What you need to know about DSCSA Medication Serialization

Created May 9, 2019 By MDScripts

Article Summary

The Drug Supply Chain and Security Act (DSCSA) addresses risks in the pharmaceutical distribution supply chain by establishing a national system that allows stakeholders and regulators to trace each package of product. Learn how these regulations are currently affecting medication suppliers and dispensers.

DSCSA Background

The Drug Supply Chain and Security Act (Title II, Drug Quality and Security Act, 2013) addresses risks in the pharmaceutical distribution supply chain by establishing a national system that allows stakeholders and regulators to trace each package of product. The serialization and traceability requirements will be phased in over 10 years (2013-2023). The law requires all sectors in the supply chain—manufacturers, repackagers, wholesale distributors, and dispensers—to participate.

Impact on Repackagers and Wholesale Medication Vendors

Repackagers and medication vendors must have adopted a traceability that supports bottle serialization by the end of 2018. Wholesale vendors have until the end of 2019. By the end of 2023 repackagers and wholesalers must participate in a system to exchange transaction level information with dispensers and manufacturers.

This requirement?s largest impact comes with the labeling of bottles and the tracking of serialized barcodes with GTIN information for every bottle that is repackaged. Non-repackaged items that are distributed by repackagers and medication vendors must utilize serialization details provided by the manufacturer.

Reference: Timeline for DSCSA

After products are serialized

Impact on Dispensers

Dispensers are not required to participate fully in the traceability exchange until 2023, but the impact on Repackagers and Wholesalers will begin affecting Dispensers starting at the end of 2018. Dispensers will begin receiving inventory with serialized barcodes that contain the necessary tracking information needed for the integrated system that will need to be in place by 2023.  

MDScripts Support

MDScripts has already begun working with many of our integrated repackager partners to add support for the GTIN barcodes with serial numbers. This is accomplished by the following process within the dispensing application:

As medication vendors begin utilizing the serialized barcodes and bottles, you should expect to go through a transition phase where some of your bottles will scan using old barcode labels and standard formats such as NDC*Lot or just Lot numbers on barcodes. As new serialized bottles begin to arrive in your inventory you may be required to start scanning the newer barcodes.

Additional Changes Coming in the Future

Over the next several years additional DSCSA regulations will be phased in that will have a greater impact on dispensers and clinics. The requirement to track each bottle's serial number and report back to a centralized monitoring service is covered under the EPCIS standard:

The EPCIS standard defines:

Standard interfaces are defined in the EPCIS standard to enable visibility event data to be captured and queried using a defined set of service operations and associated data standards, all combined with appropriate security mechanisms that satisfy the needs of user companies.EPCIS is intended to be used in conjunction with the GS1 Core Business Vocabulary (CBV) standard [CBV1.2]. The CBV standard provides definitions of data values that may be used to populate the data structures defined in the EPCIS standard. An example of tracking data for a single product from the point of manufacture to the point of dispensing is shown below. This traceability will be reported to central repositories such as MDScripts USMeds.com traceability system, which is currently being updated to manage DSCSA pedigrees.

Reference: EPCIS and Core Business Vocabulary Implementation Guideline

Reference: Stakeholder Requirements: Drug Supply Chain Security Act

For Additional questions regarding DSCSA Serialization or support for serialized barcodes within MDScripts dispensing platform please contact MDScripts Support. Additional information on the USMeds Traceability platform and work currently being done to implement DSCSA support please contact support@usmeds.com.