Chicago Accident Law Blog

Physicians who prescribe drugs over the internet without seeing the patient and the pharmacies that fill and ship the drugs have sought to evade criminal and civil liability by prescribing non controlled substances. The DEA enforces the Federal Controlled Substances Act (21 U.S.C. 80 et seq.) which explicitly prohibits the sale of controlled substances prescribed by physicians who have never seen the patient.

Non controlled prescription drugs are governed by the Food, Drug and Cosmetics Act (21 U.S.C. 301 et seq.) which does not explicitly address online prescriptions and consultations. Criminal and civil prosecutions are now being pursued against these online pharmacies and physicians who sell, ship, and prescribe non controlled prescription drugs to patients based solely on an online questionnaire and "without some sort of examination." U.S. v. Smith, 573 F. 3d 639, 651 (8th Cir. 2009).

The legal theory behind these prosecutions is that online consultations with a physician is not the basis for a legitimate prescription, and therefore constitutes the crime of misbranding under the Food, Drug and Cosmetics Act (21 U.S.C. 353(b)(1), which is prohibited under 21 U.S.C. 331(a) and (k). The introduction or delivery into interstate commerce of a drug that is misbranded is punishable under 21 U.S.C. 333(a)(1), and as a felony under 21 U.S.C. 331(a)(2) if it is done with intent to defraud or mislead. The web pages of most online pharmacies that ship prescriptions without some sort of examination do both. Frequently neither the physician nor the pharmacy are licensed to prescibe or fill prescriptions in the state into which they are shipped.
U.S. v. Smith, the Eighth Circuit stated: "A drug is misbranded unless dispensed up
In on a prescription of a practitioner licensed by law to administer such drug. 21 U.S.C. 353(b)(1)." Smith at 573 F. 3d 639, 650 (2009). The Smith court described a "prescription drug as misbranded if it dispensed other than through a valid prescription." 573 F. 3d at 651. The Court defined "valid prescription" as "...a bona fide order-i.e. directions for the preparation and administration of a...drug for a real patient who actually needs it after some sort of examination..." 573 F. 3d at 651.