Griffith University –
2012PHM Pharmacy
Practice II EOT –
QUESTIONS AND
ANSWERS |
2026/2027 LATEST
UPDATE
SECTION 1: THERAPEUTIC GOODS ADMINISTRATION,
SCHEDULING AND MEDICINES REGULATION
Questions 1–15
1. Which statement best describes the principal role of the Therapeutic Goods
Administration (TGA)?
A) Regulating therapeutic goods to protect public health and safety
B) Setting the retail prices of all medicines in Australia
C) Registering Australian pharmacists
D) Administering the Pharmaceutical Benefits Scheme
Correct Answer: Regulating therapeutic goods to protect public health and safety
,Rationale: The TGA regulates therapeutic goods in Australia with the objective of protecting
public health and safety. Its responsibilities include evaluating medicines, regulating supply,
monitoring safety, and maintaining regulatory systems such as the Australian Register of
Therapeutic Goods. Pharmacist registration is handled through the Pharmacy Board and
AHPRA, while PBS administration is separate.
2. A medicine label carries an AUST R number. What does this designation indicate?
A) The product is an unassessed complementary medicine
B) The medicine is registered in the Australian Register of Therapeutic Goods
C) The product is a Schedule 8 controlled drug
D) The medicine is exempt from TGA regulation
Correct Answer: The medicine is registered in the Australian Register of Therapeutic Goods
Rationale: AUST R identifies a registered medicine in the Australian Register of Therapeutic
Goods. Registered medicines undergo pre-market assessment of safety, quality and efficacy.
The AUST designation does not itself indicate a medicine schedule such as Schedule 8, and
medicines supplied through the Australian system generally remain subject to applicable TGA
regulatory requirements.
3. Which characteristic most appropriately distinguishes an AUST L medicine from an
AUST R medicine?
A) AUST L medicines are always prescription medicines
B) AUST L medicines are Schedule 8 medicines
C) AUST L medicines are listed lower-risk medicines for which efficacy is not assessed
before supply
D) AUST L medicines are prohibited from being sold in pharmacies
Correct Answer: AUST L medicines are listed lower-risk medicines for which efficacy is not
assessed before supply
Rationale: AUST L identifies listed medicines, generally lower-risk products whose ingredients
and indications must meet applicable requirements but whose efficacy is not assessed pre-
market in the same manner as registered medicines. AUST R identifies registered medicines
subject to pre-market evaluation. The distinction concerns the regulatory pathway rather
than the pharmacy schedule.
4. What is the principal significance of AUST L(A) on a medicine label?
A) It indicates a Schedule 4 prescription medicine
B) It means the product has no therapeutic indication
C) It identifies an unapproved imported medicine
D) It identifies an assessed listed medicine whose efficacy has undergone pre-market
assessment
,Correct Answer: It identifies an assessed listed medicine whose efficacy has undergone
pre-market assessment
Rationale: AUST L(A) identifies an assessed listed medicine. These products use lower-risk
ingredients but have indications for which efficacy evidence is assessed by the TGA before
supply. They differ from ordinary AUST L products because the efficacy of the relevant
indications has been assessed. The designation does not describe a Schedule 4 classification.
5. Which schedule is classified as a Pharmacist Only Medicine under the Australian
scheduling system?
A) Schedule 3
B) Schedule 2
C) Schedule 4
D) Schedule 8
Correct Answer: Schedule 3
Rationale: Schedule 3 medicines are Pharmacist Only Medicines and require pharmacist
involvement in their supply. Schedule 2 medicines are Pharmacy Medicines, Schedule 4
medicines are Prescription Only Medicines, and Schedule 8 medicines are Controlled Drugs.
Scheduling is a national classification framework intended to regulate access according to
the level of control needed.
6. What is the primary regulatory purpose of the Poisons Standard?
A) To determine the reimbursement price of PBS medicines
B) To classify medicines and poisons according to the level of regulatory control
required
C) To register individual pharmacists
D) To determine university pharmacy curricula
Correct Answer: To classify medicines and poisons according to the level of regulatory
control required
Rationale: The Poisons Standard, also known as the SUSMP, provides the national scheduling
framework for medicines and poisons. Substances are classified according to the degree of
regulatory control needed to protect public health and safety. State and territory legislation
gives legal effect to these scheduling decisions within each jurisdiction.
