National Health (Pharmaceutical Benefits) (Conditions for approved pharmacists) Determination 2017
PB 70 of 2017
made under the
National Health Act 1953
Compilation No. 1
Compilation date: 1 June 2023
Includes amendments up to: F2023L00511
Registered: 8 June 2023
About this compilation
This compilation
This is a compilation of the National Health (Pharmaceutical Benefits) (Conditions for approved pharmacists) Determination 2017 that shows the text of the law as amended and in force on 1 June 2023 (the compilation date).
The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.
Uncommenced amendments
The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Legislation Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the series page on the Legislation Register for the compiled law.
Application, saving and transitional provisions for provisions and amendments
If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.
Editorial changes
For more information about any editorial changes made in this compilation, see the endnotes.
Modifications
If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the series page on the Legislation Register for the compiled law.
Self‑repealing provisions
If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.
1 Name of Determination
(1) This Determination is the National Health (Pharmaceutical Benefits) (Conditions for approved pharmacists) Determination 2017.
(2) This Determination may also be cited as Determination No. PB 70 of 2017.
For paragraph 92A (1) (f) of the National Health Act 1953 (the Act), this Determination sets out conditions that apply to the approval of a person as an approved pharmacist for the purposes of Part VII of the Act (including an approval granted before the commencement of section 92A of the Act and an approval of a person or body referred to in section 83Z of the Act).
Note 1: The Minister may, after investigation and report by the appropriate Committee of Inquiry, suspend, further suspend or revoke the approval of a pharmacist if the Minister is satisfied that the pharmacist has, in relation to or arising out of the approval, been guilty of conduct which is an abuse of that approval (see section 95 of the Act). Any conduct of an approved pharmacist that is a contravention of the conditions specified in section 92A of the Act shall be deemed to be conduct that is an abuse of the pharmacist’s approval for the purposes of section 95 of the Act (see subsection 92A(3) of the Act).
Note 2: The dispensing of drugs and medicinal preparations is also regulated under State and Territory laws.
5 Definitions
(a) pharmacist (see subsection 4(1) of the Act);
(b) premises (see subsection 4(1) of the Act);
(c) prescription for the supply of a pharmaceutical benefit (see subsection 4(2) of the Act);
(d) supply of pharmaceutical benefits at premises (see subsection 4(3) of the Act).
Note 2: Under subsection 4(1A) of the Act, a word or phrase defined for the purposes of the Health Insurance Act 1973 has the meaning that it would have if used in that Act. The expression National Law used in this instrument is defined in that Act.
In this determination:
Act means the National Health Act 1953.
approval number, for an approved pharmacist in respect of particular premises, means the pharmacist’s approval number under section 16 of the Regulations in respect of those premises.
approved pharmacist has the same meaning as in Part VII of the Act.
approved premises for an approved pharmacist means premises in respect of which the pharmacist is approved for the purposes of Part VII of the National Health Act 1953.
arrangement includes a contract, agreement or understanding, written or oral, and whether or not legally enforceable.
brand has the same meaning as in Part VII of the Act.
continued dispensing prescription, for a supply of a pharmaceutical benefit in accordance with subsection 89A(1) of the Act (supply without prescription), means the prescription referred to section 3.03 of the National Health (Continued Dispensing) Determination 2022 in relation to the supply.
deferred supply authorisation has the same meaning as in the Regulations.
