Outsourcing Facilities Association v. Food and Drug Administration, 4:25-cv-00174

The Federal Food, Drug, and Cosmetic Act (FDCA) requires FDA approval for new drugs in interstate commerce, with exceptions for certain compounded drugs during shortages.
Compounders (pharmacies and outsourcing facilities) may produce compounded versions of approved drugs during FDA-declared shortages but are less regulated than manufacturers.
Ozempic® and Wegovy®, semaglutide-based drugs from Novo Nordisk, were placed on the FDA's shortage list in 2022, allowing compounding.
In February 2025, the FDA removed ("delisted") these drugs from the shortage list after determining supply exceeded demand, prompting this lawsuit.
Plaintiffs, representing compounding interests, sought a preliminary injunction to block the FDA's delisting action, arguing it was procedurally invalid and arbitrary.
The Court denied the preliminary injunction, reasoning Plaintiffs had not demonstrated a likelihood of success on the merits.

Issue	Plaintiff's Argument	Defendant's Argument	Held
FDA Delisting Action as Rulemaking	Required notice-and-comment rulemaking which FDA did not provide.	Adjudication is appropriate; rulemaking would conflict with "up-to-date" mandate.	Plaintiffs unlikely to succeed.
Arbitrary and Capricious Agency Action	Delisting relied on flawed demand and inventory data and dismissed contrary evidence.	FDA considered a wide range of up-to-date and persuasive data.	Plaintiffs unlikely to succeed.
Harm to Plaintiffs (Irreparable Injury)	Removing compounding authorization would cause unrecoverable financial losses.	No argument on this issue (financial harms deemed irreparable as to gov't).	Irreparable injury shown by Plaintiffs.
Public/Private Interest Balancing for Injunction	Patients would be deprived of needed medications if injunction not granted.	Continued compounding risks patient safety; FDA should enforce regulations.	Interests balanced; no factor prevails.

Thompson v. W. States Med. Ctr., 535 U.S. 357 (describes drug compounding as traditional pharmacy practice)
Nichols v. Alcatel USA, Inc., 532 F.3d 364 (sets out the four-factor preliminary injunction standard)
City of Dall. v. Delta Air Lines, Inc., 847 F.3d 279 (affirms PI standard including public interest)
Miss. Power & Light Co. v. United Gas Pipe Line Co., 760 F.2d 618 (district court discretion for PI)
Camp v. Pitts, 411 U.S. 138 (judicial review of agency action limited to administrative record)
FCC v. Prometheus Radio Project, 592 U.S. 414 (deferential review of agency choices unless arbitrary)