Guidance Allows FDA to Destroy Certain Drug Imports
The FDA has released a final guidance allowing it to destroy certain drug imports valued at $2,500 or less that have been refused admission into the country in an attempt to boost the integrity of the drug supply chain.
The agency will send a written notice to the owner of the affected drugs, who can request a hearing to plead his or her case against destroying the products. The drug’s owner would be liable for the storage and destruction costs, and failure to pay could result in a lien against future imports.
Importers whose drugs are valued at more than $2,500 will have the option of destroying the drugs or exporting them elsewhere. Importers will have the same options when the FDA refuses admission of a drug, including a biological product that is subject to destruction but the agency is not able to determine if it is adulterated, misbranded or unapproved.
The guidance follows draft guidance issued in May 2014.
The FDA expects 15,100 destructions each year.
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