PURPOSE: This rule adopts definitions for purposes of 20 CSR Chapter 8 governing drug outsourcers and third-party logistics providers.

1. (1) Definitions. The following definitions are applicable to 20 CSR 2220 Chapter 8:

   1. (A) “Drug outsourcer” or “Drug outsourcer facility”—An entity registered with the United States Food and Drug Administration pursuant to section 503(B) of the federal Food, Drug and Cosmetic Act, as amended by the Drug Quality and Security Act (21 section USC 353b);
   2. (B) “Drug related device”—An article that is not considered a prescription drug under federal law, but which meets the definition of a device as provided in 21 U.S.C. 321(h) and 21 U.S.C. 360j(e);
   3. (C) “Drug” or “Prescription drug”—A legend drug as defined by section 338.330, RSMo; and
   4. (D) “Third-party logistics provider” or “3PL”—An entity that provides or coordinates warehousing, or other logistics services of a prescription drug or drug-related device on behalf of a manufacturer, wholesale distributor, or dispenser of such a product, but does not take ownership of the product, nor has responsibility to direct the sale or disposition of the product. A third-party logistics provider license is required for entities conducting 3PL activities that are physically located in this state or shipping drug products into Missouri.

AUTHORITY: sections 338.140, 338.150, 338.280, and 338.350, RSMo 2016, and sections 338.315, 338.330, 338.333, 338.337, and 338.340, RSMo Supp. 2018.* Emergency rule filed Nov. 28, 2018, effective Dec. 8, 2018, expired June 5, 2019. Original rule filed Nov. 28, 2018, effective May 30, 2019.

*Original authority: 338.140, RSMo 1939, amended 1981, 1989, 1997, 2011; 338.150, RSMo 1939, amended 1951, 1961, 1980, 1981, 2011, 2013; 338.280, RSMo 1951, amended 1971, 1981; 338.315, RSMo 1989, amended 2011, 2012, 2014, 2018; 338.330, RSMo 1989, amended 1993, 1998, 2011, 2018; 338.333, RSMo 1989, amended 2010, 2012, 2018; 338.337, RSMo 1989, amended 2009, 2010, 2018; 338.340, RSMo 1989, amended 2018; and 338.350, RSMo 1989, amended 1993, 1995.