As the summer winds down, HDA is hard at work planning our 2018 Traceability Seminar, which will take place three weeks earlier, on October 17–19 at the Renaissance Washington, DC Downtown Hotel. As the industry passes the halfway mark for DSCSA implementation, our 2018 agenda leverages HDA and our members’ unique expertise to help fellow stakeholders answer critical questions while planning for the multiple milestones ahead.

As mentioned in our February 16 blog post, HDA and industry participants continue to make progress working with solution providers as Verification Router Service (VRS) solutions are developed for the 2019 DSCSA saleable returns requirement. This work has taken three paths: establishing governance processes; creating testing scenarios; and launching the testing phase.

Last year, FDA announced a period of “enforcement discretion” related to the deadline for manufacturers to serialize products under the Drug Supply Chain Security Act (DSCSA). As the industry quickly approaches the November 2018 deadline, it is essential for companies to prepare now for the reality of conducting business in a serialized environment. Is your company ready to meet the new requirements?

On February 28, FDA hosted its third and final public meeting in a series focused on "Enhanced Drug Distribution Security Under the Drug Supply Chain Security Act [DSCSA],” bringing together a broad group of stakeholders, including manufacturers, distributors, dispensers, hospitals and service providers.

Efforts to mitigate the prescription drug abuse epidemic and activities surrounding DSCSA implementation once again top the list of priorities HDA will be addressing in the year ahead, according to HDA President and CEO John M. Gray. Mr. Gray provided his perspective, along with other healthcare supply chain leaders, as part of Chain Drug Review’s annual “Pharmacy Outlook” feature, published in the January 1 issue.