Cite as: 535 U. S. 357 (2002)
Breyer, J., dissenting
by requiring that "pharmacies refrain from promoting and soliciting prescriptions for particular compounded drug products until they have been proven safe and effective").
Ensuring that the risks associated with compounded drug prescriptions are offset by the benefits is also why public health authorities, testifying in Congress, insisted that the doctor's prescription represent an individualized determination of need. See, e. g., FDA Reform Legislation: Hearings before the Subcommittee on Health and the Environment of the House Committee on Commerce, 104th Cong., 2d Sess., 120 (1996) (hereinafter FDA Reform Legislation) (statement of Mary K. Pendergast, Deputy Commissioner of the FDA and Senior Advisor to the Commissioner) (Allowing traditional compounding is "good medicine" because "an individual physician" was making "an individualized determination for a patient"). See also National Association of Boards of Pharmacy, Model State Pharmacy Act and Rules, Art. I, § 1.05(e) (1996) (hereinafter NABP Model Act) (defining "[c]ompounding" as involving a prescription "based on the Practitioner/patient/Pharmacist relationship in the course of professional practice").
And that, in part, is why federal and state authorities have long permitted pharmacists to advertise the fact that they compound drugs, while forbidding the advertisement of individual compounds. See Compliance Policy Guide 76a; Good Compounding Practices Applicable to State Licensed Pharmacies, NABP Model Act, App. C.2, subpart A (forbidding pharmacists to "solicit business (e. g., promote, advertise, or use salespersons) to compound specific drug products"). The definitions of drug manufacturing and compounding used by the NABP and at least 13 States reflect similar distinctions. NABP Model Act, Art. I, §§ 105(e), (t), and (u) (defining drug manufacturing to "include the promotion and marketing of such drugs or devices" but excluding any reference to promotion or marketing from the definition of drug compounding); Alaska Stat. §§ 08.80.480(3) and (15) (2000)
381
Page: Index Previous 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 NextLast modified: October 4, 2007