FDA Compliance

Track and Trace

DSCSA (also known as Track and Trace) is a non-funded government mandate that is rolling out in three phases that began in 2013 and is on schedule to be fully mandated by 11/27/2023.

Advasur 360 Compliance Services is a comprehensive suite of Drug Supply Chain Security Act (DSCSA) services that will help you with all current and future DSCSA requirements.

DSCSA Compliance

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.

Goals of the Drug Quality and Security Act

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:

• facilitate the exchange of information by trading partners at the individual package level
• improve efficiency of recalls
• enable prompt response to suspect and illegitimate products when found
• create transparency and accountability in the drug supply chain

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Summary of the Planned Implementation Timeframes for the DSCSA

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

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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.