Cite as: 535 U. S. 357 (2002)
Opinion of the Court
a medication tailored to the needs of an individual patient. Compounding is typically used to prepare medications that are not commercially available, such as medication for a patient who is allergic to an ingredient in a mass-produced product. It is a traditional component of the practice of pharmacy, see J. Thompson, A Practical Guide to Contemporary Pharmacy Practice 11.3 (1998), and is taught as part of the standard curriculum at most pharmacy schools, see American Council on Pharmaceutical Education, Accreditation Standards and Guidelines for the Professional Program in Pharmacy Leading to the Doctor of Pharmacy Degree, Standard 10(a) (adopted June 14, 1997). Many States specifically regulate compounding practices as part of their regulation of pharmacies. See, e. g., Cal. Code Regs., tit. 16, §§ 1716.2, 1751 (2002); Ind. Admin. Code, tit. 856, §§ 1-30-8, 1-30-18, 1-28-8 (2001); N. H. Code Admin. Rules Ann. Pharmacy, pts. PH 404, PH 702.01 (2002); 22 Tex. Admin. Code § 291.36 (2002). Some require all licensed pharmacies to offer compounding services. See, e. g., 49 Pa. Code § 27.18(p)(2) (2002); W. Va. Code St. Rules, tit. 15, § 19.4 (2002). Pharmacists may provide compounded drugs to patients only upon receipt of a valid prescription from a doctor or other medical practitioner licensed to prescribe medication. See, e. g., Okla. Admin. Code §§ 535:15-10-3, 535:15- 10-9(d) (2001); Colo. State Board of Pharmacy Rule 3.02.10 (2001).
The Federal Food, Drug, and Cosmetic Act of 1938 (FDCA), 21 U. S. C. §§ 301-397, regulates drug manufacturing, marketing, and distribution. Section 505(a) of the FDCA, 52 Stat. 1052, as amended, 76 Stat. 784, provides that "[n]o person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed [with the Food and Drug Administration] is effective with respect to such drug." 21 U. S. C. § 355(a). "[N]ew drug" is defined by § 201(p)(1) of the FDCA, 52 Stat. 1041, as amended, 76 Stat. 781, as "[a]ny drug . . . not
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