## Facts

- The United States, acting through the FDA, seized drugs worth about $680,000 from Travenol Laboratories’ Regional Compounding Center in Morton Grove, Illinois under 21 U.S.C. § 334.
- The government filed an in rem forfeiture/condemnation action alleging the drugs were held or handled in violation of the Federal Food, Drug, and Cosmetic Act (FDCA) as part of Travenol’s compounding practices.
- About $500,000 of the seizure consisted of “sterile active ingredients” that the government conceded were FDA-approved and lawful when packaged, sold, and used in compliance with applicable requirements.
- Travenol asserted the sterile active ingredients were perishable and costly to store, and moved for their release before condemnation.
- Travenol offered to accept conditions ensuring the released ingredients would be used only in FDCA-compliant ways and not in the disputed compounding program.
- The government opposed, arguing § 334 provided no authority for pre-condemnation release and implicitly barred it.
- At a hearing, the parties agreed that approximately $180,000 of finished products associated with the contested compounding practice would be destroyed, leaving the dispute focused on the sterile active ingredients.

## Issues

1. Whether 21 U.S.C. § 334 precludes a district court from ordering pre-condemnation release of properly seized products that are themselves lawful and perishable, subject to conditions protecting the public interest.

## Decision

- The court granted Travenol’s motion for pre-condemnation release of the sterile active ingredients.
- The court held that § 334 does not prohibit the court from using equitable authority to order conditional release of seized goods before condemnation.
- The court ordered release of the approximately $500,000 in sterile active ingredients subject to conditions: they could be used only in compliance with the FDCA and could not be used in the challenged compounding program.
- The court accepted the parties’ agreement that the approximately $180,000 in finished products tied to the challenged practice would be destroyed.

## Legal Principles

- When Congress assigns enforcement of a statute to federal courts, courts retain traditional equitable powers unless Congress clearly limits them.
- Silence in an FDCA seizure-and-condemnation provision does not, by itself, eliminate equitable authority to prevent waste during pending forfeiture litigation.
- In a § 334 condemnation action, a court may order pre-condemnation release of seized goods where:
  - the goods are conceded to be lawful on their own (not inherently adulterated or misbranded), and
  - the goods are perishable or otherwise at risk of deterioration or waste, and
  - conditions can be imposed to prevent use in the alleged violative conduct and to protect the public interest.
- Equity may account for in rem practice treating perishable property as appropriate for disposition or controlled release pending adjudication.

## Conclusion

The court concluded that FDCA § 334 does not bar equitable, pre-condemnation relief and ordered conditional release of FDA-approved, perishable sterile active ingredients to avoid waste while preserving the government’s enforcement interests.


United States v. Undetermined Quantities of Drugs, 675 F. Supp. 1113 (N.D. Ill. 1987)