21 Code For Federal Regulation Parts 1305, 1311 Page 66
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67(9) The system must check the substances ordered against the schedules that the
registrant is allowed to order and invalidate any order that includes substances the registrant is
not allowed to order.
(10) The system must ensure that an invalid finding cannot be bypassed or ignored and
the order filled.
(11) The system must archive the order and associate with it the digital certificate
received with the order.
(12) If a registrant sends reports on orders to DEA, the system must create a report in the
format DEA specifies, as provided in § 1305.29 of this chapter.
(d) For systems used to process CSOS orders, the system developer or vendor must have
an initial independent third-party audit of the system and an additional independent third-party
audit whenever the signing or verifying functionality is changed to determine whether it
correctly performs the functions listed under paragraphs (b) and (c) of this section. The system
developer must retain the most recent audit results and retain the results of any other audits of the
software completed within the previous two years.
§ 1311.60 Recordkeeping.
(a) A supplier and purchaser must maintain records of CSOS electronic orders and any
linked records for two years. Records may be maintained electronically. Records regarding
controlled substances that are maintained electronically must be readily retrievable from all other
records.
(b) Electronic records must be easily readable or easily rendered into a format that a
person can read. They must be made available to the Administration upon request.
66
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