As a provider of pharmacy or prescription software that transmits controlled substance prescriptions electronically, you are subject to the regulatory requirements of the DEA. Part of these requirements requires a pharmacy or prescription software system to adhere to the requirements under 1311.205 and 1311.300 respectfully. These requirements each have their 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 the EPCS transmissions, it is required that your software be audited by a qualified auditor that specializes in SysTrust (SOC 2), is a Certified Information Systems Auditor (CISA), or has been approved by the DEA. Once a successful audit has been issued, can you 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.
Skoda Minotti partners with your company to help you achieve compliance—and we make the experience seamless utilizing specialists with some of the deepest experience in the industry. Being one of the first companies to take both prescription and pharmacy software providers through certification, we have the most tenured experience in the industry.
DEA 1311 Gap Assessment. Preparing for your first DEA 1311 EPCS audit? Skoda Minotti’s specialists bring experience working with a range of companies, from Fortune 500 companies to private firms, across all industries. A Gap Assessment is the first initiative for companies that have not formally evaluated internal controls. Contact us to request a Gap Assessment.
DEA 1311 Report on Compliance. Skoda Minotti takes precise inventory of your organizational procedures and in-scope systems against DEA 1311.120 and 1311.205 to ensure compliance with all standards. We produce a Report on Compliance that confirms application controls, processing integrity, and physical security.
Why Us? We’re a full-service advisory firm with niche practice experience—and we are easy to work with. Our creative, talented professionals are committed to implementing the latest technology to build efficiencies. With more than 30 years of proven history in our field, we bring time-tested solutions and the latest innovations to your company. We also engage auditors with certifications such as CISSP, CISA, CISM, QSA, CIA, in addition to our on-site CPAs, in order to complete your company’s audit.