Forward Regulatory Plan 2022-2024: Amendments to the Food and Drug Regulations - Commercial Compounding

Title of Regulatory Initiative

Amendments to the Food and Drug Regulations – Commercial Compounding

Enabling Act

Food and Drugs Act

Description

Health Canada is proposing to develop a new regulatory framework to address commercial compounding to fill a 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)

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, 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.

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:

  • a list of acts and regulations administered by Health Canada
  • further information on Health Canada's implementation of government-wide regulatory management initiatives

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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