Hamacher Resource Group, Advasur, and Providence Health Technologies selected for FDA DSCSA Pilot Program

June 11, 2019By News

Waukesha, Wisconsin — June 11, 2019 — After a rigorous screening process, Hamacher Resource Group, Inc. (HRG) and partner organizations for track and trace services, Advasur, LLC, and Providence Health Technologies, LLC (PHT), have been selected to participate in a new Food and Drug Administration (FDA) pilot program aimed at easing Drug Supply Chain Security Act (DSCSA) compliance for small dispensers operating in the retail, hospital, long-term care, and specialty markets. Because the role of small dispensers in delivering patient care is critical, the pilot is to study the ability of such operations to comply with the data collection and submission requirements of the DSCSA within the timeframe specified in the Act. The pilot duration is proposed as six months with the final FDA presentation anticipated for first quarter 2020.

The first steps of the pilot entail measuring the awareness of the milestones to comply with DSCSA among small dispensers and assessing their compliance readiness for both the 2020 and 2023 requirements. Additionally, data collection methods that fit within small dispensers’ current workflow processes efficiently and effectively will be identified, including estimated average costs. Finally, a best practices model for small dispensers’ compliance will be developed.

Both HRG and PHT license the Advasur platform for track-and-trace solutions. HRG focuses on retail dispensers with its Rx Track-and-Trace Compliance Service, while PHT serves specialty and long-term care dispensers. According to Todd Barrett, RPh, president of PHT, “Realistically, with the volume of transactions, number of years the transaction data has to be stored, and tight turnaround if an audit is requested, dispensers must employ automation tools to be in compliance. Finding a reliable, trustworthy solution that removes most of the time burden from the pharmacist ensures the quality of patient care doesn’t need to be compromised because of these new responsibilities. Costs of implementation and maintenance must also be reasonable.”