La. Admin. Code tit. 46 § XCI-1305

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

Section XCI-1305 - General Requirements

A. A wholesale distributor shall not accept ownership of a product unless the previous owner provides the transaction history, transaction information, and a transaction statement for the product at the time of the transaction.

B. When a wholesale distributor purchases product, whether or not directly from a manufacturer, an exclusive distributor, or a repackager that purchased directly from a manufacturer, the wholesale distributor shall provide a transaction statement, transaction history, and/or transaction information in accordance with federal regulations at the time of each transaction in which the wholesale distributor transfers ownership of product to subsequent purchasers.

C. A wholesale distributor shall:

1. capture the transaction information, transaction history, and transaction statement for each transaction and maintain such information, history, and statement for not less than six years after the date of the transaction; and

2. maintain the confidentiality of the transaction information, transaction history, and transaction statement for a product in a manner that prohibits disclosure to any person other than the appropriate federal or state official except where required among trading partners.

D. Wholesale distributors physically located and conducting operation in Louisiana:

1. shall not purchase or receive product from other than trading partners licensed by the board to distribute in or into Louisiana; and

2. shall notify the board of any trading partners not licensed by this board distributing or offering to distribute product in or into Louisiana.

La. Admin. Code tit. 46, § XCI-1305

Promulgated by the Department of Health, Board of Drug and Device Distributors, LR 422187 (12/1/2016).

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