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MEDICINES, POISONS AND THERAPEUTIC GOODS REGULATION 2008 (NO 42 OF 2008)
THE LEGISLATIVE ASSEMBLY FOR
THE
AUSTRALIAN CAPITAL
TERRITORY
MEDICINES, POISONS AND
THERAPEUTIC GOODS
REGULATION 2008
SL2008-42
EXPLANATORY
STATEMENT
Minister for Health
Medicines, Poisons and Therapeutic Goods
Regulation 2008
The Medicines, Poisons and Therapeutic Goods Act 2008 (the MPTG Act)
consolidated four Acts and their regulations regarding ACT law on medicines,
poisons and prohibited substances. The Act repealed and replaced the Poisons
and Drugs Act 1978, the Poisons Act 1933, the Public
Health (Prohibited Drugs) Act 1957 and significantly amended the
Drugs of Dependence Act 1989 to effect reforms required by the
National Competition Policy Review of Drugs, Poisons and Controlled Substances
legislation (Galbally Review) and to provide for a more unified and workable
scheme. The Act adopts the Standard for the Uniform Scheduling of Drugs and
Poisons (the SUSDP), developed by the National Drugs and Poisons Schedule
Committee established under the Therapeutic Goods Act 1989
(Cwlth).
The objective of the Act, as recommended by the Galbally
Review, is to promote and protect public health and safety by minimising
medicinal misadventure with and diversion of regulated substances, accidental or
deliberate poisonings and the manufacture of regulated substances that are
subject to abuse. The Act also has the purpose of ensuring that consumers of
prescription and non-prescription medicines have adequate information to allow
them to use medicines safely and effectively. The Act establishes an
authorisation and licensing framework for medicines and poisons, as well as
grounds and powers for disciplinary action to be taken against authorised and
licences persons. The Act also controls the way in which medicines and poisons
are dealt with through a range of offences, imposing a range of potential
penalties, including the imposition of terms of imprisonment where appropriate.
Enforcement of the offences is achieved through a comprehensive range of
inspection and seizure powers, including the capacity to take and analyse
samples.
In developing the Medicines, Poisons and Therapeutic Goods
legislation an exposure draft of the Bill and Regulation was released in
December 2006 and February 2007 respectively. Both were made
available on the Legislation Register and forwarded to interested stakeholders.
Comments were received from a number of interested bodies and considered in the
further drafting of the Bill and Regulation. The Bill and Regulation have been
developed to maintain, as much as possible, the status quo for health
professionals in performing their duties.
The Regulation
The
Medicines, Poisons and Therapeutic Goods Regulation provides the detail for the
regulatory framework established by the Act. The Regulation ensures that health
professionals will still be able to prescribe, administer and dispense medicines
as they lawfully were able to do prior to commencement of the new legislation.
The Regulation also contains the more substantive detail, specific requirements,
or conditions for a range of activities and obligations contained within the
Act. Some provisions of the Regulation prescribe additional information
required for licences or authorisations, whereas other provisions impose
statutory licence conditions. There are also provisions of the Regulation
specifying requirements for activities such as labelling or
packaging.
Provisions
Given the size of this Regulation, in
places the sections are explained generally through an overview of the Chapter,
Part or Division. Individual clauses are explained in detail, where
appropriate.
Chapter 1 Preliminary
This Chapter contains
the preliminary and formal provisions. Section 1 declares the name of the
Regulation to be the Medicines, Poisons and Therapeutic Goods
Regulation 2008. Pursuant to section 2, the Regulation will share the
same commencement as the MPTG Act.
By virtue of the fact that the Act
will commence on a day fixed by the Minister, by written notice, the date fixed
by the Minister will essentially be the commencement date for the MPTG Act and
this Regulation. The only exception is amendment 6.4 in Schedule 6 of
the Regulation which will commence immediately after the MPTG Act commences.
On commencement the MPTG Act will amend the Health Professionals
Regulation 2004, which includes the insertion into Schedule 11 of the
Health Professionals Regulation 2004 a new Part 11.3. That new Part
is to be amended by amendment 6.4 in Schedule 6 of this Regulation.
Accordingly, amendment 6.4 in Schedule 6 of this Regulation cannot
occur until the MPTG Act inserts the new Part 11.3 insertion into
Schedule 11 of the Health Professionals Regulation 2004. It is for
this reason that amendment 6.4 in Schedule 6 of this Regulation will
commence immediately after the MPTG Act commences.
Sections 3 and 4
provide for the dictionary and the notes to the Regulation. Section 5 is
essentially a reminder that the Criminal Code 2000 applies to offences
against this Regulation, whereas section 6 provides an overview of matters
to which the SUSDP does not apply.
Chapter 2 Medicines – authorisations
generally
Chapter 2 addresses medicines generally, with
Part 2.1 providing an overall overview of authorisations of medicines, and
Part 2.2 explaining the inter-relationship with the Health Professional
Act 2004 and the MPTG legislation.
Part 2.1 Overview
of medicines authorisations
Section 10 General overview of
authorisations for medicines
This section reiterates that it is the MPTG
Act that prohibits dealing with medicines without an authorisation, and
section 20 of the MPTG Act sets out when a person is authorised to deal
with a medicine.
Section 11 Overview of medicines authorisations
under this regulation
Medicines authorisations under this Regulation that
are specific to health-related occupations are listed in subsection 1 of
this provision, as well as being connected to Schedule 1 of this
Regulation. Other authorisations under this Regulation are listed in
subsection 2.
Section 12 General overview of authorisation
conditions for medicines
This section essentially reiterates that
section 44 of the MPTG Act requires a person authorised to deal with a
medicine to comply with conditions to which the authorisation is subject. The
section also draws the reader’s attention to the fact that conditions on
authorisations are additional to other restrictions that may be placed upon a
person’s authorisation under the MPTG legislation.
Part 2.2
Relationship with Health Professionals Act
Section 20 Medicines
authorisations subject to Health Professionals Act
restrictions
Part 2.2 and section 20, which is the only
provision within the Part, confirm that a health professionals authorisation
under the MPTG Act to deal with a medicine is subject to any and all conditions
or restrictions to which the health professional is subject under the Health
Professionals Act 2004. Accordingly, if a health professional is not
complying with the Health Professionals Act 2004 the health
professional is also not complying with the MPTG
legislation.
Chapter 3 Medicines – supply
authorities
This Chapter contains provisions affecting authorisations to
supply medicines. The prescribing of medicines is addressed in Part 3.1,
requisitioning medicines in Part 3.2, and purchase orders for medicines are
addressed in Part 3.3. Standing orders for medicines, including standing
orders made by the Chief Health Officer and standing orders for institutions are
the subject of Part 3.4. Supply authorities generally for medicines are
within the final Part for the Chapter, Part 3.5.
Part 3.1 Prescribing
medicines
Division 3.1.1 Authorisation to prescribe
medicines
Pursuant to section 30, persons mentioned in column 2
of Schedule 1 of this Regulation may be authorised to prescribe a medicine.
Prescribing a medicine is authorised if prescribing of the medicine is amongst
the authorised dealings for the person listed in column 3 of
Schedule 1 in relation to that person, and the prescribing is consistent
with any listed restriction in column 3 of Schedule 1.
Additionally, where the prescription is a self-prescription the person
must not be a trainee dentist or intern doctor. A self-prescription for a
medicine must not be a restricted medicine. For section 30 a restricted
medicine is an anabolic steroid, a benzodiazepine, a controlled medicine or a
designated appendix D medicine.
The rest of the Division specifies
the conditions to which a prescriber’s authority is subject generally, or
in relation to prescriptions for human use involving controlled medicines or
designated appendix D medicines.
Generally, written prescriptions
need to comply with sections 40 and 41 of this Regulation. Where a
prescription is faxed to a pharmacist, the prescriber must send the original to
the pharmacist within 24 hours. Oral prescriptions must also comply with
section 41 of this Regulation, and a written version of the prescription
must be sent to the pharmacist within 24 hours.
Controlled
medicines prescriptions require an approval under Part 13.1 of this
Regulation. Dronabinol for human use has additional conditions. Appendix D
medicines prescriptions also require an approval, which is the subject of
Part 13.2 of this Regulation.
Division 3.1.2 Prescriptions
This Division details the
general requirements for written prescriptions, and the particulars that must
feature in a prescription. Through the operation of the dictionary in the MPTG
Act something is written even when in electronic form.
The general
requirements are reasonably straight forward. The prescription must be signed,
and if the prescription is amended at any point the amendment needs to be
initialled and dated. Prescriptions must be written in terms and symbols used
ordinarily in professional practice, thereby ensuring that any other
professional handling the prescription can read and interpret the prescription
accurately. Critically, if the prescription is for an unusual or dangerous dose
the prescriber needs to underline the reference to the dose and initial beside
it. This thereby indicates to any other professional dealing with the
prescription that the dose was not an error.
