Health Canada has suspended the establishment licence of Canadadrugs.com, meaning the Winnipeg-based online pharmacy can't sell prescription drugs to pharmacies until the department's concerns are fully addressed.
In announcing the suspension on Monday, Health Canada cited "significant concerns with good manufacturing practices" that were identified during a routine inspection of the company's drug wholesaling activities.
Health Canada says the licence was pulled for what Canadadrugs.com wholesales to pharmacies, other distributors or wholesalers, not for its direct-to-consumer online sales.
"The findings from Health Canada's most recent [good manufacturing practices] 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," an agency spokesperson stated in an email to CBC News on Monday afternoon.
"The lack of such controls for temperature-sensitive products may affect the product’s safety, efficacy and/or quality. As an example, Health Canada identified injectable drugs, which were frozen."
Canadadrugs.com has to demonstrate that "acceptable corrective and sustainable measures will be implemented and monitored" in according to Health Canada's requirements.
"To date, the company has not been able to demonstrate the adequate implementation of measures to address the concerns identified during inspection," the agency said.
Earlier this year, Health Canada issued recalls for drugs that Canadadrugs.com had shipped to British Columbia.
In both cases, the agency said the products in question may have been exposed to temperatures beyond recommended storage requirements.
Customers can still order from website
Individuals can still order medication from Canadadrugs.com's website because it has a valid licence from the College of Pharmacists of Manitoba to "sell drugs authorized in Canada to consumers via the internet," Health Canada said in a news release.
Officials with the College of Pharmacists of Manitoba told CBC News it licenses Canadadrugs.com's pharmacy arm and not the wholesale arm, which is regulated by Health Canada.
The college says it conducts on-site audits every three to five years and if requirements are not being met, the pharmacy manager would be notified.
If the matter is not corrected, the pharmacy would be disciplined and noted on the public record — something that has not happened with Canadadrugs.com, according to the college.
Officials would not release information on any issues or challenges that Canadadrugs.com has addressed in the past.
Health Canada says it has notified the college about its inspection findings and the suspension of Canadadrugs.com's establishment licence.
Don't be afraid of buying online, says group
A company must comply with good manufacturing practices under Food and Drug regulations to ensure medications sold in Canada are safe, effective and of high quality.
The Canadian International Pharmacy Association says customers should have no fear of buying from online pharmacies like Canadadrugs.com.
"There is nothing in this announcement that should cause anybody concern about the safety standards of CIPA members who are selling direct to consumers," said Tim Smith, the association's general manager.
The Manitoba Society of Pharmacists, which represents the interests of pharmacists in the province, says it's aware of Canadadrugs.com's licence suspension.
"Manitoba pharmacies have access to a number of pharmaceutical wholesalers and manage inventory, supply chain and drug shortages on regular basis. MSP will monitor the situation along with Manitoba Health and the College of Pharmacists of Manitoba," the society said in a statement.