"Question of the Day September 29, 2014 When do compounded medications qualify under the law as counterfeit drugs? Should more legal action be taken in this area?"
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Anonymous said...- This is a really important question. While the public health outcomes of counterfeit, substandard or falsified medications are generally the same (patient exposure to potentially unsafe or ineffective drugs), the motives behind the business models and tolerance for introducing risk of harm to patients (and manufacturing personnel) may be very different. If the penalties are similar and severe across all fronts, patients/workers will have highest level of protection. If it is easier and as profitable to make a substandard or falsified drug and not risk harsh penalties, why bother making the drugs look original at all? Call them "customized" for that particular market space.
Also worrisome--what should define a counterfeit API, and how should they be (globally) authenticated for certain necessary uses, without risking growth of substandard/counterfeit/falsified marketplace?
