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DSCSA Compliance

Now

U.S. Dispensers Subject to Federal and State DSCSA Compliance Audits

Nov. 2020

Deadline for DSCSA Compliance

In One Year

Potential Prison Term for Pharmacist's Noncompliance

For Six Years

Storage Term by Pharmacy for Electronic Advance Shipment Notices (ASNs)

DSCSA COMPLIANCE Explained

The Drug Quality and Security Act (DQSA), was enacted by Congress on November 27, 2013. Title II of DQSA, the Drug Supply Chain Security Act (DSCSA), outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. This system will enhance FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. The system will also improve detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers.

The Drug Supply Chain Security Act will require the development of an electronic, interoperable system by 2023 to identify and trace certain prescription drugs as they move through the U.S. supply chain.

The System will:

Pharmaceutical Supply Chain
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DSCSA-Planned-Implementation-Plan-2-19-14
Click Image to Visit the FDA Website for More Information

What Is Serialization

and What Does It Mean to the Pharma Industry?

Serialization is the affixing of unique serial numbers (Unique Product Identifier) to each saleable package unit of product.

Aggregation is the linking of all package levels in a parent/child relationship (i.e. bundle, case, pallet).

Track and Trace is the tracing of a product through the supply chain to the end consumer or point of dispensation.

In the U.S., the Unique Product Identifier (UPI) consists of:

  • A National Drug Code (NDC) or a Global Trade Item Number (GTIN)
  • A Serial Number (alphanumeric up to 20 characters)
  • A Lot Number
  • An Expiration Date
UPI-Example
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Counterfeit medicines have become a serious threat to public health.

10% of medicines sold worldwide are counterfeit (source: WHO)

Counterfeit  medicines are 20% more profitable than heroin (source: WHO)

Counterfeit  medicines cause 700,000 deaths / year (malaria & tuberculosis treatment only; source: OECD)

Counterfeit  medicines produce $200 billion in annual revenue (source: WCO)

Serialization Challenges For Dispensers

Timeliness: If you cannot achieve serialization compliance in time, you put your whole business at risk

Productivity: Central configuration and prequalification reduce impact on OEE and speed up deployment

Connectivity: Serial numbers, master data and event information need to be exchanged among supply chain parties and also reported in a compliant way.

Communication: Serialization implementation requires the coordination of numerous internal and external stakeholders. Don’t underestimate the scope of your project!

Serialization and Beyond: when choosing your serialization solution, don’t forget to consider future compliance and regulatory requirements. Beyond compliance, think of the business potential of your serialization data.