Providers of pharmacy or prescription software that transmits controlled substance prescriptions electronically are subject to the regulatory requirements of the Drug Enforcement Administration (DEA) 1311 Electronic Prescription for Controlled Substances (EPCS). Providers must comply with both 1311.205 and 1311.300 and each requirement has its own set of application controls accompanied by physical security and processing integrity controls.
The DEA has set a strict standard to ensure the protection of electronic approvals and fulfillment of drugs. Additionally, to be approved for DEA 1311, your software must be audited by a qualified auditor that specializes in SysTrust (SOC 2) and is a Certified Information Systems Auditor (CISA) or has been approved by the DEA.
Skoda Minotti Risk Advisory Services was one of the first companies to take both prescription and pharmacy software providers through DEA 1311 certification and we have the most tenured experience in the industry. We partner with your company to help you achieve compliance and we make the experience seamless by utilizing specialists with some of the deepest experience in the industry.
Once a successful audit has been issued, you can start transmitting or accepting electronic controlled prescriptions. These certification audits are required to be performed every two years to ensure the system still meets DEA regulations.
For more information about DEA 1311 (EPCS) services at Skoda Minotti, please complete the form below or call Ben Osbrach at 440-449-6800.