Professionals and Patients
for Customized Care v. Shalala case brief
56 F.3d 592 (5th Cir. 1995)
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56 F.3d 592 (5th Cir. 1995)
CASE SYNOPSIS: Appellant
pharmacists' organization sought review of a judgment from the United
States District Court For the Southern District of Texas, which
upheld the validity of appellee Food & Drug Administration's
(FDA) Compliance Policy Guide 7132.16 in appellant's challenge under
the Administrative Procedure Act, 5 U.S.C.S. § 500 et seq.
FACTS: Appellant pharmacists' organization 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. On appeal, the court affirmed. The court concluded 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.
CONCLUSION: Finding that the compliance policy guide challenged by appellant pharmacists' organization was not a substantive rule and was thus exempt from statutory notice-and-comment requirements, the court affirmed the district court's judgment in favor of appellee Food and Drug Administration.
FACTS: Appellant pharmacists' organization 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. On appeal, the court affirmed. The court concluded 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.
CONCLUSION: Finding that the compliance policy guide challenged by appellant pharmacists' organization was not a substantive rule and was thus exempt from statutory notice-and-comment requirements, the court affirmed the district court's judgment in favor of appellee Food and Drug Administration.
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