FDA AND PACKAGE SEIZURES

Updated: Nov 7

Prescription Justice recently addressed the issue of package seizures and their recommendations for Americans who do not receive their medications.


They profiled Elizabeth who periodically imports medication for migraine headaches at a dramatically lower price compared to what she would pay in the U.S.


Recently, the Food and Drug Administration (FDA) destroyed her medication after it was detained at an international mail facility (IMF).


After the medication was detained, Elizabeth received a notice, stating, “This article was determined to be a prescription drug but does not include the symbol ‘rx-only’ on the label.”


As the blog post describes, the law states that imports valued at $2500 or less can be destroyed if they are misbranded, unapproved, adulterated or counterfeit, but not until the importer is given “due process” to defend the prescription order. [21 USC 381(a)].


Importantly, a “misbranded” drug (as it is termed) is often the same drug sold here with different packaging and labeling. An “unapproved” drug import is often simply a foreign version of the FDA-approved drug, and just as safe and effective.


Prescription Justice offers template language available to anyone who is interested in defending the importation of their medication – available for download on their website – reclaim a drug import detained by FDA.


In this particular case, Elizabeth used the template and sent her letter to the FDA.


The FDA responded 13 days after her inquiry informing Elizabeth that her prescription drug order was destroyed. The justification was the same one given in the FDA’s first letter. Interestingly, the package destroyed by the FDA more than likely contained an FDA-approved drug.


Unfortunately, the potential for an increase in packages being destroyed at the border because of concerns over illegal fentanyl imports but these efforts were intended to end the opioid crisis, not block safe and affordable medications from reaching patients in need.


If you believe your medication has been seized by the FDA, please contact the online pharmacy directly to re-order your medication. We also encourage you to contact us at info@personalimportation.org to share your story.


For the complete Prescription Justice blog post, please click here.


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