Are you ready

Some things to consider:  Discuss a plan for storage and retrieval of TI, TH and TS (direct ordering and/or wholesaler ordering) with your Information Technology (IT) team;  Discuss requirements of your network with your wholesaler;  Discuss requirements for receiving TI, TH and TS data with your direct vendors; Consider the financial impact to your budget due to the adherence of these new requirements;  Recognize how you will handle loan/borrow situations that are managed external of your system.
Identify and become familiar with the specific exclusions from this policy.  Define record keeping standards and requirements for your practice.
  • SAGENT Serialization Customer Letter
  • FDA DSCSA web page
  • FDA webinar for review: DSCSA Updates and Readiness Check: Requirements for Dispensers and other Trading Partners Webinar
  • Webinar to identify suspect product and notification
  • Are you ready for the Drug Supply Chain Security Act?