October 23, 2020

Countdown Clock Begins on Importation Rule Enactment

Directors Sarah-Lloyd Stevenson and Matthew Rubin co-authored an article for The National Association of Boards of Pharmacy titled “Countdown Clock Begins on Importation Rule Enactment,” regarding the final Food and Drug Administration rule regarding Importation of Prescription Drugs in the Federal Register, which was published on October 1, 2020.

The publication of the final rule starts the 60-day formal notice-and-comment period before the rule becomes effective on Monday, November 30. The final rule reflects the Trump Administration’s efforts to create a federal program to approve state importation drug plans dating back to the announcement of the Safe Importation Action Plan in July 2019 and the notice of public rulemaking in December.

While the rule will not go into effect until the end of November, the Administration may have the ability to begin reviewing state-based proposals before the closure of the public comment period. To date, six states have passed laws to begin the process of requesting federal approval of importation plans under the rule: Colorado, Florida, Maine, New Hampshire, New Mexico and Vermont. At least three of these states – Colorado, Florida and Maine – have already drafted and published applications for the United States Department of Health and Human Services’ consideration, even before the final rule was released.

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