dispensing step: each of the following is a dispensing step in the dispensing of a pharmaceutical benefit:
(a) if the benefit is to be supplied on the basis of a prescription (other than a medication chart prescription), repeat authorisation or deferred supply authorisation—reviewing the prescription, repeat authorisation or deferred supply authorisation;
(b) if any of the following apply to the benefit—preparing the benefit:
(i) the benefit is a listed brand of a pharmaceutical item and the quantity of the benefit is less than a pack quantity of the listed brand of the pharmaceutical item;
(ii) the benefit requires the admixture of ready‑prepared ingredients;
(iii) the benefit is an extemporaneously‑prepared pharmaceutical benefit;
(c) if the benefit is to be supplied other than on an order lodged under section 33 of the Regulations (prescriber bag supplies)—generating, and affixing to the packaging for the benefit, a label that displays the following:
(i) for a benefit other than an extemporaneously‑prepared pharmaceutical benefit or a benefit that is to be supplied in accordance with the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011—the brand of the pharmaceutical item in the benefit;
(ii) if paragraph 40(2A)(b) or 41(2A)(b) of the Regulations applied to the prescription or continued dispensing prescription for the supply of the benefit—each drug that the benefit has;
(iii) the form (if any) and quantity or number of units of the benefit;
(iv) directions for use of the benefit in accordance with the instructions of the PBS prescriber who wrote the prescription or continued dispensing prescription for the supply of the benefit;
(v) the name of the person for whom the prescription or continued dispensing prescription for the supply of the benefit was written;
(vi) the date the benefit is dispensed;
(vii) the address of the premises at which the benefit is dispensed;
(viii) the name of the pharmacy situated at those premises (the dispensing pharmacy);
(ix) if subsection 64(1) of the Regulations applies to the benefit—the full cost of the benefit;
(d) if required by section 52 of the Regulations—preparing a repeat authorisation for the benefit;
(e) recording the dispensing of the benefit in the dispensing pharmacy’s system for recording the dispensing of pharmaceutical benefits.
Note 1: For paragraph (a), a prescription may be in the form of a paper‑based prescription or an electronic prescription (see section 39 of the Regulations).
Note 2: For subparagraphs (c)(ii), (iv) and (v), a prescription may be in the form of a paper‑based prescription, an electronic prescription or a medication chart prescription (see section 39 of the Regulations).
Note 3: For subparagraph (c)(iii), the form of a pharmaceutical benefit may be determined by reference to strength, type of unit, size of unit or otherwise, and may be such as to require the addition of a substance or substances to the drug so that it will be suitable for administration in a particular manner or at a particular strength (see subsections 85(3) and (4) of the Act).
electronic prescription has the same meaning as in the Regulations.
extemporaneously‑prepared pharmaceutical benefit has the same meaning as in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012.
listed brand has the same meaning as in Part VII of the Act.
medication chart prescription has the same meaning as in the Regulations.
pack quantity has the same meaning as in Part VII of the Act.
paper‑based prescription has the same meaning as in the Regulations.
PBS prescriber has the same meaning as in Part VII of the Act.
pharmaceutical benefit has the same meaning as in Part VII of the Act.
pharmaceutical item has the same meaning as in Part VII of the Act.
pharmacy means a business in the course of the carrying on of which pharmaceutical benefits are supplied.
record form has the same meaning as in Part VII of the Act.
registered pharmacist means an individual who is registered under the National Law in the pharmacy profession.
Regulations means the National Health (Pharmaceutical Benefits) Regulations 2017.
repeat authorisation has the same meaning as in the Regulations.
5A Application of this Determination
This Determination applies to the dispensing and supply of a drug or medicinal preparation if:
(a) the supply of the drug or medicinal preparation is to be a supply of a pharmaceutical benefit under Part VII of the Act (other than a supply taken, because of subsection 99(2A), (2AB) or (2B) of the Act, to be a supply otherwise than under Part VII of the Act); or
(b) it is purported that the supply of the drug or medicinal preparation is to be a supply of a pharmaceutical benefit under Part VII of the Act (other than a supply taken, because of subsection 99(2A), (2AB) or (2B) of the Act, to be a supply otherwise than under Part VII of the Act).
Note 1: For example, this Determination does not apply to the dispensing and supply of a drug or medicinal preparation if:
(a) the drug or medicinal preparation is not a pharmaceutical benefit; or
(b) both:
(i) the drug or medicinal preparation is supplied on the basis of a prescription; and
(ii) the person presenting the prescription requests that the drug or medicinal preparation not be supplied as a pharmaceutical benefit under Part VII of the Act.
Note 2: For example, this Determination does not apply to the dispensing and supply of a pharmaceutical benefit if:
(a) the person to whom the pharmaceutical benefit is supplied is not covered by subsection 86(1) of the Act (entitlement to receive pharmaceutical benefits); or
(b) the following circumstances apply:
(i) the pharmaceutical benefit is supplied on the basis of a prescription;
(ii) the pharmaceutical benefit is determined, under subsection 85(7) of the Act, to be a relevant pharmaceutical benefit for the purposes of section 88A of the Act (prescription of certain pharmaceutical benefits authorised only in certain circumstances);
(iii) the writing of the prescription was not authorised as mentioned in that section.
