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Published on Friday, January 5, 2024

FDA’s decision on Florida’s importation program jeopardizes patient safety

WASHINGTON, DC — The American Pharmacists Association (APhA) is dismayed that FDA gave the green light to Florida to import prescription drugs from Canada, jeopardizing patient safety and compromising our nations’ drug supply. FDA’s authorization of the State of Florida’s Section 804 Importation Program does not address significant concerns that create vulnerabilities for the introduction of counterfeit and unsafe drugs into the marketplace.

A decade of efforts to further secure the U.S. drug supply chain through the Drug Supply Chain Security Act (DSCSA), which creates specific safeguards for drug movement from the manufacturer to the pharmacy, is undermined by this decision.

“This importation program frustrates reason by undercutting our nation’s drug supply chain integrity and patient safety in exchange for little or no cost savings,” said Ilisa Bernstein, PharmD, JD, FAPhA, APhA Senior Vice President of Pharmacy Practice and Government Affairs.

By commingling FDA-approved and non-FDA-approved imported versions in the marketplace, this program will create confusion and disruption in the pharmacy, potentially limiting patient access to medications. Importantly, there is no clear or transparent demonstration that Florida’s importation program will result in significant cost savings for consumers, which is required under the law.



Jeopardizing Patient Safety: APhA stands firm against FDA's decision to import prescription drugs from Canada. Learn more about our concerns and call to action in our latest statement. (Link)


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