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The November 2018 deadlines for all-serialized product is looming
As of mid-2017, only a third of pharma companies are "very ready" for having serialized data on each package of products in commercial distribution according to a just-published 2017 survey sponsored by TraceLink, a leading traceability compliance IT firm. The response is based on 146 respondents--a fairly significant cross-section of the industry as these surveys go. According to a "basic steps" list that TraceLink has composed, not one manufacturer has completed all of listed items (some of which appear to be fairly advanced, such as having at least 80% of packing lines serialization-ready).
These serialization requirements come out of the 2013 Drug Supply Chain Security Act, which had had a November 2017 deadline for 100% serialized product. At the mid-year point, FDA announced that it was postponing that deadline to November 2018. (Other deadlines came both before and will follow after 2018; right now, pharma distributors are focused on a November 2019 deadline for properly processing returns, and the entire pharma supply chain has a November 2023 deadline for all-electronic tracking of all pharma products.)
The timing of the survey is significant: it was conducted (by an independent third-party firm) during June-July 2017, just as the postponement was announced. According to numerous industry sources Pharmaceutical Commerce has spoken to in the past six months, considerable momentum went out of the industry after the postponement; presumably companies are getting more energetic now.
The picture is slightly better among contract manufacturing organizations (CMOs), many of whom do the packaging for pharma brand owners. Half of 88 respondents said they were “very ready,” although here, too, no one CMO has completed TraceLink’s “basic” list.
Within the EU, pharma manufacturers have roughly comparable requirements under the Falsified Medicines Directive (FMD)—and a February 2019 deadline. There, only 15% of the combination of brand owners and CMOs are “very ready.”
“These survey results are startling," says Shabbir Dahoud, TraceLink CEO. “Despite goodwill efforts by industry and regulators to meet compliance on time, the industry is extremely behind in being ready... In both the US and EU, the industry-wide lag in full serialization implementations remains a concern and emphasizes the criticality of trade partner connectivity within the supply chain."
The full survey report, which includes other data on distributors and health systems compliance, is available here.