FDA spells out the rules and restrictions for states seeking to import drugs from Canada

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

For instance, there’s a long list of drugs that will be excluded from all state importation plans, including all biologics, which are generally some of the most expensive drugs, as well as controlled substances, infused drugs, and drugs that are injected intravenously (into a vein), intrathecally (into… Click here to view original post