5 Key Tips to Get Your Pharmacy Ready for DSCSA Implementation

The Drug Supply Chain Security Act (DSCSA) is nearing its final phase, and with the update from the FDA regarding small business exemptions, many pharmacies may be wondering what this means for them. The FDA’s letter grants small dispensers with fewer than 25 full-time pharmacists and pharmacy technicians a delayed deadline until November 27, 2026, for specific compliance measures. However, most of the requirements are still on track for the November 27, 2024, deadline. Here are five key tips to help your pharmacy stay on top of these complex regulations:

1. Understand what the small business exemption covers.

While the new exemption offers more time for small dispensers to comply with certain requirements like serialization, product verification, and product tracing, it doesn’t mean your pharmacy is off the hook for everything. Even if you qualify for the exemption, your pharmacy must still comply with the core DSCSA requirements by the original deadline. This includes:

• Having a GLN (Global Location Number). (Most pharmacies do, but you should confirm this and share it with all your suppliers.)
• Collecting and storing all Transaction (T3) data.
• Reconciling all drugs against your Transaction (T3) data.
• Retaining Transaction (T3) data for at least six years.

2. Prioritize compliance with core DSCSA requirements.

Regardless of the exemption, the FDA and Boards of Pharmacy will be actively enforcing key DSCSA provisions. Ensure your pharmacy is prepared by implementing processes to:

• Verify trading partners before engaging in transactions.
• Identify and investigate any suspect products.
• Report illegitimate products using FDA Form 3911.
• Develop and document procedures and policies for compliance.

3. Confirm your smallest saleable units are DSCSA-compliant.

All saleable units, especially the smallest ones, must have the proper product identifiers in place. Even with the small business exemption, this requirement remains essential. Failure to comply could lead to significant penalties or disruptions in your ability to do business.

4. Know what you don’t need to worry about (for now).

For pharmacies that qualify for the small business exemption, the extended timeline means you have more time to prepare for:

• Collecting and receiving serialized data (EPCIS).
• Conducting product verification on suspect products via the Verification Router Service (VRS).
• Performing product tracing on suspect products.

While these elements are crucial for long-term compliance, they aren’t required until 2026 for qualifying small dispensers.

5. Get ahead of full compliance with comprehensive solutions.

Even with an exemption, moving toward full compliance sooner rather than later can save your pharmacy time and effort in the long run. RedSail has chosen partners for DSCSA compliance that already offer complete DSCSA solutions, including the final interoperable phase of the law. Leveraging these tools can streamline compliance in your pharmacy and ensure that when 2026 comes around, you’re fully prepared.

Final Thoughts

The DSCSA regulations are designed to enhance patient safety and ensure the integrity of the drug supply chain. Whether your pharmacy qualifies for the small business exemption or not, taking proactive steps now will help you navigate the complexities of these regulations. By staying informed and using the right tools, your pharmacy can achieve compliance and contribute to a safer healthcare environment.

‍