Why DSCSA Compliance Should Top Your Pharmacy’s To-Do List This Fall - BestRx

Why DSCSA Compliance Should Top Your Pharmacy’s To-Do List This Fall

Posted on Aug 20, 2024

Rumors about DSCSA requirements have been swirling around the industry for a while now. However, between the original deadline extension and the FDA’s exemption ruling earlier this summer, many pharmacies have put their compliance efforts on the back burner. While you may have more time to implement some of the requirements, if you’re not working on the other components yet, your pharmacy may be a in tough spot come November. In fact, here’s why DSCSA compliance should be at the top of your pharmacy’s to-do list this fall.

Smaller dispensers, including independent pharmacies, are not fully exempt.

When the FDA released its Exemption Ruling, it left many independent pharmacies confused about what it meant for their store. Many incorrectly assumed that they would not need to adhere to DSCSA requirements for another two years.

However, while smaller stores may be eligible for a partial exemption, all pharmacies will need to be prepared to comply with other track and trace components, including:

    • Verifying trading partners and obtaining Global Location Numbers (GLNs).
    • Collecting, reconciling, and storing all T-3 data for a minimum of 6 years.
    • Confirming all products have unique product identifiers.
    • Identifying and investigating any suspicious products.
    • Reporting illegitimate products to the FDA.
    • Maintaining DSCSA procedure and policy documentation.
Even if you’re eligible, the Exemption Ruling only applies to specific DSCSA components.

Again, and we can’t stress this enough, the Exemption Ruling only applies to select DSCSA requirements. Eligible pharmacies have until November 27, 2026, to:

    • Use the unique product identifier to verify suspect or illegitimate products in their possession or control.
    • Exchange transaction information and statements in a secure, interoperable, electronic manner.
    • Require exchanged transaction information to include the product identifier at the package level for each package included in a particular transaction.
    • Verify products at the package level, including the standardized numerical identifier. For now, small dispensers can continue to rely on their current verification methods with their trading partners.

Just like last year’s extension, the FDA’s Exemption Ruling should be viewed as a temporary grace period for smaller pharmacies. The expectation is that these stores will continue working towards full compliance and be fully operational before the extension period is up.

If you didn’t submit an exemption request by the August 1 deadline, you may be on the hook for all DSCSA requirements.

The exemption ruling was intended for smaller-staffed independent pharmacies, which is defined as a dispenser with 25 or fewer full-time employees who are licensed as a pharmacist or qualify as pharmacy technicians. Eligible pharmacies were advised to submit an exemption request to the FDA online by August 1, 2024. If you did not complete this step, your store should be prepared to comply with all DSCSA requirements by November 27, 2024.

Beginning November 27, 2024, pharmacies can be audited for compliance with the first and second phases of the law.

Regardless of whether your pharmacy is eligible for the two-year exemption for select product traceability requirements, you can still be audited for compliance with the first phase of the law now, and the second phase this November. As a result, we strongly recommend that pharmacies continue to work towards full DSCSA compliance.

Looking for DSCSA support?

BestRx has been working behind the scenes on integrated solutions to help you stay compliant. Contact us today to learn more about our integration with InfiniTrak and how you can easily incorporate DSCSA requirements into your pharmacy’s workflow.