Interim Regulatory Oversight of Admixing and Compounding
About Health Canada
Statement April 19, 2013
Health Canada today 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.
Canadians can be reassured that organizations following these directions will have the active oversight in place to help ensure the safety and effectiveness of health products prepared in this way.
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.
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