Stay Ahead of Compliance:
A Guide to DSCSA for
Wholesalers & Distributors

Ensure your business is protected and efficient with our expert insights and Level 4 solution for the Drug Supply Chain Security Act.

DSCSA...|

Executive Summary


In response to growing concerns about counterfeit and
substandard drugs, the Drug Supply Chain Security Act
(DSCSA) was enacted in 2013 as part of the Drug Quality and
Security Act. The DSCSA outlines critical steps for building an
electronic system to identify and trace certain prescription
drugs as they are distributed across the United States. By
enhancing the ability to track each package’s origin and
movements, the act aims to prevent harmful drugs from
reaching consumers, thus safeguarding public health. For
wholesalers and distributors, comprehending the DSCSA's
requirements is not just about compliance; it’s about playing a
pivotal role in ensuring drug safety on a national scale.

Key Compliance Requirements for Wholesalers & Distributors

PRODUCT TRACING:

Under the DSCSA, all prescription drug transactions require documentation that identifies both the drug and its previous handlers. This includes Transaction Information (TI), and Transaction Statements (TS) — collectively known as "two (2) T's." Wholesalers and distributors need robust systems to document and store this data accurately, sharing it with partners downstream.)

VERIFICATION SYSTEMS:

A crucial aspect of DSCSA compliance is maintaining protocols to verify that prescription drugs are legitimate and fit for distribution. Verification involves checking product identifiers such as the National Drug Code (NDC), lot number, and expiration date. Additionally, having the ability to respond to verification requests from authorities within a specific time frame is essential for compliance.

RECORDKEEPING:

To ensure traceability, all transaction records must be retained for a
minimum of six years. Effective recordkeeping not only assists in regulatory inspections but also supports operational transparency and traceability, making it easier to manage recalls and investigations swiftly.

Implementation Tips for Effective Compliance

LEVERAGE TECHNOLOGY

Implement advanced 2D barcode systems that integrate with
your ERP and supply chain management software. These technologies facilitate automated tracking, reduce manual errors, and enhance overall efficiency in data handling and sharing.

STAFF TRAINING AND EDUCATION

Regularly update your team on DSCSA requirements
and provide training on recognizing suspicious activities. Empowering your staff with knowledge ensures they are prepared to maintain compliance during day-to-day
operations.

COLLABORATE WITH TRUSTED PARTNERS

Work closely with technology vendors and regulatory consultants who are well-versed in DSCSA compliance. Their expertise can offer valuable insights and technological solutions tailored to your business’s specific needs.

INTERNAL AUDITS AND REVIEWS

Establish periodic audits to evaluate your compliance
strategies. Regular audits help identify gaps, assess the effectiveness of current practices, and implement necessary adjustments proactively.

The Benefits of Being Compliant

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Achieving DSCSA compliance does more than just fulfill legal obligations; it positions your business as a trusted leader in the pharmaceutical supply chain. Compliance ensures your ability to prevent and address drug recalls effectively, minimizing potential disruptions and maintaining a steady supply flow. Furthermore, it builds confidence among consumers and stakeholders, enhancing your brand’s reputation for safety and reliability. By leading in compliance, you differentiate your business as a resilient, forward-thinking partner, fostering lasting relationships and gaining competitive advantage.

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Timelines and Tools

ENGAGE AND EQUIP: INTERACTIVE RESOURCES FOR EVERY STEP.
TIMELINE

Unless you have been granted a Wee (Wavier, Exception, or Exemption) you need to adhere to the DSCSA interoperability enforcement requirement by November 27, 2024

COMPLIANCE CHECKLIST QUIZ

Evaluate your company’s readiness by reaching out to us for a brief 30 min call to discuss your companies’ situation.

MIGRATION PROCESS AND PROCEDURES

If you currently use another system/platform for your DSCSA compliance needs but feel there could be a better alternative out there, please reach out. We have a detailed migration process in place to eliminate risk and increase user acceptance.

Need assistance with DSCSA implementation? Our expert compliance specialists are here to support you with personalized advice and solutions. Reach out to our team today.

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