A New York pharmacist is headed to prison for his role in selling diverted HIV drugs worth over $274 million dollars (that’s not a mistake folks-a quarter of a billion dollars!). Ira Gross was sentenced earlier this week to 8 to 24 years in state prison, according to a news report from LongIsland.com. This case should be seen as a stern warning that independent pharmacies have become the soft underbelly of our nation’s pharmaceutical distribution supply chain. Any increases to wholesale distributor oversight that may ensue as a result of the Drug Supply Chain Security Act (DSCSA) will undoubtedly be circumvented by unfazed and undeterred diverters. These savvy criminals will simply pivot to the path of least resistance-independent pharmacies. Increasingly, illicitly obtained prescription drugs, and even counterfeit drugs, will bypass wholesalers altogether and find their way into our supply chain through independent pharmacies. The DSCSA did not mandate an overhaul of existing pharmacy licensing standards, like it did for wholesalers. It also failed to address critical resource inadequacies among the state boards of pharmacy which became evident in the aftermath of the 2012 New England Compounding Center catastrophe and the ensuing Congressional report, titled “State of Disarray.” It’s no secret that the states and FDA are ill-equipped to oversee thousands of at-risk independent pharmacies on supply chain security and DSCSA-related issues. And that is very alarming indeed.
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- A DSCSA ENFORCEMENT STRATEGY PEP TALK FOR FDA December 19, 2019
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- FDA LEADERSHIP IS THE KEY TO STOPPING SHORTAGE DRUG DIVERSION SCHEMES October 29, 2019
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