Monday, December 9

Law Mandates Notifying Patients of Recalls

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Gov. Andrew Cuomo has signed into law new regulations requiring notification of patients after recalls of medications that could lead to serious illness or death.

The new rule applies to Class I medication recalls, the ones that the Food and Drug Administration determines have a high probability of causing serious adverse health consequences or death.

Pharmacies will be required to inform patients of Class I drug recalls made by the FDA within seven days by phone or mail.

“It’s common sense that pharmacies communicate that information to patients in real time,” Gov. Andrew Cuomo said in a written statement. “This measure will help ensure patients get the facts about a recalled drug quickly so they can talk to their doctor about safer alternatives.”

Cuomo said before the new legislation was signed and went into effect, there was no requirement for pharmacies to communicate this information to patients who received the recalled drugs.


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