A change to current laws allows the Food and Drug Administration (FDA) to destroy misbranded medications blocked from entering the United States. Prior to this, the FDA was forced to return such drugs to the shipper.

A change to current laws allows the Food and Drug Administration (FDA) to destroy misbranded medications blocked from entering the United States. Prior to this, the FDA was forced to return such drugs to the shipper.

Regulatory Affairs Professionals Society (RAPS) reports that the FDA has implemented administrative destruction of drugs refused entry into the United States. According to RAPS, for questionable drug shipments valued at $2,500 or less, the FDA has the discretion to destroy the shipments without notifying the shipper.

According to the FDA, “The primary public health benefit from adoption of the proposed rule would be the value of the illnesses or deaths avoided because the Agency destroyed a refused drug valued at $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation) that posed a public health risk. Additionally, the proposed rule may benefit firms through increases in sales, brand value, and investment in research and development if the destroyed drug is a counterfeit or an otherwise falsified version of an approved drug. The threat of destruction may also have a deterrent effect resulting in a reduction in the amount of adulterated, misbranded, or unapproved drugs (violative drugs) shipped into the United States in the future.”

The regulation change as originally proposed is authorized by amendments made to the FD&C Act by the Food and Drug Administration Safety and Innovation Act (FDASIA). In the FDA’s initial announcement of the regulation change, they noted that “this authority is intended to better protect the public health by providing an administrative process for the destruction of certain refused drugs, thus increasing the integrity of the drug supply chain.”

By S. Imber