FDA Finalizes Authority to Destroy Rejected Drug Imports

Sept. 15, 2015

The FDA has issued a final rule that allows the agency to destroy a drug valued at $2,500 or less that was refused admission into the United States.

Existing rules state that even if a misbranded or counterfeit drug is detained at the point of import, its sponsor can apply to have the drug returned within 90 days, which often leads to counterfeiters repackaging and re-shipping the drugs back to the U.S.

Owners will still have the option to export or destroy refused drugs in two situations: 1.) if the drug is valued over $2500 or 2.) if the FDA refuses admission but is not able to determine that the drug is adulterated, misbranded, or unapproved.

According to RAPS, the FDA says it's preparing for about 15,100 destructions annually.

The final rule will take effect in 30 days.

Read the RAPS article