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.


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