Drug Distributor Inspection Exemptions

PURPOSE: This rule defines requirements for Board of Pharmacy inspection exemption of wholesale drug and pharmacy distributors. (1) Inspections of drug distribution facilities shall be conducted by the board in accordance with the provisions as outlined in section 338.360, RSMo. Any drug distributor facility which has been inspected by the Food and Drug Administration (FDA) over a period of less than two (2) years and can demonstrate that all inspections resulted in a satisfactory rating shall be exempt from further inspection by the board until and upon the time that any inspection of the premises of the facility results in a less than satisfactory rating or the last full inspection by the FDA is two (2) years old or greater. (A) For purposes of this rule, the results of federal inspections that are deemed to be less than satisfactory shall include, but not be limited to, any documentation as to deficiencies in any drug distribution, repackaging, labeling, quality control or environmental policies or procedures, or both. Deficiencies may be defined as any statement which is a part of a compliance report recorded by federal inspection with or without sanctions, penalties, fines or discipline imposed. 1. For purposes of further definition, an inspection that is conducted by the FDA that is used for exemption purposes must be a full inspection of all operations and procedures of the facility. Abbreviated inspectional options as defined in federal policy guidelines may not be considered to fulfill the exemption requirements as provided in section 338.360, RSMo and this rule. 2. Any drug distribution facility which has been granted an exemption from inspection must notify the board at any time of an inspection conducted by the FDA or the Drug Enforcement Administration that results in less than a satisfactory rating as defined in subsection (1)(A) of this rule. AUTHORITY: section 338.350, RSMo Supp. 1989.* This rule originally filed as 4 CSR 220-5.040. Original rule filed Feb. 4, 1991, effective June 10, 1991. Moved to 20 CSR 2220-5.040, effective Aug. 28, 2006. *Original authority: 338.350, RSMo 1989.