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Drugs Refused Entry Would be Destroyed Without Opportunity to Export Under FDA Rule

Tuesday, May 06, 2014
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration is proposing a regulation to implement its authority to destroy drugs valued at $2,500 or less that have been refused admission into the United States under the Federal Food, Drug and Cosmetic Act. Under this proposed rule, the owner or consignee of such a drug would be provided with (1) written notice that the FDA intends to destroy the drug and (2) an opportunity to present testimony to the FDA before the drug is destroyed. Comments on this proposal are due no later than July 7.

Currently, drugs that have been refused admission into the U.S. are destroyed unless they are exported within 90 days. Certain illegal drugs may also be destroyed if they are seized and condemned under the FDA's seizure authority or seized and forfeited under U.S. Customs and Border Protection’s seizure and forfeiture authority. Drugs that are imported via an international mail facility that are refused are sent back to the U.S. Postal Service for export.

As a result, the FDA states, there is little to deter sellers from sending violative drugs or resending previously refused drugs into the U.S. via IMFs. In fact, some of the parcels returned by USPS have been resubmitted for entry by the sender with the sticker indicating prior refusal by the FDA still attached and visible. In addition, an estimated 20 million to 100 million parcels containing drugs enter the U.S. each year through IMFs, a volume that is straining limited federal resources at these facilities and making it extremely difficult to interdict all incoming shipments of violative drugs.

To address these situations, the proposed rule would implement the agency’s authority under the FDA Safety and Innovation Act to destroy refused drugs without providing the owner or consignee with the opportunity to export them. The agency notes that it intends to exercise this authority only in situations where, after providing the owner or consignee with the opportunity to introduce testimony, it has made a determination that the drug is adulterated, misbranded or unapproved. The FDA estimates that under this rule it would perform more than 12,000 destructions each year.

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