Pharmacy Law

Question 1

When citing a law it reads:

Answer 1

Part -> section -> subsection -> clause

Question 2

How is a law passed?

Answer 2

1. ) starts as a bill
2. ) read over 3 times in parliament
3. ) royal assent

Question 3

Definition of a Law:

Answer 3

Set of regulations that provide and interpretation or description of procedures to be followed in carrying out provisions of the act

Question 4

True/ False All pharmacy acts have a set of regulatons

Answer 4

True

Question 5

The acronym HPB

Answer 5

Health Protection Branch

Question 6

What is the Health Protection Branch responsible for?

Answer 6

Drug quality, safety, and efficacy. Regulated drugs imported into and manufactured for sale in Canada

Question 7

The acronym FDA

Answer 7

Food and Drugs Act (federal law)

Question 8

year FDA was brought into legislation

Answer 8

1990

Question 9

What does the FDA control?

Answer 9

The manufacture, packaging and labelling standards as well as the purchase and sale of all:
Foods, drugs, cosmetics and therapeutic devices

Question 10

FDA definition for food:

Answer 10

Any article manufactured, sold or represented for use as food or drink for human consumption

Question 11

FDA definition for drug:

Answer 11

Drug includes any substance or mixture of substances manufactured, sold or represented for use in:
Diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical state, or its symptoms in a human being or animal
Restoring, correcting or modifying organic functions in human beings or animals

Question 12

FDA definition for cosmetics:

Answer 12

Includes any substance or mixture of substances manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin, hair or teeth and includes deodorants and perfumes

Question 13

FDA definition for therapeutic device:

Answer 13

Any article, instrument, or apparatus for the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state. restoring or correcting body function. Diagnosis of pregnancy; care and before birth

Question 14

FDA definition for a teaspoon

Answer 14

1 teaspoonful = 5mls or 5cc

Question 15

True/False : Safety vials aren’t ever required for the packaging of medications

Answer 15

False: Child resistant packaging is required, patients can request snap caps but must sign a special release form yearly

Question 16

FDA definition for “Prescription”

Answer 16

Prescription means an order given by a practitioner directing that a stated amount of any drug or mixtures of drugs specified therein be dispensed for the person named in the order

Question 17

FDA definition for “Expiry date”

Answer 17

minimum as a year and month, up to and including which a drug maintains its labeled potency, purity and physical characteristics or after which the manufacturer recommend that the drug not be used.

Question 18

FDA filing regulations

Answer 18

Rx’s must be kept at minimum 2 years from the date of filing