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Pharmaceutical Product
Serialization and DQSA
By Laura Olson
Why Product Serialization for Pharmaceuticals
• Provides complete history of a product’s chain of custody from manufacturing
through dispensation
• Helps to increase the level of security in the pharmaceutical supply chain
• Enables better collection, track and trace of pharmaceutical products
throughout the supply chain
What is Serialization?
• Serialization is the process of assigning and marking each individual product
or component with unique identifiers
• Serialization code can be as detailed as required by a customer
• Serialization codes may include Global Trade Identification Number (GTIN),
product or drug description, stock-keeping unit (SKU), batch or lot number,
expiration date, production date, manufacturing line and facility in which
product was produced
• Some serialization solutions include application identifiers (AIs) for increased
flexibility
Adoption of Serialization
• Today over 50% of the pharmaceutical industry is using serialization with
coding and marking technology implemented in the manufacturing process
• Serialization is often not used by smaller pharmaceutical companies and co-
packers
• Biggest area of concern in adopting serialization is the infrastructure required
to support it
Benefits of Serialization
• Compliance with federal regulations
• Helps to ensure consumer product safety and protect against counterfeiting
• Helps to protect brand reputation
• Facilitates improvements in efficiency
• Helps to control costs and improve shipping accuracy
• Improves effectiveness and efficiency of product recalls
• Facilitates better control of inventory
• Helps minimize product chargebacks associated with packaging errors
• Helps manufacturers control pricing & how chargebacks are executed
What is DQSA and Why is This Needed
Signed into law on November 27, 2013, the Drug Quality and Security Act
(DQSA) outlines the steps to build an electronic, interoperable system to identify
and trace specific prescription drugs as they are distributed in the US
Key provisions for implementation over the next 10 years:
• Product identification
• Product tracing
• Product verification
• Detection and response
• Notification
• Wholesale licensing
• Third party logistics provider licensing
Developed to ensure a consistent response from all states to eliminate
threats to security and patient safety and improve the effectiveness of
product recalls
Serialization and DQSA
• By the end of 2017, full serialization on a package level is required
• “Product identifier” is required and must include the National Drug Code,
standardized numerical identifier, lot number, product expiration date
• Pharma manufacturers are required to place a unique serial number on
individual packages of prescription drugs to enable authentication and
product tracing from manufacturer to dispenser
• DQSA regulation provides a single nationwide system that requires
participation across all supply chain sectors
The DQSA Mandated Product Identifier Explained
00100011234013
124511236711
12 2015
A12435X
GTIN
Serial Number
Expiration Date
Lot Number
What is a Product identifier?
Standardized graphic that includes in both human-readable form and on a
machine-readable data carrier:
• Standardized numerical identifier (set of numbers or characters used to
uniquely identify each package or homogeneous case that is composed of
the National Drug Code (NDC) plus a unique alphanumeric serial number
of up to 20 characters
• Lot number
• Expiration date of the product
Contact Us
800.933.2839
Online demonstration
marketing@datexcorp.com
Web chat
@Datexcorp
Datex Corporation

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Pharmaceutical Product Serialization and DQSA

  • 2. Why Product Serialization for Pharmaceuticals • Provides complete history of a product’s chain of custody from manufacturing through dispensation • Helps to increase the level of security in the pharmaceutical supply chain • Enables better collection, track and trace of pharmaceutical products throughout the supply chain
  • 3. What is Serialization? • Serialization is the process of assigning and marking each individual product or component with unique identifiers • Serialization code can be as detailed as required by a customer • Serialization codes may include Global Trade Identification Number (GTIN), product or drug description, stock-keeping unit (SKU), batch or lot number, expiration date, production date, manufacturing line and facility in which product was produced • Some serialization solutions include application identifiers (AIs) for increased flexibility
  • 4. Adoption of Serialization • Today over 50% of the pharmaceutical industry is using serialization with coding and marking technology implemented in the manufacturing process • Serialization is often not used by smaller pharmaceutical companies and co- packers • Biggest area of concern in adopting serialization is the infrastructure required to support it
  • 5. Benefits of Serialization • Compliance with federal regulations • Helps to ensure consumer product safety and protect against counterfeiting • Helps to protect brand reputation • Facilitates improvements in efficiency • Helps to control costs and improve shipping accuracy • Improves effectiveness and efficiency of product recalls • Facilitates better control of inventory • Helps minimize product chargebacks associated with packaging errors • Helps manufacturers control pricing & how chargebacks are executed
  • 6. What is DQSA and Why is This Needed Signed into law on November 27, 2013, the Drug Quality and Security Act (DQSA) outlines the steps to build an electronic, interoperable system to identify and trace specific prescription drugs as they are distributed in the US Key provisions for implementation over the next 10 years: • Product identification • Product tracing • Product verification • Detection and response • Notification • Wholesale licensing • Third party logistics provider licensing Developed to ensure a consistent response from all states to eliminate threats to security and patient safety and improve the effectiveness of product recalls
  • 7. Serialization and DQSA • By the end of 2017, full serialization on a package level is required • “Product identifier” is required and must include the National Drug Code, standardized numerical identifier, lot number, product expiration date • Pharma manufacturers are required to place a unique serial number on individual packages of prescription drugs to enable authentication and product tracing from manufacturer to dispenser • DQSA regulation provides a single nationwide system that requires participation across all supply chain sectors
  • 8. The DQSA Mandated Product Identifier Explained 00100011234013 124511236711 12 2015 A12435X GTIN Serial Number Expiration Date Lot Number What is a Product identifier? Standardized graphic that includes in both human-readable form and on a machine-readable data carrier: • Standardized numerical identifier (set of numbers or characters used to uniquely identify each package or homogeneous case that is composed of the National Drug Code (NDC) plus a unique alphanumeric serial number of up to 20 characters • Lot number • Expiration date of the product