Part 2—Conditions
6 Standards of practice
An approved pharmacist must, in dispensing and supplying pharmaceutical benefits:
(a) comply with all legal requirements for the practice of pharmacy; and
(b) treat patients with dignity regardless of manner of payment, race, sex, age, nationality, religion, disability or any other factor; and
(c) comply with the Code of Ethics for Pharmacists (2017), published by the Pharmaceutical Society of Australia on 1 February 2017; and
(d) comply with the Professional Practice Standards – Version 5 – June 2017, published by the Pharmaceutical Society of Australia in June 2017, in relation to each patient, subject to the patient’s preparedness to:
(i) ensure that the pharmacist has ready access to the patient’s medication history; and
(ii) provide relevant personal medical information necessary for the pharmacist to individualise patient care; and
(iii) authorise medical practitioners and other health care practitioners to release relevant medical information necessary for the pharmacist to act responsibly and reasonably and to individualise patient care; and
(iv) allow the pharmacist sufficient time to dispense medications; and
(v) follow advice and directions given by the patient’s medical practitioner or pharmacist and report any unusual or adverse reactions as soon as possible; and
(e) maintain a disciplined dispensing procedure that includes:
(i) attention to accuracy of product or ingredient selection; and
(ii) accuracy of calculations; and
(iii) application of accepted techniques for the preparation of pharmaceutical products; and
(iv) appropriate packaging and storage; and
(v) accuracy of the final product; and
(vi) adequate information for the patient.
Note 1: The following are examples for subparagraph (d)(i) of ways that a patient could ensure that an approved pharmacist has ready access to the patient’s medication history:
(a) the patient having all medications, including pharmaceutical benefits, dispensed at or from a single approved premises for the pharmacist;
(b) the patient providing the pharmacist with the patient’s record forms (if any);
(c) the patient authorising the transfer of the patient’s medication history to the approved pharmacist.
Note 2: The Code of Ethics for Pharmacists (2017) and the Professional Practice Standards – Version 5 – June 2017 could in 2023 be viewed on the Pharmaceutical Society of Australia’s website (https://www.psa.org.au).
7 Continuing education
An approved pharmacist must maintain the currency of his or her pharmaceutical knowledge in accordance with the National Competency Standards Framework for Pharmacists in Australia 2016, published by the Pharmaceutical Society of Australia in 2016.
8 Ensuring other pharmacists at approved premises comply with conditions
An approved pharmacist that is approved in respect of particular premises must ensure that a registered pharmacist:
(a) who is not an approved pharmacist in respect of those premises; and
(b) who dispenses pharmaceutical benefits at those premises;
complies with the conditions set out in this Determination.
9 No purported supply of pharmaceutical benefits at or from unapproved premises
Purported supply at unapproved premises
(1) An approved pharmacist must not purport to supply a pharmaceutical benefit at premises that are not approved premises for the pharmacist.
Note: A reference to the supply of pharmaceutical benefits at premises is a reference to the supply of pharmaceutical benefits to people who are at the premises when the supply is made (see subsection 4(3) of the Act).
Purported supply from unapproved premises
(2) An approved pharmacist must not purport to supply a pharmaceutical benefit from premises that are not approved premises for the pharmacist.
10 Requirements for supply of pharmaceutical benefits at or from approved premises—dispensing steps
(1) An approved pharmacist must not supply a pharmaceutical benefit at or from approved premises for the pharmacist if a requirement in this section is not met in relation to the dispensing of the benefit.
Benefit must be at approved premises when dispensing steps performed
(2) The benefit must be at the approved premises when each dispensing step in the dispensing of the benefit is performed.
Registered pharmacist must dispense or supervise dispensing
(3) A registered pharmacist must dispense, or directly supervise the dispensing of, the benefit.
Registered pharmacist must be physically present at approved premises when dispensing steps performed
(4) The registered pharmacist dispensing, or directly supervising the dispensing of, the benefit must be physically present at the approved premises when each dispensing step in the dispensing of the benefit is performed.
(1) An approved pharmacist must not supply a pharmaceutical benefit at or from approved premises for the pharmacist if:
(a) the benefit is supplied on the basis of a prescription that is not a medication chart prescription; and
(b) the requirement in subsection (2) is not met in relation to the dispensing of the benefit.
(2) The registered pharmacist dispensing, or directly supervising the dispensing of, the benefit must, when the step mentioned in paragraph (a) of the definition of dispensing step in section 5 is performed, see the prescription at the approved premises.
