DSCSA 2023: Systech advises that stabilization period is no excuse for delayed compliance



Systech advises the pharmaceutical industry to maintain momentum amid DSCSA stabilization period and impending deadlines 

Princeton, NJ, October 17, 2023 – In light of the FDA’s recent announcement regarding a delay in the enforcement of the Drug Supply Chain Security Act (DSCSA), Systech, part of Markem-Imaje and Dover, and a leading provider of digital identification and traceability software solutions, cautions the industry against complacency. 

“While the FDA’s decision to offer this respite may offer temporary relief from enforcement repercussions, this period should be viewed as a golden opportunity to test and refine DSCSA compliance strategies and processes,” said Sreedhar Patnala, VP, Products. “The stakes in building an interoperable pharmaceutical supply chain are too high to ignore, and the benefits of full DSCSA compliance go beyond mere regulatory adherence.” 

DSCSA requirements are still set to take effect on November 27, 2023, with the stabilization period extending through November 27, 2024. It is imperative that entities throughout the pharmaceutical supply chain have advanced technologies in place this fall and fine tune their processes to ensure a seamless transition when enforcement commences. The FDA provides an overview of the key Supply Chain Security Requirements

For manufacturers, wholesalers and dispensers, the stabilization period is crucial to ensure that technologies for data connections and product verifications are in place. For pharmacies and hospitals in particular, this period is pivotal for refining compliance systems and addressing data and product misalignment issues. 

“The overall system needs to handle billions of transactions a year. It’s one thing to do a performance test in a test environment. But during actual production, everything needs to work end-to-end,” said Gregg Gorniak, Vice President – Manufacturer Operations & Data Services, Cencora (formerly AmerisourceBergen). “To get to where we need to be during the stabilization period, we have to see more data.” 

Global Packaging Business Benefits from Systech Solutions 

Nutra-Med Packaging, a contract packaging company that serves the pharmaceutical, healthcare and medical device industries, chose Systech to help achieve and maintain DSCSA compliance and supply chain traceability.  

“The delay in DSCSA enforcement will certainly have serious repercussions a year from now. By postponing required functions such as aggregation, organizations will delay the advantages of DSCSA track and trace solutions,” said Kunal Gupta, CEO of Nutra-Med. “Systech’s expertise in pharmaceutical serialization and traceability has enabled these advantages for our business while also ensuring our operation is in compliance.” 

The Pharmacy Sector & Data Alignment 

Pharmacies stand at the critical juncture between the drug supply chain and the consumer, serving as the final point of contact. The stabilization period offers an opportunity to refine data connection and product verification processes, which are foundational elements for compliance. 

“NABP supports the FDA’s decision to provide a stabilization period for DSCSA,” said NABP Executive Director/Secretary Lemrey “Al” Carter, PharmD, MS, RPh. “The entire supply chain should continue progress towards compliance. In particular, pharmacies should take advantage of the additional time to ensure they have systems and processes in place to comply.  Systech’s early adoption of VRS, and desire to become a Pulse Interoperability Partner demonstrates its commitment to pharmacies nationwide and is aligned with our goal of further securing the drug supply chain to protect public health.”  

Data and product misalignment cannot be taken lightly given the volume of prescriptions filled annually in the US. The extra year provides a chance to establish smooth processes that ensure the transition to the new regulatory landscape. 

UniTrace: A Comprehensive Solution for DSCSA Compliance 

Systech’s UniTrace suite offers a complete, cloud-based solution for the data connections required for DSCSA compliance. This platform integrates internal and external serialized item information systems, enabling end-to-end traceability in the supply chain. UniTrace for Pharmacy enables that sector to comply as well, with connections and verifications. Systech can help companies turn supply-chain complexity into connectivity with true, global traceability. 

“Our technology and expertise aim to ensure that companies not only meet but exceed DSCSA requirements, safeguarding their businesses, their partners and the patients they all work to serve,” adds Patnala.  

It is important to remember that the deadlines have not changed, and the upcoming stabilization period should be used wisely. Manufacturers, wholesalers and dispensers need to verify data connections and ensure their exception-handling processes have been tested properly.  

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