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National Health (Pharmaceutical Benefits) Amendment Regulation 2012 (No. 3)

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National Health (Pharmaceutical Benefits) Amendment Regulation 2012 (No. 3)1
Select Legislative Instrument 2012 No. 141
I, QUENTIN BRYCE, Governor-General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following regulation under the National Health Act 1953.
Dated 28 June 2012
QUENTIN BRYCE
Governor-General
By Her Excellency’s Command
TANYA PLIBERSEK
Minister for Health
1              Name of regulation
                This regulation is the National Health (Pharmaceutical Benefits) Amendment Regulation 2012 (No. 3).
2              Commencement
                This regulation commences on 1 July 2012.
3              Amendment of National Health (Pharmaceutical Benefits) Regulations 1960
                Schedule 1 amends the National Health (Pharmaceutical Benefits) Regulations 1960.
Schedule 1        Amendments
(section 3)
 
[1]           Subregulation 5 (1), definition of authority prescription, including the note
substitute
authority prescription means a prescription that prescribes a pharmaceutical benefit and that has been authorised:
                (a)    in accordance with subregulation 13 (5); or
               (b)    in accordance with authority required procedures that:
                          (i)    are part of the circumstances determined by the Minister under paragraph 85 (7) (b) of the Act for the pharmaceutical benefit; or
                         (ii)    are part of the conditions determined by the Minister under subsection 85A (2A) of the Act for the pharmaceutical benefit; or
                        (iii)    are incorporated by reference into the circumstances determined for the pharmaceutical benefit under subsection 85B (5) of the Act.
[2]           Subregulation 5 (1), definition of concessional benefit prescription
omit
[3]           Subregulation 5 (1), definition of concession card prescription
omit
[4]           Subregulation 5 (1), definition of entitlement card prescription
omit
[5]           Subregulation 5 (1)
insert
medication chart prescription means a prescription mentioned in subregulation 19AA (1).
[6]           Subregulation 5 (1), definition of paper-based prescription
omit
, including an authority prescription,
[7]           Subregulation 5 (1)
insert
paperless claim for payment means a claim for a payment from the Commonwealth, in relation to the supply of a pharmaceutical benefit:
                (a)    using the Claims Transmission System, within the meaning given by subsection 99AAA (1) of the Act; and
               (b)    to which, or in which, prescriptions, repeat authorisations or deferred supply authorisations are not required to be attached or included.
[8]           Subregulation 5 (1)
insert
supply certification form: see subregulation (4).
[9]           Subregulation 5 (1), definition of prescription
substitute
prescription means a paper-based prescription or an electronic prescription, and includes an authority prescription and a medication chart prescription.
[10]         Subregulation 5 (1)
insert
repeat authorisation form means the form mentioned in subparagraph 26 (1A) (a) (i), which is used, among other purposes, to support a claim for a payment from the Commonwealth under section 99AAA of the Act in relation to a supply of a pharmaceutical benefit.
[11]         Subregulation 5 (1)
insert
residential care has the meaning given by section 41–3 of the Aged Care Act 1997.
[12]         Subregulation 5 (1)
insert
residential medication chart has the meaning given by subregulation 19AA (6).
[13]         After subregulation 5 (3)
insert
         (4)   In these Regulations, a supply certification form means a form that:
                (a)    is included by an approved supplier in a paperless claim for payment as certification that the supply of a pharmaceutical benefit is made in accordance with the Act; and
               (b)    includes the following details:
                          (i)    the name and approval number of the supplier;
                         (ii)    the address of the premises at or from which the pharmaceutical benefits mentioned in subparagraph (iv) are supplied, being premises at or from which the supplier is approved to supply pharmaceutical benefits;
                        (iii)    the number used by the supplier to identify the claim period;
                        (iv)    for each type of prescription that is covered by the claim—the serial numbers of the pharmaceutical benefits that have been supplied and that are the subject of the claim, identified using a range of serial numbers for each of the following categories:
                                   (A)     general patients;
                                   (B)     concessional beneficiaries, dependants of concessional beneficiaries and holders of concession cards;
                                   (C)     holders of entitlement cards;
                         (v)    the total number of claims for each category mentioned in sub-subparagraphs (iv) (A) to (C);
                        (vi)    a certification that the pharmaceutical benefits mentioned in subparagraph (iv) have been supplied in accordance with the Act and instruments made under that Act;
                       (vii)    a declaration that the information in the form is correct, and signed by the supplier or an authorised representative of the supplier;
                      (viii)    particulars that identify the person signing the form under subparagraph (vii).
