The state Department of Health has approved regulations allowing Canadian pharmacies to get licensed to sell to Rhode Island residents, despite a federal ban on drug importation and strong opposition from the Food and Drug Administration.
The regulations, filed Thursday at the secretary of state’s office, will become effective in 20 days, making Rhode Island the first state to allow the licensure of Canadian pharmacies.
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Other states have taken different approaches: Illinois set up a Web site, I-SaveRx, that allows consumers to buy specific drugs from 45 locally licensed pharmacies and wholesalers in Canada, Ireland and the United Kingdom that belong to a network called CanaRx.
Wisconsin, Missouri and Kansas have since joined I-SaveRx as well. In addition, Wisconsin has a Web site that connects consumers with three Canadian pharmacies that have been inspected by state officials, but are only licensed by their local authorities.
Rhode Island Secretary of State Matthew Brown has been urging Governor Donald L. Carcieri to join I-SaveRx, too, with no success. But despite local health officials’ reluctance to jump on the Canadian pharmacy bandwagon, the General Assembly passed a law requiring them to provide for the licensure of Canadian pharmacies by Jan. 15.
After considering various options, the Department of Health decided to treat Canadian pharmacies the same as out-of-state pharmacies, and just added “or province of Canada” to the one-page section on “nonresident pharmacies.”
In an introduction to the proposed revision handed out at a final public hearing on Thursday, health officials explained that “in response to safety concerns raised by interested parties,” they had “considered more extensive and detailed requirements” for Canadian pharmacies, but ultimately chosen to treat them the same as out-of-staters.
“The statute and regulations that govern the licensure of out-of-state pharmacies have been tested and found sufficient to protect Rhode Islanders from substandard pharmacy practice,” they wrote. “We believe the same provisions will be sufficient for addressing safety concerns if the licensee is in Canada.”
But at the final hearing, pharmacy industry and retail representatives noted that the regulations said nothing about drugs having to be FDA-approved, or about sellers certifying the country where the drugs were manufactured, or even about the language in which usage directions should be printed – all issues that don’t arise with, say, a pharmacy in Maine.
In an interview, Assistant Health Director Robert J. Marshall said the regulations were a first step, to comply with the law, but “this is not the end of the process. We intend to work with all the parties about the safety issues.”
Marshall also noted that neither Rhode Island’s law nor the new regulations change the fact that there’s a ban on drug importation.
“Somewhere along the line, the federal law issue needs to be resolved one way or the other,” he said. Rhode Island is “out in front on this initiative,” he added, “so I think it would pose a new situation for the federal government. We’ll have to see what they do as a result.”
