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.

• 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.

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

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