[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1311.05]

[Page 143]
 
                         TITLE 21-FOOD AND DRUGS
 
   CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
 
PART 1311_DIGITAL CERTIFICATES--Table of Contents
 
                            Subpart A_General
 
Sec. 1311.05  Standards for technologies for electronic transmission 
of orders.

    (a) A registrant or a person with power of attorney to sign orders 
for Schedule I and II controlled substances may use any technology to 
sign and electronically transmit orders if the technology provides all 
of the following:
    (1) Authentication: The system must enable a recipient to positively 
verify the signer without direct communication with the signer and 
subsequently demonstrate to a third party, if needed, that the sender's 
identity was properly verified.
    (2) Nonrepudiation: The system must ensure that strong and 
substantial evidence is available to the recipient of the sender's 
identity, sufficient to prevent the sender from successfully denying 
having sent the data. This criterion includes the ability of a third 
party to verify the origin of the document.
    (3) Message integrity: The system must ensure that the recipient, or 
a third party, can determine whether the contents of the document have 
been altered during transmission or after receipt.
    (b) DEA has identified the following means of electronically signing 
and transmitting order forms as meeting all of the standards set forth 
in paragraph (a) of this section.
    (1) Digital signatures using Public Key Infrastructure (PKI) 
technology.
    (2) [Reserved]