Federal officials now can detain pharmaceuticals when inspectors suspect adulteration or misbranding.
The Food and Drug Administration announced in the May 29 Federal Register that, starting June 30, the agency would have authority to conduct “administrative detention” of pharmaceuticals intended for humans or animals. The change is intended to protect the public by giving the agency time to consider what actions to take when inspections raise concerns, reducing the likelihood of illnesses or deaths among drug recipients.
FDA employees conduct inspections where pharmaceuticals are made, held, moved, or imported.
The regulations announced by the agency are the product of the Food and Drug Administration Safety and Innovation Act, which was signed into law in July 2012. The law gave the FDA authority to improve protection of the integrity of the drug supply chain, which includes drug detention. The FDA already had such authority over medical devices and tobacco products.
Under the rules published in May, the FDA can detain drugs up to 20 days, unless an agency district director finds that more time is needed to seize the drugs, start injunction proceedings, or consider the need for legal action. In those cases, the detention can last 30 days.
The rules allow for appeals by those with claims to the detained drugs.