Missouri Code of State Regulations
Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE
Division 2220 - State Board of Pharmacy
Chapter 8 - Third-Party Logistic Providers and Drug Outsourcer Facilities
Section 20 CSR 2220-8.050 - Inspection Exemptions
Current through Register Vol. 49, No. 6, March 15, 2024
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.