Opinion ID: 7267
Heading Depth: 4
Heading Rank: 2

Heading: FDA's Enforcement of CPG 7132.16

Text: 53 P2C2 urges that, even if the plain language of the rule does not create a binding norm, the agency has treated CPG 7132.16 as though it establishes binding norms, and thus we should hold that it does. P2C2 reminds us that the pertinent inquiry is not only what CPG 7132.16 states that the agency will do, but also  'what the agency does in fact.'  41 54 P2C2 relies on numerous informal agency communications as evidence that the FDA has treated CPG 7132.16 as establishing a binding norm. P2C2 cites in particular to evidence that, since CPG 7132.16's promulgation: (1) the FDA has used the nine factors listed in CPG 7132.16 when inspecting pharmacies, and has relied on those factors to determine whether federal enforcement actions were warranted; (2) in numerous letters the FDA has warned pharmacists that they were engaged in drug manufacturing, rather than traditional compounding, because they were conducting some, or all, of the activities listed in CPG 7132.16, and (3) the FDA has furnished copies of CPG 7132.16 to pharmacists who inquired about the legal restrictions on drug compounding. P2C2's reliance is misplaced. 55 The fact that FDA inspectors refer to CPG 7132.16 to help determine whether a pharmacy is engaged in traditional compounding or drug manufacturing is not particularly probative whether the rule is substantive. We would expect agency employees to consider all sources of pertinent information in performing that task, whether the information be contained in a substantive rule, an interpretive rule, or a statement of policy. Indeed, what purpose would an agency's statement of policy serve if agency employees could not refer to it for guidance? 56 More probative of the nature of CPG 7132.16, however, is the language used by the FDA in warning letters to pharmacies. In one such letter, the FDA wrote that firms engaged in activities that exceed the limits of CPG 7132.16 are considered manufacturers and are subject to all the provisions of the Act. We would not dispute that if this statement were viewed in a vacuum, one could be led to conclude that the FDA was in fact treating CPG 7132.16 as a binding norm. But statements are not to be considered out of context or in isolation, and in that very same letter the FDA clearly stated that CPG 7132.16 was only used by the agency as internal guidance. Moreover, informal communications often exhibit a lack of precision of draftsmanship and such internal inconsistencies are not unexpected, which is why such documents are generally entitled to limited weight. 42 We cannot conclude, in light of all of the other circumstances, that these warning letters are sufficient to transform CPG 7132.16 into a substantive rule. 57 As with that use of CPG 7132.16, we do not find particularly probative the fact that the FDA enclosed copies of CPG 7132.16 in letters responding to some pharmacists' questions regarding the legality of compounding activities. In that correspondence, the agency pointed out that CPG 7132.16 is policy and explained further that [t]his document includes a list of factors which the FDA feels differentiates [sic] traditional compounding from drug manufacturing. The FDA noted in particular that [t]his list is not intended to be exhaustive, and other situations or factors may be considered in particular cases. By so doing, the letters made clear that CPG 7132.16 was used for guidance, but that the FDA retained discretion to conduct an individualized inquiry and to consider other factors outside the list. CPG 7132.16, for example, provides that pharmacies engaged in nontraditional compounding are subject to certain provisions of the Act, and the FDA explains in warning letters that a pharmacy's compounding may be subject to regulation under the Act. 58 We cannot conclude that the FDA has treated the factors in CPG 7132.16 as binding norms. Rather, the agency has used CPG 7132.16 for guidance to help identify those pharmacies that might be engaged in drug manufacturing activities under the guise of compounding. 59