FDA Grants Exemptions to Small Dispensers

Important Update on FDA Compliance for Small Dispensaries

Thank you to everyone who engaged with our recent post about the FDA’s Drug Supply Chain Security Act (DSCSA) requirements. We have some important clarifications and updates to share based on the latest FDA guidance.

Key Update:

The FDA has issued exemptions for small dispensaries (pharmacies) from certain DSCSA requirements until November 27, 2026. If your pharmacy has 25 or fewer full-time pharmacists or pharmacy technicians before November 27, 2024, you automatically qualify for these exemptions. There is no need to apply for these exemptions; they are granted automatically based on your pharmacy’s size.

What You Need to Know:

1. Automatic Qualification: Small dispensaries automatically qualify for the exemptions without needing to apply. This simplifies the process and provides immediate relief.
2. Notify Your Trading Partners: Even though the qualification is automatic, small dispensaries must notify their trading partners of their exempt status to ensure smooth operations and avoid any potential distribution issues.
3. Continue Compliance Efforts: Although the exemptions are automatic, it is crucial to use this additional time to fully implement the required DSCSA measures before the new deadline.

We appreciate your understanding and hope this clarification helps. Our goal is to keep you informed with the most accurate and up-to-date information to ensure your pharmacy is well-prepared for these important changes.

Stay informed and proactive in your compliance efforts. For more detailed information, you can refer to the latest FDA update here.

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Landstar Drugs & Wholesale LLC