FDA/DEA EPCS Compliance Evaluation in Arizona

FDA/DEA EPCS Compliance refers to adhering to regulations set forth by the Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA) for Electronic Prescriptions of Controlled Substances (EPCS). This initiative allows practitioners to electronically write prescriptions for controlled substances, as well as enables pharmacies to receive, dispense, and archive electronic prescriptions securely.

Key Requirements for DEA’s EPCS Regulation:

• Digital Signature Functionality:
  • The cryptographic module used for digital signatures must meet FIPS 140–2 Security Level 1 validation.
  • The electronic prescription application’s private key must be securely stored encrypted on a FIPS 140–2 Security Level 1 or higher validated cryptographic module using an approved encryption algorithm.

Pharmacy Application Requirements:

• Digital Signature Functionality for Pharmacies:
  • Pharmacies must meet the same requirements as electronic prescription applications for digitally signing prescription records upon receipt.
  • This includes using a FIPS 140–2 Security Level 1 validated cryptographic module and securely storing the private key.

Related Articles: Explore Thales FDA/DEA Regulatory Compliance: EPCS Page for more information on meeting FDA/DEA EPCS Compliance standards.

Ensure your organization is compliant with FDA/DEA EPCS regulations to safely and securely handle electronic prescriptions for controlled substances.