Example for subparagraph (b) (iv)
A medication chart prescription is a type of prescription.
[14]         Part II, heading
substitute
Part 2                 Approvals under Part VII of the Act
  
[15]         Part IIAAA, heading
substitute
Part 2A               Co-marketed brands
  
[16]         Part IIAA, heading
substitute
Part 2B               Safety net concession cards
  
[17]         Regulation 9AF
substitute
9AF         Prescribed offices
                For subsection 84DA (5) of the Act, each office mentioned in Schedule 6 is a prescribed office.
[18]         Part IIA, heading
substitute
Part 2C               Pharmaceutical benefits entitlement cards
  
[19]         Regulation 9BA
substitute
9BA        Prescribed offices
                For subsection 84E (5) of the Act, each office mentioned in Schedule 6 is a prescribed office.
[20]         Part III, heading
substitute
Part 3                 Pharmaceutical benefits
  
[21]         After subregulation 13 (1)
insert
Note   See subsection 85A (3A) of the Act for the Minister’s power to determine rules relating to an authorisation of a variation.
[22]         Part IV, heading
substitute
Part 4                 Supply of pharmaceutical benefits by particular PBS prescribers
  
[23]         Part V, heading
substitute
Part 5                 Prescriptions and supply
  
[24]         Before regulation 19
insert
18B         Purpose of Part
         (1)   Unless otherwise specified, this Part is made for section 105 of the Act.
         (2)   This Part:
                (a)    prescribes terms and conditions relating to the supply of pharmaceutical benefits; and
               (b)    provides rules about writing prescriptions.
[25]         Subregulation 19 (1)
omit
including an authority prescription,
insert
other than a medication chart prescription,
[26]         Paragraph 19 (1) (b)
omit
for an authority prescription —
insert
for an authority prescription other than an authority prescription mentioned in subregulation (6)—
[27]         Subparagraph 19 (1) (b) (ii)
substitute
                         (ii)    the streamlined authority code that is part of:
                                   (A)     the circumstances determined by the Minister under paragraph 85 (7) (b) of the Act for the pharmaceutical benefit that is prescribed; or
                                   (B)     the conditions determined by the Minister under subsection 85A (2A) of the Act for the pharmaceutical benefit that is prescribed; and
[28]         Paragraph 19 (1) (c)
omit
and signs the prescription
[29]         Subregulation 19 (1), note
omit
[30]         Subregulation 19 (2)
omit
a prescription
insert
a prescription, other than a medication chart prescription,
[31]         After subregulation 19 (5)
insert
         (6)   Paragraph (1) (b) does not apply to authority prescriptions that have been authorised in accordance with authority required procedures that are incorporated by reference into the circumstances determined for a pharmaceutical benefit under subsection 85B (5) of the Act.
Note   If a streamlined authority code or an authority approval number must be written on an authority prescription, and the code or number is not written on the authority prescription, the special patient contribution mentioned in subsection 85B (4) of the Act is not payable by the Commonwealth: see subsection 85B (5) of the Act.
[32]         After regulation 19
insert
19AA      Item in residential medication chart is prescription
         (1)   A completed item in a residential medication chart is a prescription (a medication chart prescription) if the chart contains the information set out for the chart in a condition determined under paragraph 93A (2) (b) of the Act.
         (2)   However, a completed item in a residential medication chart is not a medication chart prescription if it provides for the supply of a pharmaceutical benefit to more than one person.