Note: For supplies of pharmaceutical benefits without prescriptions, see the following:
(a) subsection 89A(1) of the Act and section 46 of the Regulations (supply without prescription);
(b) section 33 of the Regulations (prescriber bag supplies);
(c) section 48 of the Regulations (supply before surrender of written prescription).
Advances
(1) An approved pharmacist must not seek an advance under subsection 99AB(1) of the Act in relation to:
(a) the purported supply of a pharmaceutical benefit as mentioned in subsection 9(1) or (2) of this Determination; or
(b) the supply of a pharmaceutical benefit if the supply contravened subsection 10(1) or 11(1) of this Determination.
Claims for payment
(2) An approved pharmacist must not make a claim for payment from the Commonwealth in relation to:
(a) the purported supply of a pharmaceutical benefit as mentioned in subsection 9(1) or (2); or
(b) the supply of a pharmaceutical benefit if the supply contravened subsection 10(1) or 11(1).
Note: Section 99 of the Act does not authorise payment in respect of the supply of a drug or medicinal preparation by an approved pharmacist at or from premises in respect of which the pharmacist is not approved (see paragraph 99(3)(b) of the Act).
13 Deferred supply authorisations to be prepared only at approved premises
(1) This section applies to the preparation by an approved pharmacist of a deferred supply authorisation.
(2) The approved pharmacist must ensure that the authorisation is prepared by, or under the direct supervision of, a registered pharmacist who is physically present at premises that are approved premises for the approved pharmacist.
14 Approval numbers not to be used in connection with unapproved premises
An approved pharmacist must not use, or allow the use of, the pharmacist’s approval number in respect of particular premises in relation to:
(a) the dispensing of a pharmaceutical benefit at any other premises; or
(b) the purported supply of a pharmaceutical benefit at or from any other premises; or
(c) the preparation of a repeat authorisation at any other premises; or
(d) the preparation of a deferred supply authorisation at any other premises.
Note 1: For example (for paragraphs (a) and (b)), an approved pharmacist must not affix (or allow to be affixed) a label to a pharmaceutical benefit purportedly supplied by the approved pharmacist if:
(a) the label displays the approval number allotted in respect of premises that are approved premises for the pharmacist; and
(b) the benefit is dispensed at, or purportedly supplied at or from, premises other than those approved premises for the pharmacist.
Note 2: For example (for paragraph (c)), an approved pharmacist must not mark (or allow the marking) on a repeat authorisation the approval number allotted in respect of premises that are approved premises for the pharmacist if the repeat authorisation is prepared at premises other than those approved premises for the pharmacist.
Note 3: For example (for paragraph (d)), an approved pharmacist must not mark (or allow the marking) on a deferred supply authorisation the approval number allotted in respect of premises that are approved premises for the pharmacist if the deferred supply authorisation is prepared at premises other than those approved premises for the pharmacist.
15 Approved pharmacists not to enter into certain arrangements
An approved pharmacist must not enter into an arrangement with the owner or operator of another pharmacy business for the supply by the approved pharmacist of pharmaceutical benefits to persons presenting at that pharmacy business.
Part 3—Application, saving and transitional provisions
(1) Despite the amendments of this Determination made by Schedule 1 to the National Health Legislation Amendment (Conditions of Approval for Approved Pharmacists) Instrument 2023, this Determination continues to apply, as if those amendments had not been made, in relation to an approved pharmacist to whom subsection (2) applies during the period mentioned in subsection (3) for the pharmacist.
(2) For the purposes of subsection (1), this subsection applies to an approved pharmacist if, immediately before 1 June 2023, the Pharmaceutical Services Federal Committee of Inquiry was inquiring into a matter that concerns the services or conduct of the pharmacist.
(3) For the purposes of subsection (1), the period for the pharmacist begins on 1 June 2023 and ends at the end of the day on which the Committee:
(a) gives its report in relation to the matter to the pharmacist; or
(b) gives the pharmacist notice in writing that the inquiry has terminated.
Endnotes
The endnotes provide information about this compilation and the compiled law.
The following endnotes are included in every compilation:
Endnote 1—About the endnotes
Endnote 2—Abbreviation key
Endnote 3—Legislation history
Endnote 4—Amendment history
Abbreviation key—Endnote 2
The abbreviation key sets out abbreviations that may be used in the endnotes.
