediate partners but still face challenges may be exempt from DSCSA requirements.
Essential Steps for Pharmacies
With all these updates and extensions, pharmacies must use their time effectively to ensure they’re ready for full DSCSA compliance.
If you have time before enforcement is active, it’s an ideal period to prepare and test. When the FDA first announced updates to DSCSA, many vendors didn’t have their data ready, leading to a significant breakdown. Now, more vendors can support more traceable items. Work with them to ensure the data is in place, checking that they have it and confirming that you can use it.
Pharmacies should acquire global location numbers (GLNs) and share them with vendors while encouraging trading partners to be EPCIS-compliant. At the same time, ensure your staff is ready and understands the requirements and their roles in DSCSA compliance. Update your SOPs now (so you won’t scramble to adjust once those requirements are in place). Some pharmacies may want to consider delaying scanning until wholesalers update all products. Above all, review all regulations and consult a licensed attorney.
Best Practices and Solutions for DSCSA Compliance
As we’ve seen, pharmacies should take the time to work with distributors and dispensers and ensure their protocols and teams are ready. But you also need to maintain consistent DSCSA compliance without complicating your existing operations. That means tracking, verifying and storing massive quantities of electronic data throughout your purchasing process.
Multiple processes and data sources confuse things. Instead, leverage a unified purchasing management solution: a single platform that easily integrates into existing operations and automates the capture and storage of DSCSA data as part of your standard procurement process.
A system like SureCost automatically matches relevant data between purchase orders and received products, instantly creating the required historical records while flagging discrepancies and documenting actions for suspect items. That includes transfers between locations or within complex health system pharmacies: seeing each step of the transfer process—from initiating the request to receiving the item at the destination—and the ability to scan DSCSA barcode data for all inbound/outbound transfers.
The seamless, instant capture of data facilitates prompt and accurate reporting.
Pharmacies gain the capability to instantly furnish accurate data and respond to audits on a timely basis. If you suspect tampering, you can then quickly quarantine items and efficiently respond to audits within the requisite timeframe.
The right purchasing management solution ensures accountability for vendors supplying the data. But it also provides greater oversight for staff collecting and managing these items. It’s a tool for aligning teams on consistent protocols for quarantine and reconciliation.
Do More Than Comply
Without the right systems and procedures in place, pharmacies risk falling behind and failing to meet requirements. This can lead to audits, costly financial penalties, suspension or even legal action. Pharmacies must stay ready by keeping up with DSCSA regulations and making compliance secure and convenient.
Automating the capture, verification and storage of DSCSA pharmacy data is key. However, pharmacies should integrate DSCSA compliance into optimizing purchasing and inventory management. A purchasing management solution allows pharmacies to do more than just comply with regulations. It empowers you and your team to optimize purchasing and inventory. With the right solution, you can unlock better purchasing options, streamline work and drive efficiency while easing the burden on your team.