21 Code For Federal Regulation Parts 1305, 1311 Page 29
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67orders to the warehouses that hold specific items. The Form 222 system cannot take advantage
of this arrangement because the paper must accompany the order. With electronic orders, DEA
will allow a distributor with a central distribution system to divide an order and ship parts of the
order from different distribution points. New orders will not need to be generated because the
central computer system can track each item in the order and ensure that it is shipped to the
appropriate registrant only once. DEA and the supplier will have the records necessary to
maintain the closed system of control while allowing the supplier to take advantage of its own
system of distribution.
A copy of the Economic Impact Analysis of the Electronic Orders Rule is available on
the Diversion Control Program’s website.
Regulatory Flexibility Act
The Regulatory Flexibility Act (5 U.S.C. 601-612) requires Federal agencies to determine
whether regulations have a significant economic impact on a substantial number of small entities
or have a disproportionate effect on small entities. DEA, as part of its economic analysis,
considered the costs of the existing system and the electronic system on small entities. The
annualized costs of the Form 222 system for the smallest entities (Narcotic Treatment Programs
with less than $100,000 in revenues), are 1.66 percent of annual revenues; for these registrants,
the annual costs of the electronic orders are about 0.24 percent of annual revenues. For most
small entities affected by the rule, the cost of the electronic system will be less than 0.1 percent
of revenues or sales. Consequently, the Deputy Administrator hereby certifies that this
rulemaking has been drafted in accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)),
has reviewed this regulation, and by approving it certifies that this regulation will not have a
significant economic impact on a substantial number of small entities.
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