Iowa Administrative Code
Agency 657 - PHARMACY BOARD
Chapter 10 - CONTROLLED SUBSTANCES
Rule 657-10.17 - Ordering or distributing Schedule I or II controlled substances
Universal Citation: IA Admin Code 657-10.17
Current through Register Vol. 46, No. 19, March 20, 2024
(1) DEA Form 222. Except as otherwise provided by subrule 10.17(2) and under federal law, a DEA Form 222 is required for each distribution of a Schedule I or II controlled substance. An order form may be executed only on behalf of the registrant named on the order form and only if the registrant's DEA and Iowa registrations for the substances being purchased have not expired or been revoked or suspended by the issuing agency.
a.
Order forms shall be obtained, executed, and filled pursuant to DEA
requirements. Each form shall be complete, legible, and properly prepared,
executed, and endorsed and shall contain no alteration, erasure, or change of
any kind.
b. The purchaser shall
submit Copy 1 and Copy 2 of the order form to the supplier.
c. The purchaser shall maintain Copy 3 of the
order form in the files of the registrant. Upon receipt of the substances from
the supplier, the purchaser shall record on Copy 3 of the order form the
quantity of each substance received and the date of receipt.
d. The supplier shall record on Copy 1 and
Copy 2 of the order form the quantity of each substance distributed to the
purchaser and the date on which the shipment is made. The supplier shall
maintain Copy 1 of the order form in the files of the supplier and shall
forward Copy 2 of the order form to the DEA district office.
e. Order forms shall be maintained separately
from all other records of the registrant.
f. Each unaccepted, defective, or otherwise
void order form and any attached statement or other documents relating to any
order form shall be maintained in the files of the registrant.
g. If the registration of any purchaser of
Schedule I or II controlled substances is terminated for any reason, or if the
name or address of the registrant as shown on the registration is changed, the
registrant shall return all unused order forms to the DEA district
office.
(2) Electronic ordering system. A registrant authorized to order or distribute Schedule I or II controlled substances via the DEA Controlled Substances Ordering System (CSOS) shall comply with the requirements of the DEA relating to that system, including the maintenance and security of digital certificates, signatures, and passwords and all record-keeping and reporting requirements.
a. For an electronic order to be
valid, the purchaser shall sign the electronic order with a digital signature
issued to the purchaser or the purchaser's agent by the DEA.
b. An electronic order may include controlled
substances that are not in Schedule I or II and may also include noncontrolled
substances.
c. A purchaser shall
submit an order to a specific wholesale distributor appropriately licensed to
distribute in Iowa.
d. Prior to
filling an order, a supplier shall verify the integrity of the signature and
the order, verify that the digital certificate has not expired, check the
validity of the certificate, and verify the registrant's authority to order the
controlled substances.
e. The
supplier shall retain an electronic record of every order, including a record
of the number of commercial or bulk containers furnished for each item and the
date on which the supplier shipped the containers to the purchaser. The
shipping record shall be linked to the electronic record of the order. Unless
otherwise provided under federal law, a supplier shall ship the controlled
substances to the registered location associated with the digital certificate
used to sign the order.
f. If an
order cannot be filled for any reason, the supplier shall notify the purchaser
and provide a statement as to the reason the order cannot be filled. When a
purchaser receives such a statement from a supplier, the purchaser shall
electronically link the statement of nonacceptance to the original electronic
order. Neither a purchaser nor a supplier may correct a defective order; the
purchaser must issue a new order for the order to be filled.
g. When a purchaser receives a shipment, the
purchaser shall create a record of the quantity of each item received and the
date received. The record shall be electronically linked to the original order
and shall identify the individual reconciling the order. A purchaser shall, for
each order filled, retain the original signed order and all linked records for
that order for two years. The purchaser shall also retain all copies of each
unfilled or defective order and each linked statement.
h. A supplier shall retain each original
order filled and all linked records for two years. A supplier shall, for each
electronic order filled, forward to the DEA within two business days either a
copy of the electronic order or an electronic report of the order in a format
specified by the DEA.
i. Records of
CSOS electronic orders and all linked records shall be maintained by a supplier
and a purchaser for two years following the date of shipment or receipt,
respectively. Records may be maintained electronically or in hard-copy format.
Records that are maintained electronically shall be readily retrievable from
all other records, shall be easily readable or easily rendered into a readable
format, shall be readily retrievable at the registered location, and shall be
made available to the board, to the board's agents, or to the DEA upon request.
Records maintained in hard-copy format shall be maintained in the same manner
as DEA Form 222.
Disclaimer: These regulations may not be the most recent version. Iowa may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
