21 Code For Federal Regulation Parts 1305, 1311 Page 8
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67registrant, if the information on which the certificate is based changes, or if access to the private
key has been compromised or lost.
II. Discussion of Comments on the NPRM
DEA received 11 comments on its proposed rule. Commenters included the major trade
associations representing pharmacies and distributors as well as individual companies and one
vendor. This section summarizes the comments and provides DEA’s response.
Listed schedules. Several commenters were concerned with proposed rule language that
implied that the digital certificate would include extension data that indicated the schedules the
certificate holder rather than the registrant was authorized to order. The commenters stated that
it would be an additional burden on suppliers if they had to verify the eligibility of the signer, as
well as the registrant, to order specific schedules.
DEA has revised the rule language to clarify that only the registrant’s authorized
schedules will be included in the extension data. If a registrant limits an individual’s signing
authority, it is incumbent on the registrant to ensure that the individual does not sign orders for
schedules he/she is not authorized to order. The supplier is not required to verify information on
schedules beyond confirming that the registrant is authorized to order the schedules.
Attaching the digital certificate. One commenter expressed concern about the statements
in the preamble that a digital certificate be attached to each order.
Because the digital certificate serves as the equivalent of the CSA-mandated form, the
certificate, with its extension data, must be attached to each order. Including the certificate with
each order ensures that, just as with the paper forms, an accurate copy of the DEA registration
information for the customer is with the order. It should be noted that the requirement that the
digital certificate be attached to the order applies to when the order is transmitted by the
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