Use of an EPCS-certified application is the first step to legally fill or prescribe controlled substances electronically. US federal regulations require that all Electronic Prescriptions for Controlled Substances (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 navigate the individual regulatory requirements of each state.

Regulatory requirements

DEAThe DEA mandates that applications used for prescribing or filling Electronic Prescriptions for Controlled Substances 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 app certification and audits

Products are certified for a period of two (2) 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).

To search a list of UL certified applications, click here.

SERVICES

  • Project initiation
  • Requirement Matrix Review
  • Operational Testing and Test Report Generation
  • Certification
  • DEA-approved method for verifying processing integrity
  • Addresses opioid fraud and abuse
  • Increases efficiency
  • Improves patient safety
  • Maintains regulatory compliance

WHY UL

Global Market Acceptance

  • 120 year business experience
  • Operates in more than 143 countries
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  • UL Marks appear on more than 22 billion products globally
Comprehensive Testing & Certification Services

  • UL offers field evaluations, onsite training and can come to you for testing
  • Full compliance testing/evaluation to pre-scans and other preliminary testing
  • UL has engineers that work with you from design through conception and production
  • UL’s engineers average 10 plus years in the industry
  • UL has over 11 industries business units in the UL company portfolio

Knowledge of Global Standards and Regulatory Requirements

  • Covers many markets ie FDA (US), MFDS (Korean FDA), EU IVD, EU MDD
  • UL has helped to set more than 1,600 standards defining safety, security, quality and sustainability
  • UL Engineers partner with standard committees such as AAMI, ANSI and government bodies
  • UL has an FDA recognized consensus standard, UL 2900, for cybersecurity
State of the Art Facilities

  • 159 UL laboratories for testing and certification world wide
  • Tailored testing solutions, using software automation to enhance process efficiency, analyze results and reduce testing cycles
  • Over 10 Accredited UL laboratories around the world

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