20 CSR 2220-8.050 - Inspection Exemptions

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

(1) Board inspections of third-party logistics providers and drug out-sourcers will be conducted in accordance with Chapter 338, RSMo. At the discretion of the board, a third-party 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) 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.

(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.

(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).

Notes

20 CSR 2220-8.050

Adopted by Missouri Register April 15, 2019/Volume 44, Number 8, effective 5/31/2019