Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 27 - Controlled Dangerous Substances › Subchapter F - Production, Distribution, and Utilization › Section LIII-2743 - Procurement Requirements

Current through Register Vol. 50, No. 6, June 20, 2024
A. Orders
				  for Schedule I and II Controlled Substances
1. General Requirements. A licensee acquiring
				  controlled substances in Schedules I and II shall maintain a file of the
				  duplicate copies of all order forms used to obtain controlled substances within
				  these schedules. Each duplicate copy of any order form used to order controlled
				  substances shall be kept in this file a minimum of two years from the date the
				  order form was completed. This file shall be kept separate from the licensee's
				  other business or professional records. These records shall contain the full
				  name, address and license number of the supplier, the common or established
				  name of the controlled substance, its dosage form and strength, the amount, and
				  the date of receipt.
2. DEA Form
				  222. Either a DEA Form 222 or its electronic equivalent is required for each
				  distribution of a Schedule I or II controlled substance except for the
				  following:
a. distributions to persons
				  exempted from registration by federal or state law;
b. exports from the United States that
				  conform to federal requirements;
c.
				  deliveries to a registered analytical laboratory or its agent approved by
				  DEA;
d. delivery from a central
				  fill pharmacy to a retail pharmacy.
3. Electronic Orders
a. Electronic orders for Schedule I or II
				  controlled substances shall comply with the federal requirements set forth in
				   21 CFR §
													1305.21 and § 1311  or their successors.
i. To be valid, the purchaser shall sign an
				  electronic order for a Schedule I or II controlled substance with a digital
				  signature issued to the purchaser, or the purchaser's agent, by DEA as provided
				  by federal law.
ii. The following
				  data fields shall be included on an electronic order for Schedule I and II
				  controlled substances:
(a). a unique number
				  the purchaser assigns to track the order. The number shall be in the following
				  9-character format: the last two digits of the year, X, and six characters as
				  selected by the purchaser;
(b). the
				  purchaser's DEA registration number;
(c). the name of the supplier;
(d) the complete address of the supplier (may
				  be completed by either the purchaser or the supplier);
(e). the supplier's DEA registration number
				  (may be completed by either the purchaser or the supplier);
(f). the date the order is signed;
(g). the name (including strength where
				  appropriate) of the controlled substance product or the National Drug Code
				  (NDC) number (the NDC number may be completed by either the purchaser or the
				  supplier);
(h). the quantity in a
				  single package or container;
(i).
				  the number of packages or containers of each item ordered.
iii. An electronic order may include
				  controlled substances that are not in schedules I and II and non-controlled
				  substances.
b. Procedure
				  for Filling Electronic Orders
i. A purchaser
				  shall 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 licensee shall maintain
				  control of the processing of the order at all times.
ii. 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 federal law.
iii. A supplier shall do the following before
				  filling the order.
(a). Verify the integrity
				  of the signature and the order by using software that complies with federal law
				  to validate the order.
(b). Verify
				  that the digital certificate has not expired.
(c). Check the validity of the certificate
				  holder's certificate by checking the DEA's certificate revocation
				  list.
(d). Verify the licensee's
				  eligibility to order the controlled substances by checking the certificate
				  extension data.
iv. The
				  supplier shall 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 shall also include any data on the original order
				  that the supplier completes. Software used to process digitally signed orders
				  shall comply with DEA's requirements digital certificates for electronic
				  orders.
v. 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.
vi. A supplier shall
				  ship the controlled substances to the registered location associated with the
				  digital certificate used to sign the order.
vii. 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 archived.