FDA claims right to destroy small drug shipments

The FDA now has the power to destroy medicine imports valued at $2,500 or less that have been refused entry into the US as part of a clampdown on illicit trade.

New guidance published in the Federal Register grants the power to the agency provided it gives the owner or consignee of the shipment an opportunity to speak out against the destruction. 

If that option is taken, the owner or consignee - which could be the addressee on a package sent through international mail - would be liable for storage and any eventual destruction costs, and failure to pay could lead to a ban on future imports.

In cases where the medicines refused entry are valued at more than $2,500, they will have the option of either destroying them or exporting them from the US. Owners or consignees will also have the option to destroy or export a refused drug subject to destruction, including a biological product, if the FDA is not able to decide whether the medicine is, in fact, adulterated, misbranded, or unapproved.

Increasingly, small-value shipments are used to introduce unapproved, counterfeit, adulterated or misbranded drugs into the US, with an estimated 20m to 100m parcels every year containing medicines reaching the US market via international mail every year.  In many cases the drugs are purchased by consumers from rogue pharmacies on the Internet.

The text is almost identical to a draft issued last year, as none of the feedback received by the agency during the comment period led to changes. The FDA said it expects to undertake 15,100 destructions each year.