The standard particulars for
a prescription include the prescriber’s name, qualifications and business
address and telephone number, the date, and the form, strength and quantity of
medicine to be dispensed.
There are also some particulars that are only
needed for prescriptions by certain professionals, such as dentists or
optometrists. Conversely, prescriptions for an in-patient in a hospital need
not contain certain particulars.
Part 3.2 Requisitioning
medicines
Division 3.2.1 Authorisation to issue
requisitions
Section 50 Authorisation under sch 1 to issue
requisitions for medicines
– Act, s 41 (b)
Pursuant to this section, persons mentioned in column 2 of
Schedule 1 of this Regulation are authorised to issue a requisition for a
medicine if requisitioning the medicine is included in column 3 of
Schedule 1 in relation to that person, and if the issue of the requisition
is consistent with any listed restriction in column 3 of Schedule 1.
Section 51 Authorisation conditions for issuing requisitions for
medicines
– Act, s 44 (1) (b) and
(2) (b)
This section imposes a condition on a person’s
authorisation under section 50, and the condition depends on whether the
requisition was a written or oral requisition.
Written requisitions must
simply comply with sections 55 and 56 of this Regulation. An oral
requisition need only comply with section 56 of this Regulation, but the
person issuing the requisition must have a belief formed on reasonable grounds
that the requisition is reasonably necessary for the treatment of a person(s),
and the quantity requisitioned is not more than is reasonably necessary for the
treatment.
Division 3.2.2 Requisitions
Section 55 General
requirements for written requisitions
This section imposes just two
requirements. The first is that a written requisition be signed by the person
issuing the requisition. The other is if the requisition is amended at any
time, for whatever reason, the issuer of the requisition initial and date along
side the amendment. Through the operation of the dictionary in the MPTG Act
something is written even when in electronic
form.
Section 56 Particulars for requisitions
Requisitions
must, under this section, contain the name of the person issuing the requisition
and their capacity in which they are issuing the requisition. The date of issue
must also be recorded, together with the form, strength and quantity of the
medicine to be supplied on the requisition.
The pharmacy or ward to which
the medicine is to be supplied must also be recorded. A ward is, according to
the dictionary in the MPTG Act, an area of an institution used to accommodate or
treat people, including an operating theatre and an opioid dependency treatment
centre. Other areas of the hospital, such as the emergency department, would
also be covered by this definition.
Part 3.3 Medicines
purchase orders
Division 3.3.1 Authorisation to issue purchase
order
Section 60 Authorisation under sch 1 to issue purchase
orders for medicines
– Act, s 38 (1) (b) and
(2) (a)
Pursuant to this section, persons mentioned in
column 2 of Schedule 1 of this Regulation are authorised to issue a
purchase order for a medicine if issuing the purchase order is included in
column 3 of Schedule 1 in relation to that person, and if the issue of
the purchase order is consistent with any listed restriction in column 3 of
Schedule 1.
Section 61 Authorisation conditions for
issuing purchase orders for medicines
– Act,
s 44 (1) (b) and (2) (b)
A person’s
authorisation under section 60 is subject to two conditions. The first is
that the purchase order issued complies with section 62 of this Regulation.
The other is that the person must sign and send a document to the supplier
acknowledging receipt of the medicine. This written acknowledgement must be
sent not later than 24 hours after the person received the medicine.
Division 3.3.2 Purchase orders
Section 62 General
requirements for medicines purchase orders – Act,
s 38 (2) (c)
Purchase orders for medicines must, under
this section, be signed by the person issuing the order. Furthermore, if the
person issuing the purchase order amends the order at any stage, the person must
record their initials and the date along side the
amendment.
Subsection 2 specifies what information must be included
in a purchase order for a medicine, such as the form, strength and quantity of
the medicine to be supplied.
Part 3.4 Standing orders for
medicines
Division 3.4.1 CHO Standing
orders
Section 70 Authorisation of CHO to issue standing orders
for supply of medicines in public health emergencies – Act,
s 42 (b)
This provision authorises the Chief Health Officer to
issue standing orders for the supply of a medicine in an emergency relating to
public health. The provision also confirms that the authorisation under this
section operates even if a public health emergency declaration under
section 119 of the Public Health Act 1997 is not in force.
Section 71 Authorisation of CHO to issue standing orders for
administration of medicines in public health matters – Act,
s 42 (b)
A standing order is, according the dictionary in the
MPTG Act, a written order authorising the supply or administration of medicines
as stated in the order, in stated clinical circumstances. This provision
assigns the Chief Health Officer the power to issue a standing order for the
administration of medicine in public health matters. This authorisation
reflects the important role that the Chief Health Officer has in preventing,
minimising or averting public health issues.
Section 72 Particulars for CHO orders for administration of
medicines for public health matters
A standing order issued by the Chief
Health Officer under section 71 of this Regulation must contain the
particulars identified in this provision. Key particulars include a description
of the public health matter, a description of the people to whom the medicine
may be administered, the medicine and the dose and route of administration.
Division 3.4.2 Standing orders for institutions
Under
this Division, a doctor, but not an intern doctor, may be authorised to issue a
standing order for the administration of a medicine to patients at an
institution. Under section 652 of this Regulation a correctional centre
and a CYP detention place are also captured by the term institution. Such a
standing order needs to be approved by a medicines and therapeutics committee
for the institution, and the order needs to be signed by the chair of the
committee. Section 75(2) establishes what is, for the section, a medicines
and therapeutics committee.
The Division also specifies the particulars
that must feature on a standing order for administration of medicines at
institutions. This includes the dose and route of administration, the clinical
circumstances in which the medicine may be administered, and each ward to which
the order applies.
Part 3.5 Medicines supply authorities
generally
Section 80 Cancellation of invalid supply
authorities – Act, s 30 (2) (d)
From time
to time situations may arise in which a supply authority needs to be cancelled.
Section 80(1) deals with cancellations of paper-based supply authorities.
The provision directs that the word “cancelled” is marked on the
front of the supply authority, together with the person’s name and
business address. The person must also sign and date the
cancellation.
Subsection 2 of the provision relates to cancellations
of electronic supply authorities. In such circumstances the word
“cancelled” is to be marked on the supply authority, and an
electronic document containing the person’s name, business address and
signature is to be linked to the supply
authority.
Section 81 Information for CHO about controlled
medicines supplied on supply authorities – Act,
s 31 (1) (b) and (4), def required
information
Section 81 applies if a person supplies a controlled
medicine on a supply authority. The section requires certain information to be
given, in writing to the Chief Health Officer. The information includes the
date of the supply, the name of the person to whom the medicine was supplied,
and the form, strength and quantity of the medicine supplied. The information
to be given to the CHO must be provided within 7 days of the end of the
calendar month in which the supply took place.
This provision reflects
the seriousness and level of public health concern associated with controlled
medicines. The effect of the section is to enable the Chief Health Officer,
through the information required to be provided, to monitor the details, such as
quantities, of controlled medicines that are being supplied in the
ACT.
Some persons authorised under a Commonwealth or State law to
manufacture or supply controlled medicines by wholesale, are required to report
to the Therapeutic Goods Administration the supply of a controlled medicine on a
supply authority. Some medicine wholesalers must do the same.
The section
also clarifies that persons who report such supply to the Therapeutic Goods
Administration do not have to comply with this section. This recognises that to
apply this section to those persons would be an unnecessary duplication of a
reporting requirement and an unwarranted additional administrative burden.
Chapter 4 Supplying medicines
While Chapter 3
addresses supply authorities for medicines, other aspects of supplying medicines
is addressed within Chapter 4. This includes supplying medicines though
purchase orders and standing orders, supplying without prescription in
emergencies and the supply of medicines for disposal.
Part 4.1 Preliminary
Section 100 Overview of
supply authorisations for medicines
Supply authorisations for medicines
under this Regulation are listed in this section.
Part 4.2 Medicines – supply authorisations
under Sch 1
Division 4.2.1 Sch 1 medicines supply
authorisations
Section 110 Authorisation under sch 1 to
supply medicines – Act, s 26 (1) (b) and
(2) (b)
Pursuant to this section, persons mentioned in
column 2 of Schedule 1 of this Regulation are authorised to supply a
medicine if the supply is included in column 3 of Schedule 1 in
relation to that person, and if the supply is consistent with any listed
restriction in column 3 of Schedule 1.
Division 4.2.2 Dispensing medicines
This Division governs
the dispensing of medicines. As only a pharmacist may dispense medicines the
requirements imposed by this Division only concern pharmacists.
The Division
instructs how medicines are to be dispensed, as well as the authorisation
conditions that apply to the dispensing of medicines. Section 122 in the
Division specifies what must noted, in writing, on a prescription if an oral
direction is given by the prescriber to change details of the
prescription.
