21 Code For Federal Regulation Parts 1305, 1311 Page 5
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67digital certificate issued by a Certification Authority run by DEA; the approach is called the
Controlled Substance Ordering System or CSOS. Use of electronic orders is optional; registrants
may continue to issue orders on Form 222.
DEA proposed minor organizational revisions to the existing requirements in Part 1305 to
create subparts. Subpart A includes those requirements that apply to all orders. Subpart B
covers the requirements for handling Form 222 orders. Other than minor editorial changes to
make the regulations easier to read, the existing requirements for paper orders are unchanged. A
new subpart C was proposed to cover the requirements for issuing and filling electronic orders.
These requirements parallel those for Form 222 orders, but include some differences based on
the different constraints on the two systems. For example, the regulation specifies the data
elements required on an electronic order; because these elements are part of the Form 222, they
are not specified for paper orders. Orders submitted on paper must be filled by a single
registered location because the original order form must be maintained at the distribution
location in support of the distribution; electronic orders may be divided and filled from separate
registered locations owned by the same company, since the order can be retrieved directly in
verifiable form at each distributing location.
In addition to its revision of Part 1305, DEA proposed a new Part 1311 that includes the
requirements for obtaining, storing, using, and renewing digital certificates. Registrants and
people granted power of attorney by registrants to sign orders will be eligible to obtain digital
certificates. A registrant must appoint a CSOS coordinator who will serve as that registrant’s
recognized agent regarding issues pertaining to issuance of, revocation of, and changes to digital
certificates issued under that registrant’s DEA registration. These individuals serve as
knowledgeable liaisons between one or more DEA registered locations and the CSOS
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