7. Which body advises the Australian Government on the scheduling of medicines?
A) Pharmaceutical Benefits Advisory Committee
B) Pharmacy Board of Australia
C) Advisory Committee on Medicines Scheduling
D) Australian Pharmacy Council
Correct Answer: Advisory Committee on Medicines Scheduling
, Rationale: The Advisory Committee on Medicines Scheduling, or ACMS, advises and makes
recommendations concerning the appropriate level of access for medicines. Scheduling
decisions are distinct from PBS listing decisions and pharmacist registration. The Pharmacy
Board focuses on professional registration and standards, while the PBAC advises on
medicines for PBS listing.
8. Which schedule is classified as a Controlled Drug?
A) Schedule 2
B) Schedule 3
C) Schedule 4
D) Schedule 8
Correct Answer: Schedule 8
Rationale: Schedule 8 medicines are Controlled Drugs because they have a recognised
therapeutic use but also carry significant potential for abuse, misuse or dependence. They
therefore receive stricter controls concerning prescribing, storage, recording, supply and
disposal. Schedule 2, 3 and 4 medicines have progressively different access requirements.
9. Which statement best describes Schedule 9 substances?
A) They are Pharmacy Medicines available for ordinary over-the-counter supply
B) They are Pharmacist Only Medicines
C) They are prohibited substances except where permitted for legitimate purposes
under applicable law
D) They are ordinary prescription medicines
Correct Answer: They are prohibited substances except where permitted for legitimate
purposes under applicable law
Rationale: Schedule 9 substances are classified as Prohibited Substances because their use
presents a level of danger warranting prohibition of sale, supply and use, subject to specific
lawful exceptions. They are therefore not ordinary prescription or pharmacist-only medicines.
Schedule 10 contains substances considered so dangerous that prohibition is also warranted.
10. Which factor would be most relevant when the TGA determines the regulatory risk
associated with a medicine?
A) The pharmacy's opening hours
B) The medicine's ingredients, dosage form and therapeutic claims
C) The patient's Medicare number
D) The pharmacist's preferred wholesaler
Correct Answer: The medicine's ingredients, dosage form and therapeutic claims
Rationale: Regulatory classification and assessment consider characteristics such as
ingredients, dosage form and therapeutic claims. These factors help determine the
appropriate regulatory pathway and risk level. Pharmacy opening hours, individual patient
2012PHM Pharmacy
Practice II EOT –
QUESTIONS AND
ANSWERS |
2026/2027 LATEST
UPDATE
SECTION 1: THERAPEUTIC GOODS ADMINISTRATION,
SCHEDULING AND MEDICINES REGULATION
Questions 1–15
1. Which statement best describes the principal role of the Therapeutic Goods
Administration (TGA)?
A) Regulating therapeutic goods to protect public health and safety
B) Setting the retail prices of all medicines in Australia
C) Registering Australian pharmacists
D) Administering the Pharmaceutical Benefits Scheme
Correct Answer: Regulating therapeutic goods to protect public health and safety
,Rationale: The TGA regulates therapeutic goods in Australia with the objective of protecting
public health and safety. Its responsibilities include evaluating medicines, regulating supply,
monitoring safety, and maintaining regulatory systems such as the Australian Register of
Therapeutic Goods. Pharmacist registration is handled through the Pharmacy Board and
AHPRA, while PBS administration is separate.
2. A medicine label carries an AUST R number. What does this designation indicate?
A) The product is an unassessed complementary medicine
B) The medicine is registered in the Australian Register of Therapeutic Goods
C) The product is a Schedule 8 controlled drug
D) The medicine is exempt from TGA regulation
Correct Answer: The medicine is registered in the Australian Register of Therapeutic Goods
Rationale: AUST R identifies a registered medicine in the Australian Register of Therapeutic
Goods. Registered medicines undergo pre-market assessment of safety, quality and efficacy.
The AUST designation does not itself indicate a medicine schedule such as Schedule 8, and
medicines supplied through the Australian system generally remain subject to applicable TGA
regulatory requirements.
3. Which characteristic most appropriately distinguishes an AUST L medicine from an
AUST R medicine?
A) AUST L medicines are always prescription medicines
B) AUST L medicines are Schedule 8 medicines
C) AUST L medicines are listed lower-risk medicines for which efficacy is not assessed
before supply
D) AUST L medicines are prohibited from being sold in pharmacies
Correct Answer: AUST L medicines are listed lower-risk medicines for which efficacy is not
assessed before supply
Rationale: AUST L identifies listed medicines, generally lower-risk products whose ingredients
and indications must meet applicable requirements but whose efficacy is not assessed pre-
market in the same manner as registered medicines. AUST R identifies registered medicines
subject to pre-market evaluation. The distinction concerns the regulatory pathway rather
than the pharmacy schedule.
