Ensuring the usability of health IT products (1)
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 the electronic prescribing of controlled substances. UL Solutions’ 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
- Maintains regulatory compliance
Why UL Solutions
Global Market Acceptance
- Business experience reaches back to 1894
- Operates in more than 143 countries
- Our reports and certifications are recognized and accepted around the world
- UL Marks appear on more than 22 billion products globally
Comprehensive testing and certification services
- We offer field evaluations, on-site training and can come to you for testing
- Full compliance testing/evaluation to prescans and other preliminary testing
- Our engineers average more than 10 years in the industry
- Expert assistance with accreditations
- 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.
Knowledge of global standards and regulatory requirements
- Covers many markets, i.e. U.S. Food and Drug Administration, Korean Ministry of Food and Drug Safety (MFDS), European Union (EU) In Vitro Diagnostics (IVD), EU Medical Device Directive (MDD)
- We have helped to set more than 1,600 Standards defining safety, security, quality and sustainability
- Our engineers partner with standard committees, such as the Association for the Advancement of Medical Instrumentation (AAMI), the American National Standards Institute (ANSI) and government bodies
- We have an FDA-recognized consensus standard, UL 2900, for cybersecurity
- 159 UL Solutions laboratories for testing and certification worldwide
- Tailored testing solutions, using software automation to assist you to: enhance process efficiency, analyze results, and reduce testing cycles