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.)
What to do next…
Unlock this case brief with a free (no-commitment) trial membership of Quimbee.
You’ll be in good company: Quimbee is one of the most widely used and trusted sites for law students, serving more than 97,000 law students since 2011. Some law schools—such as Yale, Vanderbilt, Berkeley, and the University of Illinois—even subscribe directly to Quimbee for all their law students. Read our student testimonials.
Learn more about Quimbee’s unique (and proven) approach to achieving great grades at law school.
Quimbee is a company hell-bent on one thing: helping you get an “A” in every course you take in law school, so you can graduate at the top of your class and get a high-paying law job. We’re not just a study aid for law students; we’re the study aid for law students. Read more about Quimbee.
Here's why 175,000 law students have relied on our case briefs:
- Written by law professors and practitioners, not other law students. 14,000 briefs, keyed to 188 casebooks. Top-notch customer support.
- The right amount of information, includes the facts, issues, rule of law, holding and reasoning, and any concurrences and dissents.
- Access in your classes, works on your mobile and tablet. Massive library of related video lessons and high quality multiple-choice questions.
- Easy to use, uniform format for every case brief. Written in plain English, not in legalese. Our briefs summarize and simplify; they don’t just repeat the court’s language.