DEA Announces Approved Certification Processes for Electronic Prescriptions

August 10, 2012

By Larry K. Houck
The Drug Enforcement Administration (“DEA”) recently amended its regulations to allow practitioners to issue electronic prescriptions for controlled substances (“EPCS”) in lieu of hardcopy paper prescriptions.  See 75 Fed. Reg. 16,236 (March 31, 2010).  DEA requires that any electronic prescription application or pharmacy application used for EPCS must be reviewed, tested and determined by a third party to meet all of the required technical specifications.  21 C.F.R. § 1311.300(a).  As an alternative to the third party audit requirements of 21 C.F.R. §§ 1311(b)-(d), an electronic prescription or pharmacy application may be verified and certified as meeting DEA requirements by a certifying organization whose certification process has been approved by DEA.  21 C.F.R. § 1311.300(e).  DEA stated that it would notify registrants of any approved third party certifications on its website.  75 Fed. Reg. 16,243.

DEA announced on August 1, 2012 that it has approved the certification processes developed by two certifying organizations (77 Fed. Reg. 45,688 (Aug. 1, 2012)) and has posted relevant information about those approvals, and about an earlier approval, on the DEA Diversion Control website.