Interim NHP Compounding Policy and Interim NHP Raw Material Policy
Presentation for Homeopathic Community
April, 2006

Interim NHP Compounding Policy

• Policy Development
  • Previous Consultation
  • Interim NHP Compounding Policy
• Manufacturing Versus Compounding Table
• Related NHPD Policy Initiatives Affecting Practitioners
• Next Steps in Policy Development

Policy Development: Previous Consultation

• Focussed Consultation with Complementary and Alternative Health Care Practitioners on the Natural Health Products Regulations January 8-9, 2004 and January 27- 28, 2005
• Expert Advisory Committee (EAC)
• Management Advisory Council (MAC)

Policy Development: Interim NHP Compounding Policy

• Developed to:
  • Be used as consultation tool
  • Address the December 31, 2005 site licensing deadline
• Stakeholder feedback obtained February to March, 2006

Manufacturing Versus Compounding Table

•   Outlines permitted activities for practitioners who compound
•   Current PL and SL requirements
  •   PL not required for compounded product (compounding is a practice of medicine – provincial jurisdiction – product too)
  •   SL required for importation of NHP
  •   Intent of NHP Regulations was not to regulate the practice of compounding or the product resulting from the practice
  •   Possible regulatory amendment to exempt compounding from requirements of NHP Regulations.

Types of products that can be used to compound NHPs

• NHP with NPN, DIN-HM or DIN* (domestic or import)
• raw material, semi-processed material or processed material
• wildcrafted herb
• stock bottle (e.g. tincture)

Types of products that cannot be used to compound NHPs

• NHP withdrawn from market for safety reasons
• Substance on Schedule 2 of NHP Regulations
  • Exception for Schedule D ingredients, which are permitted in homeopathics
• Substance that otherwise does not meet NHP definition (e.g., Schedule F)
  • Exceptions for Schedule F ingredients (substances required to be sold pursuant to a prescription), which are permitted in homeopathics

Sterile products

• Compounding sterile product not permitted.

Third parties

• No SL or PL required for practitioner to compound product for:
  • another practitioner to provide to his/her patients
  • another practitioner to compound for his/her patients
     
• SL and PL required for:
  • distribution or sale of compounded product outside of an established practitioner/patient relationship

Compounding in Advance

• Practitioner permitted to compound product in advance of a practitioner-patient relationship if product given to patient in the context of a practitioner-patient relationship.
• This includes practitioner-practitioner-patient relationships.

Clinical trials

• Compounding product for use in clinical trials does not require site licence.

Compounding – Outstanding Issues

• Necessity for SL/PL to import NHP for compounding purposes

Related NHPD Policy Initiatives Affecting Practitioners

• Interim NHP Raw Material Policy
• Bulk product policy
• Professional use NHPs

Next Steps in Policy Development

• Incorporate feedback received
• Finalize NHP Compounding Policy
• Consider possible regulatory amendment

Interim NHP Raw Material Policy

• Policy Development
• Table Indicating Need for Site Licences
• Next Steps in Policy Development

Policy Development: Interim NHP Raw Material Policy

• Developed to:
  • Be used as consultation tool
  • Address the December 31, 2005 site licensing deadline
• Stakeholder feedback obtained February to March, 2006

Policy Development - Issue

• NHP Regulations do not specify whether raw materials are or are not included in the NHP definition
• Raw material not mentioned (e.g., harvested ginger root)
• Finished product not mentioned (e.g., encapsulated ginger packaged/labelled for consumer)

Policy Development – Rationale

• Safety and quality of materials
  • going directly to consumers must be assured through PL and SL requirements
  • that are ingredients in the manufacture of NHPs is ensured through SL requirements (including GMPs) and requirement of PL for final product
  • used by practitioners to compound product for their patient is ensured by the practitioner

Policy Development – Policy Statement

• A substance becomes an NHP (triggers product and site licensing requirements) when:
  • Substance component of NHP definition is met; and
  • It is manufactured, sold, or represented for use as an NHP (i.e., meets function component of NHP definition).
    
     

Policy Development – Policy Statement

•   Case specific approach – circumstances/features about a material that Health Canada looks at to determine if NHP:
  •   Nature of the substance and inherent toxicity
  •   Packaging
  •   Labelling (including claims)
  •   Accompanying information/advertising
  •   Form (e.g., in dosage form)
  •   Sender
  •   Recipient (e.g., retail outlet)
  •   Manner in which it is being sold (i.e., to customers, versus as part of the chain of manufacturing)

Policy Development – Policy Statement

• Products manufactured, sold or represented for use as NHPs are regulated as NHPs
• Products manufactured, sold or represented for use as foods are regulated as foods
• Products clearly neither foods nor finished NHPs treated as active medicinal ingredients (e.g., bulk powdered melatonin needing encapsulation and pkg)
  • AMI means no PL required to sell material, no SL required to import
  • Any processing by manufacturer requires SL

Policy Development – Policy Statement