21 Code For Federal Regulation Parts 1305, 1311 Page 18
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67Commenters questioned the use of “system.” DEA agrees with commenters that systems
for creating and processing digitally signed orders may be one or more software systems. As
noted above, DEA’s concern is the integrity and availability of the records of orders, not the
technologies and software used to create and store the information.
Comments asked that DEA include a definition or description of the subscriber
agreement. DEA does not believe that it is necessary to define the subscriber agreement. The
DEA CA will provide the agreement, appropriately titled, to each certificate holder.
Commenters objected to the statement in the NPRM that the practical implementation of
PKI systems is simple. DEA understands and explained in the NPRM that the technologies
involved in PKI systems are complex, but from the user’s standpoint, digital signatures are
simple because so much of the work is actually done by machine. After authenticating
themselves to the system and activating the key, the signer generally digitally “signs” the
document with a single key stroke.
One commenter raised issues related to digital certificates for pharmacists for use in the
electronic prescription system. This issue is beyond the scope of this notice; DEA will address
the issue when it proposes its rule for electronic prescriptions.
A commenter noted that the five-year transition period used in the economic analysis
may be optimistic. DEA recognizes that the electronic orders may phase in at a different rate;
some registrants may continue to use Forms 222 indefinitely, as the rule allows. The five-year
period was simply used to estimate costs to avoid understating those costs.
One commenter supported the proposed rule, but expressed the hope that pharmacies
would not bear the cost of implementation. DEA notes that use of electronic orders is voluntary.
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