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FEDERAL · 21 CFR

Part 1311 — Requirements for Electronic Orders and Prescriptions

36 sections · Title 21: Food and Drugs

§ 1311.01Scope.
§ 1311.02Definitions.
§ 1311.05Standards for technologies for electronic transmission of orders.
§ 1311.08Incorporation by reference.
§ 1311.10Eligibility to obtain a CSOS digital certificate.
§ 1311.15Limitations on CSOS digital certificates.
§ 1311.20Coordinators for CSOS digital certificate holders.
§ 1311.25Requirements for obtaining a CSOS digital certificate.
§ 1311.30Requirements for storing and using a private key for digitally signing orders.
§ 1311.35Number of CSOS digital certificates needed.
§ 1311.40Renewal of CSOS digital certificates.
§ 1311.45Requirements for registrants that allow powers of attorney to obtain CSOS digital certificates under their DEA registration.
§ 1311.50Requirements for recipients of digitally signed orders.
§ 1311.55Requirements for systems used to process digitally signed orders.
§ 1311.60Recordkeeping.
§ 1311.100General.
§ 1311.102Practitioner responsibilities.
§ 1311.105Requirements for obtaining an authentication credential—Individual practitioners.
§ 1311.110Requirements for obtaining an authentication credential—Individual practitioners eligible to use an electronic prescription application of an institutional practitioner.
§ 1311.115Additional requirements for two-factor authentication.
§ 1311.116Additional requirements for biometrics.
§ 1311.120Electronic prescription application requirements.
§ 1311.125Requirements for establishing logical access control—Individual practitioner.
§ 1311.130Requirements for establishing logical access control—Institutional practitioner.
§ 1311.135Requirements for creating a controlled substance prescription.
§ 1311.140Requirements for signing a controlled substance prescription.
§ 1311.145Digitally signing the prescription with the individual practitioner's private key.
§ 1311.150Additional requirements for internal application audits.
§ 1311.170Transmission requirements.
§ 1311.200Pharmacy responsibilities.
§ 1311.205Pharmacy application requirements.
§ 1311.210Archiving the initial record.
§ 1311.215Internal audit trail.
§ 1311.300Application provider requirements—Third-party audits or certifications.
§ 1311.302Additional application provider requirements.
§ 1311.305Recordkeeping.