National Health (Pharmaceutical Benefits) (Conditions of approval for approved pharmacists) Determination 2007 (Cth)

Case

National Health (Pharmaceutical Benefits) (Conditions of approval for approved pharmacists) Determination 2007 (PB 42 of 2007)

as amended

made under paragraph 92A (1) (f) of the National Health Act 1953.

Compilation start date:   1 April 2015

Includes amendments up to:           PB 24 of 2015

About this compilation

This compilation

This is a compilation of the National Health (Pharmaceutical Benefits) (Conditions of approval for approved pharmacists) Determination 2007 (PB 42 of 2007) as in force on 1 April 2015. It includes any commenced amendment affecting the legislation to that date.

This compilation was prepared on 21 April 2015.

The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of each amended provision.

Uncommenced amendments

The effect of uncommenced amendments is not reflected in the text of the compiled law but the text of the amendments is included in the endnotes.

Application, saving and transitional provisions for provisions and amendments

If the operation of a provision or amendment is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.

Modifications

If a provision of the compiled law is affected by a modification that is in force, details are included in the endnotes.

Provisions ceasing to have effect

If a provision of the compiled law has expired or otherwise ceased to have effect 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 of approval for approved pharmacists) Determination 2007.

    (2)   This Determination may also be cited as Determination No. PB 42 of 2007.

  2. Commencement

    This Determination commences on 29 August 2007.

  3. Revocation

    Determination No. PB 16 of 1995 made by the Minister on 10 November 1995 under paragraph 92A (1) (f) of the National Health Act 1953 is revoked.

  4. Purpose

    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 Under subsection 84 (1) of the Act, approved pharmacist means a person for the time being approved under section 90 of the Act and includes:

    (a) a person treated as having been so approved under any provision of a law of the Commonwealth other than section 91 of the Act; and

    (b) except so far as subsection 90 (3) of the Act is concerned — a person treated as having been so approved under section 91 of the Act.

4A           Definitions

In this determination:

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.

medication chart prescription has the same meaning as in the National Health (Pharmaceutical Benefits) Regulations 1960.

reference time means the start of the day the National Health (Pharmaceutical Benefits) (Conditions of approval for approved pharmacists) Amendment (Supply from Premises) Determination 2014 commences.

  1. Standards of practice

    An approved pharmacist must, in dispensing prescriptions for pharmaceutical benefits and in 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 Pharmaceutical Society of Australia’s Code of Ethics for Pharmacists 2011, as existing at the reference time; and

    (d)    comply with the Pharmaceutical Society of Australia’s Professional Practice Standards 2010, as existing at the reference time, 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.

    Examples for subparagraph (d) (i) of ways of ensuring that a pharmacist has ready access to a patient’s medication history

    ·Having all prescriptions dispensed at a single pharmacy

    ·Providing the pharmacist with a patient‑held medication record form from another pharmacy or a prescriber

    ·Authorising the transfer of the patient’s medication history from another pharmacy.

    Note:          The Code of Ethics for Pharmacists 2011 and the Professional Practice Standards 2010 could in 2014 be viewed on the Pharmaceutical Society of Australia’s website (>

    Continuing education

    An approved pharmacist must maintain the currency of his or her pharmaceutical knowledge in accordance with the Pharmaceutical Society of Australia’s National Competency Standards Framework for Pharmacists in Australia 2010, as existing at the reference time.

    Note:          The National Competency Standards Framework for Pharmacists in Australia 2010 could in 2014 be viewed on the Pharmaceutical Society of Australia’s website (>

    Other pharmacists at pharmacy

    A person who is an approved pharmacist in respect of a pharmacy at particular premises must ensure that a pharmacist:

    (a)    who is not an approved pharmacist; and

    (b)    who supplies pharmaceutical benefits at or from those premises;

    complies with the conditions set out in sections 5 and 6.

8              Claims for payment

(1)  An approved pharmacist must not make a claim for payment from the Commonwealth in relation to the supply of a pharmaceutical benefit unless it was supplied at or from approved premises for the pharmacist.

(2)  An approved pharmacist must not make a claim for payment from the Commonwealth in relation to the supply of a pharmaceutical benefit if that pharmaceutical benefit was never at approved premises for the pharmacist.

(3)  An approved pharmacist must not make a claim for payment from the Commonwealth in relation to the supply of a pharmaceutical benefit unless the pharmacist, or an agent of the pharmacist, was present at approved premises for the pharmacist at the time the pharmaceutical benefit was dispensed.

(4)  An approved pharmacist must not make a claim for payment from the Commonwealth in relation to the supply of a pharmaceutical benefit on the basis of a prescription (other than a medication chart prescription) unless the pharmacist, or an agent of the pharmacist, has seen the prescription at approved premises for the pharmacist.

Note: A supply in accordance with subsection 89A(1) of the National Health Act 1953 (supply of pharmaceutical benefit without prescription) or on an order lodged under regulation 16 of the National Health (Pharmaceutical Benefits) Regulations 1960 (prescriber bag supplies) would not be a supply on the basis of a prescription.

