21 Code For Federal Regulation Parts 1305, 1311 Page 13
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67Commenters also recommended that for central processing of orders that DEA allow
either the central location or the location filling part of the order to create the record. DEA
agrees that either location may create the record and has revised the rule. DEA’s concern is not
with the creation of the record, but with its maintenance. The registrant that distributes a
controlled substance must maintain a full record of the order and make it available for DEA on
request.
One commenter raised the issue of linking a single certificate to multiple locations. As
DEA explained in the NPRM, DEA understands the concern and has taken steps to reduce the
burden for individuals who hold keys for many locations, but to serve as an equivalent of a Form
222, each digital certificate must be specific to a single registered location.
Endorsed, lost, and canceled orders. Commenters questioned whether the proposed rule
for endorsing electronic orders could be implemented, noting that the requirements were
confusing and cumbersome. DEA has reviewed this issue and agrees with the commenters that
endorsing electronic orders in a manner that provides adequate safeguards may be technically too
complicated. Consequently, DEA has decided to not allow endorsement of electronic orders.
Because orders are rarely endorsed and the almost instantaneous communication of electronic
orders and confirmations mean that a purchaser will learn that the supplier cannot fill all or part
of an order shortly after the order is submitted, DEA does not expect this to pose any significant
problem for registrants. The purchaser can quickly issue a new electronic order to another
supplier for any items the first supplier cannot fill. Finally, if the order is originally submitted to
a firm that processes orders centrally, the central processing supplier can fill the order from
multiple locations without endorsement.
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