Cite as: 535 U. S. 357 (2002)
Opinion of the Court
manufacturing, distributing, and promoting unapproved new drugs for human use in a manner that is clearly outside the bounds of traditional pharmacy practice and that constitute violations of the [FDCA]." Ibid. The Guide expressed concern that drug products "manufactured and distributed in commercial amounts without [the] FDA's prior approval" could harm the public health. Id., at 73a.
In light of these considerations, the Guide announced that it was FDA policy to permit pharmacists to compound drugs after receipt of a valid prescription for an individual patient or to compound drugs in "very limited quantities" before receipt of a valid prescription if they could document a history of receiving valid prescriptions "generated solely within an established professional practitioner-patient-pharmacy relationship" and if they maintained the prescription on file as required by state law. Id., at 73a-75a. Compounding in such circumstances was permitted as long as the pharmacy's activities did not raise "the kinds of concerns normally associated with a manufacturer." Id., at 76a. The Guide listed nine examples of activities that the FDA believed raised such concerns and that would therefore be considered by the agency in determining whether to bring an enforcement action. These activities included: "[s]oliciting business (e. g., promoting, advertising, or using salespersons) to compound specific drug products, product classes, or therapeutic classes of drug products"; "[c]ompounding, regularly, or in inordinate amounts, drug products that are commercially available . . . and that are essentially generic copies of commercially available, FDA-approved drug products"; using commercial scale manufacturing or testing equipment to compound drugs; offering compounded drugs at wholesale; and "[d]istributing inordinate amounts of compounded products out of state." Id., at 76a-77a. The Guide further warned that pharmacies could not dispense drugs to third parties for resale to individual patients without losing their status as retail entities. Id., at 75a.
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