2013-054
April 30, 2013
I would like to set the record straight about the discussion between Health Canada and Marchese Health Care. Marchese came to us in November 2011 representing itself as a provincially accredited pharmacy with specific questions about proposed activities. Health Canada provided advice to Marchese about those activities as they relate to the Food and Drugs Act, based on the information they provided. We outlined the activities that would require them to submit an application to Health Canada. To date, no such application has been received. At no time did Health Canada refuse to regulate Marchese.
On April 19, 2013, Health Canada provided direction to organizations involved in the compounding and admixing of medications that will allow them to continue providing these services while Health Canada and the provinces and territories work together to determine the proper long-term oversight of these activities.
Under this direction, compounding and admixing activities can continue under one of the following three conditions:
- They are done within a hospital, meeting provincial regulatory requirements;
- They are done, outside a hospital, as a service under the supervision of a provincially licenced pharmacist; or
- They are done in a manner that meets the licencing and manufacturing requirements of the federal Food and Drugs Act.
Health Canada will continue to work with the provinces and territories to find a long-term solution that will provide certainty going forward on the regulatory oversight of these kinds of compounding and mixing activities.
Sincerely,
Diana Dowthwaite
Director General
Health Products and Food Branch Inspectorate
Health Canada
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