San Antonio Express-News
April 8, 2003

Prescription Medication Imports

copyright 2003, Paul Premack

Buying prescription drugs from Canada or Mexico causes a collision between what is legal and what is practical. Strictly speaking, personal importation of drugs is illegal under the United States Federal Food, Drug, and Cosmetic Act. That includes any drug, including a foreign-made version of a U.S. approved drug that has not been manufactured in accordance to Food and Drug Administration (FDA) approval.

Historically, FDA enforcement of the law has been very lax. In fact, FDA has used an informal standard since the 1950’s that allows individuals to import prescription drugs for personal use. The standard, set out in the FDA’s Regulation Procedure Manual, requires five conditions to be met. They are: 1) the intended use must be for a serious condition for which effective treatment may not be available domestically, 2) the product must not be considered to represent an unreasonable risk, 3) the patient must affirm in writing that it is for personal use and provide the name and address of the U.S.-licensed doctor responsible for treatment, or provide evidence that the drug is for continuation of a treatment begun in a foreign country, 4) the product is limited to a three-month supply or less, and cannot be resold, and 5) there must be no known commercialization or promotion to U.S. residents by those involved in distribution of the product.

The personal use standard is used only as operational guidance for FDA personnel. It does not give you any legally enforceable rights, and may be changed at any time.

According to Joe McCallion, a consumer safety officer in the FDA's Office of Regulatory Affairs, cost is not a factor that allows you to personally import a medicine. The FDA gives this example: a person decides that her heart medication is cheaper in Mexico, and attempts to import the drug from Mexico. FDA would not allow this, since it cannot assure that the medication has been properly manufactured and since that medication is available in the U.S.

FDA does not, however, check any personal bags when you cross the border and does not inspect personal shipments. U.S. Customs is supposed to watch for these things. If you bring a personal prescription across the border, or have it shipped to you, you may be violating federal law.

Online prescriptions have also been a legal challenge for Canada’s government. In May 2001, Canada took action against "The Canadian Drug Store Inc." which was allegedly filling prescriptions online without being licensed and without registered pharmacists.

FDA publications acknowledge that there is a significant cost difference between drugs available in the US and abroad. They assert, however, that many drugs sold across the border are of unknown quality with inadequate directions for use and may pose a risk to a patient's health. FDA recommends that you obtain your prescription drugs in the US.