Professionals and Patients for Customized Care v. Shalala

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, we affirm.

I

FACTS AND PROCEEDINGS

In 1992, the FDA promulgated CPG 7132.16 to address what the agency perceived to be a burgeoning problem in the pharmaceutical…