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# FDA Sued Over Drug Compounding Restrictions
- URL: https://www.fdaweb.com/fda-sued-over-drug-compounding-restrictions/
- Published: 2024-10-28T12:00:00.000Z
- Updated: 2026-09-14T14:45:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158068

Drug compounding outfit FarmaKeio Outsourcing has filed a lawsuit in the Northern Texas District Court against FDA seeking a court order to permit the compounding of sodium thiosulfate, an active ingredient used to treat severe medical conditions including cyanide poisoning and calciphylaxis.

The firm’s [complaint ](http://www.fdaweb.com/download.php?file=compounding%5F10-2024.pdf)challenges what it calls FDA’s “unlawful action” to restrict compounding for ingredients where there is a clinical need. “In the decade since Congress ordered it to establish the clinical-need list of drug substances that may be compounded by outsourcing facilities, the agency has listed a sum-total of five drug substances, all of them since 2022 and all of them subject to extra-statutory restrictions — for example, limiting compounded products to those intended for topical use only,” it says.

The complaint notes that the agency has rejected 22 drug substances by wrongly interpreting “clinical need to encompass a host of factors that have nothing to do with clinical need… Whereas Congress directed FDA to consider whether drug substances are needed in clinical treatment — the plain meaning of the statutory term — FDA rejects drug substances based on irrelevant considerations including how compounded versions might compare to existing drug products approved under its preferred ‘new drug’ regulatory regime.”

FarmaKeio Outsourcing contends FDA has wrongly interpreted the statute. “Congress acted to make compounded versions of drugs available based on clinical need,” it says. “But FDA believes Congress ought to have erected a higher standard to limit compounding and subject more drug products that might otherwise be compounded to FDA approval as ‘new drugs.’ The FDA has no authority to override Congress. The court’s intervention is required to set the agency straight, restore the compounding-friendly system that Congress enacted, set aside FDA’s unlawful rejection of sodium thiosulfate, and ensure that patients have access to high-quality and affordable compounded products that their physicians have determined are needed for their treatment.”