21 CFR Part 1311 — Requirements for Electronic Orders and Prescriptions
Subpart A — General
Subpart B — Obtaining and Using Digital Certificates for Electronic Orders
- § 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.
Subpart C — Electronic Prescriptions
- § 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.