PURPOSE: This rule defines requirements for inspection standards for drug outsourcers and third-party logistics providers and standards for inspection exemptions for thirdparty logistic providers.

1. (1) Board inspections of third-party logistics providers and drug outsourcers will be conducted in accordance with Chapter 338, RSMo. At the discretion of the board, a thirdparty logistics provider facility that has been inspected by the United States Food and Drug Administration (FDA) within the previous two (2) years may be exempt from inspection by the board if the FDA inspection(s) resulted in a satisfactory rating. The FDA inspection must be a full inspection of all facility operations and procedures.

2. (2) The board may terminate an exemption under this section if deemed necessary or appropriate, if the last full FDA inspection is two (2) years old or greater or if any subsequent facility inspection by a state or federal entity results in less than a satisfactory rating.

   1. (A) For purposes of this rule, a less than satisfactory rating includes, but is not limited to, any documented deficiency related to third-party logistic provider operations, drug distribution, repackaging, labeling, quality control, environmental policies/procedures, or controlled substances. Deficiencies include any statement that is a part of a federal compliance, inspection or observational report with or without sanctions, penalties, fines, or discipline imposed.
   2. (B) Licensees granted an inspection exemption under this section shall notify the board if any inspection conducted by the FDA or the Drug Enforcement Administration results in less than a satisfactory rating as defined in subsection (2)(A).

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.* 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.