(5)  An approved pharmacist must not make a claim for payment from the Commonwealth in relation to the supply of a pharmaceutical benefit on the basis of a medication chart prescription unless the pharmacist, or an agent of the pharmacist, has seen the chart or a copy of the chart containing the prescription at approved premises for the pharmacist.

(6)  Subsections (2) to (5) do not limit subsection (1).

(7) This section does not apply in relation to the supply of a pharmaceutical benefit in respect of which the pharmacist is entitled to a payment in accordance with subsection 99(3A) of the National Health Act 1953 (supply of pharmaceutical benefit before obtaining approval).

Note: See also subsection 100(3) of the National Health Act 1953 (instruments made for the purposes of Part VII of that Act have effect subject to special arrangements).

9              Application of amendments made by the National Health (Pharmaceutical Benefits) (Conditions of approval for approved pharmacists) Amendment (Supply from Premises) Determination 2014

(1)  The amendments made by Schedule 1 to the National Health (Pharmaceutical Benefits) (Conditions of approval for approved pharmacists) Amendment (Supply from Premises) Determination 2014 apply on and after the commencement of that Schedule in relation to an approved pharmacist’s approval, whether it was granted before, on or after that commencement.

(2)  Section 8 of this determination, as inserted by Schedule 1 to the National Health (Pharmaceutical Benefits) (Conditions of approval for approved pharmacists) Amendment (Supply from Premises) Determination 2014, applies in relation to a supply of a pharmaceutical benefit that occurs on or after the commencement of that Schedule.

(3)  This section is repealed on the day after the end of the period of 6 months beginning on the day this section commences.

Endnotes

Endnote 1—About the endnotes

The endnotes provide details of the history of this legislation and its provisions. The following endnotes are included in each compilation:

Endnote 1—About the endnotes
Endnote 2—Abbreviation key
Endnote 3—Legislation history
Endnote 4—Amendment history
Endnote 5—Uncommenced amendments
Endnote 6—Modifications
Endnote 7—Misdescribed amendments
Endnote 8—Miscellaneous

If there is no information under a particular endnote, the word “none” will appear in square brackets after the endnote heading.

Abbreviation key—Endnote 2
The abbreviation key in this endnote 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 the compiled law. The information includes commencement information for amending laws and details of 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 level. It also includes information about any provisions that have expired or otherwise ceased to have effect in accordance with a provision of the compiled law.

Uncommenced amendments—Endnote 5
The effect of uncommenced amendments is not reflected in the text of the compiled law, but the text of the amendments is included in endnote 5.

Modifications—Endnote 6

If the compiled law is affected by a modification that is in force, details of the modification are included in endnote 6.

Misdescribed amendments—Endnote 7

An amendment is a misdescribed amendment if the effect of the amendment cannot be incorporated into the text of the compilation. Any misdescribed amendment is included in endnote 7.

Miscellaneous—Endnote 8
Endnote 8 includes any additional information that may be helpful for a reader of the compilation.

Endnote 2—Abbreviation key

ad = added or inserted pres = present
am = amended prev = previous
c = clause(s) (prev) = previously
Ch = Chapter(s) Pt = Part(s)
def = definition(s) r = regulation(s)/rule(s)
Dict = Dictionary Reg = Regulation/Regulations
disallowed = disallowed by Parliament reloc = relocated
Div = Division(s) renum = renumbered
exp = expired or ceased to have effect rep = repealed
hdg = heading(s) rs = repealed and substituted
LI = legislative instrument s = section(s)
LIA = Legislative Instruments Act 2003 Sch = Schedule(s)
mod = modified/modification Sdiv = Subdivision(s)
No = Number(s) SLI = Select Legislative Instrument
o = order(s) SR = Statutory Rules
Ord = Ordinance Sub-Ch = Sub-Chapter(s)
orig = original SubPt = Subpart(s)
par = paragraph(s)/subparagraph(s)
          /sub-subparagraph(s)

Endnote 3—Legislation history

Name FRLI registration or gazettal Commencement Application, saving and transitional provisions

PB 42 of 2007

28 Aug 2007
(F2007L02703)
29 Aug 2007

PB 81 of 2014

19 Nov 2014
(F2014L01559)
1 Dec 2014
PB 24 of 2015

9 April 2015

(F2015L00511)

1 April 2015

Endnote 4—Amendment history

Provision affected How affected
s 4A....................................... ad. PB 81 of 2014
s 5.......................................... am PB 81 of 2014
s 6...................................... am am PB 81 of 2014
s 8......................................... a ad PB 81 of 2014; PB24 of 2015
s 9.......................................... ad PB 81 of 2014

Endnote 5—Uncommenced amendments [none]

Endnote 6—Modifications [none]

Endnote 7—Misdescribed amendments [none]

Endnote 8—Miscellaneous [none]

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