Health Canada Publishes Summary Report on Canadian Pharmacy Compliance Inspections

Canada's Health Products and Food Branch Inspectorate (Inspectorate) has recently published a Summary Report on the on-site compliance inspections it conducted earlier this year of Canadian pharmacies selling prescription drugs via the Internet or via other forms of distance dispensing, such as mail order. The Inspectorate assessed 11 selected pharmacies for compliance with the Food and Drugs Act (Act) and Food and Drugs Regulations (Regulations), which establish the regulatory regime relating to the sale of prescription drugs in Canada. Overall, the Inspectorate found that the pharmacies' activities were in compliance with the Act and Regulations, and that the products being sold were approved for sale in Canada. Several areas of non-compliance, however, were observed, including that:

• temperature-sensitive drug products were being packaged and shipped in a way that could risk exposure of the products to temperatures potentially affecting their safety and effectiveness;
• prescription drugs were being supplied wholesale without the proper license; and
• prescriptions were signed with rubber stamps or electronic signatures, which are not valid written prescriptions as required by the Regulations.

The Inspectorate notified the non-compliant pharmacies of their obligations under the Act and Regulations and asked them to cease such activities. The pharmacies have now confirmed that they have taken the appropriate measures to come into compliance. In addition to addressing the inspected pharmacies, the Inspectorate issued a general notice to all pharmacies in Canada, whether or not they operate via the Internet or distance dispensing, outlining their obligations under the Act and Regulations. A similar round of inspections verifying compliance is expected to take place early in 2005. For the Summary Report, see: http://makeashorterlink.com/?O2. For the general notice sent to Canadian pharmacies, see: http://makeashorterlink.com/?G1CF5131A. For FAQs on the compliance inspection, visit: http://makeashorterlink.com/?X5DF2131A. Summary by: Rosa Kim