[Code of Federal Regulations]
[Title 21, Volume 9]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1305.22]

[Page 77]
 
                         TITLE 21-FOOD AND DRUGS
 
   CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
 
PART 1305_ORDERS FOR SCHEDULE I AND II CONTROLLED SUBSTANCES--
Table of Contents
 
                       Subpart C_Electronic Orders
 
Sec. 1305.22  Procedure for filling electronic orders.

    (a) A purchaser must submit the order to a specific supplier. The 
supplier may initially process the order (e.g., entry of the order into 
the computer system, billing functions, inventory identification, etc.) 
centrally at any location, regardless of the location's registration 
with DEA. Following centralized processing, the supplier may distribute 
the order to one or more registered locations maintained by the supplier 
for filling. The registrant must maintain control of the processing of 
the order at all times.
    (b) A supplier may fill the order for a Schedule I or II controlled 
substance, if possible and if the supplier desires to do so and is 
authorized to do so under Sec. 1305.06.
    (c) A supplier must do the following before filling the order:
    (1) Verify the integrity of the signature and the order by using 
software that complies with Part 1311 of this chapter to validate the 
order.
    (2) Verify that the digital certificate has not expired.
    (3) Check the validity of the certificate holder's certificate by 
checking the Certificate Revocation List. The supplier may cache the 
Certificate Revocation List until it expires.
    (4) Verify the registrant's eligibility to order the controlled 
substances by checking the certificate extension data.
    (d) The supplier must retain an electronic record of every order, 
and, linked to each order, a record of the number of commercial or bulk 
containers furnished on each item and the date on which the supplier 
shipped the containers to the purchaser. The linked record must also 
include any data on the original order that the supplier completes. 
Software used to handle digitally signed orders must comply with part 
1311 of this chapter.
    (e) If an order cannot be filled in its entirety, a supplier may 
fill it in part and supply the balance by additional shipments within 60 
days following the date of the order. No order is valid more than 60 
days after its execution by the purchaser, except as specified in 
paragraph (h) of this section.
    (f) A supplier must ship the controlled substances to the registered 
location associated with the digital certificate used to sign the order, 
except as specified in paragraph (h) of this section.
    (g) When a purchaser receives a shipment, the purchaser must create 
a record of the quantity of each item received and the date received. 
The record must be electronically linked to the original order and 
archived.
    (h) Registered procurement officers of the Defense Supply Center of 
the Defense Logistics Agency may order controlled substances for 
delivery to armed services establishments within the United States. 
These orders may be shipped to locations other than the registered 
location, and in partial shipments at different times not to exceed six 
months from the date of the order, as designated by the procurement 
officer when submitting the order.