Athenex Pharma Solutions, LLC v. Azar, II

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA _________________________________________ ) ATHENEX INC., et al., ) ) Plaintiffs, ) ) v. ) Case No. 19-cv-00603 (APM) ) ALEX M. AZAR II, et al. ) ) Defendants. ) _________________________________________ ) MEMORANDUM OPINION I. INTRODUCTION In 2013, Congress added Section 503B to the Food, Drug, and Cosmetic Act, creating a new category of drug manufacturer known as an “outsourcing facility.” Such facilities are permitted to sell large quantities of compounded drugs directly to hospitals and health care professionals without receiving…