Title 21, Part 1311 — Requirements for Electronic Orders and Prescriptions

Scope.

Definitions.

Standards for technologies for electronic transmission of orders.

Incorporation by reference.

Eligibility to obtain a CSOS digital certificate.

Limitations on CSOS digital certificates.

Coordinators for CSOS digital certificate holders.

Requirements for obtaining a CSOS digital certificate.

Requirements for storing and using a private key for digitally signing orders.

Number of CSOS digital certificates needed.

Renewal of CSOS digital certificates.

Requirements for registrants that allow powers of attorney to obtain CSOS digital certificates under their DEA registration.

Requirements for recipients of digitally signed orders.

Requirements for systems used to process digitally signed orders.

Recordkeeping.

General.

Practitioner responsibilities.

Requirements for obtaining an authentication credential—Individual practitioners.

Requirements for obtaining an authentication credential—Individual practitioners eligible to use an electronic prescription application of an institutional practitioner.

Additional requirements for two-factor authentication.

Additional requirements for biometrics.

Electronic prescription application requirements.

Requirements for establishing logical access control—Individual practitioner.

Requirements for establishing logical access control—Institutional practitioner.

Requirements for creating a controlled substance prescription.

Requirements for signing a controlled substance prescription.

Digitally signing the prescription with the individual practitioner's private key.

Additional requirements for internal application audits.

Transmission requirements.

Pharmacy responsibilities.

Pharmacy application requirements.

Archiving the initial record.

Internal audit trail.

Application provider requirements—Third-party audits or certifications.

Additional application provider requirements.

Recordkeeping.