21 Code For Federal Regulation Parts 1305, 1311 Page 3
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67DEA. Upon receipt of the order, the purchasers must also annotate their copy, noting the
quantity of controlled substances received and date of receipt.
Regulatory History
Although the paper-based regulatory structure limits diversion, it does not address or
provide for the use of modern computer technologies. DEA issued more than six million
individual order forms in fiscal year 2003. Because both the purchaser and supplier must
maintain copies of the form for two years, the order system requires the maintenance of more
than 24 million forms. Many, if not most, of the registrants using Form 222 place all their orders
for Schedules III – V controlled substances electronically. Many suppliers receive electronic
notice from their purchasers of their intention to place Schedule I and II orders, but the orders
cannot be filled until the supplier receives the DEA-issued Form 222 from the purchaser. The
processing of the Form 222 takes one to three days from the time the form is completed to the
time the order is delivered; electronic orders can be processed and filled immediately.
DEA Pilot Project
Industry asked DEA to provide an electronic means to satisfy the legal requirements for
order forms. DEA began discussions with the regulated industry regarding CSOS standards in
1999. On January 11, 2002, DEA published a notice in the Federal Register expressing its intent
to conduct a pilot project to conduct performance verification testing of public key infrastructure
enabled controlled substances orders. This pilot project was conducted in partnership with two
industry associations—the Health Care Distribution Management Association and the National
Association of Chain Drug Stores. A total of 22 DEA registrants were listed as initial pilot
participants. Initial pilot objectives were to ascertain the level of compatibility and usability of
CSOS standards for electronic controlled substances ordering applications and to test industry’s
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