370
Opinion of the Court
small-scale compounding to make safety and efficacy testing of their compounded drugs economically feasible, so requiring such testing would force pharmacists to stop providing compounded drugs. Given this, the Government needs to be able to draw a line between small-scale compounding and large-scale drug manufacturing. That line must distinguish compounded drugs produced on such a small scale that they could not undergo safety and efficacy testing from drugs produced and sold on a large enough scale that they could undergo such testing and therefore must do so.
The Government argues that the FDAMA's speech-related provisions provide just such a line, i. e., that, in the terms of Central Hudson, they "directly advanc[e] the governmental interest[s] asserted." 447 U. S., at 566. Those provisions use advertising as the trigger for requiring FDA approval—essentially, as long as pharmacists do not advertise particular compounded drugs, they may sell compounded drugs without first undergoing safety and efficacy testing and obtaining FDA approval. If they advertise their compounded drugs, however, FDA approval is required. The Government explains that traditional (or, in its view, desirable) compounding responds to a physician's prescription and an individual patient's particular medical situation, and that "[a]dvertising the particular products created in the provision of [such] service (as opposed to advertising the compounding service itself) is not necessary to . . . this type of responsive and customized service." Brief for Petitioners 34. The Government argues that advertising particular products is useful in a broad market but is not useful when particular products are designed in response to an individual's "often unique need[s]." Ibid. The Government contends that, because of this, advertising is not typically associated with compounding for particular individuals. In contrast it is typically associated, the Government claims, with large-scale production of a drug for a substantial market. The Government argues that advertis-
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