Title 21

PART 1311

Part 1311 - Requirements For Electronic Orders And Prescriptions

PART 1311 - REQUIREMENTS FOR ELECTRONIC ORDERS AND PRESCRIPTIONS 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.

21:9.0.1.1.12.1SUBPART A
Subpart A - General
21:9.0.1.1.12.1.42.1SECTION 1311.01
   1311.01 Scope.
21:9.0.1.1.12.1.42.2SECTION 1311.02
   1311.02 Definitions.
21:9.0.1.1.12.1.42.3SECTION 1311.05
   1311.05 Standards for technologies for electronic transmission of orders.
21:9.0.1.1.12.1.42.4SECTION 1311.08
   1311.08 Incorporation by reference.
21:9.0.1.1.12.2SUBPART B
Subpart B - Obtaining and Using Digital Certificates for Electronic Orders
21:9.0.1.1.12.2.42.1SECTION 1311.10
   1311.10 Eligibility to obtain a CSOS digital certificate.
21:9.0.1.1.12.2.42.2SECTION 1311.15
   1311.15 Limitations on CSOS digital certificates.
21:9.0.1.1.12.2.42.3SECTION 1311.20
   1311.20 Coordinators for CSOS digital certificate holders.
21:9.0.1.1.12.2.42.4SECTION 1311.25
   1311.25 Requirements for obtaining a CSOS digital certificate.
21:9.0.1.1.12.2.42.5SECTION 1311.30
   1311.30 Requirements for storing and using a private key for digitally signing orders.
21:9.0.1.1.12.2.42.6SECTION 1311.35
   1311.35 Number of CSOS digital certificates needed.
21:9.0.1.1.12.2.42.7SECTION 1311.40
   1311.40 Renewal of CSOS digital certificates.
21:9.0.1.1.12.2.42.8SECTION 1311.45
   1311.45 Requirements for registrants that allow powers of attorney to obtain CSOS digital certificates under their DEA registration.
21:9.0.1.1.12.2.42.9SECTION 1311.50
   1311.50 Requirements for recipients of digitally signed orders.
21:9.0.1.1.12.2.42.10SECTION 1311.55
   1311.55 Requirements for systems used to process digitally signed orders.
21:9.0.1.1.12.2.42.11SECTION 1311.60
   1311.60 Recordkeeping.
21:9.0.1.1.12.3SUBPART C
Subpart C - Electronic Prescriptions
21:9.0.1.1.12.3.42.1SECTION 1311.100
   1311.100 General.
21:9.0.1.1.12.3.42.2SECTION 1311.102
   1311.102 Practitioner responsibilities.
21:9.0.1.1.12.3.42.3SECTION 1311.105
   1311.105 Requirements for obtaining an authentication credential - Individual practitioners.
21:9.0.1.1.12.3.42.4SECTION 1311.110
   1311.110 Requirements for obtaining an authentication credential - Individual practitioners eligible to use an electronic prescription application of an institutional practitioner.
21:9.0.1.1.12.3.42.5SECTION 1311.115
   1311.115 Additional requirements for two-factor authentication.
21:9.0.1.1.12.3.42.6SECTION 1311.116
   1311.116 Additional requirements for biometrics.
21:9.0.1.1.12.3.42.7SECTION 1311.120
   1311.120 Electronic prescription application requirements.
21:9.0.1.1.12.3.42.8SECTION 1311.125
   1311.125 Requirements for establishing logical access control - Individual practitioner.
21:9.0.1.1.12.3.42.9SECTION 1311.130
   1311.130 Requirements for establishing logical access control - Institutional practitioner.
21:9.0.1.1.12.3.42.10SECTION 1311.135
   1311.135 Requirements for creating a controlled substance prescription.
21:9.0.1.1.12.3.42.11SECTION 1311.140
   1311.140 Requirements for signing a controlled substance prescription.
21:9.0.1.1.12.3.42.12SECTION 1311.145
   1311.145 Digitally signing the prescription with the individual practitioner's private key.
21:9.0.1.1.12.3.42.13SECTION 1311.150
   1311.150 Additional requirements for internal application audits.
21:9.0.1.1.12.3.42.14SECTION 1311.170
   1311.170 Transmission requirements.
21:9.0.1.1.12.3.42.15SECTION 1311.200
   1311.200 Pharmacy responsibilities.
21:9.0.1.1.12.3.42.16SECTION 1311.205
   1311.205 Pharmacy application requirements.
21:9.0.1.1.12.3.42.17SECTION 1311.210
   1311.210 Archiving the initial record.
21:9.0.1.1.12.3.42.18SECTION 1311.215
   1311.215 Internal audit trail.
21:9.0.1.1.12.3.42.19SECTION 1311.300
   1311.300 Application provider requirements - Third-party audits or certifications.
21:9.0.1.1.12.3.42.20SECTION 1311.302
   1311.302 Additional application provider requirements.
21:9.0.1.1.12.3.42.21SECTION 1311.305
   1311.305 Recordkeeping.