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Drug Product Defect Reporting (9.6)

Drug Product Defect Reporting (9.6) - Policies, Clinical, UWHC Clinical, Department Specific, Pharmacy, Purchasing and Inventory

9.6





Effective Date:

October 2003
⌧Pharmacy Policy Manual
Chapter: Purchasing - Inventory
Operations Procedure Manual
Chapter:
Policy #:
9.6

Original
⌧ Revision 11/11
Page 1
of 1
Title: Drug Product Defect Reporting



I. POLICY: All suspected defective drug products will be reported via the on-line “Med
Watch” program

II. PROCEDURE:
A. Defective drug products will by reported by a central pharmacist assistant under the
supervision of a pharmacist.
B. The pharmacist assistant will access the following “Med Watch” web site:
https://www.accessdata.fda.gov/scripts/medwatch/
C. The pharmacist assistant will complete all information on the online form and submit it.
This person will make a copy of the report for pharmacy and file it in the Drug Defect
folder.
D. Defective products from the lot will be removed from all pharmacy areas. All defective
drug products will be labeled “Defective Drug Product—Not For Use” and will be
quarantined from all other drugs until a request is received to return it to the
manufacturer.
E. The pharmaceutical company responsible for the defective product will be notified by
“Med Watch”.
F. A report listing all drug product problems will be sent to the DUE Committee quarterly.




Approved By:________________________
Director of Pharmacy

Date:________________