Understanding Health Canada's Proposed Raw Materials and Compounding Policies: What They Mean for TCM Herbal Practitioners

The regulation of Natural Health Products (NHPs) in Canada continues to evolve, and over the past several years ATCMA has been actively involved in discussions with Health Canada's Natural and Non-prescription Health Products Directorate (NNHPD) regarding upcoming policy changes.

ATCMA's priority is ensuring that new federal policies recognize the unique way Chinese herbal medicine is practised while protecting continued access to safe, high-quality herbal products for both practitioners and patients.

ATCMA Has Been at the Table

ATCMA has been regularly consulted by Health Canada's NNHPD throughout the development of these policies. We have also sought feedback from Canadian importers and distributors of Chinese herbal products to better understand how the proposed changes may affect the profession.

We are currently providing feedback on two key policy areas:

• Compounding
• Raw Materials

Our goal is to ensure these policies are practical for TCM practitioners while recognizing the realities of the Canadian Chinese herbal medicine supply chain.

How This Applies to TCM

Traditional Chinese Medicine practitioners routinely customize herbal prescriptions based on each patient's individual presentation. This individualized approach closely aligns with Health Canada's proposed definition of compounding.

The proposed policy recognizes that compounding:

• is part of professional practice;
• occurs within a practitioner-patient relationship;
• produces customized formulations for individual patients; and
• should not be treated as commercial manufacturing when these conditions are met.

From ATCMA's perspective, this is an important recognition of how Chinese herbal medicine is practised.

Understanding the Proposed Raw Materials and Compounding Policies

Recently, some herbal associations outside the TCM profession have expressed concerns that the proposed policies could significantly restrict practitioners' access to herbs.

While we recognize that different herbal professions may have different practice models, our interpretation of the proposed Raw Materials and Compounding Policies has not led us to the same conclusion for Traditional Chinese Medicine.

The proposed policies distinguish between raw materials, practitioner compounding, and commercial manufacturing. In general, they state that:

• Raw materials imported for further manufacturing or compounding do not require a site licence or product licence simply for importation.
• Herbs or Natural Health Products imported by a health care practitioner solely for compounding within a practitioner-patient relationship do not require a site licence or product licence.
• Compounded products prepared within a practitioner-patient relationship do not require a Natural Product Number (NPN).
• Practitioners may compound commonly used formulations in advance based on historical prescribing patterns, provided they are dispensed only after an individual patient assessment.
• Compounded products cannot be advertised or sold to the general public.

The policies distinguish practitioner compounding from commercial manufacturing. Manufacturing generally refers to producing products for commercial distribution, selling products outside of a practitioner-patient relationship, advertising compounded products to the public, or producing products on a scale that is inconsistent with individualized patient care.

ATCMA's focus is to ensure the final policies:

• preserve practitioner access to high-quality Chinese herbal medicines;
• recognize practitioner compounding as distinct from commercial manufacturing;
• avoid unnecessary regulatory burdens that could reduce product availability; and
• create an appropriate regulatory pathway for concentrated practitioner-use herbal granules.

What ATCMA Is Asking For

A Third Category for Practitioner-Use Herbal Granules

One of ATCMA's key recommendations is the creation of a third regulatory category specifically for concentrated Chinese herbal granules and powders intended exclusively for practitioner compounding.

Currently, concentrated herbal granules are treated the same as consumer Natural Health Products, meaning each product requires its own NPN. We are recommending that professional-use granules used only for practitioner compounding be regulated differently.

Under this approach, practitioner-use granules would not require individual NPNs, annual product licensing fees, or consumer retail labelling. Importers would still be required to hold site licences and comply with Good Manufacturing Practices (GMP) and all applicable safety requirements.

We believe this approach would protect public safety while preserving access to the herbal medicines TCM practitioners rely on every day.

Review the Proposed Policies and Share Your Feedback

Although ATCMA is providing feedback on behalf of the profession, practitioners and businesses may also participate directly.

Health Canada is seeking feedback on these proposed policies. We encourage practitioners, importers, distributors, and others involved in Chinese herbal medicine to review the proposals and consider how they may affect your practice or business.

The proposed policies can be found here:

• Raw Materials Policy: Health Canada – Raw Materials Policy
• Compounding Policy: Health Canada – Compounding Policy

To provide your feedback, go to: https://www.canada.ca/en/health-canada/services/drugs-health-products/public-involvement-consultations/natural-health-products/compounding-raw-materials-policy.html?mc_cid=0b5f5628aa&mc_eid=92eb27d960

ATCMA Will Continue to Advocate

Health Canada's policies are still evolving, and ATCMA will continue participating in discussions with the NNHPD on behalf of the profession.

We remain committed to advocating for practical, evidence-informed regulation that protects public safety while preserving the practice of Traditional Chinese Medicine and ensuring practitioners continue to have access to the herbal medicines their patients need.

As more information becomes available, we will continue to keep our members informed and represent the interests of TCM practitioners throughout the policy development process.