The Division also contains the requirements that must be
met in regard to the labelling of dispensed medicines, the marking of dispensed
prescriptions, and the details required for written records of medicines
dispensed. Through the operation of the dictionary in the MPTG Act something is
written even when in electronic form.
Division 4.2.3 Supplying
medicines on requisitions
Authorisations to issue a requisition are
addressed in section 50 of this Regulation. This Division governs the
supply of medicines on requisitions.
The Division details the
requirements for supply of medicines on a requisition, and the authorisation
conditions that apply. The Division also contains the requirements that must be
met in regard to the labelling of medicines supplied on requisition, the marking
of filled requisitions, and the details required for written records of
medicines supplied on requisition. Through the operation of the
dictionary in the MPTG Act something is written even when in electronic
form.
Division 4.2.4 Supplying medicines on purchase
orders
The issue of purchase orders is addressed in Part 3.3 of this
Regulation. This Division governs the supply of medicines on a purchase order.
This Division details the requirements for supply of medicines on a purchase
order, and the authorisation conditions that apply.
Under this Division,
a person who supplies a medicine to someone else on a purchase order is required
to make a written record of the supply. The information required to be kept
under this provision includes the date of the order, the date the order is
supplied, and the form, strength and quantity of the medicine supplied. For
obvious reasons, the details of the person to whom the medicine was supplied is
also required to be recorded.
Through a comparison of the record made
under this section with the purchase order to which the supply relates,
discrepancies and variations should be identifiable. Identification of such
variances and discrepancies may enable the identification of medicines being
misused, redirected or unusual supply patterns. Therefore, the keeping of such
records is required from a regulatory perspective.
Under section 11
of the Electronic Transactions Act 2001 records can be kept in an
electronic format provided certain criteria can be met. Accordingly, a
requirement to keep a written record is met if the record is kept in an
electronic form.
Division 4.2.5 Supplying medicines on standing
orders
The issue of standing orders is addressed in Part 3.4 of this
Regulation. This Division governs the supply of medicines on a standing order.
The Division details the requirements for supply of medicines on a
standing order, and the authorisation conditions that apply. The Division also
contains the requirements that must be met in regard to the labelling of
medicines supplied on a standing order and the details required for written
records of medicines supplied on standing order . Through the operation
of the dictionary in the MPTG Act something is written even when in electronic
form.
Division 4.2.6 Supplying medicines during
consultations
This Division governs the supply of medicines, such as
‘sample packs’, during consultations. The Division details the
authorisation conditions that apply, as well as the requirements that must be
met in regard to the labelling of medicines supplied during consultations, and
the details required for written records of medicines supplied during a
consultation.
It must be noted that under the MPTG Act, the definition of
supply does not include administration of the medicine. The requirement for the
appropriate supply and prescription of medicines in section 7 of the MPTG
should also be noted.
Section 163 imposes additional requirements
when the medicine to be supplied during a consultation is a controlled medicine
for human use. First and foremost, the supplier must have a controlled
medicines approval under Part 13.1, and comply with each condition of the
approval. The remaining conditions apply depending on whether or not the
approval under Part 13.1 was for a particular form of the medicine, a
particular strength of the medicine, or a particular quantity.
Where a
controlled medicine is supplied for human use during a consultation, the
prescriber must give to the CHO, within 7 days of the end of the calendar
month in which the supply took place, information required under
section 164(2). This information includes the prescriber’s name,
business address and telephone number, the date of supply, and the form,
strength and quantity of the medicine supplied. Critically, the name and
address of the person to whom the medicine was supplied must also be recorded.
Through the operation of the dictionary in the MPTG Act something is written
even when in electronic form.
Division 4.2.7 Selling
pseudoephedrine by retail
Pseudoephedrine-based products are legally
available over the counter in pharmacies for the treatment of ailments such as
colds and flu. However, a significant and growing problem within Australia is
the diversion of pseudoephedrine for illegal manufacture into methamphetamines,
such as ‘speed’ and ‘ice’. Pseudoephedrine is the key
chemical ingredient in the manufacture of methamphetamine.
Large
quantities of Pseudoephedrine-based products are used in the illegal
manufacture of methamphetamines. As the purchase of large quantities from a
single source is of itself naturally suspicious and likely to be reported to law
enforcement authorities, a practice referred to as “pseudo running”
has resulted. “Pseudo runners” travel from pharmacy to pharmacy
accumulating enough pseudoephedrine-based products to manufacture a significant
quantity of methamphetamines. By spreading out purchases, the volume of
pseudoephedrine-based products being purchased by a single individual becomes
extremely difficult to detect.
This division requires ACT pharmacists to
record sales of pseudoephedrine which will be accessible by law enforcement
agencies to identify and track suspicious sales. In addition to imposing this
requirement on pharmacists, the Regulation also gives pharmacists the legal
authority to request and record personal information, and to refuse sales of
pseudoephedrine where required information is not provided. Division 4.2.7
also specifically enable members of the public to access records relating to
them, and to request corrections if necessary. This is supported by a review
mechanism should the pharmacy that created the record refuse to change a record
as requested by a member of the public. The review mechanism created empowers
the Chief Health Officer to consider written positions from both the buyer and
the seller, and to direct alterations to the record if the Chief Health Officer
considers it appropriate to do so.
Section 170 Meaning of
retail sale – div 4.2.7
This section
stipulates that for Division 4.2.7 the phrase “retail sale”
does not include supply on prescription.
Section 171 Authorisation conditions for retail sale of
pseudoephedrine
– Act, s 44 (1) (b) and
(2) (b)
Under this section, a persons’ authorisation to supply
pseudoephedrine under section 110 of this Regulation is subject to
conditions under Division 4.2.7 when sold by retail sale.
Key
conditions include that the pseudoephedrine is supplied in accordance with
section 7 of the MPTG Act, and that the seller complies with
section 172 of this regulation. Additionally, pseudoephedrine records must
be kept at the seller’s business premises, unless the Chief Health Officer
has given written approval for records to be kept at another place. Records
must also be kept for a period of 2 years from the date the sale is
made.
A further condition is that if a buyer requests to see a record
pertaining to them that was made by the seller, the seller must allow the buyer
to see the record within a reasonable period. It is important to note that in
order to see a record made about them a buyer must attend the seller’s
business that made the record. A seller is under no obligation to come to the
buyer. Furthermore, a buyer can only see records of sales made from that
business, and a seller cannot change a record made by a different seller.
What amounts to a reasonable period is not specified by the legislation.
As such, determining what a reasonable period is will be dependent upon a common
understanding of the phrase applied in the individual circumstances of each
situation. This approach recognises that the nature of a seller’s
business will limit when it is reasonable to give a buyer access to a record.
It would be an unreasonable imposition upon a seller’s business if a buyer
were entitled to immediate access to a record. To do so would make no allowance
for requests made during peak periods of trade, or shortly before the close of
trade for the business.
In determining what should amount to a
reasonable period for the purposes of this section, regard should also be had to
the availability of the buyer to return at a more appropriate time. In most
circumstances a reasonable period will be the earliest opportunity that is
manageable for both the seller and the buyer. To achieve this it is possible,
as well as appropriate, for the seller and buyer to agree upon a suitable time
to arrange for the buyer to see the record.
Having inspected a record a
buyer may, if they believe the record to be incorrect, request that the seller
change the record. If the seller is satisfied that the record is incorrect, it
is a condition upon the seller’s authorisation under section 110 of
this regulation that the seller amend the record. Possible examples could be
minor spelling errors of a person’s name or address. More often than not,
a clear discrepancy between details on a receipt for purchase and on the record
made concerning the purchase would warrant a correction of the record.
Section 172 Requirement to tell buyer about pseudoephedrine
sales record
This section applies if pseudoephedrine is to be sold by
retail to a customer, referred to within the sections as the buyer. The section
requires that before a sale can proceed the seller must inform the buyer of
certain information. Under section 172 the buyer must be informed that the
seller is required to make a record of the sale, and that if the buyer refuses
to, or cannot provide the required information, the seller cannot sell the
customer pseudoephedrine. This requirement ensures that the customer knows that
the seller is legally obligated to make a record and legally obligated not to
sell pseudoephedrine unless the record is made.
Additionally, the
customer must be informed that the record may be made available to a limited
group of people, primarily law police officers, other pharmacists and the Chief
Health Officer and his staff. Additionally, a customer must be informed that
the Pharmacy Guild of Australia may also have access to the information
recorded.
The Pharmacy Guild of Australia developed and administers the
Project STOP database. Project STOP is a tool that pharmacies can elect to use
to record sales of pseudoephedrine. However, a seller does not need to utilise
the Project STOP system to comply with the requirements of this Regulation.
