The Drug Supply Chain Security Act (DSCSA) enforcement discretion ended today March 1, 2016 for pharmacies and dispensers. However, yesterday Feb 29, the FDA posted a new guidance called “Requirements for Transactions With First Responders Under Section 582 of the Federal Food, Drug, and Cosmetic Act–Compliance Policy; Guidance for Industry“. In this guidance the FDA does state that transactions between dispensers and first responders may present challenges. The listed challenges are “exchange of product tracing information,” “conducting businesses with authorized trading partners,” and “having a verification system in place.” Due to these challenges, The FDA has decided to take no action against certain trading partners and first responders until further notice.
So what does this mean? It means in that if you perform any transactions with any first responders such as an ambulance company and don’t have a process in place for managing T3s with them, the FDA will not take any action against you. However, for everything else, dispensers must comply with all other requirements of the DSCSA.
Free DSCSA Evaluation
Contact TrackTraceRx today to receive a free evaluation of your DSCSA current policy and procedures. This free consultation will allow you to have a piece of mind that you are following the correct procedures in order to meet ALL DSCSA requirements. TrackTraceRx will also provide you with a FREE Standard Operating Procedure (SOP) template which is required by the DSCSA during a FDA inspection.