         (3)   A medication chart prescription must not be prepared using a computer program that operates, or may operate, to indicate on a prescription by default, for subsection 103 (2A) of the Act, that only the brand of pharmaceutical benefit specified in the prescription is to be supplied.
         (4)   If a section in a residential medication chart requires a streamlined authority code (if any) to be entered, the code is the streamlined authority code that is part of:
                (a)    the circumstances determined by the Minister under paragraph 85 (7) (b) of the Act for the pharmaceutical benefit that is prescribed; or
               (b)    the conditions determined by the Minister under subsection 85A (2A) of the Act for the pharmaceutical benefit that is prescribed; or
                (c)    the circumstances determined for the pharmaceutical benefit under subsection 85B (5) of the Act.
         (5)   However, a streamlined authority code mentioned in paragraph (4) (c) does not need to be entered in a section of a chart for the section to be a completed item.
Note   If the streamlined authority code is not written in the section of the chart, the special patient contribution mentioned in subsection 85B (4) of the Act is not payable by the Commonwealth: see subsection 85B (5) of the Act.
         (6)   In this regulation:
completed item in a residential medication chart means a section of the chart:
                (a)    in which the medical practitioner prescribing the pharmaceutical benefit has:
                          (i)    entered the information about the pharmaceutical benefit that the section requires the medical practitioner to enter; and
                         (ii)    written the date of prescribing; and
                        (iii)    written his or her signature; and
               (b)    in which appears the letters ‘PBS’.
Examples for subparagraph (a) (i)
Particulars sufficient to identify the pharmaceutical benefit being prescribed, and the dose, route and frequency of administration of the pharmaceutical benefit.
Note   An item in a residential medication chart may set out fields that only need to have information filled in if the information is relevant to that prescription.
residential medication chart means a chart:
                (a)    for prescribing, and recording the administration of, pharmaceutical benefits to persons receiving residential care; and
               (b)    that contains the standard fields and characteristics for the chart, as set out in a condition determined under paragraph 93A (2) (b) of the Act.
Note   A residential medication chart may also be used for prescribing, and recording the administration of, drugs, medicines and other substances that are not pharmaceutical benefits.
[33]         Regulation 19A, heading
substitute
19A         Information about status of person
[34]         Before subregulation 19A (1)
insert
      (1A)   This regulation does not apply in relation to a medication chart prescription.
Note   See regulation 21C for information about the status of a person for a medication chart prescription, and for a continued dispensing supply under section 89A of the Act.
[35]         Regulation 20
omit
[36]         Before subregulation 21 (1)
insert
      (1A)   This regulation does not apply in relation to the supply of a pharmaceutical benefit, under subsection 93A (4) of the Act, on the basis of a medication chart prescription.
Note   See regulation 21A.
[37]         After regulation 21
insert
21A         Supply of pharmaceutical benefit on basis of medication chart prescription
         (1)   This regulation applies in relation to the supply of a pharmaceutical benefit, under subsection 93A (4) of the Act, on the basis of a medication chart prescription.
         (2)   An approved pharmacist or an approved medical practitioner may supply a pharmaceutical benefit on the basis of a medication chart prescription only if:
                (a)    a copy of the residential medication chart is given to the approved pharmacist or approved medical practitioner; and
               (b)    the residential medication chart is written in accordance with any requirements for the chart in these Regulations and any conditions determined under paragraph 93A (2) (b) of the Act; and
                (c)    the date on which the pharmaceutical benefit is supplied by the approved pharmacist or approved medical practitioner is:
                          (i)    during the period of validity of the residential medication chart; and
                         (ii)    is no later than the stop date (if any) indicated in the prescription; and
               (d)    the approved pharmacist or approved medical practitioner writes on the copy of the residential medication chart the following for the supply:
                          (i)    the approved pharmacist’s or approved medical practitioner’s name and approval number under regulation 8A;
                         (ii)    an identification number for the supply;
                        (iii)    the date on which the pharmaceutical benefit is supplied.
