Home ••• fda-dea-epcs Americas Compliance FDA/DEA EPCS REGULATION Comply with Electronic Prescriptions for Controlled Substances (EPCS) requirements EPCS revises DEA’s regulations to provide practitioners with the option of writing prescriptions for controlled substances electronically as well as receiving, dispensing and archiving electronic prescriptions. The electronic prescription application must incorporate a secure process for practitioner authentication. Entrust can help prepare organizations to meet these regulations through: FIPS-certified protection of private keys; Industry-leading experience in designing and implementing PKI solutions; A secure execution environment for running sensitive cryptographic processes. Regulation Regulation The DEA's EPCS Regulation "Electronic Prescriptions for Controlled Substances" revises DEA's regulations to provide practitioners with the option of writing prescriptions for controlled substances electronically. The regulations will also permit pharmacies to receive, dispense, and archive electronic prescriptions. The DEA’s requirements for EPCS include: (16) The digital signature functionality must meet the following requirements: (i) The cryptographic module used to digitally sign the data elements required by part 1306 of this chapter must be at least FIPS 140–2 Security Level 1 validated. FIPS 140–2 is incorporated by reference in Section 1311.08. .... (iii) The electronic prescription application's private key must be stored encrypted on a FIPS 140–2 Security Level 1 or higher validated cryptographic module using a FIPS-approved encryption algorithm. FIPS 140–2 is incorporated by reference in Section 1311.08. In addition, in “§1311.205 Pharmacy application requirements” in the same DEA publication, the section states: (b) The pharmacy application must meet the following requirements: (4) For pharmacy applications that digitally sign prescription records upon receipt, the digital signature functionality must meet the following requirements: (i) The cryptographic module used to digitally sign the data elements required by part 1306 of this chapter must be at least FIPS 140–2 Security Level 1 validated. FIPS 140–2 is incorporated by reference in Section 1311.08. .... (iii) The pharmacy application's private key must be stored encrypted on a FIPS 140–2 Security Level 1 or higher validated cryptographic module using a FIPS-approved encryption algorithm. FIPS 140–2 is incorporated by reference in Section 1311.08. Regulation Compliance Resources Related Solutions FedRAMP Program The Federal Risk and Authorization Management Program LEARN MORE HIPAA | HITECH For electronic health information security and the timely disclosure of data breaches LEARN MORE FDA/DEA: CSOS Controlled Substance Ordering System LEARN MORE Related Products nShield Hardware Security Modules Hardened, tamper-resistant environments for secure cryptographic processing and key management. nShield Connect Networked appliances that deliver cryptographic key services to applications distributed across servers and virtual machines. Contact Contact Sales Contact Support Find a Location Company About Careers Events Webinars Newsroom Blog Press Releases News Product Resources Entrust Store Resources Library Training Legal and Compliance Covid 19 Updates Social Twitter Facebook Instagram LinkedIn YouTube English 中文 Português Français Deutsch Русский 한국어 Español Italiano 日本語 Legal Privacy Statement Internet Based Ads Terms of Service Terms of Use Company Policies Cookie Policy ©2021 Entrust Corporation. All rights reserved. This website uses necessary cookies to make our site work. We’d also like to set optional analytics cookies to help us improve our website by collecting and reporting information on how you use it. Using this tool will set a cookie on your device to remember your preferences. To read more about how we use cookies, see ourCookie Policy. Cookies Settings Accept All Cookies