FDA Rule To Destroy Drugs Denied Entry Into US

FDA Implements Rule to Destroy Certain Drugs That Have Been Refused Entry into the US

FDA is implementing its authority to destroy a drug valued at $2,500 or less after being denied admission into the United States. The final rule was announced on the Federal Register on Tuesday, September 15, 2015, and will take effect 30 days later (October 15, 2015).  In this announcement, the Agency says that implementation of this rule will allow FDA to protect the “integrity of the drug supply chain by providing a disincentive for the importation of drugs that are adulterated, misbranded, or unapproved in violation of section 505 of the FD&C Act (21 U.S.C. 355) (unapproved drugs) and reducing the likelihood of such drugs being refused admission and subsequently offered for reimportation.”

Existing rule states that FDA has authority to destroy a drug [valued at $2,500 or less] that has been refused admission into the US without providing the sponsor with the opportunity to export the drug. This means that even if a drug that is misbranded or counterfeit is detained during importation, the sponsor can still apply to have the product returned to him/her, preventing FDA from destroying it.

In accordance with the final rule, owners or consignees will continue to have the same options available for submitting testimony. However, the final rule does state that “the the owner or consignee of a drug that has been refused admission into the United States, and that is valued at $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation) with: (1) Written notice that FDA intends to destroy the drug and (2) an opportunity to present testimony to the Agency before the drug is destroyed.”

Under the final rule, FDA will have the authority to destroy the drug [valued at $2,500 or less] after being denied admission into the US without providing the sponsor with the option to have the drug destroyed or exported.  However, the Agency has said that sponsors will be provided with options for their refused drug in the following situations:

  1. If FDA is unable to prove that the product is misbranded, adulterated, or unapproved
  2. If the drug has a value greater than $2,500

FDA has passed this rule as part of its efforts to protect the drug supply chain, and the Agency is hoping that the rule will deter companies from importing drugs that are adulterated, misbranded, or unapproved. It will certainly be interesting to have the chance to see how this works out, but only time will tell. For more information on interpretation of the final rule and to learn if and how this will apply to you, email us here.