Dispenser Track & Trace Enforcement — Extended to March 1, 2016
Friday, October 30, 2015
The Drug Supply Chain Security Act (DSCSA) required dispensers to comply with new requirements related to product tracing beginning July 1, 2015.
FDA issued a guidance this week DSCSA Implementation: Product Tracing Requirements for Dispensers–Compliance Policy (Revised) that extends a previously issued Compliance Policy from November 1, 2015 to March 1, 2016 because some dispensers – primarily smaller, independent pharmacies and health systems – have expressed that they need additional time.
FDA previously published a Compliance Policy on July 6, 2015. It stated FDA did not intend to take action until November 1, 2015, against dispensers that accepted ownership of product without receiving the product tracing information or who did not capture and maintain the product tracing information as required by the law. You can access the guidance at http://www.fda.gov/DrugsSafetly/DrugIntegrityandSupplyChainSecurity/
DrugSupplyChainSecurityAct.default.htm for the latest activities on the DSCSA.
Minnesota pharmacies in need of a solution to meet the track and trace requirements may wish to research InfiniTrak’s comprehensive software solution. MPhA has partnered with InfiniTrak to give Minnesota pharmacists licensing access to InfiniTrak, an innovative, cost-effective tool that streamlines pharmacy compliance with the trace and trace requirements of the Drug Supply Chain Security Act. The product has been developed in conjunction with the National Alliance of State Pharmacy Associations (NASPA). InfiniTrak enables users to produce required reports and respond to FDA audits with accuracy and ease. This breakthrough Track and Trace product allows independent, small chain and other pharmacies to take control of their business through easy automation, compliance and connection to consumers. With a partnership between MPhA and InfiniTrak, users will have the support from two organizations with a track record of success. InfiniTrak is competitively priced and allows users complete control of all the data they are required to send and receive to comply with the DSCSA. If your pharmacy has an interest in learning more about Infinitrak, visit http://www.infinitrak.us.
If you are interested in signing up for the service, contact Marsha Millonig or Jacquie Durant at the MPhA office.