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Regulations last checked for updates: Dec 19, 2025
Title 21 - Food and Drugs last revised: Dec 17, 2025
All Titles
Title 21
Chapter II
Part 1311
Subpart C - 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.
authority:
21 U.S.C. 821
,
828
,
829
,
871
,
958
,
965
,
unless
source:
70 FR 16915, Apr. 1, 2005, unless otherwise noted.
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