Natural Health Product Compounding Policy: Overview
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Disclaimer
This document does not constitute part of the Food and Drugs Act (the Act) or the Natural Health Products Regulations (the Regulations) and in the event of any inconsistency or conflict between the Act or Regulations and this document, the Act or the Regulations take precedence. This document is an administrative document that is intended to facilitate compliance by the regulated party with the Act, the Regulations and the applicable administrative policies. This document is not intended to provide legal advice regarding the interpretation of the Act or Regulations. If a regulated party has questions about their legal obligations or responsibilities under the Act or Regulations, they should seek the advice of legal counsel.
Introduction
The Regulations outline the requirements to obtain a natural health product (NHP) licence and the activities that require a site licence. A product licence is required before an NHP can be sold in Canada and a site licence is required to manufacture, package, label and/or import an NHP for sale in Canada.
Compounding is a recognized activity that can be part of a health care practitioner's practice and as such, would not fall under federal jurisdiction.
The Natural and Non-prescription Health Products Directorate (NNHPD) of Health Canada recognizes the need to clearly differentiate between the activities of compounding and manufacturing of NHPs, including whether or not a site licence is required for a particular activity associated with the product and whether a product licence is required for the product.
Purpose
The purpose of this document is to:
- Provide assistance in distinguishing between the activities of compounding and manufacturing of NHPs in Canada and whether product and site licence requirements apply.
- Acknowledge that, in addition to the federal legislation and regulations that are in place to ensure safety, efficacy and quality of products for sale in Canada, there are provincial/territorial legislation and regulations that could be applicable to the practice of compounding. This document aims to delineate federal responsibilities related to licensing of NHPs in Canada versus the provincial or territorial responsibility of delivering health care.
Scope
The NHP Compounding Policy differentiates between two activities:
- manufacturing of NHPs, which is subject to the Regulations
- compounding of NHPs, which falls outside the scope of the Regulations
This policy applies to:
- substances listed under Schedule 1 of the Regulations (Included Natural Health Products Substances)
This policy does not apply to:
- substances listed under Schedule 2 of the Regulations (Excluded Natural Health Product Substances)
- substances that are compounded for use in clinical trials
Background
The Regulations set out the requirements for the manufacturing, packaging, labelling, importation, distribution, storage and sale of NHPs in Canada. The practice of complementary, alternative or traditional medicine is not within the scope of the Regulations and is not regulated by Health Canada.
In 2006, NNHPD released the first iteration of the NHP Compounding Policy following consultations with a broad range of practitioners, including pharmacists, Traditional Chinese Medicine practitioners, herbalists and naturopathic doctors.
As the policy was implemented, challenges were identified with uncertainty surrounding regulatory requirements for licensable activities versus compounding.
To address this, NNHPD undertook further consultations with input gathered from practitioners, licensing bodies and professional associations at both provincial and federal levels. The updated policy offers clearer guidance to support compliance and addresses longstanding questions in the field. This revised version replaces the 2006 policy.