Professionals and Patients for Customized Care v. Shalala
United States Court of Appeals for the Fifth Circuit
56 F.3d 592 (1995)
Relevant factsFree
The FDA (defendant) issued a compliance policy guide listing nine non-exclusive factors it would consider before enforcing federal drug-manufacturing restrictions against retail pharmacies, while retaining full discretion to weigh other factors or decline enforcement even when all nine were present; P2C2 (plaintiff) sued, arguing the guide was actually a substantive rule requiring notice-and-comment rulemaking, and the district court ruled for the FDA.
IssueFree
Whether a federal agency needs to follow the Administrative Procedure Act's notice and comment procedures if the agency issues a nonsubstantive statement of policy or interpretative rule.
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