Furthermore, this Regulation should not be read in such a way as to infer that
it obligates or encourages the use of the Project STOP system. It is up to
individual sellers to determine how best to comply with the requirements of this
Regulation.
By informing the customer of these matters the customer is
made aware of the reason behind the record being made, and also assured that the
record cannot be used by any other persons or for any other reason. Finally,
under subsection 1(d), the customer must be advised that they have the
right to access the record and have any mistake corrected.
Section 173 Required information for pseudoephedrine sales
record
The required information to be recorded is stated in
section 173. Records kept in accordance with this provision must be in
English and in writing. The records must also be made in such a way that the
records are easily retrievable.
Under section 11 of the Electronic
Transactions Act 2001 records can be kept in an electronic format
provided certain criteria can be met. Accordingly, the requirement for records
to be in writing and the on-line Project STOP system are not incompatible.
Information to be recorded includes the date of sale and the brand name,
dosage form and quantity of pseudoephedrine sold. Information about the buyer
must also be recorded, including the buyer’s name and address, the kind of
identification produced and the unique identification number from the
identification shown. Through the range of information collected in the record
of sale enforcement authorities should be able to identify persons who make, or
attempt to make, an unusually high number of purchases or quantities of
pseudoephedrine.
In addition to requiring that the record of the sale
include the type of identification shown, the section also prescribes what types
of identification can be lawfully accepted. In doing so the section
distinguishes between a photo identification document and a non-photo
identification document.
The provision permits a seller to accept
only two types of non-photo identification. The first is a person’s birth
certificate provided that it identifies the issuing jurisdiction and the date it
was issued. Provided it meets these criteria birth certificates issued by any
Australian State or Territory can be accepted, as can any foreign issued birth
certificate. The other form of non-photo identification that can be accepted is
a seniors card issued by the ACT, the Northern Territory or another Australian
State.
Section 174 Failure to amend pseudoephedrine sales
record
Section 174 applies if a buyer has requested a seller change
a record under section 171 of this regulation and the seller has refused
the request. If this situation arises, a buyer can write to the ACT Chief
Health Officer asking that the Chief Health Officer direct the seller to change
the record. An application to the Chief Health Officer must be in writing, and
should provide as much detail and supporting evidence as the buyer is able to
provide. For example, if the date of sale or quantity of pseudoephedrine
purchased is disputed, the buyer should attach a copy of the sales receipt to
support the application.
Having received a written application, the
Chief Health Officer must give a copy of the application to the seller
identified in the application. In providing a copy of the application to the
seller the Chief Health Officer must ask the seller to make the amendment sought
and notify the Chief Health Officer that the change has been made, or send
written reasons to the Chief Health Officer stating why the amendment sought
should not be made. A written response detailing why the seller believes the
record should not be amended as sought should be provided to the Chief Health
Officer within 10 working days.
Section 175 Pseudoephedrine
sales record – decision by CHO
Under this provision the
Chief Health Officer must consider an application received from the buyer and
any response submitted by the seller, and then make a decision. Under
section 175 the Chief Health Officer can direct the seller to change the
record in accordance with the application, or refuse the application.
Crucially, the Chief Health Officer may also direct the seller to change
the record in a way other than in accordance with the application. This enables
the Chief Health Officer to determine that the information recorded about the
sale should remain unchanged, but that a notation be added to the record that
the buyer disputes all or part of the record.
This approach may be
necessary where a buyer disputes the quantity purchased, or even the sale
itself, but cannot provide sufficient evidence that contradicts the record.
What ever the decision of the Chief Health Officer, written notice of the
decision must be provided to both the seller and the
buyer.
Pseudo runners may attempt to avoid detection through the use
of fake or stolen identification. As a result, there is the possibility that a
buyer may be able to show that they did not or could not have made a sale to
which their details are recorded. In such circumstances it is possible that the
buyer’s identify, or an identifying document, has been stolen or
reproduced by a pseudo runner. Should such a situation occur, it would be
necessary for records to remain unaltered despite the provision of clear
evidence by the buyer that they did not make the purchases recorded.
Division 4.2.8 Supplying pharmacist only
medicines
Section 180 Authorisation conditions for supply of
pharmacist only medicines
- Act, s 44 (1) (b) and
(2) (b)
An authorisation under section 110 of this Regulation
is subject to the condition that the person personally hand the medicine to the
customer who is personally in attendance, and that the customer is given
adequate instructions on the medicine’s use at the time of supply. The
instructions provided may, under this section, be given either orally or in
writing.
The only situations in which this section does not apply is in
regard to the supply of pharmacist only medicine at an institution or on a
supply authority.
Part 4.3 Authorisations to supply without
prescription in emergencies
Part 4.3 applies to prescription only
medicines other than an anabolic steroid, a designated appendix D
medicines, and a benzodiazepine. Within this Part the permissible medicines are
referred to as designated prescription only medicines. As controlled medicines
are not considered a prescription only medicine under section 11 of the
MPTG Act, this Part does not apply to controlled medicines.
This Part
authorises a pharmacist to supply a designated prescription only medicine
without a prescription in an emergency situation under section 251, subject
to certain conditions identified in section 252. The Part also details the
labelling requirements involved in the supply of medicines without a
prescription in an emergency. Additionally, a pharmacist that supplies a
designated prescription only medicine under section 251 of this Regulation
must make a written record of the supply. Under the Electronic Transactions
Act 2001 if something is kept in an electronic form it is considered to
be written.
Part 4.4 Authorisation to supply medicines for
disposal
Section 260 Authorisation to supply medicines to
pharmacists for disposal
- Act,
s 26 (1) (b)
This provision gives a generic authorisation
to supply a medicine to a pharmacist so that the pharmacist may dispose of the
medicine. This provision recognises the importance of enabling the proper
disposal of medicines that are old, no longer needed, or for which the
manufacturer’s pack or labelling has been lost. The provision also
recognises that surrender of a medicine for disposal to a pharmacist is
supported by the Australian Government through the Return of Unwanted Medicines
program.
Section 261 Authorisation to supply medicines to
commercial disposal operators for disposal - Act,
s 26 (1) (b)
This provision gives a generic authorisation
to supply a medicine for the purposes of disposal to a person holding an
environmental authorisation for the disposal of medicines, or to an adult acting
on their behalf.
Like with section 260, this provision recognises
the importance of enabling the proper disposal of medicines that are old, no
longer needed, or for which the manufacturer’s pack or labelling has been
lost. The provision also recognises that surrender of a medicine for disposal
to a commercial disposal operator is more desirable than the medicine ended up
in landfill or in waste water.
Part 4.5 Wholesale supply of
medicines under corresponding laws
This Part contains only one section;
section 270. This provision imposes conditions upon persons who supply
medicines by wholesale under corresponding laws. A key condition is that the
person, and all of their employees and agents, comply with the Australian Code
of Good Wholesaling Practice for Therapeutic Goods for Human Use, and the
Medicines Australia Code of Conduct.
The Part also requires that a
medicine in the person’s possession is stored within the storage
temperature range for the medicine recommended by the manufacturer of the
medicine. Certain medicines may become ineffective or possibly even harmful if
they exceed or fall below a particular temperature range. Compliance with any
other environmental condition that is necessary to preserve the stability and
therapeutic quality of a medicine is also required. Such a condition could be a
simple as keep out sunlight or storage in a dry location. Nevertheless, as
failure to observe such a condition could possibly make the medicine harmful or
reduce the medicine’s therapeutic quality, it is critical that such
conditions are observed.
The section also directs that sample packs of
controlled medicines must not be supplied. Also, a medicine must not be
supplied to another person unless that person is authorised to possess the
medicines and the supply conforms with section 140 of this Regulation.
Chapter 5 Administering medicines
This Chapter provides
for the administration of medicines by certain persons. Part 5.1 addresses
persons in health-related occupations. Part 5.2 enables some persons, in
limited circumstances, to administer medicines themselves. These limited sets
of circumstances covers the administration of the medicine by the person to
themself, to an animal to which they are in charge, or to assist another person
administer a medicine to themself.
Part 5.1 Authorisations for
health-related occupations
Section 350 Authorisation under
sch 1 for people in health-related occupations to administer
medicines - Act, s 37 (1) (b) and
(3) (b)
Pursuant to this section, persons mentioned in column 2
of Schedule 1 of this Regulation may be authorised to administer a
medicine. Administering a medicine is authorised if administration is amongst
the authorised dealings for the person listed in column 3 of
Schedule 1 in relation to that person, and if administration of the
medicine is consistent with any listed restriction in column 3 of
Schedule 1.
A person who administers a medicine who is not
authorised to do so may have breached section 37(1) or section 37(3)
of the MPTG Act. Similarly, a person who is authorised to obtain a medicine by
Schedule 1, but does not comply with a restriction to which the
authorisation is subject, may also have breached the MPTG
Act.
