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Professionals and Patients for Customized Care v. Shalala

United States Court of Appeals for the Fifth Circuit
56 F.3d 592 (1995)


The federal Food and Drug Administration (FDA) (defendant) issued a compliance policy guide (CPG) that provided information about how the FDA would enforce the Federal Food, Drugs, and Cosmetics Act (FFDCA), 21 U.S.C. § 301 et seq. The FFDCA prohibited retail pharmacies from engaging in certain prescription-drug-manufacturing activities. The CPG contained a list of nine non-exclusive factors that the FDA would consider before enforcing the FFDCA in this context. The CPG also stated that the FDA could consider other factors in appropriate circumstances, and that the FDA could decide not to enforce the FFDCA even if all nine factors were present. The FDA characterized the CPG as an interpretative rule or policy statement. The Administrative Procedure Act’s (APA’s), 5 U.S.C. § 551 et seq., notice and comment provisions do not apply to interpretative rules or policy statements. Professionals and Patients for Customized Care (P2C2) (plaintiff) rejected the FDA’s characterization of the CPG as an interpretative rule or statement of policy. P2C2 sued the FDA, contending that the CPG was a substantive rule that required the APA’s notice and comment procedures. The federal district court ruled in the FDA’s favor. P2C2 appealed to the United States Court of Appeals for the Fifth Circuit.

Rule of Law


Holding and Reasoning (Wiener, J.)

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