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MEDICAL CENTER PHARMACY v. MUKASEY

No. 06-51583.

536 F.3d 383 (2008)

MEDICAL CENTER PHARMACY; Applied Pharmacy; College Pharmacy; Med Shop Total Care Pharmacy; Pet Health Pharmacy Incorporated; Plum Creek Pharmaceuticals Incorporated; Premier Pharmacy; University Compounding Pharmacy; Veterinary Pharmacies of America; Women's International Pharmacy Incorporated, Plaintiffs-Appellees, v. Michael B. MUKASEY, U.S. Attorney General, United States Department of Justice, in His Official Capacity; Michael O. Leavitt, Secretary, Department of Health and Human Services, in His Official Capacity; Andrew C. von Eschenbach, Commissioner of the United States Food and Drug Administration, in His Official Capacity, Defendants-Appellants.

United States Court of Appeals, Fifth Circuit.

July 18, 2008.

Attorney(s) appearing for the Case

Deborah Ann Pearce (argued), Powell & Pearce, New Orleans, LA, Terry Lane Scarborough, Matthew Thomas Slimp, Hance Scarborough LLP, Austin, TX, for Plaintiffs-Appellees.

Christine N. Kohl (argued), Douglas N. Letter, U.S. Dept. of Justice, Civil Div., Gerald Cooper Kell, Senior Trial Atty., U.S. Dept. of Justice, Office of Consumer Litigation, Washington, DC, for Defendants-Appellants.

Andrew Stephen Krulwich, Eve Jennifer Reed, Benjamin Boyce Reed, Wiley Rein LLP, Washington, DC, for Wyeth, Amicus Curiae.

Jeffrey Neil Gibbs, Hyman, Phelps & McNamara, Washington, DC, for Intern. Academy of Compunding Pharmacists, Amicus Curiae.

Andrew Layton Schlafly, Far Hills, NJ, for Ass'n of American Physicians & Surgeons, Inc., Amicus Curiae.

Steven Pierce Benson, O'Brien, Butler, McConihe & Schaefer PLLC, Washington, DC, for American Pharmacists Ass'n, Amicus Curiae.

Before HIGGINBOTHAM, DAVIS and SMITH, Circuit Judges.

JERRY E. SMITH, Circuit Judge:

In this appeal we clarify the extent to which the Federal Food Drug and Cosmetic Act of 1938 (the "FDCA" or the "Act"), 21 U.S.C. §§ 301-397, permits the Food and Drug Administration ("FDA") to regulate a common practice of pharmacies known as "compounding." Ten pharmacies specializing in compounding prescription drugs for human and animal use (the "Pharmacies") sued various federal agencies (collectively, the "FDA") for declaratory...

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