Requirements for Electronic Prescriptions for Controlled Substances (EPCS)
EPCS requires the individual practitioner be responsible for ensuring the electronic prescription conforms to all legal requirements and the pharmacist, acting under the authority of the DEA-registered pharmacy, has a corresponding responsibility to ensure the prescription is valid and meets all legal requirements.
In order to electronically prescribe controlled substances, some of the major DEA requirements prescribers must adhere to include:
- Use of an e-prescribing application that is certified by a DEA approved entity.
- Completion of a compliant identity-proofing process.
- Use of a secure, two-factor authentication process to sign prescriptions for controlled substances.
Before any application may be used for electronic prescriptions for controlled substances, it must be reviewed, tested, and determined by a third party to meet all of the requirements of 21 CFR Part 1311. Therefore, a practitioner cannot issue EPCS and a pharmacy cannot process the prescription until the software application provider obtains a third party audit or certification review that determines the software application complies with DEA's requirements and the application provider provides the audit/certification report to the pharmacy.
For more information regarding the DEA's requirements for electronically prescribing and/or processing controlled substances, please visit the DEA's website at http://www.deadiversion.usdoj.gov/ecomm/e_rx/index.html.