Simplifying DSCSA Compliance: What You Need to Know

DSCSA Compliance doesn't have to be complicated. Here's what you need to know.

If you're in the pharmacy business, you may have been hearing about DSCSA compliance for a while. Even though it can seem complex, the right technology solution can integrate it easily with your daily operations. The significant amount of data that pharmacies will need to handle and store is one of the toughest problems to manage. In this blog post, we'll break down DSCSA compliance into simpler terms and guide you through it.

Why DSCSA Compliance Matters

• Patient Safety

At its core, DSCSA compliance is about patient safety. It reduces the risk of patients receiving counterfeit medications, ultimately safeguarding their health.

• Regulatory Compliance

Failure to comply with DSCSA regulations can result in severe penalties for pharmacies, distributors and manufacturers. Non-compliance will not be tolerated.

• Supply Chain Integrity

A secure pharmaceutical supply chain benefits all stakeholders. It builds trust among consumers and ensures the authenticity and efficacy of the medications they receive.

Three Key Components of DSCSA Compliance

1. Serialization: Pharmaceutical manufacturers must affix a unique product identifier to each package of prescription medication. This identifier contains crucial information, including the National Drug Code (NDC), serial number, lot number, and expiration date.

2. Traceability: DSCSA mandates that all trading partners, including manufacturers, distributors, repackagers, and dispensers, maintain detailed transaction records. These records must be readily accessible for efficient tracing of product history in case of recalls or suspicious activity.

3. Verification: Dispensers, like pharmacies, are required to verify the authenticity of prescription drugs before dispensing them to patients. This helps ensure that only safe and legitimate medications reach consumers. Read more >