Section 351 Authorisation conditions for administration of
medicines at institutions by people in health-related
occupations - Act, s 44 (1) (b) and
(2) (b)
An authorisation under section 350 is subject to the
conditions imposed by this provision. Where the medicine is administered under
a standing order to a patient at an institution, the administration must be
recorded in the patient’s medical records (eg medication chart). In this
provision an institution includes correctional centres and CYP detention
places.
For controlled medicines to be administered to a patient at an
institution there are further conditions. In this scenario the medicine is not
to be removed from a storage receptacle until immediately before it is
administered. The administration must be witnessed by another person,
preferably by a prescribed witness. Finally, the administration must be
recorded in the patient’s medical records and the applicable controlled
medicines register as per the requirements in section 543 of this
Regulation.
The only exception to the recording of the administration in
a controlled medicines register is when the medicine was administered from a
dose administration aid dispensed for the patient at a residential aged care
or residential disability care facility, or to a detainee at a correctional
centre or CYP detention place.
Part 5.2 Other administration
authorisations
Section 360 Authorisation for self-administration
etc of medicines
- Act, s 37 (2) (b) and
(3) (b)
Section 360 is limited to situations where the medicine
was obtained from someone who is authorised to supply the medicine. If the
medicine was improperly obtained, specifically having been supplied by a person
who is not authorised to supply a medicine, this section would not make the use
of that medicine lawful.
Subsection 2 sets out four situations in
which a person will be authorised to administer a medicine themselves. The
first two situations covered permit a person who is a prescriber, being a person
authorised to prescribe, to self administer. For medicines, other than a
restricted medicine, it is permissible for a prescriber to self administer. For
restricted medicines, defined in section 30 of this regulation, a
prescriber may also self administer provided that the medicine has been
prescribed or supplied by another person who is authorised to prescribe, with
the exception of a trainee dentist, intern doctor, related person or employee.
Some of the persons to whom the exception applies are selected as their
level of knowledge, experience, qualification or certification, are such that
they may not adequately question the appropriateness of the supply of the
medicine. Persons related to or employed by the prescriber are selected as
their relationship may make them susceptible to pressure or influence by the
other person.
Not surprisingly, the section permits a person who is not
a prescriber, which will cover most people, to self administer a medicine
provided it has been supplied to that person for their own use. Similarly, a
person who is the custodian of an animal may administer a medicine to that
animal if the medicine was supplied for that animal’s use.
The
definition of custodian in the dictionary covers the lawful owner of the animal,
or where the parent or guardian of the lawful owner. However, the definition
would also cover persons who have lawful custody of an animal, thereby extending
to dog catchers, the RSPCA, refuge shelters, kennels, canneries and
stables.
Section 361 Authorisation for administration of
medicines by assistants
- Act,
s 37 (1) (b)
The effect of this provision is to authorise
persons to administer a medicine to someone else. This is permissible if the
person being assisted asks for assistance in taking the medicine. This could
arise if the person is in a distressed state, or if the person simply needs
assistance due to their age or a physical impairment. It is also permissible in
situations where the person needing the medicine is under a legal disability,
and the assistance is authorised by the person’s parents or guardians.
This scenario could arise at a child care centre, where the parent’s have
given the centre permission to administer a particular medicine should the need
arise.
Whatever the situation, the provision requires that the medicine
has been obtained by the person to be assisted, or by someone authorised to
supply that person, such as a parent. Furthermore, the medicine must only be
administered in accordance with the directions on the medicine’s
label.
The section provides instruction on who is considered a person
under a legal disability, which includes persons with impaired decision-making
ability. Impaired decision-making ability is also defined in the section.
Chapter 6 Obtaining and possessing medicines
The MPTG Act
contains a number of offences for obtaining or being in possession of certain
medicines without lawful authority. Section 35(1) of the MPTG Act contains
an offence for obtaining a declared substance without authorisation to do so.
Similarly, under section 35(2) of the MPTG Act a person who obtains a
declared substance when they are not authorisation to obtain such a substance
also commits an offence. To be in possession of a declared substance without an
authority to possess that substance is an offence pursuant to section 36 of
the MPTG Act.
What constitutes a declared substance is explained by the
MPTG Act. The purpose of this Chapter of the Regulation, in conjunction with
Schedule 1 of the Regulation, is to establish the persons who are
authorised to obtain or possess such medicines and substances.
Section 370 Authorisation under sch 1 to obtain and possess
medicines
- Act, s 35 (1) (b), (2) (b) and s 36
(b)
Pursuant to this section, persons mentioned in column 2 of
Schedule 1 of this Regulation may be authorised to obtain a medicine.
Obtaining a medicine is authorised if obtaining the medicine is amongst the
authorised dealings for the person listed in column 3 of Schedule 1 in
relation to that person, and if the medicine was obtained in a way that is
consistent with any listed restriction in column 3 of Schedule 1. A
person who obtains a medicine who is not assigned the authority to do so by
Schedule 1 may have breached section 35(1) of the MPTG Act.
Similarly, a person who is authorised to obtain a medicine by Schedule 1,
but does not comply with a restriction to which the authorisation is subject,
may also have breached section 35(1) of the MPTG
Act.
Section 371 Authorisation to obtain and possess medicines
for certain personal use-related dealings - Act, s 35 (1) (b),
(2) (b) and s 36 (b)
The effect of this provision is to authorise
persons to obtain medicines if the medicine is to be used for their own personal
use. Similarly, this section authorises a person to obtain a medicine as agent
for another person, in circumstances where the medicine is for the personal use
of that other person. Pursuant to subsection 1 of this provision, this
authorisation is conditional upon the medicine being obtained from a person who
authorised to supply the medicine.
It is this section that prevents a
person filling a prescription at a pharmacist, either for themselves or for a
family member, from committing an offence against section 35 or
section 36 of the MPTG Act. However, even if the medicine obtained is for
personal use, if the medicine is not supplied by someone authorised to do so,
obtaining or possessing the medicine may still constitute an offence.
Chapter 7 Manufacturing medicines
Section 33 of the
MPTG Act contains an offence for manufacturing a regulated substance without
authorisation to do so. This Chapter, in conjunction with Schedule 1 of
this Regulation, assigns authority to manufacture to certain specified health
related occupations.
Section 380 Authorisation under sch 1
to manufacture medicines - Act, s 33 (b)
Pursuant to this
section, persons mentioned in column 2 of Schedule 1 of this
Regulation may be authorised to manufacture a medicine. If manufacturing a
medicine is amongst the authorised dealings for the person listed in
column 3 of Schedule 1 in relation to that person, and if the
manufacture is consistent with any listed restriction for the manufacturing,
then the person is duly authorised. A person who manufactures a medicine who is
not assigned the authority to manufacture by Schedule 1 may have breached
section 33 of the MPTG Act. Similarly, a person who is authorised to
manufacture by Schedule 1, but does not comply with a restriction to which
the authorisation is subject may also have breached section 33 of the MPTG
Act.
Chapter 8 Discarding medicines
This Chapter governs
the discarding, and thereby disposal, of medicines. It details what constitutes
the proper disposal of a medicine, but also addresses the discarding of residues
of medicines by persons who have administered the medicine for their own use.
Section 390 Discarding controlled
medicines – Act, s 34 (1) (a)
The disposal
of a controlled medicine may only be handled by a select category of persons,
referred to within the MPTG legislation as prescribed discarding witnesses.
Under section 545 of this Regulation, a prescribed discarding witness
includes, amongst others, persons as doctors, nurses, pharmacists, dentists and
medicines and poisons inspectors.
This section establishes that a
controlled medicine must only be disposed of by a prescribed discarding witness
and in the presence of another prescribed discarding witness. However, an
exception to this rule exists in circumstances where a controlled medicine has
been administered by a person who is both authorised to administer and a
prescribed discarding witness. In this limited set of circumstances, if another
prescribed discarding witness is not reasonably available then the person
administering the medicine may discard the residue in the presence of an
ordinary person. It is important to note that this exception is limited to the
discarding of the residue of a controlled medicine.
For example, if a
controlled medicine has just been administered to a patient by a doctor, the
doctor may discard the residue of the medicine with the patient as the witness,
without the need for another doctor or a nurse to be present. However, if a
pharmacist were disposing of old or damaged stock of a controlled medicine that
pharmacist will require another prescribed discarding witness to verify the
disposal of the medicines.
The discarding of a medicine under this
section is taken to have been properly and validly performed if the medicine is
destroyed so that it is unable to be used. The disposal of seized substances is
more onerous and tightly controlled than this section, and is governed by
Division 11.4 of the Drugs of Dependence
Act 1989.
Chapter 9 Other medicines
authorisations
This Chapter provides for a number of specific and limited
authorisations in regard to medicines for a range of persons not addressed in
other Chapters.
