Full enforcement of the Drug Supply Chain Security Act (DSCSA) will be phased in across the pharmaceutical supply chain starting in 2025 and extending through 2026 for entities that qualify as 'connected trading partners' under the FDA's latest exemption. Ensure your pharmacy is prepared by taking these three essential steps now:
1. Verify and Share Your Global Identifiers
Action: Confirm your pharmacy has the correct Global Location Number (GLN) and, if needed, a Global Company Prefix (GCP). If your GLN was issued through a managed program or needs to be transferred to your company-owned GCP, confirm accuracy with your GPO or wholesaler.
Why It Matters: These identifiers ensure DSCSA-required serialized data flows smoothly from your trading partners to RxTransparent.
Next Step: Submit your GLN and GCP (if applicable) to Inmar here and share them with your trading partners to prevent data errors.
Resources:
- Step-by-Step Guide to GLNs and GCPs
- GS1's What is a GLN and How Do I Get One?
- GS1's What Is a GS1 Company Prefix?
- Verify your GLN with GS1
2. Train Your Team on Serialized Product Receiving and Reconciling
Action: Train your staff to verify serialized data for products with RxTransparent as soon as shipments are received.
Why It Matters: Immediate reconciliation is mandatory for DSCSA compliance and helps avoid delays or inventory issues.
Next Step: Implement a training schedule to ensure staff are comfortable with both the technology and the product verification process.
Resources:
Log in to RxTransparent to:
- Register for LIVE user training
- Review the In-App Guide
- Review recorded trainings
3. Assess Your Need for Waivers, Exceptions, or Exemptions (WEE)
Action: Work with your regulatory team to determine if your pharmacy qualifies for a Waiver, Exception, or Exemption (WEE).
Why It Matters: Even with a WEE, you must manage ownership transfers and maintain your GLN. Keep Inmar and trading partners updated on any changes to your WEE status.
Next Step: If you’ve applied for a WEE, check the status of your application and notify your trading partners of any updates.
Resources:
- FDA's Waivers and Exemptions Beyond the Stabilization Period
- FDA's The Drug Supply Chain Security Act (DSCSA) Waivers, Exceptions, and Exemptions
- FDA's Welcome to CDER NextGen Your direct line to the FDA
- FDA's Waivers and Exemptions Beyond the Stabilization Period
Be Proactive: Review Your SOPs Now
Start reviewing your Standard Operating Procedures (SOPs) today. Early preparation will help your team handle exceptions smoothly, reduce delays, and maintain seamless patient care.