FDA Eliminates Export Option for Small Shipments of Illegal Prescription Drugs
The Food and Drug Administration on Sept. 15 issued a final rule that makes it easier for the agency to destroy small shipments of illegal prescription drugs imported via international mail or express courier (here). The new regulations would allow FDA to destroy drug shipments valued at $2,500 or less that have been refused admission to the U.S., without giving the consignee the option of exporting the drugs. FDA is still required to give notice to the owner or consignee and the opportunity to request a hearing. The final rule takes effect Oct. 15.
Sign up for a free preview to unlock the rest of this article
If your job depends on informed compliance, you need International Trade Today. Delivered every business day and available any time online, only International Trade Today helps you stay current on the increasingly complex international trade regulatory environment.
Currently No Consequences for Sending Illegal Prescription Drugs
According to FDA's proposed rule, from which the agency made no changes, the new procedures are necessary to stem the tide of illegal prescription drug imports. FDA says it seized more than 14,000 illicit prescription drug shipments during 2009-2012, out of a total of 45,000 under examination. International mail shipments constituted the majority of shipments that were seized. Currently, however, there is “little deterrence” to prevent sellers of illegal prescription drugs from simply resending refused shipments. When FDA finds a violation and refuses admission, it sends the package back to the courier for export back to sender. The packages are often resent, sometimes with the sticker indicating prior refusal by FDA still attached and visible, said the agency.
Final Rule Allows Destruction of Illegal Shipments Under $2,500
Under the final rule, FDA now has a process for directly destroying small shipments of adulterated, misbranded, or unapproved drugs instead of sending the package back to the courier for export. The direct destruction process is available only for shipments valued at $2,500 or less. The drug's owner or consignee will be liable for FDA's storage and disposal costs. The express courier will not be liable for storage costs unless it is also owner or consignee, said FDA. If a drug is sent by international mail, FDA generally considers the addressee of the parcel to be the owner or consignee of the drug, said the agency.
Similarly to the administrative process for refusing admission, FDA has to provide notice that it intends to destroy the shipment to the owner or consignee (normally the addressee on the package), and must allow the owner or consignee to introduce testimony at a hearing before the shipment is destroyed. Under the new regulations, FDA can combine the destruction proceeding with the notice and hearing on refusal of admission.
(Federal Register 09/15/15)