Judge Grants FDA Summary Judgment In Row Over Drug Exclusion From Bulk List

( March 9, 2026, 3:08 PM EDT) -- FORT WORTH, Texas — An outsourcing facility that neither compounds sodium thiosulfate “nor has a facility capable of doing so” lacks standing to challenge a decision by the U.S. Food and Drug Administration to decline to add the drug to a list of bulk drug substances approved for compounding, a Texas federal judge ruled in granting summary judgment to the government (FarmaKeio Outsourcing, LLC v. United States Food And Drug Administration, et al., No. 2401040, N.D. Texas, 2026 U.S. Dist. LEXIS 46434)....