Drugs, Poisons and Controlled Substances Amendment (Administration of Schedule 3 and 4 Poisons by Pharmacists) Regulations 2016
Authorised by the Chief Parliamentary Counsel
Authorised Version
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Drugs, Poisons and Controlled Substances
Amendment (Administration of Schedule 3 and 4
Poisons by Pharmacists) Regulations 2016
S.R. No. 20/2016
TABLE OF PROVISIONS
Regulation Page
1 Objective 1
2 Authorising provisions 1
3 Commencement 1
4 Pharmacist administration, sale or supply authorised from within
Victoria 2
5 New regulations 49A and 49B inserted 2
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Endnotes 5
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1
STATUTORY RULES 2016
S.R. No. 20/2016
Drugs, Poisons and Controlled Substances Act 1981
Drugs, Poisons and Controlled Substances
Amendment (Administration of Schedule 3 and 4
Poisons by Pharmacists) Regulations 2016
The Governor in Council makes the following Regulations:
Dated: 12 April 2016
Responsible Minister:
JILL HENNESSY
Minister for Health
ANDREW ROBINSON
Clerk of the Executive Council
1 Objective
The objective of these Regulations is to amend
the Drugs, Poisons and Controlled Substances
Regulations 2006 in relation to the administration
of Schedule 3 poisons and Schedule 4 poisons by
pharmacists.
2 Authorising provisions
These Regulations are made under sections 129
and 132 of the Drugs, Poisons and Controlled
Substances Act 1981.
3 Commencement
These Regulations come into operation on
13 April 2016.
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Drugs, Poisons and Controlled Substances Amendment (Administration of
Schedule 3 and 4 Poisons by Pharmacists) Regulations 2016
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4 Pharmacist administration, sale or supply
authorised from within Victoria
After regulation 15(1)(c) of the Drugs, Poisons
and Controlled Substances Regulations 2006 1
insert—
"(ca) in accordance with regulation 49A(1); or".
5 New regulations 49A and 49B inserted
After regulation 49 of the Drugs, Poisons and
Controlled Substances Regulations 2006 insert—
"49A Administration of Schedule 4 poison by a
pharmacist without instruction
(1) A pharmacist may administer a Schedule 4
poison without an instruction from a
registered medical practitioner, dentist, nurse
practitioner or an authorised registered
midwife if—
(a) the pharmacist has taken all reasonable
steps to ensure a therapeutic need exists
for the poison; and
(b) the Secretary has approved the poison
under regulation 49B; and
(c) the administration complies with the
conditions specified in the approval
(if any).
(2) A pharmacist may administer a Schedule 3
poison without an instruction from a
registered medical practitioner, dentist, nurse
practitioner or an authorised registered
midwife if—
(a) as a consequence of the administration
of a Schedule 4 poison, a therapeutic
need exists for the Schedule 3 poison;
and
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Drugs, Poisons and Controlled Substances Amendment (Administration of
Schedule 3 and 4 Poisons by Pharmacists) Regulations 2016
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(b) the pharmacist has taken all reasonable
steps to ensure that therapeutic need
exists.
(3) Nothing in subregulation (2) limits any other
authorisation of a pharmacist to administer a
Schedule 3 poison.
49B Secretary may approve Schedule 4 poison
for administration by pharmacist without
instruction
(1) For the purposes of regulation 49A(1), the
Secretary may, by notice published in the
Government Gazette, approve a Schedule 4
poison as suitable for administration as
described in that regulation.
(2) An approval notice under subregulation (1)
takes effect—
(a) on the date of publication of the
approval notice in the Government
Gazette; or
(b) on a later date specified in the notice.
(3) The Secretary must not approve a Schedule 4
poison under subregulation (1) unless the
Secretary considers that the approval is
necessary for the provision of health
services.
(4) The Secretary may specify in an approval
notice under subregulation (1) that the
approval is subject to—
(a) a condition that a pharmacist may
administer the Schedule 4 poison
specified in the approval only in
premises that satisfy specified criteria;
or
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Drugs, Poisons and Controlled Substances Amendment (Administration of
Schedule 3 and 4 Poisons by Pharmacists) Regulations 2016
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(b) a condition that a pharmacist may
administer the Schedule 4 poison
specified in the approval only if the
pharmacist has completed specified
training or qualifications; or
(c) a condition that a pharmacist may
administer the Schedule 4 poison
specified in the approval only to
persons belonging to a specified class;
or
(d) any other condition the Secretary
considers is necessary for the proper
administration of the Schedule 4
poison.".
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Endnotes
Drugs, Poisons and Controlled Substances Amendment (Administration of
Schedule 3 and 4 Poisons by Pharmacists) Regulations 2016
S.R. No. 20/2016
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Endnotes
1 Reg. 4: S.R. No. 57/2006. Reprint No. 1 as at 16 June 2011. Reprinted to
S.R. No. 131/2010 and subsequently amended by S.R. Nos 136/2012,
50/2013, 107/2013, 108/2013, 194/2014, 14/2015 and 110/2015.
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