FDA To Hold First DSCSA Meeting
by Craig Hodgson, on October 20, 2016
The Drug Supply Chain Security Act (DSCSA) aims to protect U.S. consumers from counterfeit or contaminated pharmaceutical drugs. First signed into law by President Obama in 2013, the DSCSA includes a lengthy adjustment period that runs between 2015 and 2024.
The speed by which organizations have adopted these new regulations tends to hinge on their size. As Packaging Digest points out in a recent article, many of the largest pharmaceutical companies have already used their resources to get started on the serialization process. However, smaller companies have waited. Some may be delaying what could be a costly transition, while others might simply be seeking more guidance.
"The speed by which organizations have adopted these new regulations tends to hinge on their size."
The Food and Drug Administration is required to hold at least five meetings during this implementation process. The first one is scheduled for October. Securing Industry reported that the agency will listen to feedback from the firms about its track-and-trace requirements.
"This may include the processes needed to utilize the product identifiers to enhance tracing of product at the package level, including allowing for verification, aggregation, and inference, as necessary," the FDA announced in a statement.
Later, in November, the Healthcare Distribution Alliance plans to hold its annual Traceability Seminar, where industry leaders will discuss the challenges of implementation and what they have learned so far, according to Healthcare Packaging.
Manufacturers need to standardize their barcode labeling in order to better track legitimate products and make it easier for care providers and patients to spot fake medicines that may do them harm. An Enterprise Labeling Solution can automate and centralize this process to avoid labeling errors and comply with regulatory changes.
For more on pharmaceutical labeling in the pharma industry check out this on demand webinar.