On July 23, the U.S. Court of Appeals for the District of Columbia Circuit unan­i­mous­ly affirmed a low­er court rul­ing that the Food and Drug Administration (FDA) failed to ful­fill its duties under the Food, Drug, and Cosmetic Act (FDCA) when it per­mit­ted with­out inspec­tion the impor­ta­tion of for­eign drugs for use in lethal injec­tions. The Court con­clud­ed, ​“The FDCA impos­es manda­to­ry duties upon the agency charged with its enforce­ment. The FDA act­ed in dero­ga­tion of those duties by per­mit­ting the impor­ta­tion of thiopen­tal, a con­ced­ed­ly mis­brand­ed and unap­proved new drug, and by declar­ing that it would not in the future sam­ple and exam­ine for­eign ship­ments of the drug despite know­ing they may have been pre­pared in an unreg­is­tered estab­lish­ment.” In 2009, the last U.S. man­u­fac­tur­er of sodi­um thiopen­tal announced it would cease pro­duc­tion of the drug com­mon­ly used by states in lethal injec­tions. Some states then turned to inter­na­tion­al man­u­fac­tur­ers and import­ed drugs which were not approved by the FDA. The rul­ing reject­ed the FDA’s claim that it had dis­cre­tion to allow unap­proved drugs into the U.S. Read full text of the rul­ing.

The Court of Appeals over­turned the low­er court’s order that the import­ed drugs be turned over to the FDA because some states were not par­ties to the suit orig­i­nal­ly brought by death row inmates in three states. 

(“Appeals court says FDA can’t allow unap­proved drug to be import­ed for exe­cu­tions,” Associated Press, July 23, 2013; Cook v. FDA, No. 12 – 5176, D.C. Cir. (2013)). See Lethal Injection.

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