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

Title 21 Code of Federal Regulations

PART 1311 —REQUIREMENTS FOR ELECTRONIC ORDERS AND PRESCRIPTIONS

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.

Authority: 21 U.S.C. 821, 828, 829, 871(b), 958(e), 965, unless otherwise noted.

Source: 70 FR 16915, Apr. 1, 2005, unless otherwise noted.

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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