Legislation history and amendment history—Endnotes 3 and 4
Amending laws are annotated in the legislation history and amendment history.
The legislation history in endnote 3 provides information about each law that has amended (or will amend) the compiled law. The information includes commencement details for amending laws and details of any application, saving or transitional provisions that are not included in this compilation.
The amendment history in endnote 4 provides information about amendments at the provision (generally section or equivalent) level. It also includes information about any provision of the compiled law that has been repealed in accordance with a provision of the law.
Editorial changes
The Legislation Act 2003 authorises First Parliamentary Counsel to make editorial and presentational changes to a compiled law in preparing a compilation of the law for registration. The changes must not change the effect of the law. Editorial changes take effect from the compilation registration date.
If the compilation includes editorial changes, the endnotes include a brief outline of the changes in general terms. Full details of any changes can be obtained from the Office of Parliamentary Counsel.
Misdescribed amendments
A misdescribed amendment is an amendment that does not accurately describe how an amendment is to be made. If, despite the misdescription, the amendment can be given effect as intended, then the misdescribed amendment can be incorporated through an editorial change made under section 15V of the Legislation Act 2003.
If a misdescribed amendment cannot be given effect as intended, the amendment is not incorporated and “(md not incorp)” is added to the amendment history.
Endnote 2—Abbreviation key
ad = added or inserted | o = order(s) |
am = amended | Ord = Ordinance |
amdt = amendment | orig = original |
c = clause(s) | par = paragraph(s)/subparagraph(s) |
C[x] = Compilation No. x | /sub‑subparagraph(s) |
Ch = Chapter(s) | pres = present |
def = definition(s) | prev = previous |
Dict = Dictionary | (prev…) = previously |
disallowed = disallowed by Parliament | Pt = Part(s) |
Div = Division(s) | r = regulation(s)/rule(s) |
ed = editorial change | reloc = relocated |
exp = expires/expired or ceases/ceased to have | renum = renumbered |
effect | rep = repealed |
F = Federal Register of Legislation | rs = repealed and substituted |
gaz = gazette | s = section(s)/subsection(s) |
LA = Legislation Act 2003 | Sch = Schedule(s) |
LIA = Legislative Instruments Act 2003 | Sdiv = Subdivision(s) |
(md) = misdescribed amendment can be given | SLI = Select Legislative Instrument |
effect | SR = Statutory Rules |
(md not incorp) = misdescribed amendment | Sub‑Ch = Sub‑Chapter(s) |
cannot be given effect | SubPt = Subpart(s) |
mod = modified/modification | underlining = whole or part not |
No. = Number(s) | commenced or to be commenced |
Endnote 3—Legislation history
Name | Registration | Commencement | Application, saving and transitional provisions |
National Health (Pharmaceutical Benefits) (Conditions of approval for approved pharmacists) Determination 2017 (PB 70 of 2017) | 29 Sept 2017 (F2017L01297) | 30 Sept 2017 (s 2) |
|
National Health Legislation Amendment (Conditions of Approval for Approved Pharmacists) Instrument 2023 (PB 17 of 2023) | 1 May 2023 (F2023L00511) | Sch 1: 1 June 2023 (s 2(1) item 1) | — |
Endnote 4—Amendment history
Provision affected | How affected |
Title.................... | am F2023L00511 |
Part 1 |
|
Part 1 heading............. | ad F2023L00511 |
s 1..................... | am F2023L00511 |
s 2..................... | rep LA s 48D |
s 3..................... | rep LA s 48C |
s 4..................... | am F2023L00511 |
s 5..................... | am F2023L00511 |
s 5A.................... | ad F2023L00511 |
Part 2 |
|
Part 2 heading............. | ad F2023L00511 |
s 6..................... | am F2023L00511 |
s 7..................... | am F2023L00511 |
s 8..................... | rs F2023L00511 |
s 9..................... | rs F2023L00511 |
s 10.................... | ad F2023L00511 |
s 11.................... | ad F2023L00511 |
s 12.................... | ad F2023L00511 |
s 13.................... | ad F2023L00511 |
s 14.................... | ad F2023L00511 |
s 15.................... | ad F2023L00511 |
Part 3 |
|
Part 3................... | ad F2023L00511 |
s 16.................... | ad F2023L00511 |