Part 9.1 Authorisations for delivery people
and commercial disposal operators
Part 9.1 gives authorisations to
delivery people and commercial disposal operators so that the handling of
medicines by such persons in the ordinary course of their employment is
authorised and lawful under the MPTG legislation.
Part 9.2 Emergency supply and administration of adrenaline and
salbutamol
Part 9.2 contains one section; section 410. That
provision authorises the supply and administration of adrenaline or salbutamol
in emergencies.
Through the operation of section 410, if a person
is in urgent need of salbutamol another person may lawfully supply salbutamol in
a metered inhaler to the person requiring assistance. If the person in need of
assistance cannot administer the salbutamol themselves, or will require
assistance to administer the salbutamol, a person may administer the salbutamol
to the ailing person or supply the salbutamol to a third person who will
administer the salbutamol to the ailing person. In each instance the salbutamol
delivered through the use of a metered inhaler.
The same section enables
a person to supply adrenaline to a person in need of assistance. The provision
also operates to permit a person to administer adrenaline directly to the person
needing assistance through the use of a single use automatic injector that
delivers no more than 0.3 miligrams of adrenaline, or to supply adrenaline
to a third person who will administer adrenaline directly to the person needing
assistance, also through the use of a single use automatic
injector.
Part 9.3 Medicines authorisations for corrections
functions
Part 9.3 gives authorisations for persons working within
corrections facilities, and ensures such persons do not breach the MPTG
legislation through the ordinary course of their
employment.
Part 9.4 Authorisations for medicines research and
education program purposes
other than controlled medicines
The
provisions in Part 9.4 give authorisations for medicines, other than
controlled medicines, for research and education program purposes. The
provisions in this Part enable scientifically qualified persons employed at a
recognised research institution to handle medicines without contravening the
MPTG legislation. For controlled medicines, Research and education programs
will require a licence under Chapter 14.
A scientifically qualified
person is, according to the dictionary in this Regulation, a dentist, doctor,
pharmacist or veterinary surgeon, excluding trainees and interns. A person who
has been awarded a doctorate for scientific studies is also considered a
scientifically qualified person.
Section 20(5) of the MPTG Act lists
recognised research institutions, which include the University of Canberra, the
ANU, the Canberra Hospital, the CSIRO, or any other entity prescribed by this
Regulation.
Part 9.5 Authorisations under medicines
licences
Division 9.5.1 Controlled medicines research and
education program licence
authorisations
The governance
structure for the issuing of controlled medicines research and education
programs licences is contained in Part 14.2 of this Regulation. This
Division establishes what is authorised by a licence issued under
Part 14.2. Section 440 authorises a licence-holder to obtain and
possess a controlled medicine at the premises to which the licence relates, as
well as to supply the controlled medicine to anyone taking part in the program
for the purposes of the program. Furthermore, the program supervisor and anyone
taking part in the program is authorised to deal with the medicines stated on
the licence, provided the dealing is in accordance with the terms of the
licence.
Controlled medicines research and education programs at the
Canberra Hospital are also authorised to issue written requisitions for the
controlled medicines, whereas programs at other locations are authorised to
issue a purchase order for the controlled medicine.
Controlled medicines
research and education programs at the Canberra Hospital are under the
authorisation condition that a controlled medicine is obtained under a
requisition that complies with sections 55 and 56 of this Regulation.
Programs at other locations are subject to the condition that the medicine is
purchased on a complying purchase order. For a medicine a complying purchase
order is, according to the dictionary in this Regulation, a purchase order
pursuant to section 62.
Division 9.5.2 First-aid kit licence
authorisations
The governance structure for the issuing of first-aid kit
licences is contained in Part 14.3 of this Regulation. This Division
establishes what is authorised by a licence issued under Part 14.3.
Section 450(2) authorises a licence-holder to issue purchase orders, and
obtain on a purchase order, medicines deemed to be authorised medicines
under subsection 1. The authorisation to obtain a medicine under this
Division is subject to the condition that the medicine is purchased on a
complying purchase order. For a medicine a complying purchase order is,
according to the dictionary in this Regulation, a purchase order pursuant to
section 62.
In this section, authorised medicines are
medicines identified in the licence for the first-aid kit as well as pharmacy
medicines and pharmacist only medicines for the first-aid kit.
The
licence-holder is also authorised to possess authorised medicines as part of the
first-aid kit where it is for the emergency treatment of a person’s
medical condition. The licence-holder is also authorised to administer the
authorised medicines if they reasonably believe that this is necessary for the
emergency treatment of the person’s medical condition.
Division 9.5.3 Wholesalers licence authorisations
The
governance structure for the issuing of wholesalers licences is contained in
Part 14.4 of this Regulation. This Division establishes what is authorised
by a licence issued under Part 14.4. Section 460 authorises a
licence-holder to do a variety of things from the premises stated on the
licence, including issue purchase orders for medicines stated on the licence,
obtain those medicines on a purchase order for the purposes of sale by
wholesale, and to possess at the premises the licensed medicines.
Of
particular importance for a wholesalers licence, the Division authorises the
sale of medicines by wholesale, from the premises stated on the licence, to a
person that is authorised to issue a purchase order for the medicine.
Furthermore, the licence-holder is authorised to sell by wholesale to a person
in another jurisdiction, including overseas, provided that person is lawfully
able to obtain the medicine by wholesale.
It should be noted that the
authorisations under this Division apply to all wholesaler’s licences,
unless a licence expressly states that a particular type of dealing is not
authorised. In effect, this means that the terms of an issued licence can
overrule or contradict the authorisations in this Division. For example, a
licence could be issued that states the licensee is not authorised to supply by
wholesale to a person in another country. Supply by wholesale to a person in
another country will also be prevented if the medicine to which the licence
relates is a prohibited export under the Commonwealth Customs
Act 1901. In such circumstances the authorisation to supply to a person
in another country does not apply.
The authorisation to obtain a medicine
under this Division is also subject to the condition that the medicine is
purchased on a complying purchase order. For a medicine a complying purchase
order is, according to the dictionary in this Regulation, a purchase order
pursuant to section 62. Additionally, a medicine may only be sold under a
wholesaler’s licence on a complying purchase order.
It is also a
condition on the authorisation that the licence-holder, and all employees and
agents of the licence-holder, comply the Australian Code of Good Wholesaling
Practice for Therapeutic Goods for Human Use, and the Medicines Australia Code
of Conduct (eg the latter, mentioned in section 460(e), applies to the supply of
sample packs).
Division 9.5.4 Opioid dependency treatment
licence authorisations
The governance structure for the issuing of opioid
dependency treatment licences is contained in Part 14.5 of this Regulation.
This Division establishes what is authorised by a licence issued under
Part 14.5. The only medicines to which an opioid dependency treatment
licence relates are buprenorphine and methadone for the treatment of a
person’s drug dependency.
Section 470 authorises a
licence-holder, and any other pharmacist at the pharmacy to which the licence
relates, to issue purchase orders, obtain on a purchase order, possess, and
dispense or administer in accordance with a prescription. It is also
permissible to supply to a nurse at the licensed pharmacy for administration
under the supervision of a pharmacist.
The authorisation to obtain a
medicine under this Division is subject to the condition that the buprenorphine
or methadone is purchased on a complying purchase order. For a medicine a
complying purchase order is, according to the dictionary in this Regulation, a
purchase order pursuant to section 62.
It is also a condition on the
authorisation that a person to whom buprenorphine or methadone is administered
sign a written acknowledgement that reflects the approved name or brand name of
the medicine administered, the date it was administered, and the form, strength
and quantity of the medicine administered.
Division 9.5.5 Pharmacy medicines rural communities
licences
The governance structure for the issuing of pharmacy medicines
rural communities licences is contained in Part 14.6 of this Regulation.
This Division establishes what is authorised by a licence issued under
Part 14.6. Section 480 authorises a licence-holder to issue purchase
orders for pharmacy medicines stated on the licence, obtain those medicines on a
purchase order, and to possess at the retail premises and sell by retail those
same medicines.
This Division also authorises an employee of the
licence-holder to possess the medicines at the retail premises and sell by
retail the medicines. This recognises the commercial practicalities as it
should not be expected that the licence-holder will be present at the place of
business at all times on each occasion that the business is trading.
It
should be noted that the wording of the authorisation only permits medicines
stated on the licence to be sold to customers attending the business premises.
This thereby prevents sales over the internet or by mail order under the
licence. This is further reinforced by an authorisation condition to the same
effect.
The authorisation to obtain a medicine under this Division is
subject to the condition that the medicine is purchased on a complying purchase
order. For a medicine a complying purchase order is, according to the dictionary
in this Regulation, a purchase order pursuant to section 62.