4. What is the principal significance of AUST L(A) on a medicine label?
A) It indicates a Schedule 4 prescription medicine
B) It means the product has no therapeutic indication
C) It identifies an unapproved imported medicine
D) It identifies an assessed listed medicine whose efficacy has undergone pre-market
assessment
,Correct Answer: It identifies an assessed listed medicine whose efficacy has undergone
pre-market assessment
Rationale: AUST L(A) identifies an assessed listed medicine. These products use lower-risk
ingredients but have indications for which efficacy evidence is assessed by the TGA before
supply. They differ from ordinary AUST L products because the efficacy of the relevant
indications has been assessed. The designation does not describe a Schedule 4 classification.
5. Which schedule is classified as a Pharmacist Only Medicine under the Australian
scheduling system?
A) Schedule 3
B) Schedule 2
C) Schedule 4
D) Schedule 8
Correct Answer: Schedule 3
Rationale: Schedule 3 medicines are Pharmacist Only Medicines and require pharmacist
involvement in their supply. Schedule 2 medicines are Pharmacy Medicines, Schedule 4
medicines are Prescription Only Medicines, and Schedule 8 medicines are Controlled Drugs.
Scheduling is a national classification framework intended to regulate access according to
the level of control needed.
6. What is the primary regulatory purpose of the Poisons Standard?
A) To determine the reimbursement price of PBS medicines
B) To classify medicines and poisons according to the level of regulatory control
required
C) To register individual pharmacists
D) To determine university pharmacy curricula
Correct Answer: To classify medicines and poisons according to the level of regulatory
control required
Rationale: The Poisons Standard, also known as the SUSMP, provides the national scheduling
framework for medicines and poisons. Substances are classified according to the degree of
regulatory control needed to protect public health and safety. State and territory legislation
gives legal effect to these scheduling decisions within each jurisdiction.
7. Which body advises the Australian Government on the scheduling of medicines?
A) Pharmaceutical Benefits Advisory Committee
B) Pharmacy Board of Australia
C) Advisory Committee on Medicines Scheduling
D) Australian Pharmacy Council
Correct Answer: Advisory Committee on Medicines Scheduling
, Rationale: The Advisory Committee on Medicines Scheduling, or ACMS, advises and makes
recommendations concerning the appropriate level of access for medicines. Scheduling
decisions are distinct from PBS listing decisions and pharmacist registration. The Pharmacy
Board focuses on professional registration and standards, while the PBAC advises on
medicines for PBS listing.
8. Which schedule is classified as a Controlled Drug?
A) Schedule 2
B) Schedule 3
C) Schedule 4
D) Schedule 8
Correct Answer: Schedule 8
Rationale: Schedule 8 medicines are Controlled Drugs because they have a recognised
therapeutic use but also carry significant potential for abuse, misuse or dependence. They
therefore receive stricter controls concerning prescribing, storage, recording, supply and
disposal. Schedule 2, 3 and 4 medicines have progressively different access requirements.
9. Which statement best describes Schedule 9 substances?
A) They are Pharmacy Medicines available for ordinary over-the-counter supply
B) They are Pharmacist Only Medicines
C) They are prohibited substances except where permitted for legitimate purposes
under applicable law
D) They are ordinary prescription medicines
Correct Answer: They are prohibited substances except where permitted for legitimate
purposes under applicable law
Rationale: Schedule 9 substances are classified as Prohibited Substances because their use
presents a level of danger warranting prohibition of sale, supply and use, subject to specific
lawful exceptions. They are therefore not ordinary prescription or pharmacist-only medicines.
Schedule 10 contains substances considered so dangerous that prohibition is also warranted.
10. Which factor would be most relevant when the TGA determines the regulatory risk
associated with a medicine?
A) The pharmacy's opening hours
B) The medicine's ingredients, dosage form and therapeutic claims
C) The patient's Medicare number
D) The pharmacist's preferred wholesaler
Correct Answer: The medicine's ingredients, dosage form and therapeutic claims
Rationale: Regulatory classification and assessment consider characteristics such as
ingredients, dosage form and therapeutic claims. These factors help determine the
appropriate regulatory pathway and risk level. Pharmacy opening hours, individual patient
