Jan. 5 (UPI) — The U.S. Food and Drug Administration on Friday approved a plan to allow Florida to import prescription drugs from Canada.
The FDA said the section 804 import program, or SIP, was “the first step on this pathway” toward allowing Florida to import certain Canadian prescription drugs if they would “significantly reduce the cost to the American consumer without imposing additional risk to public health and safety.”
The agency said the program was authorized on a temporary basis for two years beginning from when the FDA was first notified of the first drug shipment to be imported.
Before drugs can be imported, the FDA said Florida’s Agency for Health Care Administration will have to relabel imported medicines and ensure they are tested meet FDA standards.
The HCA will also have to submit information on each drug to the FDA for approval.
Florida will also be responsible for ensuring the integrity of the supply chain, monitoring and submitting reports of adverse reactions, complying with drug recall procedures and making quarterly reports to the FDA.
“The sponsor of any program the FDA authorizes is responsible for implementing all aspects of their program such as importation and distribution,” the FDA said.
The pathway was established by an executive order signed by President Joe Biden in July 2021 that aimed “to reduce the trend of corporate consolidation, in healthcare as well as other economic sectors including technology and agriculture.
Other states or tribes are also encouraged to submit proposals for their own SIP, the FDA said Friday.
“The FDA is committed to working with states and Indian tribes that seek to develop successful section 804 importation proposals,” FDA Commissioner Rober Califf said. “These proposals must demonstrate the programs would result in significant cost savings to consumers without adding risk of exposure to unsafe or ineffective drugs.”