What must a pharmacy application be able to do to process electronic controlled substance prescriptions?
A. The application requirements are detailed in 21 C.F.R. 1311.205. Generally, the application must be able to import, display, and store the required contents of a controlled substance prescription accurately and consistently. The application must be able to digitally sign and archive the controlled substance prescription or import and archive the record that the last intermediary digitally signed. The application must electronically accept and store all of the information that DEA requires to be annotated to document the dispensing of a prescription. The application must allow the pharmacy to limit access for the annotation, alteration (to the extent such alteration is permitted by DEA regulations), or deletion of controlled substance prescription information to specific individuals or roles. The application must have an internal audit trail that documents whenever a prescription is received, altered, annotated, or deleted. The application must conduct an internal audit that identifi
