Forward Regulatory Plan 2019-2021: 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

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 new framework is being built upon existing regulatory frameworks within the Food and Drug Regulations.

Regulatory cooperation efforts (domestic and international)

The proposed regulatory framework would take into considerations existing Provincial/Territorial regulatory regimes and other foreign regulators' approaches governing commercial compounding activities.

Potential impacts on Canadians, including businesses

The introduction of risk-based requirements would increase regulatory certainty and oversight on compounded products for Canadians.

Consultations

A targeted group of stakeholders have provided feedback on the proposed development of a federal framework for commercial compounding.

Canadians will have the opportunity to provide further input during consultations on a proposal for a federal framework expected to take place before pre-publication in Canada Gazette, Part l in spring 2021 and last at least 30 days.

Further information

Additional information can be requested from the Departmental contact.

Departmental contact information

Kim Dayman-Rutkus
Director
Policy and Regulatory Strategies Directorate
Regulatory Operations and Enforcement Branch
Health Canada
Telephone: 613-954-6785
Email: kim.dayman-rutkus@canada.ca

Date the regulatory initiative was first included in the Forward Regulatory Plan

October 1, 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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