Final Rule on Destroying Refused Medical Devices and Counterfeit Drugs Issued
A final rule that will allow the FDA to dispose of low-value medical devices and medicines more easily will take effect June 30. Currently, importers of medical devices valued at $2,500 or less have the option of re-exporting the device if it is barred from entering the U.S. In the case of drug shipments under that dollar threshold, the FDA has to prove the medicines are counterfeit, misbranded, adulterated or not approved in the U.S.; with the change, the agency will be allowed to destroy the drugs if it appears they are counterfeit, etc., unless the owner or consignee asks to testify on the medicines' admissibility.
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The change is part of implementing the Safeguarding Therapeutics Act, which was enacted in January 2021.
Having administrative destruction would prevent devices that were refused admission from being re-imported "by unscrupulous sellers who attempt to circumvent U.S. import regulatory systems," the agency explained. It also hopes that more shipments being destroyed, rather than re-exported, will increase deterrence for senders of violative shipments.
The agency received 10 comments on its proposed rule (see 2210060035), most of which supported the agency's approach. The FDA is not making any changes to the text of that proposed regulation. The agency said a foreign government that submitted a comment asked the FDA to clarify whether the $2,500 applies to the value of the shipment, or one device within a shipment. The FDA said it applies to a singular device's value, but also said it does not expect the implementation of the rule to affect containerized imports. It said express couriers and international mail are the pathways these devices are entering. It gave examples of the type of products it has encountered in the mail or express shipments: ineffective N95 masks, COVID tests, substandard contact lenses and blood sugar test strips.
In estimating the costs and benefits of the rule, the FDA estimated that it will destroy 65% of refused devices, and that the benefits might be worth about $317,000, including lower costs to the post offices and express couriers that don't have to send the goods back. The cost of holding and destroying the goods might be about $475,000; however, these benefits do not include avoided illnesses or injuries by consumers who would have received counterfeit pills or substandard medical items.