Part 1311 — Requirements for Electronic Orders and Prescriptions
Current through Sep 8, 2026
Authority: 21 U.S.C. 821, 828, 829, 871(b), 958(e), 965, unless otherwise noted.
Source: 70 FR 16915, Apr. 1, 2005, unless otherwise noted.
Sections
- § 1311.01 Scope.
- § 1311.02 Definitions.
- § 1311.05 Standards for technologies for electronic transmission of orders.
- § 1311.08 Incorporation by reference.
- § 1311.10 Eligibility to obtain a CSOS digital certificate.
- § 1311.15 Limitations on CSOS digital certificates.
- § 1311.20 Coordinators for CSOS digital certificate holders.
- § 1311.25 Requirements for obtaining a CSOS digital certificate.
- § 1311.30 Requirements for storing and using a private key for digitally signing orders.
- § 1311.35 Number of CSOS digital certificates needed.
- § 1311.40 Renewal of CSOS digital certificates.
- § 1311.45 Requirements for registrants that allow powers of attorney to obtain CSOS digital certificates under their DEA registration.
- § 1311.50 Requirements for recipients of digitally signed orders.
- § 1311.55 Requirements for systems used to process digitally signed orders.
- § 1311.60 Recordkeeping.
- § 1311.100 General.
- § 1311.102 Practitioner responsibilities.
- § 1311.105 Requirements for obtaining an authentication credential—Individual practitioners.
- § 1311.110 Requirements for obtaining an authentication credential—Individual practitioners eligible to use an electronic prescription application of an institutional practitioner.
- § 1311.115 Additional requirements for two-factor authentication.
- § 1311.116 Additional requirements for biometrics.
- § 1311.120 Electronic prescription application requirements.
- § 1311.125 Requirements for establishing logical access control—Individual practitioner.
- § 1311.130 Requirements for establishing logical access control—Institutional practitioner.
- § 1311.135 Requirements for creating a controlled substance prescription.
- § 1311.140 Requirements for signing a controlled substance prescription.
- § 1311.145 Digitally signing the prescription with the individual practitioner's private key.
- § 1311.150 Additional requirements for internal application audits.
- § 1311.170 Transmission requirements.
- § 1311.200 Pharmacy responsibilities.
- § 1311.205 Pharmacy application requirements.
- § 1311.210 Archiving the initial record.
- § 1311.215 Internal audit trail.
- § 1311.300 Application provider requirements—Third-party audits or certifications.
- § 1311.302 Additional application provider requirements.
- § 1311.305 Recordkeeping.