Forward Regulatory Plan 2023-2025: 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

Food and Drugs Act


Health Canada is proposing to develop a federal framework to regulate outsourced drug preparation in Canada. Outsourced drug preparation refers to the non-patient specific preparation of drugs for sale to a health care professional or health care institution. The goal of this proposed regulatory framework is to support regulatory oversight for drug products prepared by outsourced drug preparation facilities. The proposed framework is designed to protect people in Canada from drug products made using unsafe, poor-quality practices.

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.

The proposed regulatory framework would take into consideration existing provincial/territorial regulatory regimes and other foreign regulators' approaches governing outsourced drug preparation activities.

Potential impacts on people in Canada, including businesses

The introduction of risk-based requirements and prohibitions would increase regulatory certainty and oversight on products for people in Canada.


Provincial and territorial pharmacy regulatory authorities were consulted in 2019, 2021 and 2023. Health Canada engaged with provincial and territorial representatives in spring 2023. 

Additional consultations with certain stakeholders may occur prior to Canada Gazette, Part I, pre-publication, as needed.

People in Canada 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 in spring 2024 and last 75 days.

Further information

Related information can be found in the current Policy on Manufacturing and Compounding Drug Products in Canada (POL-0051).

Additional information can be requested from the departmental contact.

Departmental contact information

Stephanie Mangan
Policy and Regulatory Strategies Directorate
Regulatory Operations and Enforcement Branch
Health Canada

Telephone: 343-550-4584

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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