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Jurisprudence > Federal Pharmacy Laws Powerpoint > Flashcards

Federal Pharmacy Laws Powerpoint Flashcards

1
Q

What must happen for an act to a law to be passed?

A

A bill is read three times in parliament then it is given royal assent.

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2
Q

When citing a law, how does it read?

A

Part —> Section —> subsection —> clause

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3
Q

What are the 6 federal laws listed?

A
  1. Food and Drugs Act
  2. Controlled Drugs and Substances Act
  3. Natural Health Products Regulations
  4. The Hazardous Products Act
  5. The Excise Act
    WHIMS
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4
Q

What does HPB mean?

A

Health Protection Branch

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5
Q

What is the Health Protection Branch responsible for?

A

Drug quality, safety, and efficiency. It regulates drugs imported into and manufactured for sale in Canada.

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6
Q

When was the Food and Drugs Act put into effect?

A

1990

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7
Q

What does the Food and Drugs Act do?

A

Controls the manufacture, packaging, labeling and advertising standards, as well as the purchase and sale of all foods, drugs, cosmetics and therapeutic devices.

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8
Q

What is the FDA definition for food?

A

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.

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9
Q

What is the FDA definition of drug?

A

Drug includes any substance or mixture that is manufactured, sold, or represented for use in:

  1. Diagnosis, treatment, or prevention of a disorder.
  2. Disinfection
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10
Q

What is the FDA definition of cosmetics?

A

Any substance or mixture used for cleansing, altering complexion, skin, hair, or teeth and includes deodorants or perfumes.

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11
Q

What is the FDA definition of a therapeutic device?

A

Any article, instrument, or apparatus used in:

  1. Treatment of a disorder
  2. Diagnosis of pregnancy an care before and after birth
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12
Q

What is the FDA definition of safety vials?

A

Child resistant packaging of drug products as well for safety testing of such packaging.

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13
Q

What happens if a patient asks for a snap cap vial?

A

They must sigh a special release form once a year.

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14
Q

What is the FDA definition of perscription?

A

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.

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15
Q

What is the FDA definition of a teaspoon?

A

5mL or 5cc

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16
Q

What is the FDA definition of a expiration date?

A

minimum a year and month, up to and including that date.

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17
Q

The FDA stipulates that a prescription must be kept in a pharmacy for how long?

A

No less than 2 years.

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18
Q

What is FDA Schedule A?

A

Lists disorders, diseases, and abnormal physical states. Examples include asthma, glaucoma, and thyroid disease.

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19
Q

What is FDA Schedule B?

A

A list of established sources on drugs accepted as a set of standards for purity (pharmacopoeias)

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20
Q

What is the BP under FDA schedule B?

A

The British Pharmacopoeia

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21
Q

What is the USP under FDA Schedule B?

A

The United States Pharmacopoeia

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22
Q

What is the NF under FDA schedule B?

A

The National Formulary

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23
Q

What is FDA Schedule C?

A

List of radio-pharmaceuticals and substances used in the preparation of radio-pharmaceuticals

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24
Q

What is the FDA Schedule D?

A

List of biological products.

Examples are glucagon and insulin.

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25
Q

What is part A of the Food and Drug Regulations of the FDA?

A

Administration

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26
Q

What is part B of the Food and Drug Regulations of the FDA?

A

Deals with food

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27
Q

What is part C of the Food and Drug Regulations of the FDA?

A

Drugs

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28
Q

What is part D of the Food and Drug Regulations of the FDA?

A

Vitamins, minerals, and amino acids

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29
Q

What is part E of the Food and Drug Regulations of the FDA?

A

Cyclamate and Saccharin Sweeteners

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30
Q

What is part F of the Food and Drug Regulations of the FDA?

A

Required a prescription to be dispensed

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31
Q

What is part G of the Food and Drug Regulations of the FDA?

A

Controlled Drugs

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32
Q

What is part J of the Food and Drug Regulations of the FDA?

A

Restricted Drugs

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33
Q

What is the symbol of schedule F drugs?

A

Pr in a rectangle

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34
Q

In 2013, FDA schedule F was replaced by what?

A

The Prescription Drug List

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35
Q

What is F1 of FDA Schedule F?

A

Prescription Drug List

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36
Q

What is F2 of FDA Schedule F?

A

May be sold without a prescription for veterinary use.

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37
Q

What is C1 of FDA Part G?

A

Amphetamines

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38
Q

What is C2 of FDA Part G?

A

Barbiturates

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39
Q

What is C3 of FDA Part G?

A

Anabolic Steroids

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40
Q

When was the Controlled Drugs and Substances Act put into effect?

A

1997

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41
Q

What does CDSA stand for?

A

Controlled Drug and Substances Act

42
Q

What is the Controlled Drug and Substances Act?

A

An act that provides for the control of narcotics, controlled drugs and targeted substances.

43
Q

What is the purpose of the CDSA?

A

To provide law enforcement authorities with the power to arrest or charge people who are illegally importing, exporting, producing, or distributing controlled substances.

44
Q

How many schedules are under the CDSA?

A

8

45
Q

What is schedule I under the CDSA?

A

Narcotics

46
Q

What is schedule II under the CDSA?

A

Cannabis

47
Q

What is schedule III under the CDSA?

A

Amphetamines

48
Q

What is schedule IV under CDSA?

A

Barbiturates, benzodaizepines, anabolic steroids

49
Q

What is schedule V under the CDSA?

A

Proplyhexedrine

50
Q

What is schedule VI under the CDSA?

A

Precursors

51
Q

What is schedule VII under the CDSA?

A

Cannabis that serves enforcement purposes regarding possession.

52
Q

What is schedule VIII?

A

Cannabis that serves enforcement purposes regarding trafficking.

