Fishers, IN – The Drug Supply Chain Security Act (DSCSA), will come fully into force in 2023, requiring an electronic, interoperable track and trace system that will monitor the distribution of drugs in the US to prevent counterfeit, contaminated, and diverted drugs.

Many pharmaceutical companies, contract manufacturing organizations, and contract packagers relaxed when a one-year postponement was announced last year, but now the deadline is real. The first due date for timely serialization compliance is imminent: November 26, 2018. DSCSA mandates printing unique product identification codes on all Rx units of sale and homogenous cases distributed domestically.

Clarke Solutions offers comprehensive serialization and traceability solutions. Subject matter experts at Clarke can support every step of the process, from the first planning meeting through final implementation, partnering with companies to provide a complete, robust solution to meet the DSCSA requirements well before the November deadline.

When asked about DSCSA, Clarke CEO John Duffin noted, “Deadlines for serialization are coming and not only must Pharmaceutical manufacturers and packagers be FDA compliant, these changes will ensure improved product security and brand protection by combating the issue of counterfeit, stolen, contaminated product in the supply chain.”

Established in 1997, Clarke Solutions helps ensure quality, safe, and compliant products for clients through innovative and cost-effective solutions for specific manufacturing and packaging service requirements. Clarke’s talented and passionate team – headquartered in a 30,000 square foot facility in Fishers, Indiana – becomes part of your team, providing personalized attention and two decades of documented best practices to deliver measurable results.

For more information about Clarke and its services, visit To reach Clarke, call (317) 849-0330 or email