Brief Fact Summary. Professionals and Patients for Customized Care (Plaintiff- Appellant) contended that the District Court erred in its determination that the Food and Drug Administration (FDA) Compliance Policy Guide (Guide) was not a substantive rule.
Synopsis of Rule of Law. The APA requires agencies to afford interested parties notice and an opportunity to comment to proposed substantive rules.
Issue. Was the Guide a substantive rule, making it subject to the APA’s notice and comment requirement?
Held. No, the Guide was not a substantive rule, and notice and comment was not required. Affirmed. The FDA treated the factors in CPG 7132.16 as guidelines to help identify whether a particular pharmacy might be engaged in unlawful compounding, not as binding norms. The language of CPG 7132.16 made it clear that it was not intended to foreclose the agency’s discretion in bringing an enforcement proceeding. Dissent. None. Concurrence. None.
Discussion. A general statement of policy (falling outside the notice and comment requirement) is “a statement by an administrative agency announcing motivating factors the agency will consider, or tentative goals toward which it will aim, in determining the resolution of a substantive question of regulation.” This definition fits CPG 7132.16 exactly.