21 Code For Federal Regulation Parts 1305, 1311 Page 4
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67ability to deploy these systems. All technical test objectives were successfully realized in early
phases of the pilot with registrants demonstrating the ability to retrieve and manage their CSOS
digital certificates. Where participants expressed difficulty or reported undue burden with
processes (e.g., with initial notarization requirements for enrollment) proposed technical
standards were reviewed and modified, where possible, without compromising necessary
nonrepudiation and security services objectives.
In August 2002, pilot participants began using CSOS certificates in simulated
environments with DEA providing access to a test suite of CSOS certificates. Pilot participants
demonstrated the ability to send, receive and validate digitally signed controlled substances
orders in a test environment, and also demonstrated the ability to accurately reject orders, as
appropriate. Pilot outcomes allowed DEA to identify and resolve potential challenges before the
controlled substances ordering system was proposed. DEA continues to provide test resources to
industry through the use of its pilot system, allowing continued refinement of CSOS
applications.
Summary of Proposed Rule
On June 27, 2003, DEA issued a Notice of Proposed Rulemaking (NPRM) in which DEA
proposed revisions to its regulations to allow electronic orders if those orders were signed using
an electronic signature that met three criteria - authentication, non-repudiation, and record
integrity (68 FR 38558). Because only digital signatures based on certificates issued by a
Certification Authority as part of a public key infrastructure (PKI) meet all three criteria, DEA
proposed requirements that apply to obtaining and using digital certificates.
DEA proposed allowing regulated entities who are eligible to order Schedule I and II
controlled substances to issue and process electronic orders if those orders are signed using a
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