         (3)   For paragraph (2) (c), the period of validity of a residential medication chart:
                (a)    starts on the day in a calendar month (the first calendar month) when the first prescription for a pharmaceutical benefit is written in the residential medication chart; and
               (b)    ends on the last day of the third calendar month that starts after the first calendar month.
Example
The first prescription is written in a residential medication chart on 11 June. The period of validity of the residential medication chart starts on 11 June and ends on 30 September.
Note   calendar month is defined in section 2B of the Acts Interpretation Act 1901.
         (4)   An approved pharmacist or an approved medical practitioner may supply up to a maximum quantity of a pharmaceutical item or pharmaceutical benefit more than once on the basis of a particular medication chart prescription for the pharmaceutical benefit only if:
                (a)    the prescription indicates that an ongoing supply of the pharmaceutical benefit is authorised for the period of validity of the chart; or
               (b)    the prescription indicates a stop date for the supply of the pharmaceutical benefit and, based on the dose and frequency of administration of the pharmaceutical benefit indicated in the prescription, more than one supply of a maximum quantity of the pharmaceutical item or pharmaceutical benefit is needed before the stop date is reached.
Note   See paragraph 85A (2) (a) of the Act in relation to maximum quantities of pharmaceutical items or pharmaceutical benefits.
         (5)   If paragraphs (4) (a) and (b) do not apply, an approved pharmacist or an approved medical practitioner may only supply the quantity of the pharmaceutical benefit needed to give effect to the prescription, up to a maximum quantity of the pharmaceutical item or pharmaceutical benefit.
Note   The following information entered in the prescription may also indicate the quantity of the pharmaceutical benefit that is needed:
(a)   the dose and frequency of administration of the pharmaceutical benefit;
(b)   the date of prescribing, or the start date (if any) for administration of the pharmaceutical benefit;
(c)   the stop date (if any) for administration of the pharmaceutical benefit.
         (6)   However, for a supply:
                (a)    on the basis of a prescription mentioned in paragraph (4) (a); or
               (b)    mentioned in subregulation (5);
an approved pharmacist or an approved medical practitioner may supply up to a maximum quantity of the pharmaceutical item or pharmaceutical benefit even if the period of validity of the residential medication chart will end before administration of that quantity in accordance with the prescription would finish.
         (7)   An approved hospital authority must not supply a pharmaceutical benefit on the basis of a medication chart prescription.
21B         Continued dispensing supply of pharmaceutical benefit
         (1)   This regulation applies in relation to the supply of a pharmaceutical benefit to a person by an approved pharmacist under subsection 89A (1) of the Act.
         (2)   The approved pharmacist must not supply the pharmaceutical benefit unless the approved pharmacist writes on the repeat authorisation form for the supply:
                (a)    the approved pharmacist’s name and approval number under regulation 8A; and
               (b)    an identification number for the supply; and
                (c)    the date on which the pharmaceutical benefit is supplied by the approved pharmacist.
21C         Information about status of person—continued dispensing and medication chart prescriptions
         (1)   This regulation applies in relation to:
                (a)    the supply of a pharmaceutical benefit to a person (the patient) by an approved pharmacist under subsection 89A (1) of the Act; and
               (b)    the supply of a pharmaceutical benefit by an approved medical practitioner or approved pharmacist, under subsection 93A (4) of the Act, on the basis of a medication chart prescription written for a person (the patient).
         (2)   The approved pharmacist or approved medical practitioner must collect the following information at the time of supply:
                (a)    information about whether the patient is, at the time of the supply:
                          (i)    a concessional beneficiary or a dependant of a concessional beneficiary; or
                         (ii)    the holder of a concession card or entitlement card;
               (b)    for a person mentioned in subparagraph (a) (i)—the number specified on a card, issued by the Commonwealth, as an entitlement number (however described) in relation to the person;
                (c)    for a person mentioned in subparagraph (a) (ii)—the number of the concession card or entitlement card.
