The Art of the Botanical Dispensary: Maintaining Autonomy with the Compounding Policy

Submitted by Colleen Emery, Cl.H, RHT (BCHA)

Creating customized Herbal Medicine for Client Centred Care is paramount to providing access to health care that makes meaningful changes to a person’s wellness. Working 1:1 with clients and preparing medicine specifically for their needs allows the Herbalist to ensure that the person is receiving the most appropriate herbs necessary to their wellness goals.

When a Herbalist working in practice with clients has access to herbal medicine that allows them to create specific, customized formulations for their clients, the outcomes are the most efficient and effective to wellness plans. Simply put, Herbal Medicine works best when we treat people with health conditions as opposed to the health condition itself. The action of preparing customized herbal medicine is the tradition of herbal medicine. Static, shelf ready products, often lack the flexibility that is needed to meet specific client needs in a capacity the yields the most notable outcomes for health.

In Canada, the Natural Health Product Compounding Policy offers the Herbalist in practice the distinction to create customized herbal medicine within the client practitioner relationship. Herbalists are permitted to create medicines for their clients and dispense directly to them within this relationship. Canada is one of the few countries in the world to have this policy in place, making it an incredible opportunity for the Herbalist in practice to maintain autonomy while staying true to the tradition of Herbal Medicine Compounding.

THE BACKGROUND & DETAILS OF THE COMPOUNDING POLICY

On January 1, 2004, the Natural Health Products Regulations came into force in Canada. The NHP Regulations contain requirements for the manufacture, packaging, labelling, storage, importation, distribution and sale of NHPs. Visit this link to view how the Canadian Council of Herbal Associations (CCHA) was formed in relation to this regulation: https://docs.google.com/document/d/1SzMcU2O3eWaIHOIWtzsQir4zRtf4DH83OINXXh36vs8/edit?usp=sharing

At this juncture a dedicated group of Herbalists from across Canada sat at the bargaining table with the NHP regulatory board to ensure the access to compounding herbal medicine was maintained, creating the Compounding Policy.

As quoted from the Health Canada website:

“NHPD consulted on this interim policy with Health Canada colleagues and health care practitioners, including pharmacists, Traditional Chinese Medicine practitioners, herbalists, naturopathic doctors, practitioners of Aboriginal medicine, homeopaths, etc.

The NHP Compounding Policy distinguishes between the manufacturing of natural health products, an activity regulated by the Natural Health Products Regulations (NHP Regulations), and the compounding of natural health products, an activity unregulated by NHP Regulations.

Compounding is an activity performed by a health care practitioner in the context of a practitioner-patient relationship. It is an activity that generally falls under provincial or territorial jurisdiction. A site licence is therefore not required to compound, and the compounded product does not require a product licence to be sold. Responsibility for the safety, efficacy and quality of the compounded product is assumed by the health care practitioner.”

DEFINITIONS

A manufacturer is defined as:

"Manufacturer" means a person who fabricates or processes a natural health product for the purpose of sale but does not include a pharmacist or other health care practitioner who, at the request of a patient, compounds a natural health product for the purpose of sale to that patient.

This product is then sold outside of the client / patient practitioner relationship or what is consider third party sales.

A practitioner is defined as:

A person who works in a professional, medical, health related profession that requires skill, practice, training and education.

Herbal Medicine Practitioner

Is defined as a person who practices using herbs within a profession health practice, dispensing and recommending herbal medicine within the context of the professional patient/client relationship.

A well-rounded education experience of 2000 minimum training hours and a minimum of 500 hours of supervised clinical experience yields a professional Herbal Medicine Practitioner.

This practitioner then is able to work within the Compounding Policy to create customized herbal medicine for their client base.

For a full description of the categories of education hours recommended visit: https://www.bcherbalists.ca/resources/Documents/BCHA%20RHT%20Education%20Guidelines.pdf

SCENARIOS THAT FIT THE COMPOUNDING POLICY

For a full description visit: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/legislation-guidelines/policies/compounding-policy.html

The following are all scenarios that are within the scope of the compounding policy whereas a practitioner of herbal medicine create/compounds these medicines to dispense directly to their clients. The Natural Health Product (NHP) must be within Schedule 1, Subsection 1 of the NHP definition policy, found in the link above.

• 1)       Practitioner uses an NHP with NPN or DIN-HM or DIN to compound product
• 2)       Practitioner uses an NHP with neither an NPN nor DIN-HM nor a DIN to compound product
• 3)       Practitioner uses raw material to compound product
• 4)       Practitioner wildcrafts or cultivates a herb for use in a compounded product.
• 5)       Practitioner compounds product for another practitioner to provide to their patients.
• 6)       Practitioner provides a stock bottle (e.g., a tincture) to another practitioner to be used by that practitioner to compound product.
• 7)       Practitioner uses a stock bottle (e.g., a tincture) provided by another practitioner to compound product.
• 8)       Practitioner compounds a product in advance of a practitioner-patient relationship (i.e., bulk compounding) AND product is given to patient in the context of a practitioner-patient relationship.

Impermissible within the scope of the Compounding Policy

• 1)       Practitioner uses an NHP withdrawn from the market for safety reasons to compound product.
• 2)       Practitioner uses any substance listed on Schedule 2 to the Natural Health Products Regulations to compound product. Schedule 2 substances do not fit the definition of a NHP. Schedule 2 can be found in the link above.
• 3)       Practitioner uses any substance that does not meet the NHP definition to compound product
• 4)       Practitioner compounds product intended for distribution or sale outside the established practitioner-patient relationship. This is manufacturing.

There are many advantages to working within the Compounding Policy to create specific medicines for clients, to become autonomous with your medicine supply and to empower the practitioner to deepen the tradition of Herbal Medicine Practice. When a Herbal Medicine Practitioner operates within the Compounding Policy this also opens up the ability to create community amongst peers. To be a able to open your Botanical Dispensary to other practitioners to submit their client formulations and compound these for their clients creates balance and reciprocity within our practice. This action also creates an ability to learn from one another and show support to each other in a clinical practice. Too often practitioners of Herbal Medicine work independent of each other, loosing that connection to community.

For more information about Herbal Medicine regulation visit the above links in the article or contact your provincial association.