Statement from Health Canada on FDA decision on Florida bulk drug importation plan
January 8, 2024 | Ottawa, Ontario | Health Canada
On January 5, the U.S. Food and Drug Administration (FDA) approved the state of Florida's plan to import select Canadian prescription drugs in bulk. The Government of Canada is taking all necessary action to safeguard the drug supply and ensure Canadians have access to the prescription drugs they need and has been clear in its position: bulk importation will not provide an effective solution to the problem of high drug prices in the U.S.
Regulations have been implemented under the Food and Drugs Act to prohibit certain drugs intended for the Canadian market from being sold for consumption outside of Canada if that sale could cause, or worsen, a drug shortage in Canada. This includes all drugs that are eligible for bulk importation to the U.S., including those identified in Florida's bulk importation plan, or any other US state's future importation programs.
Health Canada is actively monitoring the Canadian drug supply and continues to ensure that Canadians have access to the drugs that they need. The Department has informed regulated parties of their obligations under Canadian regulations, including the requirement to not distribute a drug to another person for consumption or use outside Canada unless the person holding the licence has reasonable grounds to believe that the distribution will not cause or worsen a shortage of the drug in Canada and has retained detailed records of the information relied upon to make that determination. The Department will not hesitate to take immediate action to address non-compliance, ranging from requesting a plan for corrective measures, issuing a public advisory or other forms of communication, to taking action on the licenses of regulated parties who contravene the export prohibition if warranted.
Health Canada has listened to Canadians and has consulted with industry stakeholders, pharmacists, provinces and territories, patient groups, and medical associations. All agree that the Canadian government must remain focused on ensuring a stable and adequate supply of prescription drugs for Canadians. Health Canada stands ready to take immediate additional action, if needed, to help safeguard the Canadian drug supply.
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