Lexology January 10, 2024
The US Food and Drug Administration (“FDA”) announced last Friday that it had approved a drug importation program proposed by Florida’s Agency for Health Care Administration under section 804 of the Federal Food, Drug and Cosmetic Act . Through this section 804 importation program (also called a “SIP” under the implementing rule, 21 CFR 251), Florida is authorized to import certain eligible prescription drugs from Canada; however, trade is a two-way street. In response, Health Canada released a statement on January 8, 2024 that the Government of Canada was “taking all necessary action to safeguard the drug supply and ensure Canadians have access to the prescription drugs they need”.
Drugs that are eligible to be imported to Florida, according to...
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