It is
also a condition on the authorisation that pharmacy medicines to which the
licence relates are sold in manufacturer’s packs and are labelled either
in accordance with section 502 of this Regulation or pursuant to an
approval under section 193 of the MPTG
Act.
Chapter 10 Packaging and labelling of medicines
generally
General requirements for the packaging and labelling of
medicines are set out within Chapter 10.
Section 500 When
pharmacy medicines and pharmacist only medicines to be supplied in
manufacturer’s packs - Act, s 59 (1) (c) (i)
and (2) (c) (i)
This provision establishes that a health
professional, or an employee acting under their direction, must only supply a
pharmacy medicine or pharmacist only medicine in a whole manufacturer’s
pack. For this section, supply does not include dispensing. The meaning of a
manufacturer’s pack is provided in the dictionary in this
Regulation.
This requirement does not apply to pharmacists and intern
pharmacists at a hospital, and prescribers supplying a medicine during a
consultation. For the purposes of this section these persons are not treated as
health professionals.
Section 600(e) of this Regulation enables a
licence to be issued to a person who is not a pharmacist to sell, by retail,
pharmacy medicines. Such licences were primarily contemplated to avoid
disadvantaging rural communities that are without a local pharmacist by
providing another mechanism whereby pharmacist only medicines could be made
available for retail sale to the community. Accordingly, such licences are
referred to as a pharmacy medicines rural communities licence. Under
section 500(3), a pharmacy medicines rural licence-holder, and employees
acting under their direction, can only sell pharmacy medicines in a whole
manufacturers pack.
Section 501 Packaging of supplied
manufacturer’s packs of medicines
- Act,
s 59 (1) (c) (i) and (2) (c) (i)
The
packaging requirements of a manufacturer’s pack of a medicine is set out
in this section. Manufacturer’s pack can be packaged in accordance with
paragraphs 21 through to 27 of the SUSDP. Manufacturer’s pack may
also be packaged in a container approved under section 193 of the MPTG or
in a container in which the medicine may be sold under a corresponding
law.
Section 502 Labelling of supplied manufacturer’s packs
of medicines
- Act, s 60 (1) (c) (i) and
(2) (c) (i)
A manufacturer’s pack of a supplied
medicine must, under this section, be labelled in accordance with
paragraphs 3 through to 19 of the SUSDP, section 193 of the MPTG
Act or a corresponding law. However, under this section supply of a medicine is
not extended to include dispensing of a medicine or supplying a medicine on a
requisition or standing order.
Additionally, a label featuring the
pharmacy’s name, business address and phone number must be affixed to a
manufacturer’s packs of a pharmacist only medicine sold by retail at a
community pharmacy. Similarly, a label featuring the licence-holder’s
name, business address and phone number must be affixed to a
manufacturer’s packs of a pharmacy medicine sold by a pharmacy medicines
rural communities licence-holder.
Such labels ensure the contact
details of the supplier are readily accessible should the person taking the
medicine, or someone else assisting that person, have any questions or concerns
about the medicine. This case be critically important should an adverse
reaction or misadventure associated with the medicine occur.
Chapter 11 Storage of medicines
The correct, safe and
appropriate storage of medicines is the focus of Chapter 11 of this
regulation. The Chapter is divided into four Parts, the first containing only
meanings of terms used throughout the Chapter, and the second Part setting out
general storage requirements for medicines. Additional storage requirements for
medicines, other than controlled medicines, are within Part 3 whereas
specific storage requirement for controlled medicines are in the fourth
Part.
Part 11.1 Preliminary
Section 510 Meaning of
prescribed person – ch 11
This provision sets
out who is, for the purposes of Chapter 11, a prescribed person. Included
are certain health professionals such as doctors, dentists and podiatrists.
However, the listed persons also extends to persons in charge of correctional
centres, and to persons in charge of a residential aged care facility, or a
disability care facility, where such a facility is without a pharmacy.
A controlled medicines research and education program licence-holder is
also considered a prescribed person. Controlled medicines research and
education program licences are the subject of Part 14.2 of this Regulation.
Section 511 Meaning of
key – ch 11
Within Chapter 11, in
addition to its ordinary meaning, a key includes an electronic swipe card
or an electronic proximity device. This is a reflection on increasing
prevalence in the community of such technology.
Part 11.2 Storage
requirements for medicines generally
Section 515 Storage of
medicines generally – Act, s 61 (b) and
(c)
Section 515 operates to impose a duty upon a prescribed person
to ensure that a medicine in the person’s possession is stored within the
storage temperature range for the medicine recommended by the manufacturer of
the medicine. Certain medicines may become ineffective or possibly even harmful
if they exceed or fall below a particular temperature range. The section also
requires the prescribed person to ensure compliance with any other environmental
condition that is necessary to preserve the stability and therapeutic quality of
a medicine in the person’s possession. Such a condition could be a simple
as keep out sunlight or storage in a dry location. Nevertheless, as failure to
observe such a condition could possibly make the medicine harmful or reduce the
medicine’s therapeutic quality, it is critical that such conditions are
observed.
Where the prescribed person is a person listed in
section 510(i), the duty to ensure the medicine is stored as required by
section 515(1) does not apply if that person does not have control over the
disposition of the medicine. This recognises that for the persons listed in
section 510(i), although they are in charge of a particular facility or
workplace, there may be medicines present for which they have no control.
Part 11.3 Additional storage requirements for medicines other
than controlled medicines
Section 520 Storage of medicines other
than controlled medicines in community pharmacies – Act,
s 61 (b) and (c)
This provision imposes an obligations
upon the pharmacist responsible for the management of a community pharmacy in
regard to the storage of pharmacy medicines, under subsection 1, and
pharmacist only medicines under subsection 2.
The first subsection
requires the pharmacist to ensure that pharmacy medicines for retail sale are
stored within 4 metres of, and within sight of, the pharmacy’s
dispensary. The practical application of this requirement will vary for each
pharmacy subject to the pharmacy’s overall size, and the size of the
dispensary at the pharmacy.
The requirement that the medicine be stored
within sight of the dispensary should not be interpreted narrowly. It would be
commercially impractical to expect that all medicines would be stored in such a
way as to be in sight of all areas of the dispensary at all times. It is to be
expected, and permissible, for medicines to be stored on a shelf that is visible
from one side of the dispensary but not the other. Similarly, there will be
medicines that from time to time are not within sight of the dispensary,
temporarily, because of the presence of an obstruction, most probably a
customer. However, area of a pharmacy that are never visible from the
dispensary, or are usually out of sight of the dispensary, should not be used to
store a pharmacy medicine. Such areas of floor space are best utilised for
products not regulated by the MPTG legislation.
Pharmacy medicines that
are not for retail sale, which may include stock in storage that will eventually
become available for retail sale, must be stored in such a manner as to restrict
public access to the medicines.
Stricter storage requirements for
pharmacist only medicines and prescription medicines are imposed by the second
subsection. Such medicines must be stored in a part of the pharmacy premises to
which the public does not have access. Additionally, such medicines must be
stored so that only a pharmacist, or a person under the direct supervision of a
pharmacist, has access to the medicine. It should be noted that a pharmacist
does not include an intern pharmacist, thereby meaning that an intern pharmacist
should only access such medicines when under the direct supervision of a
pharmacist.
Section 521 Storage of medicines other than
controlled medicines by other people
– Act,
s 61 (b) and (c)
Under this provision a prescribed person
as defined by section 510 must ensure that medicines in their possession,
other than controlled medicines, are stored so that public access to the
medicine is restricted. The only category of prescribed persons exempted from
this requirement is pharmacists responsible for the management of a community
pharmacy, who are subject to the storage requirements imposed by
section 520.
Where the prescribed person is a person listed in
section 510(i), the duty to ensure the medicine is stored as required by
section 515(1) does not apply if that person does not have control over the
disposition of the medicine. This recognises that for the persons listed in
section 510(i), although they are in charge of a particular facility or
workplace, there may be medicines present for which they have no control.
Section 522 Storage of pharmacy medicines by pharmacy medicines
rural communities licence-holders – Act, s 61 (b)
and (c)
Section 600(e) of this Regulation enables a licence to
be issued to a person who is not a pharmacist to sell, by retail, pharmacy
medicines. Such licences were primarily contemplated to avoid disadvantaging
rural communities that are without a local pharmacist by providing another
mechanism whereby pharmacist only medicines could be made available for retail
sale to the community. Accordingly, such licences are referred to as a pharmacy
medicines rural communities licence.
An obligation is imposed by this
provision on the holder of a pharmacy medicines rural communities licence to
store a pharmacy medicine, for retail sale, in such a way as to ensure public
access to the medicine is restricted.
Part 11.4 Additional
storage requirements for controlled medicines
Section 530 Meaning
of personal custody – pt 11.4
In addition to
its ordinary meaning, for Part 11.4 personal custody includes, by
virtue of this section, keeping a key in a combination-operated key safe,
provided the person keeps the combination confidential.
