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The Administrative Procedure Act (APA), 5 U.S.C.S. § 500 et seq, exempts from notice-and-comment procedures interpretative rules, general statements of policy, and rules of agency organization, procedure, or practice. In contrast, if a rule is "substantive," the exemption is inapplicable, and the full panoply of notice-and-comment requirements must be adhered to scrupulously. The APA's notice and comment exemptions must be narrowly construed.
Appellant, Professionals and Patients for Customized Care, filed suit claiming that appellee Food and Drug Administration's (FDA) Compliance Policy Guide (CPG) 7132.16 was invalid because it was a substantive rule issued in violation of the notice-and-comment requirement of the Administrative Procedure Act (APA), 5 U.S.C.S. § 500 et seq. Appellee did not consider CPG 7132.16 a substantive rule, but instead as an internal guide for identifying those pharmacies that manufactured drugs under the guise of traditional compounding. The district court concluded that CPG 7132.16 was not a substantive rule and thus was not subject to the APA's notice-and-comment requirement. Appellant challenged the decision.
Was CPG 7132.16 a substantive rule subject to the APA's notice-and-comment requirement?
The court found that the district court did not clearly err in finding that the rule announced in CPG 7132.16 did not effect a substantive change to already applicable regulations, but that it merely provided guidance on an old problem of unregulated drug manufacturing. The court found that CPG 7132.16 could be characterized as a statement of policy or an interpretive rule, either of which was exempt from the APA's notice-and-comment requirement.