Office of Diversion Control, US Department of Justice, Drug Enforcement Administration

Title 21 Code of Federal Regulations

PART 1311 — DIGITAL CERTIFICATES

Subpart A — General

Section 1311.01 Scope

Section 1311.02 Definitions

Section 1311.05 Standards for technologies for electronic transmission of orders

Section 1311.08 Incorporation by reference

Subpart B — Obtaining and Using Digital Certificates for Electronic Orders

Section 1311.10 Eligibility to obtain a CSOS digital certificate

Section 1311.15 Limitations on CSOS digital certificates

Section 1311.20 Coordinators for CSOS digital certificate holders

Section 1311.25 Requirements for obtaining a CSOS digital certificate

Section 1311.30 Requirements for storing and using a private key for digitally signing orders

Section 1311.35 Number of CSOS digital certificates needed

Section 1311.40 Renewal of CSOS digital certificates

Section 1311.45 Requirements for registrants that allow powers of attorney to obtain CSOS digital certificates under their DEA registration

Section 1311.50 Requirements for recipients of digitally signed orders

Section 1311.55 Requirements for systems used to process digitally signed orders

Section 1311.60 Recordkeeping

Subpart C — Electronic Prescriptions

Section 1311.100 General

Section 1311.102 Practitioner responsibilities

Section 1311.105 Requirements for obtaining an authentication credential--Individual practitioners

Section 1311.110 Requirements for obtaining an authentication credential--Individual practitioners eligible to use an electronic prescription application of an institutional practitioner

Section 1311.115 Additional requirements for two-factor authentication

Section 1311.116 Additional requirements for biometrics

Section 1311.120 Electronic prescription application requirements

Section 1311.125 Requirements for establishing logical access control--Individual practitioner

Section 1311.130 Requirements for establishing logical access control--Institutional practitioner

Section 1311.135 Requirements for creating a controlled substance prescription

Section 1311.140 Requirements for signing a controlled substance prescription

Section 1311.145 Digitally signing the prescription with the individual practitioner's private key

Section 1311.150 Additional requirements for internal application audits

Section 1311.170 Transmission requirements

Section 1311.200 Pharmacy responsibilities

Section 1311.205 Pharmacy application requirements

Section 1311.210 Archiving the initial record

Section 1311.215 Internal audit trail

Section 1311.300 Application provider requirements--Third-party audits or certifications

Section 1311.302 Additional application provider requirements

Section 1311.305 Recordkeeping

NOTICE: This is an unofficial version. An official version of this publication may be obtained directly from the Government Printing Office (GPO).

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U.S. DEPARTMENT OF JUSTICE  •  DRUG ENFORCEMENT ADMINISTRATION
Office of Diversion Control  •  8701 Morrissette Drive  •  Springfield, VA 22152  •  1-800-882-9539