21 Code For Federal Regulation Parts 1305, 1311 Page 21
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67Sections 1305.25 and 1305.26 specify the requirements for handling unaccepted and
defective electronic orders and lost orders.
Section 1305.27 covers preservation of electronic orders.
Section 1305.28 covers canceling and voiding electronic orders.
Section 1305.29 specifies the requirements for reporting electronic orders to DEA.
Suppliers may submit either a copy of the order and its linked records or a report in a format
DEA specifies. DEA intends that the report will be identical to the ARCOS report in format with
four additional data elements: the NDC number, quantity, unit, and strength ordered.
New Part 1311 covers the requirements for digital certificates. Subpart A includes the
scope, definitions, standards for electronic orders, and incorporations by reference. Subpart B
covers the requirements for obtaining and using CSOS digital certificates.
Section 1311.10 specifies who is eligible to obtain a CSOS certificate; § 1311.15 covers
the limitation of certificates to the schedules authorized for the DEA registration under which the
certificate is issued. The revised section states that the registrant is responsible for ensuring that
any person whose signing authority the registrant limits abides by those limits.
Section 1311.20 specifies the requirements for CSOS coordinators.
Section 1311.25 specifies the requirements for obtaining a CSOS certificate.
Section 1311.30 provides the requirements for using and storing a digital certificate.
Section 1311.35 specifies the number of certificates needed.
Section 1311.40 specifies when a new certificate must be obtained.
Section 1311.45 specifies requirements for registrants that grant power of attorney
authority.
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