More than 1,200 chemotherapy patients received diluted chemotherapy treatments as a result of a regulatory loophole that allowed companies that mix drugs to remain uninspected by the provincial College of Pharmacists. DeCou, a spokeswoman from the College of Pharmacists, says that the College is "in the final stages of developing a draft regulation that will provide the College with necessary authority to inspect premises where pharmacists and pharmacy technicians practices, including where drugs are prepared." Prior to this regulation, the College did not have jurisdiction over inspecting drug preparation facilities. The role of Health Canada, which is responsible for regulating, inspecting, and overseeing drug manufacturers throughout Canada, also is unclear in this situation.
Because Marchese Solutions operated under the supervision of a pharmacist, inspections of the company are under the jurisdiction of the College of Pharmacists under these new regulations. Prior to the drafting of these regulations, however, it is unclear which regulatory organizations had jurisdiction over companies like Marchese Solutions. Current federal regulations do not specifically state that companies, such as Marchese Solutions, are under the jurisdiction of Health Canada and, so, Health Canada has not been required to conduct inspections of these companies and their manufacturing facilities.
For almost twenty years, Health Canada has questioned whether it has jurisdictional oversight of companies that compound drugs, like Marchese Solutions.
There are currently no consistent, Canada-wide regulations for drug-compounding companies. The number of unregulated companies that are mixing cancer drugs is unknown to both the federal and provincial governments.
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