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Drug Supply Chain Security Act (DSCSA)

On November 8th-10th, representatives of our team traveled to Washington, D.C. to attend the Healthcare Distributor Alliance (HDA) 2017 Traceability seminar. Our team has attended this seminar for the last four years to stay informed of the pharmaceutical supply chain industry's efforts to implement the most recent regulations from the Drug Supply Chain Security Act (DSCSA). Every year, the Healthcare Distribution Alliance (HDA) has provided a traceability seminar in an effort to gather supply chain leaders to  "learn more about upcoming DSCSA implementation milestones as well as innovative approaches and lessons learned as distributors, manufacturers and dispensers implement serialization and traceability technologies to further preserve the safety and security of the healthcare supply chain."1

The Drug Quality and Security Act (DQSA), enacted by Congress in 2013, has a large impact on the work that we do everyday. The Dispensary of Hope has been particularly focused on Title II of DQSA, the Drug Supply Chain Security Act (DSCSA) which "outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States."2 The move to an electronic system will provide better measures to safeguard the integrity of medication by identifying medication that "may be counterfeit, stolen, contaminated, or otherwise harmful."2

During our time at the seminar, we learned more about the industry's overall goal of implementing a standardized electronic system to track and trace product information from production to dispensing of the medication. As the manufacturers recognize that this electronic system is complex, they understand that communication within the supply chain is crucial and will be a factor in the success of this system, particularly the communication between trading partners. 

The Dispensary of Hope is currently in the process of assuring our systems are prepared for the 2019 requirements for Wholesale Distributors by implementing a state of the art Warehouse Management System to meet all the mandates. The Dispensary of Hope COO, Josh Kravitz said, "DSCSA preparedness is just one way we ensure there are no double standards between medication given to insured and uninsured patients." To view the timeline for the federal implementation of DSCSA, click here. Please remember that DSCSA requirements for dispensers differs from distributors and varies based on charitable designation. The links below and your state Board of Pharmacy can provide further information. 

 

Want to learn more? Check out the links below:

1. Learn more about the Traceability Seminar here

2. Learn more about the Drug Quality and Security Act here.

3. Learn more about your role in meeting the FDA expectations as a dispenser here and here