adulterated or misbranded drugs into interstate commerce); id. at § 331(d) (prohibiting introduction of unapproved drugs into interstate commerce).
Baxter has articulated a legitimate concern, as federal officials have been known to exploit the ever-widening definition of interstate commerce to intervene in the smaller matters of life. Nevertheless, nothing indicates that such will happen on account of the court's ruling in this case. Moreover, were the FDA to choose to regulate legally the preparation of drug doses by physicians, pharmacists, or hospitals, this court would not be the place to call for a halt to such activity. Such objections would be better directed at Congress or the agency itself.
This court thus concludes that the chemotherapeutic TRC products, except those containing vincristine, methotrexate, and fluorouracil, are new drugs within the definition of § 321(p), and have not received FDA approval pursuant to § 355(a). Accordingly, Baxter's sales of these chemotherapeutic TRC products violated § 331(d) of the Act. Baxter's failure to obtain approval of these products under § 355(a) also means that these products are not exempt from the labeling requirements of § 352(f) (1). This section requires labels to bear "adequate directions for use," which the FDA defines as "directions under which the layman can use a drug safely and for the purposes for which it is intended." 21 C.F.R. § 201.5. Since Baxter restricted distribution of these products to prescription use only, perforce its labels are not "adequate" for use. The FDA has regulations providing exemptions from § 352(f) (1), see, for example, 21 C.F.R. § 201.100, but Baxter has not shown that it has complied with them. As a result, these chemotherapeutic TRC products are misbranded under § 352(f) (1), and hence Baxter's sales of them violated §§ 331(a) and (k) of the Act.
Similarly, this court must conclude that Baxter has not received certification of its antibiotic TRC products pursuant to § 357 of the Act. Baxter has not received an exemption from § 357 for these products pursuant to 21 C.F.R. § 433.1, so these products are unapproved antibiotics. They are thus misbranded under § 352(l) of the Act, which means that in producing and selling them Baxter violated §§ 331(a) and (k) of the Act.
This leaves the court with the chemotherapeutic TRC products containing vincristine, methotrexate, and fluorouracil. These drugs as approved by the FDA are ready-to-use, unlike the 14 other approved drugs discussed in this opinion. As noted earlier, the TRCs take small quantities of these drugs and pool them, creating larger quantities. In the process of pooling vincristine and methotrexate, Baxter diluted them from their FDA-approved concentrations. This procedure takes Baxter's vincristine and methotrexate products out of the Kaybel repackaging exception, as it makes the repackaged products different from the originals. As for the bioequivalency exception suggested in Generix Drug, Baxter does not refute the testimony of the government's experts that dilution of these drugs causes them to act differently. The court will not find bioequivalency where the unapproved compound does not have the same properties as the approved drug. Thus, since Baxter did not repackage vincristine and methotrexate along the lines of Kaybel, nor produced compounds which are the bioequivalents of FDA-approved drugs, Baxter's vincristine and methotrexate compounds were new drugs within the definition of § 321(p). Baxter did not receive FDA approval of these products pursuant to § 355(a), and thus its sales of them, for the reasons stated earlier, violated §§ 331(a), (d), and (k) of the Act.
Baxter's fluorouracil products present a different case, however. Baxter merely pooled small quantities of fluorouracil to make larger quantities, without diluting it. Baxter's fluorouracil products thus had a better chance of falling under the Kaybel repackaging or Generix Drug bioequivalency exceptions. Baxter encounters yet another problem, however, in arguing for the application of these exceptions to its fluorouracil products: its unapproved packaging.
The FDA-approved labels for fluorouracil state that it is supplied in 10- and 100-ml ampules or vials. The 10-ml vials generally provide enough fluorouracil for a single dose, while the 100-ml vials come in what are called "pharmacy bulk packages."
According to the unrefuted testimony of government experts, Baxter took fluorouracil, removed it from approved vials, and pooled it in Viaflex (R) brand polyvinyl chloride bags for resale. The FDA-approved labels of fluorouracil do not indicate if this was proper. Moreover, the container in which a manufacturer places a drug is often as important as what is in the drug itself. The Act suggests this in various places. In § 321(p), the Act focuses the inquiry on whether something is a "new drug" on the substance's safety and effectiveness "for use under the conditions prescribed, recommended, or suggested in the labeling thereof . . . ." Pursuant to its statutory authority, the FDA requires drug manufacturers to get approval of any parenteral (i.e., injectable) drug product "packaged in a plastic immediate container." If the applicant does not get FDA approval of the container, the FDA will consider the resulting product to be a new drug under § 321(p). See 21 C.F.R. § 310.509(a).
Baxter admits that it never received approval of its packaging of its fluorouracil products from the FDA. The FDA considers products such as these to be new drugs; § 321(p) does not clearly state to the contrary, and thus the sole question for this court is whether the FDA's interpretation of § 321(p) as put forth in 21 C.F.R. § 310.509(a) is based on a permissible construction of the Act. See Chevron, 467 U.S. at 842-43.
Unfortunately for Baxter, the company has not challenged the wisdom of 21 C.F.R. § 310.509(a). For several reasons this court deems it unwise to conjure its own objections to the regulation. It is undisputed from the government and Baxter's experts that the packaging of a drug can be critical to its safety and effectiveness. Containers can interact with the drug, diminishing its effectiveness or even rendering it hazardous. Moreover, the FDA-approved label directions of fluorouracil suggest that sterility of the compound is very important; the FDA should and must assure itself that Baxter's Viaflex R TM bags match or surpass the approved 10- and 100-ml vials in their aseptic qualities. This court thus holds that 21 C.F.R. § 310.509(a) is based on a permissible construction of § 321(p), and thus by failing to gain approval of its packaging of fluorouracil in its Viaflex (R) bags, Baxter introduced a new drug in violation of § 355(a). Its sales of its fluorouracil TRC products thus violated §§ 331(a), (d), and (k) of the Act.
Having found that Baxter has violated the Act, and that there is a cognizable danger of recurrent violation, this court enjoins Baxter Healthcare Corporation and Glaxo Specialties, Inc. from preparing, repackaging, or distributing the 35 TRC products listed in the government's complaint, pending trial on the merits.