Many U.S. companies offer consumers access to Canadian pharmacies to escape high prescription drug prices. Most of these companies operate the same way as Rx Depot. The company will take prescriptions from consumers and fax the prescriptions to Canadian pharmacies. The prescriptions are then filled and mailed directly to consumers.

The Food and Drug Administration, according to documents filed in the Oklahoma court, took issue with the possibility of unapproved drugs being imported and distributed, the possibility of drugs being improperly stored or tampered with while in Canada and the re-importation of drugs manufactured in the United States by someone other than the manufacturer.

“We’ve always wanted the FDA to provide some clear direction for how pharmacies should conduct business in the future,” said Michael Polzin, spokesman for Walgreen Co. “We’re glad to see they’ve indicated they are going to back laws that are already on the books and take action against those who violate those laws.”

Polzin said the FDA had clearly stated the operation of storefronts offering this sort of access does not fall under the “personal use clause.”

One aspect of the legality of the issue deals with the difference between a storefront operation providing access to drugs and a consumer’s direct relation with a Canadian mail-order pharmacy, according to David MacKay, executive director of the Canadian International Pharmacy Association,

MacKay said the FDA has said it will not go after individuals obtaining drugs for their own personal use. He said storefront operations are questionable under U.S. law. However, MacKay disputed almost every claim of the FDA in the Oklahoma case.

He said drugs are typically shipped from wholesalers to the Canadian pharmacies, and shipped directly to consumers in the United States in “the original unit of use with a tamper evidence seal.”

He said Canadian pharmacists do not open bottles of drugs to count them. The FDA, according to court documents, said this could lead to consumers getting more drugs than their prescription called for.

MacKay said the extra drugs are a result of packaging that Canadian pharmacists do not disrupt. Pharmacists usually round up, if necessary, when prescribing drugs to U.S. citizens because they do not open the packages, so consumers end up with more drugs than originally prescribed, he said.

Another concern is the possibility of counterfeit drugs being sent to consumers through the mail order system, the FDA stated in court documents.

“We don’t have a counterfeit (drug) problem in Canada,” Mackay said. “We never have.”

At least two companies like this operate in Wisconsin — Canada Drug Service in Wauwatosa and Rx Depot Canada of Mequon LLC.

“If the feds look in our direction, we’ll have to deal with it then,” said Joseph Zaks, a member of Rx Depot Canada of Mequon. He said Rx Depot Canada has two operating organizations, one in New York with four storefront locations and one in Mequon that operates as an office, which receives calls from consumers interested in imported drugs.

Zaks said his organization also asks consumers for medical records to fax to Canadian pharmacists, which his office does not keep on record.

“All we do is make a connection between” the doctor in the United States and the pharmacist in Canada, he said. “We allow them to cross the border through our office. We don’t get involved in the filling of (prescriptions). We just facilitate it.”