07/10/2026
For clarity sake, this informed letter about the compounding policy is exceptional if you are struggling to understand the complexity of it all. Please if you need one. Remember July 12 is the last day.
Response to Health Canada's Consultation: Updates to the NHP Compounding and Raw Materials Policies
Thank you for the opportunity to provide comments on Health Canada's proposed updates to the Natural Health Product (NHP) Compounding Policy and Raw Materials Policy.
I support Health Canada's commitment to protecting public health, improving regulatory clarity, and ensuring that broad commercial manufacturing is not inappropriately conducted under the guise of compounding.
At the same time, because these proposed policies have the potential to significantly influence professional practice, compliance expectations, and business operations across Canada's natural health products sector, I believe it is important that both the consultation process and the final policies reflect the principles of transparency, proportionality, and evidence-based decision-making.
These principles are consistent with the Government of Canada's broader approach to regulatory and policy development. The Cabinet Directive on Regulation emphasizes that government interventions should be evidence-based, proportionate to risk, transparent, and developed through meaningful engagement with affected stakeholders, while also recognizing the importance of selecting the appropriate instrument to achieve the desired policy objective.
This distinction is particularly relevant where guidance or policy documents may have significant practical effects despite not creating new legal obligations.
1. Consultation Process and Policy Development
Proposed Policies Should Clearly Reflect Their Status as Proposals
Health Canada's consultation webpage clearly states that stakeholder feedback is being sought on proposed updates to the NHP Compounding Policy and Raw Materials Policy. However, the accompanying policy documents are drafted in the style of finalized guidance rather than proposed policy.
Much of the language is definitive, describing what Health Canada considers to constitute compounding, manufacturing, or the regulatory status of raw materials, with relatively little indication that these interpretations remain open to revision through consultation.
As a result, the documents give the impression that the substantive policy positions have already been established and that consultation is focused primarily on implementation rather than on the proposed interpretations themselves.
Meaningful consultation is strengthened when stakeholders can easily distinguish between existing policy, proposed policy, and areas where Health Canada is actively seeking input.
Clearly identifying proposed interpretations, highlighting substantive changes from previous guidance, and indicating where stakeholder feedback may influence the final policy would better reflect the stated purpose of the consultation and encourage more meaningful participation.
This approach would also align with the Government of Canada's principles for policy development, which emphasize early engagement, transparency, and consideration of stakeholder input throughout the development of initiatives.
Policies Are Not Regulations
These documents are policies, not regulations.
Policies play an important role in explaining how Health Canada intends to interpret and administer existing legislation, but they do not themselves create new legal obligations.
Nevertheless, policy documents can have significant practical effects because they frequently influence compliance decisions, inspection practices, enforcement expectations, and operational decisions.
For many practitioners, suppliers, manufacturers, and small businesses, published policy documents become the practical benchmark against which activities are assessed.
When policy documents are drafted using language that appears definitive and authoritative, they can influence behaviour in much the same way as regulation, despite not having the force of law. This places an important responsibility on Health Canada to ensure that proposed policy interpretations are clearly identified as proposals, supported by transparent evidence and rationale, and remain genuinely open to revision through consultation.
The Need for Clear Policy Rationale
The consultation would also be strengthened by providing a clearer explanation of the rationale underlying significant policy changes.
While the proposed policies identify activities that Health Canada considers to constitute manufacturing rather than compounding, and similarly propose revised interpretations regarding raw materials, they basically emphasize the conclusion more than the analytical framework supporting it.
For significant policy changes, it would assist stakeholders if Health Canada explained:
• the specific regulatory or public health concern being addressed
• the evidence demonstrating that the concern exists
• why the proposed interpretation is considered the most appropriate and proportionate response
• why alternative approaches were not adopted
Providing this context would enable stakeholders to offer more informed feedback, improve transparency, and reinforce confidence that the final policies are grounded in evidence, proportionality, and sound regulatory governance.
2. Principles of Proportionate and Risk-Based Regulation
The distinction between commercial manufacturing and individualized compounding should remain grounded in regulatory risk.
Commercial production intended for broad distribution presents different risks from patient-specific preparations produced following an individualized professional assessment. These activities warrant different approaches.
A proportionate framework allows Health Canada to focus oversight where public health risks are greatest while preserving access to individualized care provided by practitioners acting within their scope of practice.
This approach is consistent with the regulatory principles applied in other comparable regulatory systems. Comparable jurisdictions recognize that commercial manufacturing and patient-specific preparation serve different purposes and may appropriately be subject to different oversight mechanisms.
For example, the United States and Australia distinguish between commercial manufacturing of natural health products or complementary medicines and individualized preparations made for identified patients. While the specific legislative frameworks differ, both systems recognize that patient-specific preparations should not be treated as manufactured commercial products solely because they involve established formulations or similar preparation methods.
Similarly, European jurisdictions generally maintain a distinction between commercially authorized herbal medicinal products and extemporaneous preparations made for individual patients under professional practice frameworks.
These examples demonstrate that maintaining a clear distinction between commercial production and legitimate individualized care is compatible with strong public health oversight. The objective should not be to minimize oversight, but rather to ensure that regulatory requirements are appropriately matched to the nature and risk profile of the activity being regulated.
3. Proposed Compounding Policy
Recognize the Nature of Individualized Practice
The proposed policy appropriately recognizes that patient-specific compounding is distinct from commercial manufacturing. However, additional clarification would help ensure that individualized clinical practice is not inadvertently captured within definitions intended to address commercial production.
Many practitioners (such as naturopathic practitioners, Traditional Chinese Medicine practitioners, clinical herbalists, pharmacists, and others who prepare individualized natural health products) develop formulations based on an individualized assessment of each patient's unique clinical presentation.
