DSCSA: 2017 Deadline for Prescription Drug Manufacturers Fast Approaching
by Laura Johnson, on May 26, 2017
The Drug Supply Chain Security Act (DSCSA) is approaching full implementation, and companies at all levels of the pharmaceutical supply chain have to take note. Regulators put this system into place to ensure the traceability of prescription drugs all the way from their manufacture to end use, and the responsibility for correctly implementing it falls on every step of production and distribution.
Rolling Deadlines Start Now
The date to obey DSCSA differs by level of the supply chain. LSPediA explained that manufacturers must get ready now, as their compliance deadline is November 27, 2017. Repackagers must comply by November 27, 2018, and wholesale distributors have one more year, until November 27, 2019.
Manufacturers must have their product-tracing transaction information and serialization data stored in electronic form. From 2015 until 2017, this could be done on paper.
Pharmaceutical Processing noted that serialization entails a unique identifier on each unit produced, as well as sealed, homogenous cases. Companies have to respond to identifier information requests made by trading partners within 24 hours. Furthermore, when a product is returned and intended for resale, the manufacturer must verify its information.
Companies have to ensure that their databases hold identifier content for at least six years following transactions. As Pharmaceutical Processing explained, DSCSA is not for one size or type of company - every business in the pharmaceutical supply chain will have to comply, regardless of its unique situation.
Compliance is Essential
Succeeding in the pharmaceutical sector involves complying with relevant rules at all times. One slip could have major consequences for organizations. This means that securing the right labeling solution is a mission-critical responsibility.
Leaders must ensure they use a standardized labeling solution so that records are universally accessible and traceable. The benefits of these systems go beyond helping companies stay in compliance and extend to increased efficiency and accuracy of record keeping. No matter how complicated a manufacturer's supply chain is, the whole operation must be brought into compliance.
For more on pharmaceutical labeling check out our recent Q&A on that topic.