Government Compliance Services

  • DEA 1311 (EPCS) Compliance
  • NIST
  • FDA CRF 21

DEA Part 1311 for Electronic Prescription for Controlled Substances (EPCS) was released in 2011 and the DEA requires that application provides both the prescribing and pharmacy to undergo a application audit to verify their compliance with the DEA rules.  The DEA requires these applications to be reviewed for compliance with the specific standard part 1311.120 for prescriber applications and part 1311.205 for pharmacy applications.  Application providers must prove to their auditor that they have met all requirements and their system meets physical security and processing integrity standards.

DEA 1311.120 for application service providers for EPCS services has 28 standards that all applications must comply with.  We audit your organizational procedures and in scope systems against the DEA 1311.120 standard and deliver your Report on Compliance that covers all 28 standards, processing integrity and physical security.

DEA 1311.205 for application service provides for EPCS services have 18 standards that all applications must comply with.  Pharmacies have a unique requirement where they must validate the prescribers submissions prior to excepting the transaction.

Who can certify your application? The DEA has stated that companies who perform SysTrust, SAS 70, or a CISA can execute these reports.  Assurance Concepts meets all of these requirements and has proven experience by successfully getting clients through their certification and registered with SureScripts.

Assurance Concepts specializes in DEA 1311 and other government compliance standards.  Contact us today to learn more about our services.

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