Drug Compounder Loses Challenge to FDA Bulk Substance Decision

A large-scale drug compounder failed to show that it has standing to challenge the FDA’s decision to exclude a certain ingredient from a list that determines what can be used to make a customized medication, a federal judge ruled.

Texas-based drug compounder FarmaKeio Outsourcing LLC couldn’t set forth specific facts to demonstrate that it would be injured by the Food and Drug Administration’s action to leave out sodium thiosulfate from the agency’s bulk drug substances list, Judge Reed O’Connor for the US District Court for the Northern District of Texas said in an opinion filed March 5.

The outsourcing facility ...