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Six Months to DSCSA Enforcement Date

As the enforcement date for unit-level product identifiers nears, challenges lie ahead for manufacturers and the industry as a whole.

Saturday, May 26, the pharmaceutical industry will be just six months out from the DSCSA serialization enforcement date of Nov. 26, 2018. The deadline for compliance remained Nov. 27 of 2017, but last summer, the FDA stated they would not enforce the manufacturers’ unit-level product identifier requirements under the DSCSA for another full year.

With deadlines looming, resources for equipment and software have been put to the test, with some manufacturers citing long lead times for system implementation. With this in mind, many providers have developed preconfigured systems to get existing lines compliant quickly, without quite as many bells and whistles or customization.

Persistence Market Research suggests that the biggest issue facing those who require pharmaceutical traceability is the cost. “Estimates range from a conservative $250,000 all the way up to $1 million per line depending on how complex and automated it already is. These lines will experience production downtime while the changes are being made causing potential sales revenue losses,” says Persistence in its upcoming report, Track-and-Trace and Serialization Market: Global Industry Trend Analysis 2012 to 2017 and Forecast 2017 – 2025.

Some companies choose to work with CMOs, or even upgrade a CMO’s packaging line themselves. In either option, it’s an expensive endeavor.  The report also cites data management as another challenge, as large amounts of information must be stored for years, and accessible in a timely manner.

And looking past the enforcement date, much of the industry is still in need of education to meet the full drug product tracing goals. As we reportedrecently, the Office of the Inspector General (OIG) issued a report showing that there’s still a need for training “to ensure all dispensers understand their responsibilities to receive complete drug product tracing information from trading partners before taking ownership.”

Of 40 dispensers interviewed between Dec. 2016 and Feb. 2017, twenty-six received all required drug product tracing information from their trading partners, while 14 were missing these elements, including two that the report said were “unaware of the DSCSA and requirements for drug product tracing.”

For coverage on recent guidance documents, check out:

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