Forward Regulatory Plan 2022-2024: Amendments to the Food and Drug Regulations – Outsourced Drug Preparation (formerly Commercial Compounding)
Title of Regulatory Initiative
Amendments to the Food and Drug Regulations – Outsourced Drug Preparation (formerly Commercial Compounding)
Enabling Act
Description
Health Canada is proposing to develop a new regulatory framework to address outsourced drug preparation (commercial compounding) to fill a gap in regulatory oversight. Outsourced drug preparation 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)
This initiative is not part of a formal regulatory cooperation work plan.
Potential impacts on Canadians, including businesses
It is anticipated that the proposed regulatory framework would take into consideration existing provincial/territorial regulatory regimes and other foreign regulators' approaches governing commercial compounding activities.
The introduction of risk-based requirements would increase regulatory certainty and oversight on commercially compounded products for Canadians.
Consultations
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, pre-publication.
Canadians will have the opportunity to provide comments on the regulatory proposal during the Canada Gazette, Part I, public comment period, which is expected to take place fall 2023 and last 75 days.
Further information
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
Catherine Hudon
Director
Policy and Regulatory Strategies Directorate
Regulatory Operations and Enforcement Branch
Health Canada
Telephone: 343-540-8524
Email: prsd-questionsdspr@hc-sc.gc.ca
Date the regulatory initiative was first included in the Forward Regulatory Plan
October 2014
Consult Health Canada's acts and regulations web page for:
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Consult the following for links to the Cabinet Directive on Regulation and supporting policies and guidance, and for information on government-wide regulatory initiatives implemented by departments and agencies across the Government of Canada:
To learn about upcoming or ongoing consultations on proposed federal regulations, visit:
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