PROF. & PATIENTS FOR CUSTOMIZED CARE v. SHALALA

No. 94-20402.

56 F.3d 592 (1995)

PROFESSIONALS AND PATIENTS FOR CUSTOMIZED CARE, Plaintiff-Appellant, v. Donna SHALALA, et al., Defendants-Appellees.

United States Court of Appeals, Fifth Circuit.

June 15, 1995.


Attorney(s) appearing for the Case

John M. Simpson, Kathleen Kauffman di Bene, Irwin Cohen, Fulbright & Jaworski, Washington DC, for appellant.

Jacqueline H. Eagle, Atty., Office of Consumer Litigation, U.S. Dept. of Justice, Washington DC, Daniel David Hu, Hays Jenkins, Jr., Asst. U.S. Attys., Gaynell Griffin Jones, U.S. Atty., Houston, TX, David Jay Horowitz, Asst. Chief Counsel for Enforcement, Food and Drug Admin., Rockville, MD, for appellees.

Before WISDOM, WIENER and PARKER, Circuit Judges.


WIENER, Circuit Judge:

In this challenge brought pursuant to the Administrative Procedure Act (APA),1 Plaintiff-Appellant Professionals and Patients for Customized Care (P2C2) contends that the district court erred in concluding that Food & Drug Administration (FDA) Compliance Policy Guide 7132.16 (CPG 7132.16) is not a substantive rule and thus is not subject to the APA's notice-and-comment requirement. Finding no reversible error...

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