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Title 21

Displaying title 21, up to date as of 8/07/2026. Title 21 was last amended 8/06/2026.
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Title 21Food and DrugsPart / Section
Chapter IIDrug Enforcement Administration, Department of Justice1300 – 1399
Part 1311Requirements for Electronic Orders and Prescriptions1311.01 – 1311.305
Subpart CElectronic Prescriptions1311.100 – 1311.305
§ 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.