As the changes to state laws per DSCSA continues to sweep the country, the Opioid Epidemic has now also begun to significantly impact the state regulation of the pharmaceutical supply chain.
Specifically, state governments have pointed the blame of the Opioid Epidemic at pharmaceutical manufacturers and distributors; and now, between new legislation and existing lawsuits, they are looking at the same companies to foot the bill for their response to the epidemic.
However, the “Sunset Clause” demonstrates the focus on responding to the epidemic. Simply put, if Minnesota receives a sum total of $250 million from the increased fees and/or lawsuits, then the annual registration will decrease by $50,000 annually and the product registration fee will be discontinued.
New York Opioid Tax – Round 2
This is the second time Opioid Tax legislation has been passed in New York because the first tax was ruled unconstitutional for violating interstate commerce laws, specifically because the law prevented the cost being passed to New York consumers but not consumers from other states.
Enforcement of the Opioid Tax is likely a ways off. Now that the law has passed, it will take at least a few months for the NYSED Board of Pharmacy to figure out how to promulgate rules, and then another few months before implementation and enforcement.
Maintaining Compliance: Marina Monitor
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