FDA seeks greater destruction powers for small shipments

The Food and Drug Administration (FDA) is seeking greater powers to destroy small shipments of medicines that are refused admission to the US.

Under the proposal published in the Federal Register, the FDA would have the right to destroy any drug valued at $2,500 or less, provided it gives the owner of consignee of the shipment an opportunity to speak out against the destruction.

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.

"This proposed regulation will allow FDA to better protect the public health by providing an administrative process for the destruction of certain refused drugs, thus increasing the integrity of the drug supply chain," said the agency.

The need for a new administrative procedure to simplify the destruction of illicit shipments was introduced as a requirement of the 2012 FDASIA legislation, in recognition that the current situation - which allows drugs rejected for admission to be exported and then re-imported at a later date.

The new regulation would allow the FDA to ensure shipments are destroyed before the owner or consignee has the opportunity to export them.

"Some of the parcels returned by the US Postal Service (USPS) have been resubmitted for entry into the US by the sender, with the sticker indicating prior refusal by FDA still attached and visible." Says the Federal Register notice.


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