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Electronic Code of Federal Regulations

e-CFR data is current as of January 16, 2020

Title 21Chapter IIPart 1311


TITLE 21—Food and Drugs

CHAPTER II—DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE

PART 1311—REQUIREMENTS FOR ELECTRONIC ORDERS AND PRESCRIPTIONS

rule

Subpart A—GENERAL

§1311.01
Scope.
§1311.02
Definitions.
§1311.05
Standards for technologies for electronic transmission of orders.
§1311.08
Incorporation by reference.
rule

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.
rule

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.

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