Use of an EPCS-certified application is the first step toward filling or prescribing controlled substances electronically. U.S. federal regulations require that all EPCS must be processed by approved applications per the Drug Enforcement Administration (DEA). An increasing number of states are passing legislation to mandate electronic prescribing of controlled substances. UL’s staff of experts can help you to navigate the individual regulatory requirements of each state.
The DEA mandates that applications used for prescribing or filling EPCS meet all the requirements stated in 21 CFR Part 1311 Subpart C. These requirements include the use of cryptographic digital signatures, two-factor authentication and Federal Information Processing Standard (FIPS) 140-2 validated cryptographic modules.
EPCS application certification and audits
Products are certified for a period of two years from the date of certificate issuance. Pharmacies and prescribers must also complete an audit to address processing integrity (prevention of insider threats and outsider attacks).
- Project initiation
- Requirement matrix review
- Operational testing and test report generation
- DEA-approved method for verifying processing integrity
- Addresses opioid fraud and abuse
- Increases efficiency
- Improves patient safety
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- Compliance with the DEA’s stringent security requirements. We have the required accreditations and expertise to help you meet DEA requirements for your EPCS application.
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