FDA Issues Final Order Refusing to Release Illegally Imported Lethal-Injection Drugs to States

The U.S. Food and Drug Administration (FDA) has issued a final order refus­ing to release ille­gal­ly import­ed med­i­cines that the states of Texas and Arizona had intend­ed to use in executions. 

On April 20, 2017, the FDA noti­fied prison offi­cials that it would not release the two states’ ship­ments of 1,000 vials each of sodi­um thiopen­tal that the FDA had seized at U.S. air­ports in October 2015 when the states had attempt­ed to import the drug from a sup­pli­er in India. Both ship­ments were halt­ed at the air­port by FDA offi­cials, who said the impor­ta­tion of the drugs vio­lat­ed fed­er­al reg­u­la­tions. A third ship­ment of 1,000 vials of the drug ordered by Nebraska was halt­ed by FedEx before it left India because the ship­ping com­pa­ny was not pro­vid­ed paper­work indi­cat­ing FDA approval to import the drugs. 

Sodium thiopen­tal, an anes­thet­ic wide­ly used in exe­cu­tions pri­or to 2010, is no longer pro­duced by any U.S. phar­ma­ceu­ti­cal man­u­fac­tur­ers, and the FDA has said that it has no legal uses in the U.S. In January 2017, the Texas Department of Criminal Justice sued the FDA, demand­ing a final deci­sion on the detained imports. In a state­ment, the FDA announced it had ​“made a final deci­sion, refus­ing admis­sion of the detained drugs into the United States.” 

FDA press offi­cer Lyndsay Meyer said that the ship­ments of sodi­um thiopen­tal had been con­fis­cat­ed because the detained drugs appeared to be unap­proved new drugs and mis­brand­ed drugs. The ship­ments, the agency said, must be either export­ed or destroyed with­in 90 days. Texas insist­ed that the import was cov­ered by a ​“law enforce­ment exemp­tion,” because the drug was intend­ed for use in exe­cu­tions. The FDA said its deci­sion was made in com­pli­ance with a 2012 court order: ​“The court order requires the FDA to refuse admis­sion to the US any ship­ment of for­eign man­u­fac­tured sodi­um thiopen­tal being offered for impor­ta­tion that appears to be an unap­proved new drug or a misbranded drug.” 

Since 2012, Texas has used anoth­er anes­thet­ic, pen­to­bar­bi­tal, in all exe­cu­tions. Arizona has used sev­er­al dif­fer­ent lethal-injec­tion pro­to­cols since sodi­um thiopen­tal became unavailable.