380
Breyer, J., dissenting
ciated with drug manufacturing" while others are "intended to ensure that the compounded drugs that qualify for the exemption have appropriate assurances of quality and safety since [they] would not be subject to the more comprehensive regulatory requirements that apply to manufactured drug products").
This second intermediate objective is logically related to Congress' primary end—the minimizing of safety risks. The statute's basic exemption from testing requirements inherently creates risks simply by placing untested drugs in the hands of the consumer. Where an individual has a specific medical need for a specially tailored drug those risks are likely offset. But where an untested drug is a convenience, not a necessity, that offset is unlikely to be present.
That presumably is why neither the Food and Drug Administration (FDA) nor Congress anywhere suggests that all that matters is the total amount of a particular drug's sales. That is why the statute's history suggests that the amount supplied is not the whole story. See S. Rep. No. 105-43, p. 67 (1997) (statute seeks to assure "continued availability of compounded drug products as a component of individualized therapy, . . . while . . . prevent[ing] small-scale manufacturing under the guise of compounding" (emphasis added)); accord, H. R. Conf. Rep. No. 105-399, p. 94 (1997). That is why the statute itself, as well as the FDA policy that the statute reflects, lists several distinguishing factors, of which advertising is one. See FDA Compliance Policy Guide 7132.16, reprinted in App. to Pet. for Cert. 71a-77a (hereinafter Compliance Policy Guide). And that is likely why, when faced with the possibility of severing the advertising restriction from the rest of the statute, the Government argued that the "other conditions in section 353a alone are inadequate to achieve Congress's desired balance among competing interests." See Brief for Appellants in No. 99-17424 (CA9), p. 57. See also id., at 55 (to nullify advertising restrictions would undermine " 'finely tuned balance' " achieved
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