53
Q

What is the symbol for CDSA Schedule I?

A

An N in a circle

54
Q

What are the 3 categories of Narcotics under the CDSA Schedule I?

A
  1. Straight narcotics (ONLY written)
  2. Verbal prescription narcotics
  3. Codeine exempt products
55
Q

What do straight narcotics contain?

A

Only one narcotic, or one narcotic and one non-narcotic product.

56
Q

What are the rules regarding straight narcotics under CDSA schedule 1?

A

Must be written
Cannot be refilled
Cannot be transferred
Purchase and record of sale must be recorded

57
Q

What do verbal prescription narcotics contain?

A

One narcotic and at least two non-narcotic products

58
Q

What are the rules regarding verbal prescription narcotics under CDSA schedule 1?

A

Can be verbal or written
Cannot have refills
Cannot be transferred
Must record receipt but not sale of VPN narcotics

59
Q

What does VPN stand for?

A

Verbal Prescription Narcotics

60
Q

What do Codeine Exempted Products contain?

A

Codeine (8mg or less for solid, and 20mg or 30ml or less for liquid)
Two other non-narcotic ingredients

61
Q

What are the rules regarding Codeine Exempted Products under CDSA schedule 1?

A

Can be bought over the counter without prescription

Must record the receipt

62
Q

How long must the hard copy of narcotic prescriptions under CDSA schedule I?

A

2 years

63
Q

What is a part-fill?

A

When a practitioner prescribes a narcotic to be dispensed in divided portions.

64
Q

To part-fill narcotics, what must the prescribe indicate?

A
  1. The total quantity prescribed
  2. The quantity to be dispensed
  3. The intervals at which it may be dispensed.
65
Q

What drugs can NEVER be VPN as per the Narcotic Control Register? (5)

A
  1. Diaxetylmorphine (heroin)
  2. Hydrocodone
  3. Methadone
  4. Oxycodone
  5. Pentazocine
66
Q

What is the symbol for CDSA schedule III and IV?

A

a C in a dimond

67
Q

Which schedules under the CDSA have to do with controlled substances?

A

Schedule III and IV

68
Q

What part of the FDA relates to the CDSA Schedule III and IV - Controlled substances

A

FDA Part G - C1, C2 & C3

69
Q

What part of the FDA relates to CDSA Schedule III - Amphetamines?

A

FDA Part G, C1

70
Q

In the CDSA, what is the most highly regulated of the controlled drugs?

A

Amphetamines

71
Q

What part of the FDA relates to Schedule IV - Barbiturates?

A

FDA Part G, C2

72
Q

What part of the FDA relates to Schedule IV - Anabolic Steroids?

A

FDA Part G, C3

73
Q

What is the symbol for Schedule IV?

A

T/C in a square

74
Q

Is CDSA schedule V - Propylhexedrine approved for sale in Canada?

A

NOT approved for sale in Canada

75
Q

What is CDSA schedule VI - Precursors regulated by?

A

The precursor control regulations

76
Q

What is the legal limit for Schedule VII?

A

3kg cannibis resin / 3kg cannabis

77
Q

What is the legal limit under schedule VIII?

A

Cannabis resin (1g) / 30g cannabis

78
Q

What does NHP Regulations stand for?

A

Natural Health Product Regulation

79
Q

When did NHP Regulations come into effect?

A

2004

80
Q

What was the aim for NHP Regulations?

A

Provide access to consumer
Ensure safety of products
Ensure quality of products
Permit an efficacy claim

81
Q

What is included under Natural Health Products?

A

Minerals
Vitamins
Trace elements
Amino Acids

82
Q

What does NPN stand for pertaining to the Natural Health Product Regulation in Canada product numbers?

A

Natural health products

83
Q

What does DIN-HM stand for pertaining to the Natural Health Product Regulation in Canada product numbers?

A

Homeopathic products

84
Q

How can someone tell if a NHP Regulation product has been reviewed and approved by Health Canada?

A

The product will bear an 8 digit product licence proceeded by the letters NPN

85
Q

What is the purpose of the Hazardous Products Act?

A

To prohibit the advertising, sale and importation of hazardous products.

86
Q

What is listed under Schedule 1 of the Hazardous Products Act?

A

Common household items that could result in danger or harm.

87
Q

What is listed under the Hazardous Products Act, Schedule 2, Class A?

A

Compressed gas

88
Q

What is listed under the Hazardous Products Act, Schedule 2, Class B?

A

Flammable and combustible material

89
Q

What is listed under the Hazardous Products Act, Schedule 2, Class C?

A

Oxidizing material

90
Q

What is listed under the Hazardous Products Act, Schedule 2, Class D?

A

Poisonous and infectious material

91
Q

What is listed under the Hazardous Products Act, Schedule 2, Class E?

A

Corrosive material

92
Q

What is listed under the Hazardous Products Act, Schedule 2, Class F?

A

Dangerously reactive material

93
Q

What is the Excise Act?

A

A federal law that controls the manufacture, purchase, and sale of alcohol and alcohol products in Canada.

94
Q

What does WHIMS stand for?

A

Workplace Hazardous Material Information System

95
Q

What is WHIMS?

A

Describes the dangers of the materials you are exposed to on the job.

96
Q

What are the 3 employees rights under WHIMS?

A
  1. Right to know
  2. Right to refuse
  3. Right to participate
97
Q

What does HPA stand for?

A

Hazardous Products Act

98
Q

What does CPR stand for in terms of WHIMIS?

A

Controlled Products Regulations

99
Q

What does HPR stand for?

A

Hazardous Products Regulations

100
Q

What does FPT stand for?

A

Federal, provincial, and territorial

101
Q

What does OHS stand for?

A

Occupational Health and Safety

Jurisprudence (9 decks)

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