La. Admin. Code tit. 46 § LIII-2743

Current through Register Vol. 50, No. 9, September 20, 2024

Section LIII-2743 - Procurement Requirements

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.

B. Orders for schedule III, IV, and V controlled substances. All licensees acquiring controlled substances in schedules III, IV, or V shall maintain complete and accurate records of all order forms a minimum of two years from the date of each such receipt. 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.

C. Acquisition of Controlled Dangerous Substances by Institutional Facilities

1. A Louisiana-licensed pharmacy in possession of a valid Louisiana CDS license and DEA registration may include a portion of its controlled dangerous substance inventory within an emergency drug kit (EDK) placed in a non-federally registered institutional facility, but only under the following conditions:

a. the EDK bears a valid EDK permit issued by the board; and

b. the inclusion and management of controlled dangerous substances in such EDK shall comply with the provisions of Section 1713. J of these rules.

La. Admin. Code tit. 46, § LIII-2743

Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 34:2148 (October 2008), amended LR 39:313 (February 2013).

AUTHORITY NOTE: Promulgated in accordance with R.S. 40:972.