Health Canada yanks Canadadrugs.com's licence over manufacturing concerns

TORONTO - Health Canada has suspended the licence of pharmaceutical wholesaler Canadadrugs.com LP over what it calls "significant concerns" about its manufacturing practices, following a recent inspection of the company's operations.

Suspension of its establishment licence means the Winnipeg company cannot wholesale drugs to retail pharmacies, other distributors or wholesalers until these concerns are fully addressed, Health Canada said in an advisory Monday.

Canadadrugs.com also sells prescription medications to consumers online, a part of the company's business that is not affected by having its federal licence revoked.

Health Canada said companies must comply with good manufacturing practices, or GMP, under Food and Drug regulations to ensure medications sold in Canada are safe, effective and of high quality.

"The findings from Health Canada's most recent GMP inspection are serious and indicate that the company is not able to demonstrate or provide evidence that the necessary controls are in place to ensure proper conditions are maintained during the transport and storage of temperature-sensitive drug products," department spokesman Gary Holub said by email.

Such poor controls for temperature-sensitive products could affect products' safety, efficacy and quality, said Holub, noting that the inspection turned up injectable drugs that were frozen.

"The company is required to demonstrate to Health Canada that acceptable corrective and sustainable measures will be implemented and monitored in accordance with GMP requirements," he said. "To date, the company has not been able to demonstrate the adequate implementation of measures to address the concerns identified during inspection."

Canadadrugs.com did not respond Monday to several requests by The Canadian Press for comment about its federal licence being pulled.

The 13-year-old company is also separately licensed as a pharmacy by the College of Pharmacists of Manitoba, which allows it to sell medications authorized in Canada to consumers via the Internet.

As that licence remains valid, Canadians are still able to purchase medications through the company's website, said Health Canada, which has notified the college about its inspection findings and the suspension of Canadadrugs.com's federal establishment licence.

"They're still licensed with us," college registrar Ronald Guse said from Winnipeg. "We want to get more details on the Health Canada action and then we will decide what the status of the licence is. But it's too early at this time to say one way or the other."

The college, which grants licences to community-practice, hospital and clinical pharmacies, has a mandate that would allow it to investigate Canadadrugs.com's operations, said Guse.

"And as it becomes clear what the concerns of Health Canada are that led to the suspension, then we would look at whether we send somebody to review their practices as well," he said.

In March, the company recalled units of a birth-control patch and a liquid injectable drug after they were exposed to temperatures "outside of the recommended storage requirements."

Canadadrugs.com also sells prescription drugs outside Canada through its website. It is among a number of Canadian online pharmacies tapping into the lucrative U.S. market. Because drug prices are controlled by Canada's public health system, online pharmacies often are able to offer many top-selling medications far below U.S. prices.