United States v. Regenerative Sciences, LLC

Opinion for the court filed by Circuit Judge GRIFFITH.

GRIFFITH, Circuit Judge:

In this civil enforcement action, we must decide whether the appellants — three individuals and a related corporate entity— violated federal laws regulating the manufacture and labeling of drugs and biological products by producing, as part of their medical practice, a substance consisting of a mixture of a patient’s stem cells and the antibiotic doxycycline. Because we conclude that they did, we affirm the district court’s judgment and the permanent injunction it entered against appellants.

I

A

This case involves two…