Compounding Problems and Compounding Confusion: Federal Regulation of Compounded Drug Products and the FDAMA Circuit Split

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I. INTRODUCTION

Drug compounding is the long-standing pharmacy practice of mixing, combining, or altering ingrethents to create drugs tailored to individual patient needs. Compounding is as old as the practice of pharmacy and close to the heart of the modern profession. Indeed, the mortar and pestle - an iconic emblem of compounding - have long been the prevailing symbol of pharmacy. Prior to the emergence of commercially available drug products, the practice of compounding was the practice of pharmacy - to create medicines, early pharmacists inevitably needed to extract and compound natural vegetable, animal, and mineral substances. 1 In one impressive example of successful early compounding, God commanded Moses to "compoundeth" a holy anointing oil of myrrh, cinnamon, cassia, olive oil, and sweet calamus.2 Not generally one to shrink from a challenge, Moses followed God's recipe and used his compounded oil to anoint the vessels of the Tabernacle and High Priest.3

For most of our history, the federal government virtually ignored the practice of compounding, leaving the matter to the individual State Boards of Pharmacy in their general regulatory oversight of the profession. In the early 1990s, however, a confluence of events - including a resurgence in the practice's popularity and an increased awareness of the practice's risks - led the United States Food and Drug Administration ("FDA") to assert regulatory jurisdiction over compounding for the first time. The FDA's assertion of regulatory authority triggered a fierce backlash from organized pharmacy and a protracted legislative battle. This battle eventually culminated in the passage of the Food and Drug Administration Modernization Act of 1997 ("FDAMA") which, in pertinent part, clarified the status of pharmacy compounding under federal law.4

In 2002, the Supreme Court declared certain compounding-related provisions of the FDAMA unconstitutional on First Amendment grounds in Thompson v. Western States Medical Center.5 In the wake of Western States Medical Center, a circuit split has emerged on the severability of the unconstitutional provisions from the remainder of the compounding-related provisions of the FDAMA.6 The Ninth Circuit has held the unconstitutional provisions to be unseverable and thus declared the compounding-related provisions of the FDAMA entirely invalid.7 The Fifth Circuit has held the unconstitutional provisions to be severable and thus found the compounding provisions of the FDAMA to be continuing in effect.8 This Note examines this significant circuit split and the related questions of why the split happened, why it matters, and which circuit got it right.

Part II of this Note presents an introduction to the practice of compounding, explaining both its history and continuing importance in our modern health care system. Part III documents the serious and often severe risks that inhere in the practice of compounding. In particular, Part III reviews five general types of compounding risks - subpotency, superpotency, contamination, overmedication, and medication-replacement. Part IV introduces compounding's 'pirate manufacturing problem.' For decades, rogue pharmacies have engaged in large-scale manufacturing under the guise of compounding. This problem is both widespread and dangerous and it has, by most indications, been the primary impetus for the FDA's renewed interest in the area. Part V explains the unsettled federal regulatory framework that provides the backdrop for a consideration of the FDAMA circuit split. Part VI then turns to the circuit split and examines its two principal cases - the Ninth Circuit and Supreme Court decisions in Thompson v. Western States Medical Center and the Fifth Circuit decision in Medical Center Pharmacy v. Mukasey. Part VII, finally, offers a closer look at the issue and implications of severability. It argues that while the Ninth Circuit position has merit, the Fifth Circuit's analysis is both more defensible and more faithful to Supreme Court precedent. …