What you need to know about DSCSA Medication Serialization
Created May 9, 2019 By MDScripts
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.
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.
After products are serialized
Suppliers can only buy and sell products encoded with product identifiers (unless grandfathered under section 582(a)(5))
Repackagers (beginning 11/27/2018)
Wholesale distributors (beginning 11/27/2019)
Dispensers (beginning 11/27/2020)
Verification must be done for product at the package level, including the standardized numerical identifier (NDC and serial number) *see respective sections of 582 for specific verification requirements
Manufacturers: starting 11/27/2017
Repackagers: starting 11/27/2018
Wholesale distributors: starting 11/27/2019
Dispensers: starting 11/27/2020
Enhanced product tracing to be implemented by 2023 at the package-level.
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 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:
Adding logic to recognize the repackager's specific barcode format, which can vary depending on how they chose to implement the regulations within their processes.
Provide a masking scheme so that when users scan individual bottles the system still recognizes which items are being dispensed from inventory
Automatically capture serial number for the user and store with dispense data. This requirement will become mandatory in 2020.
Serial Number can be enabled as an input field under Home -> My Site -> Input Fields so that users can begin seeing what serial numbers are being captured when medications with serialized barcodes are dispensed.
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:
A data model for visibility event data using the eXtensible Markup Language (XML);
Open, standardized interfaces that allow for seamless integration of well-defined services in inter-company environments as well as within companies. There are two interfaces defined in the EPCIS standard:
A capture interface through which visibility event data conforming to the EPCIS data model may be delivered from capturing applications to a receiver, typically a persistent repository of EPCIS data; and
A query interface through which EPCIS event data may be requested by and delivered to a business application or a trading partner.
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.