Individualized care frequently involves adapting established formulations to meet a patient's specific needs. Modifications may include changes to ingredient selection, ingredient ratios, dosage, or the removal or substitution of ingredients because of allergies, contraindications, sensitivities, interactions, patient preferences, or evolving clinical circumstances.
The repeated application of recognized clinical formulation principles should not, by itself, be interpreted as evidence of manufacturing.
A practitioner may appropriately prescribe variations of a common therapeutic approach while still preparing genuinely individualized formulations for specifically identified patients. Clarifying this principle is important to reduce uncertainty while supporting consistent interpretation.
Avoid Overly Rigid Distinctions That Do Not Reflect Clinical Practice
Individualized healthcare does not always fit neatly into binary categories.
Many systems of healthcare (such as naturopathic medicine, Traditional Chinese Medicine, Western herbal medicine, Ayurveda, and integrative healthcare) are based on adapting recognized therapeutic principles to the individual patient rather than creating an entirely novel formulation for every case.
Policies intended to distinguish compounding from manufacturing should therefore avoid overly rigid criteria that may not accurately reflect individualized clinical practice.
The fact that practitioners may draw upon established formulation principles, traditional formula families, or evidence-informed therapeutic approaches should not, in itself, be interpreted as evidence of commercial manufacturing.
Maintaining flexibility within a risk-based framework would better support patient-centred care.
4. Proposed Raw Materials Policy
The proposed Raw Materials Policy raises separate but equally important considerations.
Raw materials used in the preparation of individualized natural health products (such as botanical ingredients, extracts, homeopathic substances, and other natural health product ingredients) are essential inputs used by practitioners and compounders to prepare patient-specific formulations.
Regulatory approaches affecting access to these materials should therefore be carefully calibrated to the actual risks being addressed.
Any additional controls should be proportionate, evidence-based, and demonstrably necessary to improve public health outcomes.
Restrictions on access to legitimate raw materials should be supported by a clear explanation of the specific risks they are intended to mitigate and evidence that the proposed approach is likely to achieve those objectives.
Consideration should also be given to the cumulative administrative burden that policy changes may impose on practitioners, pharmacies, specialized suppliers, manufacturers of raw materials, and small Canadian businesses, particularly where existing professional standards, quality assurance systems, and supply-chain controls already provide significant safeguards.
The Government of Canada's regulatory approach recognizes the importance of considering regulatory impacts, including administrative burden and the effects on small businesses, when developing regulatory initiatives. The final policy should therefore ensure that any additional requirements are necessary, proportionate, and supported by demonstrated public health benefits.
Health Canada has an opportunity to ensure that the final policy supports both patient safety and continued access to individualized care without creating unnecessary barriers to professional practice, innovation, or the availability of quality raw materials required for legitimate patient-specific compounding.
5. International Regulatory Alignment
Canada's framework should continue to reflect international best practices while remaining appropriate to the Canadian context.
Comparable jurisdictions recognize that commercial manufacturing and patient-specific preparation serve different purposes and warrant different approaches.
The United States and Australia both distinguish between commercial manufacturing of natural health products or complementary medicines and individualized preparations made for identified patients. While the specific legislative frameworks differ, both systems recognize that patient-specific preparations should not be treated as manufactured commercial products solely because they involve established formulations or similar preparation methods.
European jurisdictions similarly distinguish between commercially authorized herbal medicinal products and extemporaneous preparations prepared for individual patients within professional practice frameworks. Although the details vary between jurisdictions, the underlying principle is consistent: products intended for broad commercial distribution and preparations created to meet the needs of identified patient represent different activities with different regulatory considerations.
These examples demonstrate that maintaining a clear distinction between commercial production and individualized care is compatible with strong public health oversight.
Canada's approach should continue to support regulatory objectives while avoiding unnecessary divergence from comparable jurisdictions where such divergence does not provide a clear public health benefit. Maintaining broadly compatible principles supports responsible sourcing of ingredients, innovation, practitioner mobility, and regulatory cooperation, while reducing unnecessary barriers for Canadian practitioners, suppliers, and businesses.
Where Canada's approach differs from comparable jurisdictions, it would be helpful for Health Canada to explain the evidence supporting that divergence, the specific risk being addressed, and the anticipated public health benefits resulting from the different approach.
6. Recommendations
I recommend that Health Canada:
• clearly present the consultation documents as proposed policies under consultation rather than finalized guidance
• distinguish more explicitly between legislative and regulatory requirements and policy interpretations
• identify significant changes from previous guidance and explain the rationale supporting those changes
• provide greater transparency regarding the evidence and policy rationale supporting proposed interpretations
• maintain a clear, risk-based distinction between patient-specific compounding and commercial manufacturing
• clarify that individualized modification of recognized formulations for identified patients remains acceptable compounding
• avoid interpretive approaches that unintentionally capture established individualized healthcare practices
• ensure that policies governing raw materials remain proportionate and evidence-based
• consider the cumulative impacts of additional administrative requirements on practitioners, specialized suppliers, and small Canadian businesses, and
• continue to pursue approaches that support public health while remaining broadly aligned with comparable international jurisdictions where appropriate.
Conclusion
I appreciate Health Canada's commitment to improving regulatory/policy clarity and protecting public health.
This consultation presents an important opportunity, and I want to emphasize the importance of preserving access to (and not over-burdening/over-regulating) individualized care provided by practitioners acting within their scope of practice.
By ensuring that the final policies are transparent, evidence-based, proportionate, and informed by meaningful stakeholder consultation, Health Canada can achieve its public health objectives while supporting innovation, professional practice, and patient access within Canada's natural health products sector.
Thank you for considering these comments.
