Since the enactment of the Drug Supply Chain Security Act in 2013, members of the pharmaceutical supply chain have undertaken efforts to meet each of the major milestones contained within the statute’s 10-year timeline to further secure the safety of the products being distributed. The industry’s progress to 2023 interoperability was top of mind as supply chain and other stakeholders came together at HDA’s recent Traceability Online Seminar.
Industry and service providers continue to work to implement the Drug Supply Chain Security Act’s (DSCSA) serialized saleable return milestone. With the end of FDA-granted enforcement discretion ending on November 27, 2020, and the industry simultaneously responding to COVID-19, it is all hands on deck to reach the compliance finish line.
HDA has published “A Year in Review,” which chronicles the Alliance’s 2019 activities. Highlighted accomplishments include:
With 2020 underway, HDA’s John M. Gray provided perspective on the vital role of pharmaceutical distributors and the Alliance’s policy priorities as part of Chain Drug Review’s annual “Pharmacy Outlook” feature.
It has been clear for some time that the pharmaceutical supply chain has been concerned with meeting the November 27, 2019, saleable returns milestone. As the HDA’s Research Foundation’s annual Serialization Readiness Survey (conducted in May) notes, 79 percent of manufacturers have concerns with the viability of the Verification Router Service (VRS), while 82 percent of distributors are unsure about meeting the requirement.