Federal Pharmacy Laws Powerpoint Flashcards
What must happen for an act to a law to be passed?
A bill is read three times in parliament then it is given royal assent.
When citing a law, how does it read?
Part —> Section —> subsection —> clause
What are the 6 federal laws listed?
- Food and Drugs Act
- Controlled Drugs and Substances Act
- Natural Health Products Regulations
- The Hazardous Products Act
- The Excise Act
WHIMS
What does HPB mean?
Health Protection Branch
What is the Health Protection Branch responsible for?
Drug quality, safety, and efficiency. It regulates drugs imported into and manufactured for sale in Canada.
When was the Food and Drugs Act put into effect?
1990
What does the Food and Drugs Act do?
Controls the manufacture, packaging, labeling and advertising standards, as well as the purchase and sale of all foods, drugs, cosmetics and therapeutic devices.
What is the FDA definition for food?
Food includes any article manufactured, sold, or represented for use as food or drink for human beings, chewing gum, and any ingredient that may be mixed with food for any purpose.
What is the FDA definition of drug?
Drug includes any substance or mixture that is manufactured, sold, or represented for use in:
- Diagnosis, treatment, or prevention of a disorder.
- Disinfection
What is the FDA definition of cosmetics?
Any substance or mixture used for cleansing, altering complexion, skin, hair, or teeth and includes deodorants or perfumes.
What is the FDA definition of a therapeutic device?
Any article, instrument, or apparatus used in:
- Treatment of a disorder
- Diagnosis of pregnancy an care before and after birth
What is the FDA definition of safety vials?
Child resistant packaging of drug products as well for safety testing of such packaging.
What happens if a patient asks for a snap cap vial?
They must sigh a special release form once a year.
What is the FDA definition of perscription?
An order given by a practitioner directing that a stated amount of any drug specified therein be dispensed for the person named in the order.
What is the FDA definition of a teaspoon?
5mL or 5cc
What is the FDA definition of a expiration date?
minimum a year and month, up to and including that date.
The FDA stipulates that a prescription must be kept in a pharmacy for how long?
No less than 2 years.
What is FDA Schedule A?
Lists disorders, diseases, and abnormal physical states. Examples include asthma, glaucoma, and thyroid disease.
What is FDA Schedule B?
A list of established sources on drugs accepted as a set of standards for purity (pharmacopoeias)
What is the BP under FDA schedule B?
The British Pharmacopoeia
What is the USP under FDA Schedule B?
The United States Pharmacopoeia
What is the NF under FDA schedule B?
The National Formulary
What is FDA Schedule C?
List of radio-pharmaceuticals and substances used in the preparation of radio-pharmaceuticals
What is the FDA Schedule D?
List of biological products.
Examples are glucagon and insulin.