Texas Drug Compounder Challenges FDA ‘Clinical Need’ Decision

The FDA’s decision to exclude sodium thiosulfate from a list that allows outsourcing facilities to compound drugs that are in clinical need is unlawful, FarmaKeio Outsourcing LLC told a federal court.

The Food and Drug Administration acted arbitrarily and capriciously when it left out sodium thiosulfate from a “clinical need list” of drug substances that may be compounded by outsourcing facilities, FarmaKeio wrote Oct. 25 in a complaint filed with the US District Court for the Northern District of Texas.

Sodium thiosulfate is an active ingredient that treats severe medical conditions including cyanide poisoning and calciphylaxis.

Congress authorizes outsourcing facilities ...