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10 Feb 2014

Rx-360 Summary of Michigan State University Center for Anti-Counterfeiting and Product Protection Risk of Counterfeiting Report

Michigan State University Center for Anti-Counterfeiting and Product Protection published a report titled “Assessing the Risks of Counterfeiting and Illicit Diversion for Health Care Products” in November 2013. 


This report addresses the multiple risks of counterfeit and diverted health care products including adulteration with dangerous chemicals, and diluted/sub-potent APIs and dosage form. The adulterations can happen either through inadvertent GMP failures or through intentional economic motivated adulteration. Further complicating this issue is the fact that legitimate product that is not maintained under appropriate environmental conditions or handled incorrectly, as may happen with diverted health care products, may lose potency and become ineffective or even harmful. 

The paper identifies potential questions that should be considered in determining the potential risk to patients from a counterfeit or diversion incident (see pages 3–8). Answers to these questions identify areas of concern that should be considered to mitigate the identified risks. Such activities are meant to be ongoing and reviewed frequently as the landscape for these type of illegal activities changes rapidly.


To view or download the summary, click here

To view or download the report, click here


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