Natural Health Product Compounding Policy: Policy statement

On this page

• Overview
• Compounding
• Manufacturing
• Additional guidance to support imported shipments

Overview

The following section outlines the guiding principles for Natural Health Product (NHP) compounding and NHP manufacturing and can be used to help determine if an activity will be captured under the scope of compounding or instead be considered a manufacturing activity. Depending on the nature of the activity, different regulatory requirements will apply.

Compounding

Compounding is an activity performed by a health care practitioner in the context of a practitioner-patient relationship. Compounding includes preparing, combining or modifying one or more medicinal ingredients to produce a final product customized to an exact specification tailored to a patient's needs, and in a dosage form suitable for the patient.

This policy is based on the following guiding principles:

• Compounding must be a legitimate part of the practice of the complementary and alternative health care practitioner and must not be used as a means to bypass the federal legislative/regulatory requirements (product and site licensing).
• The compounded product must be customized by the practitioner to the patient's needs and sold in a different form/format or have a different composition than the original substance used for compounding. In other words, the original product must not be sold as is.
• A compounded product must only be made in the context of a practitioner-patient relationship. When requested, the practitioner must demonstrate that a patient-practitioner relationship exists, and the product needs to be customized to the patient's needs.
• Compounding in bulk may be acceptable in advance of a practitioner-patient relationship, so long as the quantity compounded is based on the history of use based on previous trends of prescribing a specific formulation. This includes preparing multiple doses ahead of time for commonly used treatments, such as an allergy formulation before allergy season. The compounded product should only be made available to the patient following specific assessment by the practitioner.
• The compounded product treats the symptoms and needs of a particular patient, and if required, provides a product that is:
  • free of preservatives, dyes and chemical allergens and;
  • is in a palatable flavoured dosage form.
• Compounding should only be done if there is a therapeutic need or lack of authorized product availability and should not be done solely for commercial reasons for the health care practitioner.
• The compounded product must not aim to replicate an authorized NHP that is available commercially for consumers.
• Packaging and labelling compounded products are critical for safety and patient care.
  • Packaging and labelling should reflect the compounded product.
  • The label of the prepared product must be distinguishable from a commercial label (specific to the patient it was prepared for).
  • Information on the product label must be accurate and clear, and the directions of use should be tailored to the patient's specific needs.
• All NHP manufacturing and compounding activities are to be regulated and fall under either federal, provincial or territorial jurisdiction.
• Health care practitioners are responsible for patient safety and following the standards for patient care in their provincial/territorial jurisdiction.
• In distinguishing between compounding and manufacturing, Health Canada may require additional information to verify the appropriate application of this policy and may take appropriate action to ensure compliance with the Food and Drugs Act (the Act) or the Natural Health Products Regulations (the Regulations).
• Repackaging of NHPs in finished dosage form outside the scope of the practitioner-patient relationship (for resale, bulk repackaging or relabelling) is not considered the activity of compounding.

When the outlined guiding principles are met:

• Health care practitioners who import substances intended solely for the purposes of compounding do not require a site licence for importation.
• Third party entities outside the practitioner-patient relationship who import NHPs on behalf of practitioners intended for use in compounding, would require a site licence for importation and a product licence for the NHP.
• A site licence is not required to compound, and the compounded product does not require a product licence to be sold to a patient in Canada.
• The responsibility for the safety, efficacy and quality of a compounded product is assumed by the health care practitioner. While some health care practitioners may not be regulated by the provinces or territories, they remain nonetheless responsible for the compounded product they provide to their patients.
• Health Canada expects all NHPs to meet established specifications for identity, purity, potency and quantity, with finished product testing and quality oversight consistent with Good Manufacturing Practices. Practitioners who compound for individual patients are encouraged to source raw materials from reputable suppliers with traceable documentation and verify identity and quality prior to use.
• Health care practitioners may contract compounding services to another health care practitioner as part of their professional practice, this activity would also not require a site or product licence.
• Producing a product that requires only minor modification prior to direct administration when such modification amounts to mere directions of use (Example: addition of liquid to a powder) is not considered compounding.
• Health care practitioners cannot advertise a compounded product to the general public.

Manufacturing

An activity will be considered manufacturing in any of the following circumstances:

• Health care practitioners who produce products without being able to demonstrate that a practitioner-patient relationship exists.
• Advertising a compounded product to the general public.
• Producing a product identical to an approved NHP that is already commercially available in Canada. To be in line with compounding, this should only be done if there is a therapeutic need or lack of authorized product availability.
• Outsourcing the production or facilitating the sale of a product by a third party for the purpose of commercial distribution.
• Producing products intended for distribution or sale outside the demonstrated practitioner-patient relationship.
• Producing products made in such a scale, time and frequency to fall outside of a practitioner-patient relationship.

Additional guidance to support imported shipments

To facilitate Health Canada's decision-making on imported substances (raw material and finished NHPs), the following information should accompany each shipment (as applicable):

• Material/product identity,
• Supplier details (name, address),
• Lot number(s),
• Expiry date,
• Storage requirements,
• Intended use/claims associated with product,
• and Product and site licence numbers.

To facilitate the importation of substances for the purpose of compounding in the context of practitioner-patient relationship, Health Canada recommends to clearly identify on the label that the substance is intended "for compounding NHPs". In addition to the above, complementary, traditional and alternative health care practitioners, should include the following information to accompany each shipment:

• licence/registration number, address, and
• governing body.

Please note: Health Canada's Regulatory Operations and Enforcement Branch may request additional information to assist in making their admissibility decision.

For more information regarding raw materials used for NHPs, please refer to the Natural Health Product Raw Materials Policy.

For more information regarding drug compounding please refer to the Policy on Manufacturing and Compounding Drug Products in Canada (POL-0051).