DEA Clarifications On Certification Process for Audits of CS E-Prescribing Software

October 27, 2011 9:59 am Topics: Electronic prescriptions

In a Federal Register notice (PDF), DEA emphasizes that third-party audits of software applications for Electronic Prescriptions for Controlled Substances (EPCS) must encompass all applicable requirements in DEA regulations, including security, and must address “processing integrity” as set forth in the regulations. Further DEA recommends that, where questions or gaps may arise in reviewing a particular application, federal guidelines set forth in National Institute of Standards and Technology Special Publication 800–53A should be consulted. DEA has also announced the first DEA-approved certification process for EPCS. Once approved, certifying organizations with a certification process approved by DEA pursuant to the regulations are posted on DEA’s Web site. Detailed background information is provided in the Federal Register notice.