Iowa Admin. Code r. 657-17.2

Current through Register Vol. 47, No. 8, October 30, 2024
Rule 657-17.2 - Definitions

In addition to the definitions found in Iowa Code section 155A.3, which are adopted for the purposes of this chapter, the following definitions shall apply:

"Drug Supply Chain Security Act" or "DSCSA " means the law enacted by Congress in November 2013 which establishes the minimum standards for ensuring a legitimate drug supply chain.

"Facility manager" means the individual responsible for managing the daily operations of the wholesale distribution facility.

"FDA " means the United States Food and Drug Administration.

"Returns processor" means a person who owns or operates an establishment that dispositions or otherwise processes saleable or nonsaleable product received from a purchaser, manufacturer, or seller who purchased or received such product at wholesale, such that the product may be processed for credit to the purchaser, manufacturer, or seller, or disposed of for no further distribution.

"Wholesale distribution" means the distribution of a drug to a person other than a consumer or patient, or the receipt of a drug by a person other than a consumer or patient, but does not include transactions identified in Iowa Code section 155A.3 and DSCSA.

"Wholesale distributor" means a person, other than a manufacturer, a manufacturer's co-licensed partner, a third-party logistics provider, or a repackager, engaged in the wholesale distribution of a prescription drug.

Iowa Admin. Code r. 657-17.2

Amended by IAB December 19, 2018/Volume XLI, Number 13, effective 1/23/2019
Amended by IAB March 25, 2020/Volume XLII, Number 20, effective 4/29/2020