Forward Regulatory Plan 2021-2023: Amendments to the Food and Drug Regulations - Commercial Compounding
Title of Regulatory Initiative
Amendments to the Food and Drug Regulations - Commercial Compounding
Food and Drugs Act
A new regulatory framework to address commercial compounding is being developed with the aim to fill a current gap in regulatory oversight. Commercial compounding is a set of activities that combines elements of two well-defined activities that are regulated by different levels of government in Canada: drug manufacturing and traditional drug compounding performed by pharmacies and hospitals for individual patients.
This proposed new framework is being built upon existing regulatory frameworks within the Food and Drug Regulations.
Regulatory cooperation efforts (domestic and international)
The introduction of risk-based requirements would increase regulatory certainty and oversight on commercially compounded products for Canadians.
Potential impacts on Canadians, including businesses
The proposed regulatory framework would take into consideration existing provincial/territorial regulatory regimes and other foreign regulators' approaches governing commercial compounding activities.
Targeted groups of stakeholders have provided feedback on the proposed development of a federal framework for commercial compounding.
Health Canada intends to undertake a stakeholder consultation process on this proposal prior to Canada Gazette, Part I, publication.
Canadians will have further opportunity to provide comments on the regulatory proposal during the Canada Gazette, Part I, public comment period, which is expected to take place fall 2022.
Related information on the current Policy on Manufacturing and Compounding Drug Products in Canada (POL-0051) can be found on Health Canada’s website.
Additional information can be requested from the departmental contact.
Departmental contact information
Policy and Regulatory Strategies Directorate
Regulatory Operations and Enforcement Branch
Date the regulatory initiative was first included in the Forward Regulatory Plan
October 1, 2014
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