Flashcards in Chapter 15 - Regulation of NHPs Deck (22)
When was the Food and Drug Act first passed?
What was the Food and Drug Act originally concerned with?
Food, drugs, therapeutic devices, and cosmetics.
Food and Drug Act update in 1985 was to...
Ensure product safety. Ingredients must be disclosed. Drugs must be effective. Cannot advertise cure for serious diseases to the general public. And controlled substances like amphetamines.
Schedule A Diseases
Serious ones like cancer.
When did the Natural Health Products Regulations of the Food and Drug Act come into effect?
What does the Natural Health Products Regulations of the Food and Drug Act cover?
All NHPs: vitamins and minerals, herbal medicines, homeopathic treatments, traditional medicines, probiotics, amino acids and fatty acids.
What is a Site Licence?
A licence that all sites that manufacture, package, label and import must have.
Getting a site licence requires...
Specific labelling and packaging requirements, safety and efficacy evidence, maintaining proper distribution records, having procedures for handling/storage/delivery and procedures for product recalls, a good manufacturing process, and must report serious adverse reactions to Health Canada.
Site licencing requirements do not apply to...
Practitioners who compound products on an individual basis and retailers.
What is a Product Licence?
A licence for a Natural Health Product.
How do you get a NHP licensed?
You must tell Health Canada: medical ingredients, non-medical ingredients, source, dose, potency, and recommended uses.
What is an exemption number?
A number given to unevaluated products.
What does an exemption number look like?
What does a Natural Product Number look like?
What does a Homeopathic Medicine Number look like?
What must labels on NHPs look like?
Must include product name, product licence number, quantity, recommended use, cautionary statements, and special storage needs.
Who provides the evidence for safety and efficacy?
What might evidence for safety and efficacy of a NHP to quality for a NPN consist of?
Clinical trials, references to published studies, pharmacopoeias, and traditional resources.
A proposed amendment to the Food and Drugs Act that was tabled and never passed.
What would Bill C-51 have done?
Protected and promoted health and safety. Encouraged accurate and consistent product representation. And adding prohibitions on giving false or misleading information.
What was the public reaction to Bill C-51?
Lots of people protested arguing it would be too much regulation.