Document ID: chunk:federal_register_of_legislation:F2024C00583:reg:6:p1
Version: federal_register_of_legislation:F2024C00583
Segment Type: reg
Provision Reference: reg 6 (pt 1/2)
Character Range: 4747–7793

6  Definitions
 (1) In this Determination:
Act means the National Health Act 1953.
agreed purchase quantity, in relation to an ingredient of an extemporaneously‑prepared pharmaceutical benefit, means the quantity of the ingredient that is agreed upon between the Secretary of the Department of Health and the Pharmacy Guild of Australia as the quantity for which the basic wholesale price is to be ascertained.
approved ex‑manufacturer price has the same meaning as in subsection 84(1) of the Act.
basic wholesale price has the same meaning as in subsection 98B(3) of the Act.
dangerous drug means:
 (a) a pharmaceutical benefit mentioned in Schedule 3 to the National Health (Commonwealth Price and Conditions for Commonwealth Payments for Supply of Pharmaceutical Benefits) Determination 2019; or
 (b) a pharmaceutical benefit that, under the law of a State or Territory, is classified as a dangerous drug.
dangerous drug fee means an amount of $5.37.
determined quantity of a listed brand of a pharmaceutical item has the same meaning as in subsection 84(1) of the Act.
exceptional prescription means a prescription for an extemporaneously‑ prepared pharmaceutical benefit that is not a standard formula preparation and for which the price of the ingredients, calculated in accordance with sections 19 to 21, is not less than twice the amount calculated under section 30, excluding the container price and extemporaneously‑prepared dispensing fee.
extemporaneously‑prepared dispensing fee means an amount of $10.71.
extemporaneously‑prepared pharmaceutical benefit means a pharmaceutical benefit that is not a ready‑prepared pharmaceutical benefit.
maximum quantity of a brand of a pharmaceutical item, or a pharmaceutical benefit that has a pharmaceutical item, means a quantity or number of units of the pharmaceutical item determined under paragraph 85A(2)(a) of the Act in relation to that brand of pharmaceutical item.
pack quantity has the same meaning as in subsection 84(1) of the Act.
Note: The Minister may determine one or more pack quantities for a brand of a pharmaceutical item under subsection 84AK(2) of the Act.  The quantities determined are the quantities in manufacturer's PBS packs.
pharmaceutical item has the meaning given by section 84AB of the Act.
price to pharmacists means the approved ex‑manufacturer price or proportional ex‑manufacturer price for the particular quantity, plus the wholesale mark‑up worked out under section 11.
proportional ex‑manufacturer price has the same meaning as in subsection 84(1) of the Act.
ready‑prepared dispensing fee means an amount of $8.67.
ready‑prepared pharmaceutical benefit means a brand of a pharmaceutical item for which there is a determination under subsection 85(6) of the Act.
Regulations means the National Health (Pharmaceutical Benefits) Regulations 2017.
standard formula preparation means an extemporaneously‑prepared pharmaceutical benefit mentioned in Schedule 5 to the National Health (Commonwealth Price and Conditions for Commonwealth Payments for Supply of