         (3)   The approved pharmacist or approved medical practitioner must include the information collected under subregulation (2) in the claim for a payment from the Commonwealth in relation to the supply using the Claims Transmission System, within the meaning given by subsection 99AAA (1) of the Act.
[38]         Subregulation 22 (5)
substitute
         (5)   This regulation does not apply to:
                (a)    a pharmaceutical benefit for which the prescription must be in writing, under a law of the State or Territory where the premises of the approved pharmacist are located; and
               (b)    a pharmaceutical benefit to be supplied, under subsection 93A (4) of the Act, on the basis of a medication chart prescription.
[39]         Paragraph 24 (1) (a)
after
written;
insert
and
[40]         Subregulation 24 (2)
omit
1 occasion
insert
one occasion
[41]         After subregulation 24 (2)
insert
         (3)   However, this regulation does not apply in relation to the writing of a medication chart prescription.
[42]         After regulation 24
insert
24A         Continued dispensing—repeated supply not to be supplied on one occasion
         (1)   This regulation applies in relation to the supply (the continued dispensing supply) of a pharmaceutical benefit by an approved pharmacist under subsection 89A (1) of the Act on the basis of a previous prescription from a PBS prescriber.
         (2)   If the PBS prescriber directed in the prescription the supply on one occasion of a quantity or number of units of the pharmaceutical benefit allowable under subsection 88 (6) of the Act, instead of directing a repeated supply, the direction does not apply for the purposes of the continued dispensing supply.
[43]         Paragraph 25 (2) (a)
omit
1 prescription
insert
one prescription
[44]         After subregulation 25 (4)
insert
Continued Dispensing
         (5)   Subject to subregulation (2), if the pharmaceutical benefit is supplied to a person by an approved pharmacist (the supplier) under subsection 89A (1) of the Act, subregulation (3) or (4) applies as if:
                (a)    the person had presented the supplier with a prescription that:
                          (i)    had been written by a PBS prescriber in accordance with the Act and these Regulations; and
                         (ii)    did not include a medicare number; and
                        (iii)    did not direct a repeated supply of the pharmaceutical benefit; and
               (b)    subparagraphs (3) (b) (ii) and (c) (ii) or (4) (b) (ii) and (c) (ii) were omitted, and the words ‘immediate supply necessary’ were required to be written on the repeat authorisation form for the supply; and
                (c)    subparagraphs (3) (b) (iii) and (c) (iii) or (4) (b) (iii) and (c) (iii) were omitted, and the supplier were required to sign the repeat authorisation form mentioned in paragraph (b).
Medication chart prescriptions
         (6)   Subject to subregulation (2), if the pharmaceutical benefit is supplied by an approved pharmacist or an approved medical practitioner (the supplier), under subsection 93A (4) of the Act, on the basis of a medication chart prescription:
                (a)    subregulation (1) does not apply; and
               (b)    subregulation (3) or (4) applies as if:
                          (i)    the supply is made to the facility providing the residential care to the person for whom the prescription was written; and
                         (ii)    the words ‘immediate supply necessary’ and the supplier’s signature were required to be written on the copy of the residential medication chart given to the supplier.
[45]         Before subregulation 26 (1)
insert
   (1AA)   This regulation does not apply in relation to the supply of a pharmaceutical benefit, under subsection 93A (4) of the Act, on the basis of a medication chart prescription.
[46]         After regulation 26
insert
26AA      Repeat authorisation form—continued dispensing
         (1)   An approved pharmacist must use a repeat authorisation form for the purposes of making a claim for a payment from the Commonwealth under section 99AAA of the Act in relation to a supply of a pharmaceutical benefit under subsection 89A (1) of the Act.
         (2)   However, the approved pharmacist must not use the form for authorising a repeated supply of the pharmaceutical benefit under that subsection.
[47]         Before subregulation 26A (1)
insert
      (1A)   This regulation does not apply in relation to the supply of a pharmaceutical benefit, under subsection 93A (4) of the Act, on the basis of a medication chart prescription.
