Opinion ID: 7267
Heading Depth: 4
Heading Rank: 3

Heading: Substantive Change in Regulations

Text: 77 If an agency pronouncement is to be an interpretative rule or a statement of policy, though, it cannot effect[ ] a substantive change in the regulations. 53 P2C2 posits that CPG 7132.16 effects such a substantive change, arguing that never before did the FDA regulate compounding activities. But there is nothing new or changed about the law that CPG 7132.16 clarifies. 78 The district court found that CPG 7132.16 does not plow new legal ground, as the rule expressly states that traditional compounding activity is not the subject of this CPG 7132.16. Moreover, the FDA introduced into evidence warning letters proving that long before CPG 7132.16 issued the agency had instituted enforcement actions against pharmacies engaged in drug manufacturing under the guise of compounding. 79 In conclusion, we are satisfied that the district court did not clearly err in finding that the rule announced in CPG 7132.16 does not effect a substantive change to already applicable regulations, but that it merely provides guidance on an old problem--unregulated drug manufacturing. As we agree, then, that CPG 7132.16 is not a substantive rule, and thus is not subject to APA notice-and-comment requirements, the district court's judgment is, in all respects, 80 AFFIRMED.