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Administrative Law Keyed to Asimow
Professionals and Patients for Customized Care v. Shalala
Citation:
56 F.3d 592 (1995)Facts
In 1992, the FDA promulgated CPG 7132.16 to address what it perceived as a growing problem of establishments with pharmacy licenses engaging in drug manufacturing rather than traditional compounding. Traditional compounding involves a pharmacist combining ingredients for an individual patient pursuant to a physician’s prescription, and is primarily regulated by state law. The FDA had become aware that many establishments with pharmacy licenses were purchasing bulk drug substances, combining them into specific drug products before receiving prescriptions, and then marketing these products to practitioners and patients. The FDA suspected these establishments were trying to circumvent federal regulations that apply to drug manufacturers. CPG 7132.16 identified nine factors the FDA would consider in determining whether to initiate enforcement actions against pharmacies engaged in these practices. P2C2, representing pharmacies affected by this guidance, challenged the CPG as a substantive rule that required notice-and-comment rulemaking under the APA.
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