La. Admin. Code tit. 46 § XCI-1303

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

Section XCI-1303 - Definitions

A. As used in this chapter, the following terms are defined herein.

Exclusive Distributor-the wholesale distributor that directly purchased the product from the manufacturer and is the sole distributor of that manufacturers product to a subsequent repackager, wholesale distributor, or retail dispenser.

Illegitimate Product-a product in which credible evidence shows that it:

a. is counterfeit, diverted or stolen;

b. is intentionally adulterated such that the product would result in serious adverse health consequences or death to humans;

c. is the subject of a fraudulent transaction; or

d. appears otherwise unfit for distribution such that the product would be reasonably likely to result in serious adverse health consequences or death to humans.

Suspect Product-a product for which there is reason to believe it may be illegitimate.

Trading Partners-a manufacturer, repackager, wholesale distributor, or retail dispenser from whom a manufacturer, repackager, wholesale distributor, or retail dispenser accepts direct ownership of a product or to whom a manufacturer, repackager, wholesale distributor, or retail dispenser transfers direct ownership of a product; or a third-party logistics provider from whom a manufacturer, repackager, wholesale distributor, or retail dispenser accepts direct possession of a product or to whom a manufacturer, repackager, wholesale distributor, or retail dispenser transfers direct possession of a product.

La. Admin. Code tit. 46, § XCI-1303

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.