21 C.F.R. § 1311.05 Standards for technologies for electronic transmission of orders.
Title 21 - Food and Drugs
(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]
Title 21: Food and Drugs
PART 1311—Digital Certificates
Subpart A—General
§ 1311.05 Standards for technologies for electronic transmission of orders.
