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Code of Federal Regulations (Last Updated: July 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter II - Drug Enforcement Administration, Department of Justice |
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Part 1311 - Requirements for Electronic Orders and Prescriptions |
Subpart A - General |
§ 1311.01 - Scope. |
§ 1311.02 - Definitions. |
§ 1311.05 - Standards for technologies for electronic transmission of orders. |
§ 1311.08 - Incorporation by reference. |
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. |