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Pharmaceutical companies and contract manufacturing organizations report lack of readiness for the November 2018 US Drug Supply Chain Security Act serialization deadline.
In December 2017, TraceLink released findings from a survey of 660 serialization partners, including 174 pharmaceutical companies and 155 contract manufacturing organizations (CMOs) (1). Results, due to be published during the first quarter of 2018, suggest that only one third of the pharma company and CMO executives surveyed see their companies as being “very ready” for the US Drug Supply Chain Security Act (DSCSA) serialization deadline in November 2018.
Most of the companies who feel well prepared had taken many of the necessary steps, but there were some notable gaps. For example, only 8% had integrated efforts with most (i.e., 81-100%) of their CMOs. Only 11% reported that 81-100% of their CMOs were ready to ship serialized product, while only 12% reported that internal packaging line equipment had been ordered and fully installed, and that 81-100% of their internal packaging lines were ready. In addition, 23% were not concerned about equipment and skills shortages affecting serialization compliance, and only 37% had moved away from paper-based lot transaction records. Half of CMOs surveyed felt very ready for DSCSA, but only 23% reported that they are integrated with their pharma customers, while 22% say brand owners are ready for integration. Only 9% are concerned about equipment shortages having an impact on compliance. For pharma companies and CMOs, only one third reported feeling “very ready” for the EU’s Falsified Medicines Directive (FMD).
An earlier 2017 survey (2) by the Healthcare Distributors Association examined the industry’s readiness for serialization based on responses from professionals at 67 manufacturers, including 15 of the top 20 based on product sales. This survey also found readiness gaps, with 3% of generics and 34% of branded-product manufacturers expecting to ship 100% serialized product to distributors by November 2017. By November 2018, however, 69% of generics and 91% of branded pharma companies are expected to do so.
By November 2017, 24% expected to send serialized data to distributors, 33% said they will send it by November 2018, and 30% expect to send it between 2018 and 2023. However, 13% are unsure that they will send serialized data.
1. Tracelink Webcast, “The 2017 Global Drug Supply, Safety and Traceability Report,” tracelink.com, Dec. 7, 2017.
2. Healthcare Distribution Alliance, Manufacturer Serialization Readiness Survey: Executive Summary, healthcaredistribution.org.
Vol. 31, No. 1
When referring to this article, please cite it as A. Shanley, "Surveys Redefine ‘Ready’," BioPharm International 31 (1) 2018.