La. Admin. Code tit. 46 § XCI-311

Current through Register Vol. 50, No. 11, November 20, 2024

Section XCI-311 - Drug or Device Distribution Recordkeeping

A. Drug or device distributors shall establish and maintain perpetual inventories and records of all transactions regarding the receipt and distribution or other disposition of drugs or devices. These records shall include the following information:

1. source of the drugs or devices, the name and principal address of the seller or transferor, and the address of the facility or physical location from which the drugs or devices were shipped;

2. the identity and quantity of the drugs or devices received and distributed or disposed of; and

3. the dates of receipt and distribution of the drugs or devices.

B. Drug or device distributors shall establish and maintain financial records, including all financial and banking receipts as they relate to drug, device, or medical gas sales, distribution, inventories, receipts or deliveries and monthly banking statements and deposit receipts for all banking accounts containing funds with which drugs or devices have been purchased and/or sold for a minimum of three years from the date each record was created.

C. Inventories and records shall be made available for inspection and photocopying by any official authorized by the board for a period of three years following disposition of the drugs or devices at issue.

D. Records described in this regulation that are kept at the inspection site facility or licensed physical location or that can be immediately retrieved by computer or other electronic means shall be readily available for authorized inspection during the retention period. Records kept at a central location apart from the inspection site facility or licensed physical location and not electronically retrievable shall be made available for inspection within two working days of a request by any official authorized by the board.

E. Copies of current licenses for customers who are authorized by law or regulation to procure or possess drugs or devices shall be maintained for all customers that are shipped or sold drugs or devices. If customer licenses are maintained off site, a list of customer names, addresses, license numbers, and license expiration dates shall be maintained at the licensed distribution location for all customers that are shipped or sold drugs or devices.

F. Distributors that distribute medical gas are not required to maintain a perpetual inventory on oxygen, but are required to maintain perpetual inventories on all other medical gases.

G . Drug or device distributors physically located and conducting operations in Louisiana:

1. shall not purchase or receive drugs or devices from other than drug or device distributors licensed by the board to distribute in or into Louisiana; and

2. shall notify the board of any distributors not licensed by this board distributing or offering to distribute drugs or devices in or into Louisiana.

La. Admin. Code tit. 46, § XCI-311

Promulgated by the Department of Health and Hospitals, Board of Wholesale Drug Distributors, LR 18:383 (April 1992), amended LR 29:1480 (August 2003), LR 32:399 (March 2006), LR 34:875 (May 2008), LR 36:322 (February 2010), LR 39:2758 (October 2013), Amended by the Department of Health, Board of Drug and Device Distributors, LR 422186 (12/1/2016).

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:3461-3482.