MEDICAL CENTER PHARMACY v. HOLDER

No. 10-50031.

634 F.3d 830 (2011)

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-Appellants, v. Eric H. HOLDER, Jr., U.S. Attorney General, In his official capacity as Attorney General, United States Department of Justice; Kathleen Sebelius, In her official capacity as Secretary of the Department of Health and Human Services; Margaret A. Hamburg, In her official capacity as Commissioner of the United States Food and Drug Administration, Defendants-Appellees.

United States Court of Appeals, Fifth Circuit.

February 25, 2011.


Attorney(s) appearing for the Case

Deborah Ann Pearce (argued), Law Offices of Deborah Pearce, New Orleans, LA, Terry Lane Scarborough , Hance Scarborough, L.L.P., Austin, TX, for Plaintiffs-Appellants.

Christine Noel Kohl (argued), Douglas Neal Letter , U.S. Dept. of Justice, Civ. Div., App. Staff, Washington, DC, for Defendants-Appellees.

Before WIENER, GARZA, and PRADO, Circuit Judges.


PRADO, Circuit Judge:

This case is before us for the second time. In our first opinion,1 we held that "compounded" drugs are "new" drugs under the Federal Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. §§ 301-399a, but that they are exempt from the FDCA's adulteration, misbranding, and new-drug-approval provisions if they comply with the conditions set forth in 21 U.S.C. §§ 353a and 360b(a).

On remand, the...

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