Track & Trace

MaXQ codes, which can be expressed as QR, alphanumeric, or bar codes, are generated by Kezzler at over one billion a minute and printed by Amcor at industrial speed. The dynamic codes are activated by brand owners and can be managed using Kezzler’s technology platform.

As a metaphor for change, “a perfect storm” may be overused. Still, for health systems, it is an apt descriptor, given the flood of disruptive events on the horizon. The transition to ICD-10 diagnostic codes, the explosion of risk-sharing models of care and looming biosimilars approvals are just a few of the key trends that promise to shake up pharmacy operations.

These are only a few of the opportunities that drug counterfeiters have seized upon in order to turn a profit at the expense of consumers’ health and manufacturers’ reputations.
As a result, a number of countries around the world are in the process of rolling out serialization-based anti-counterfeiting regulations. These include the European Union’s Falsified Medicines Directive, the United States’ Drug Supply Chain Security Act and China’s electronic drug supervision code requirement.
Here’s what you need to know.

Amcor (ASX:AMC), a global leader in flexible and rigid plastics packaging, and Kezzler AS, a leader in serialization business services, today announced a global partnership to offer customers a full service, advanced packaging serialization, backed by a cloud platform. The new product, MaXQ, offers brand owners unique identification codes printed on every pack. The dynamic codes can be used for digital consumer engagement, anti-counterfeiting, track and trace, and other activations.

The US Food and Drug Administration (FDA) plans to give drug dispensers—i.e. pharmacies—an additional four months to comply with federal track and trace requirements established under the Drug Supply Chain Security Act (DSCSA).

The Drug Supply Chain Security Act (DSCSA) outlines critical steps to build an electronic, interoperable system to identify and trace prescription drugs as they are distributed in the United States. DSCSA has staged implementation over a 10-year period that began with the enactment of the law in November 2013. So where does DSCSA stand now? DCAT Value Chain Insights examines key implementation activities.

Track and trace, serialization and e-pedigrees have been topics of great interest in pharma for over 10 years. This week brought reminders that many companies have yet to develop a plan or strategy for taking action on the first step of true traceability: serialization.

Pharmacies must be compliant with new regulatory requirements under the new track-and-trace law—the Drug Supply Chain Security Act (DSCSA). Some key requirements took effect on January 1, 2015. The next key deadline is July 1, 2015.
The APhA Government Affairs team’s printable checklist to help pharmacies comply with the DSCSA is now posted on pharmacist.com, ahead of the upcoming July issue of Pharmacy Today.

This year, Federal Drug Supply Chain Security Act (DSCSA) drug traceability requirements become mandatory. The new DSCSA requirements will be implemented in three phases over a 10-year period. Phase one, which started on Jan. 1, 2015 and will be in effect until December 2022, requires the exchange of “chain-of-ownership data.”

This year, Federal Drug Supply Chain Security Act (DSCSA) drug traceability requirements become mandatory. The new DSCSA requirements will be implemented in three phases over a 10-year period. Phase one, which started on Jan. 1, 2015 and will be in effect until December 2022, requires the exchange of “chain-of-ownership data.” Beginning in November 2017, the second phase will require that “pharmaceutical products be marked with a national drug code, serial number, lot number, and expiration date in machine-readable and human-readable form.” The final phase of the DSCSA requirements, starting in 2023, will require trading partners to share all data necessary to track serialized items to the product’s origin (1).