January/February 2004 - Ontario College of Pharmacists

The Regulations are not intended to regulate the practice
of complementary and alternative health care practitioners
nor the practice of traditional Aboriginal medicine.
The NHP Directorate intends to adopt a guidance document
regarding the distinction between manufacture and
sale of NHPs and compounding and distribution of
compounded products by both complementary and alternative
health care practitioners and Aboriginal Healers.
Schedule 1: Includes Natural Health Product
Substances (Subsection 1(1))
Item
1.
2.
3.
4.
5.
6.
7.
8.
Substances
A plant or a plant material, an alga, a
bacterium, a fungus or a non-human animal
material
An extract or isolate of a substance
described in item 1, the primary molecular
structure of which is identical to that which
it had prior to its extraction or isolation
Any of the following vitamins:
biotin
folate
niacin
pantothenic acid
riboflavin
thiamine
vitamin A
vitamin B6
vitamin B12
vitamin C
vitamin D
vitamin E
An amino acid
An essential fatty acid
A synthetic duplicate of a substance
described in any of items 2 to 5
A mineral
A probiotic
What is included in the definition of a
natural health product?
Schedule I indicates the medicinal ingredients included as
a natural health product. (It is important to note that
synthetic duplicates of NHPs are also included, as
mentioned in #6).
Express Exclusions
There is also a schedule of express exclusions (Schedule
2). This schedule identifies products that might fall within
the definition of a NHP.
However, certain products do not fall under the scope of
the Regulations, such as: 1) an antibiotic or its synthetic
duplicate; 2) a substance that is administered by puncturing
the dermis; 3) a substance regulated under the Tobacco Act;
4) a substance set out in any of Schedules I to V of the
Controlled Drugs and Substances Act; and 5) radiopharmaceuticals
(Schedule C to FDA).
In addition, a substance set out in Schedule D (biologics)
of the Food and Drugs Act is excluded, except: i) a drug that
is prepared from any of the following microorganisms,
namely, an alga, a bacterium or a fungus; and ii) any
substance set out in Schedule D when it is prepared in accordance
with the practices of homeopathic pharmacy.
Schedule 2: Excluded Natural Health Product
Substances (Subsection 1(1))
Item
1.
2.
3.
4.
Substances
A substance set out in Schedule C to the Act
A substance set out in Schedule D to the
Act, except for the following:
(a) a drug that is prepared from any of the
following micro-organisms, namely, an
alga, a bacterium or a fungus; and
(b) any substance set out on Schedule D
when it is prepared in accordance with
the practices of homeopathic pharmacy
A substance regulated under the Tobacco Act
A substance set out in any of Schedules I to
V of the Controlled Drugs and Substances Act
This article contains excerpts form the Natural Health Products website. The complete NHP Regulations can be viewed on
Health Canada’s website at www.healthcanada.ca/nhpd
Pharmacy Connection January • February 2004 19