[48]         Regulation 30
omit
When
insert
For subsection 87 (4) of the Act, when
[49]         Subregulation 31 (1)
substitute
         (1)   A person commits an offence if:
                (a)    the person receives a pharmaceutical benefit under Part VII of the Act (whether or not for the person’s own use) from an approved supplier; and
               (b)    the supply of the pharmaceutical benefit by the approved supplier is not a supply under subsection 89A (1) of the Act; and
                (c)    at the time of supply, the approved supplier is not permitted to make a paperless claim for payment in relation to the supply of the pharmaceutical benefit; and
               (d)    at the time of supply, the approved supplier asks the person to write on the prescription, repeat authorisation or deferred supply authorisation for the pharmaceutical benefit:
                          (i)    an acknowledgment that the person has received the benefit; and
                         (ii)    the date on which the person received the benefit; and
                        (iii)    if the benefit is not for the person’s own use—the person’s address; and
                (e)    it is practicable for the person to comply with the request mentioned in paragraph (d); and
                (f)    the person does not comply with the request mentioned in paragraph (d).
Penalty:   0.2 penalty units.
[50]         Subregulations 31 (3) and (4)
substitute
         (3)   An approved supplier commits an offence if:
                (a)    the approved supplier supplies a pharmaceutical benefit under Part VII of the Act, other than under subsection 89A (1) of the Act; and
               (b)    it is not practicable for the approved supplier to obtain, from the person receiving the pharmaceutical benefit (whether or not for the person’s own use), a written acknowledgement that the person has received the benefit; and
                (c)    the approved supplier does not make a paperless claim for payment in relation to the supply of the pharmaceutical benefit; and
               (d)    the approved supplier does not certify on the prescription, repeat authorisation or deferred supply authorisation for the pharmaceutical benefit:
                          (i)    the date on which the pharmaceutical benefit was supplied by the approved supplier; and
                         (ii)    the reason why it was not practicable for the approved supplier to obtain the written acknowledgement mentioned in paragraph (b).
Penalty:   0.2 penalty units.
Paperless claim for payment from Commonwealth
         (4)   An approved supplier commits an offence if:
                (a)    the approved supplier supplies a pharmaceutical benefit under Part VII of the Act, other than under subsection 89A (1) of the Act; and
               (b)    the approved supplier makes a paperless claim for payment in relation to the supply of the pharmaceutical benefit; and
                (c)    the approved supplier does not include a completed supply certification form in the paperless claim for payment.
Penalty:   0.2 penalty units.
Continued dispensing supply of pharmaceutical benefit
         (5)   A person commits an offence if:
                (a)    the person receives a pharmaceutical benefit (whether or not for the person’s own use) from an approved pharmacist under subsection 89A (1) of the Act; and
               (b)    at the time of the supply, the approved pharmacist asks the person to write on the repeat authorisation form for the supply:
                          (i)    an acknowledgement that the person has received the pharmaceutical benefit; and
                         (ii)    the date on which the person received the benefit; and
                        (iii)    if the benefit is not for the person’s own use—the person’s address; and
                (c)    it is practicable for the person to comply with the request mentioned in paragraph (b); and
               (d)    the person does not comply with the request mentioned in paragraph (b).
Penalty:   0.2 penalty units.
         (6)   An approved pharmacist commits an offence if:
                (a)    the approved pharmacist supplies a pharmaceutical benefit to a person under subsection 89A (1) of the Act; and
               (b)    it is not practicable for the approved pharmacist to obtain, from the person receiving the pharmaceutical benefit (whether or not for the person’s own use), a written acknowledgement that the person has received the benefit; and
                (c)    the approved pharmacist does not write on the repeat authorisation form for the supply:
                          (i)    the date on which the pharmaceutical benefit was supplied by the approved pharmacist; and
                         (ii)    the reason why it was not practicable for the approved pharmacist to obtain the written acknowledgement mentioned in paragraph (b).
