This blog is written by Mr. Steven C. Schurr, Esq. and focuses on health care law matters that pertain to food and drug law, regulatory compliance, privacy rights, insurance coverage, state and federal disability coverage, patient advocacy issues, and mental health coverage and treatment.

Thursday, August 28, 2008

Importation of Medicines via the Internet

Is it legal to order prescription pharmaceuticals over the internet? If not, your shipment could be seized at the border by US Customs and you could receive an alarming letter.

In the United States, the FDA has given guidelines for review of the personal importation of pharmacuetical products. They will generally be allowed on a doctor's prescription being for personal use only and no more than a 3 months supply.

FDA personnel are responsible for monitoring mail importations. If a customs officer examines a parcel, he/she is to set is aside if it appears to contain a drug, biologic, or device that the FDA has specifically requested to be held.

Additional issues arise when the pharmaceutical in question is a controlled substance, such as Valium, and falls under the jurisdiction of the US Drug Enforcement Administration.

Can an individual legally order drugs using the internet without seeing a doctor? No.

Federal law requires that "A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice" (21 CFR 1306.04(a)). In other words, there must be a bona fide doctor/patient relationship.

Four elements indicate a legitimate doctor/patient relationship: 1.) patient has a medical complaint; 2.) medical history has been taken; 3.) physical examination has been performed; and 4.) some logical connection exists between the medical complaint, the medical history, the physical examination and the drug prescribed.

A patient completing a questionnaire that is then reviewed by a physician hired by or working on behalf of an internet pharmacy does not establish a doctor/patient relationship.

In addition, providing false material information to obtain controlled substances could be considered obtaining a controlled substance by fraud and deceit, which is subject to Federal and State penalties. Illegal importation of controlled substances is a felony that may result in imprisonment and fines (21 U.S.C. 960).

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