Penalty:   0.2 penalty units.
         (7)   An offence against this regulation is an offence of strict liability.
[51]         Part VI, heading
substitute
Part 6                 Miscellaneous
  
[52]         Before regulation 32
insert
31B         Purpose of Part
                Unless otherwise specified, this Part is made for section 105 or 140 of the Act.
[53]         After subregulation 32 (1)
insert
      (1A)   However, subregulation (1) does not apply to:
                (a)    the supply of a pharmaceutical benefit under subsection 89A (1) of the Act; or
               (b)    the supply of a pharmaceutical benefit, under subsection 93A (4) of the Act, on the basis of a medication chart prescription.
Note   See regulations 32A and 32B.
[54]         After regulation 32
insert
32A         Keeping documents—continued dispensing
         (1)   This regulation applies if an approved pharmacist supplies a pharmaceutical benefit to a person under subsection 89A (1) of the Act.
         (2)   The approved pharmacist commits an offence if:
                (a)    the approved pharmacist supplies a pharmaceutical benefit to a person under subsection 89A (1) of the Act; and
               (b)    the approved pharmacist does not keep the following information for at least 2 years from the date on which the pharmaceutical benefit was supplied by the approved pharmacist:
                          (i)    the information that supports the claim for payment made under section 99AAA of the Act in relation to the supply of the pharmaceutical benefit;
                         (ii)    the information, about the supply of the pharmaceutical benefit, that is given to the PBS prescriber who most recently prescribed the pharmaceutical benefit to the person.
Penalty:   0.2 penalty units.
         (3)   An offence against this regulation is an offence of strict liability.
32B         Keeping documents—medication chart prescriptions
         (1)   This regulation applies if an approved pharmacist or an approved medical practitioner supplies a pharmaceutical benefit, under subsection 93A (4) of the Act, on the basis of a medication chart prescription.
         (2)   The approved pharmacist or approved medical practitioner commits an offence if:
                (a)    the approved pharmacist or approved medical practitioner supplies a pharmaceutical benefit on the basis of a medication chart prescription; and
               (b)    the approved pharmacist or approved medical practitioner does not keep a copy of the residential medication chart in which the prescription is written for at least 2 years from the date on which the last pharmaceutical benefit was supplied by the approved pharmacist or approved medical practitioner on the basis of a prescription in the residential medication chart.
Penalty:   0.2 penalty units.
         (3)   An offence against this regulation is an offence of strict liability.
[55]         Regulation 35, at the foot
insert
Note   See also paragraph 103 (5) (f) of the Act.
[56]         Paragraph 36 (2) (d)
omit
applies.
insert
applies; or
[57]         After paragraph 36 (2) (d)
insert
                (e)    the supply of a pharmaceutical benefit, under subsection 93A (4) of the Act, on the basis of a medication chart prescription.
[58]         After regulation 37
insert
37AA      Payment for pharmaceutical benefit supplied on basis of medication chart prescription
                For subsection 93A (6) of the Act, an approved pharmacist or approved medical practitioner who supplied a pharmaceutical benefit under subsection 93A (4) of the Act, to a prescribed institution mentioned in paragraph 93A (1) (b) of the Act, is entitled to payment from the Commonwealth for the supply of the pharmaceutical benefit at the rate, and subject to the conditions:
                (a)    determined by the Minister; and
               (b)    that apply at the time of the supply.
[59]         Part VIA, heading
substitute
Part 6A               Price reductions
  
[60]         Regulation 37A, heading
substitute
37A         Definitions for Part
[61]         Regulation 37EA
omit
prices of a listed brands of pharmaceutical items
insert
price of a listed brand of a pharmaceutical item
[62]         Regulation 38, heading
substitute
38            Definitions for Part
[63]         Regulation 38A, heading
substitute
38A         Appointments to Committee—nominating bodies
[64]         Regulation 38B, heading
substitute
38B         Number of nominations for appointment
Note
1.       All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. See www.comlaw.gov.au.