Where the
prescribed person is a person listed in section 510(i), the duty to ensure
the medicine is stored as required by section 515(1) does not apply if that
person does not have control over the disposition of the medicine. This
recognises that for the persons listed in section 510(i), although they are
in charge of a particular facility or workplace, there may be medicines present
for which they have no control.
Section 531 Storage of
controlled medicines by wholesalers licence-holders
– Act,
s 61 (b) and (c)
Controlled medicines in the possession of
a wholesalers licence-holder must, unless required for immediate supply, be
stored in a vault. Furthermore, such a vault must meet or better the
requirements for a vault set out in Schedule 5, section 5.8 of this
Regulation, and be fitted with an alarm system.
These strict security
requirements reflect the elevated security concern posed by the quantities of a
controlled medicine that a wholesaler’s licence-holder is likely to
possess.
If the total quantity of controlled medicines held by the
licence-holder at any time is not large enough to merit storage in a vault, the
approval of the Chief Health Officer can be sought to instead store the
controlled medicines in a safe or strong room. Should the Chief Health Officer
give approval under this section, that approval must be given in
writing.
If the Chief Health Officer approves the use of a safe, the safe
must meet or better the requirements set out for a safe in Schedule 5,
section 5.6 of this Regulation, and be fitted with an alarm system.
If the Chief Health Officer approves the use of a strong room, the
strong room must meet or better the requirements set out for a strong room in
Schedule 5, section 5.7 of this Regulation, and be fitted with an
alarm system.
Section 532 Storage of controlled medicines for
certain health-related occupations
– Act,
s 61 (b) and (c)
Controlled medicines in the possession of
a designated person must be stored by designated persons in either a locked
container that is securely attached to a building and prevents ready access to
the container’s contents, or is a locked drawer, cupboard, room or
vehicle. If such a container is unlocked through the usage of a combination
lock, the designated person must keep the combination confidential. Where such
a container is unlocked using a key, which by virtue of section 511
includes an electronic swipe card or proximity card, the designated person must
keep personal custody of the key.
If a designated person keeps the
medicine in a drawer, cupboard, room or vehicle, the designated person must keep
personal custody of the key that would enable access to the medicine. Once
again, the operation of section 511 extends the meaning of key to include
an electronic swipe card or proximity card.
The only situation in which
these storage requirements do not apply is where the controlled medicine is
being carried by the designated person in a first-aid kit that is locked, or
unlocked because it is in immediate use. Even then, is mandatory that the
designated person keep personal custody of the key to the first-aid
kit.
In addition to its ordinary meaning, for Part 11.4 personal
custody includes, by virtue of section 530, keeping a key in a
combination-operated key safe, provided the person keeps the combination
confidential.
In section 531, a designated person includes a
dentist, doctor, or veterinary surgeon, save for such a person at an
institution. As the definitions of a dentist, doctor and veterinary surgeon in
this Regulation do not include trainees or interns, this section does not
authorise a trainee or intern to have a controlled medicine in a first-aid kit.
A first-aid kit licence-holder is also a designated person under this
section. First-aid kits licences are obtained under Division 9.5.2 of this
Regulation, and enables the licence-holder to posses certain medicines and
purchase medicines through a purchase order. Such a licence also allows, in
certain situations and subject to certain conditions, the supply or even
administering of medicines.
The third category of designated
persons is ambulance officers employed by a State, Territory or the
Commonwealth. As such, ambulance officers of private companies and not
employed by a State, Territory or the Commonwealth are not designated
persons under this section, and will only be regarded as designated person
if they possess a first-aid kit licence.
Section 533 Storage of
controlled medicines by certain other prescribed
people
– Act, s 61 (b)
and (c)
Persons to which this section applies must ensure that
controlled medicines are stored in a storage receptacle, which includes
medicines cabinets, safes, strong rooms and vaults. Which ever storage
receptacle is used, it must meet or better the requirements for that storage
receptacle set out in Schedule 5 of this Regulation.
Furthermore,
persons to which this section applies must keep the storage receptacle securely
locked when not in immediate use. If such a storage receptacle is unlocked
through the usage of a combination lock, the person must keep the combination
confidential. Where such a container is unlocked using a key, which by virtue
of section 511 includes an electronic swipe card or proximity card, the
person must keep personal custody of the key.
Where the person to which
this section applies is the chief pharmacist at an institution, the storage
receptacle must also be fitted with an alarm system.
Section 533
applies to persons listed in section 510 as prescribed persons, unless
excluded, if they are in possession of a controlled medicine, unless that
possession is for the immediate administration of the controlled
medicine.
Persons excluded from the application of this section are
dentists, doctors and veterinary surgeons at an institution in recognition that
others, such as the person in charge of a ward, carry the responsibility for
storage under this section. In situations where the controlled medicine is
dispensed in a dose administration aid, possession of the controlled medicine by
the person in charge of a residential aged care or residential disability care
facility are also excluded, as too are the persons in charge of a correctional
centre or CYP detention place. In this regulation a CYP detention place is
a detention place under the ACT Children and Young People
Act 2008.
Section 533 also does not apply to a prescribed
person listed in section 510(i) if the person does not have control over
the disposition of the medicine.
Chapter 12 Controlled medicines
registers
Section 540 Keeping of controlled medicines registers
by certain people
– Act, s 48 (a) and
s 50 (1) (b) and (2) (b)
Within this provision is
Table 540 that lists, in column 2, prescribed persons who must keep a
controlled medicines register for all controlled medicines in their possession.
Column 3 of the same table specifies where the register is to be kept.
Section 540 also contains several exceptions to the requirement to
keep a controlled medicines register for a controlled medicine in the
person’s possession. The first exception is for a controlled medicine in
a first-aid kit. This is because section 541 addresses the keeping of
controlled medicines registers for first-aid kit holders.
The remaining
exceptions relate to a controlled medicine dispensed in a dose administration
aid, and apply to persons in charge of residential aged care facilities,
residential disability care facilities, correction centres and detention places
under the Children and Young People Act 2008.
Table 540 does not include pharmacists. Instead, subsection 4
of the provision requires a pharmacist responsible for the management of a
community pharmacy at which controlled medicines are kept to keep a controlled
medicines register. Inclusion of pharmacists in Table 540 is not necessary
as section 48 of the MPTG Act already requires a controlled medicines
register to be kept for a community pharmacy.
Section 541 Keeping
of controlled medicines registers by first-aid kit
holders
– Act, s 48 (a) and
s 50 (1) (b) and (2) (b)
In this Regulation, a bag or
container of medicines and other medical supplies kept by a person for the
purposes of health care or emergency treatment is a first-aid kit.
Some
first-aid kits possessed by dentists, doctors, veterinary surgeons, or ambulance
officers employed by a State, Territory or the Commonwealth, include controlled
medicines. Where this is the case, this provision requires that a controlled
medicines register be kept with the first-aid kit.
It is also possible
to obtain a first-aid kit licence under Division 9.5.2 of this Regulation.
A first-aid kit licence enables the licence-holder to posses certain medicines
and purchase medicines through a purchase order. Such a licence also allows, in
certain situation and subject to certain conditions, the supply or even
administering of medicines. If a first-aid kit possessed by a first-aid kit
licence-holder contains controlled medicine, the licence-holder also is required
by this section to keep a controlled medicines register with the first-aid
kit.
As the definitions of a dentist, doctor and veterinary surgeon in
this Regulation do not include trainees or interns, this section does not
authorise a trainee or intern to have a controlled medicine in a first-aid kit.
Similarly, ambulance officers of private companies and not employed by a State,
Territory or the Commonwealth are not authorised by virtue of their employment
to have a first-aid kit containing a controlled medicine. To lawfully have a
controlled medicine in a first-aid kit, any of these persons would need to
possess a first-aid kit licence authorising possession of a controlled medicine.
Section 542 Form of controlled medicines
registers – Act, s 49 (1) (b) and
(2) (b)
Under this section, each page in a controlled medicines
register must relate to a single form and strength of a controlled medicine.
This means that if a single controlled medicine were possessed, but in different
sized ampoules, each ampoule size requires its own page in the
register.
Where a controlled medicines register is kept electronically,
which is permissible, a separate record must be used for each form and strength
of controlled medicine kept.
Section 543 Making entries in
controlled medicines registers – Act,
s 51 (1) (b)
Under section 51 of the MPTG Act a
person who must keep a register for a regulated substance commits an offence
unless that person ensures that the details prescribed by this Regulation are
recorded.
In regard to a controlled medicine, the details required to be
record under section 51 of the MPTG Act are listed in this provision.
Amongst the details for dealing with a controlled medicine that must be recorded
are the nature of the dealing itself, the date of the dealing, and the form,
strength and quantity of the medicine dealt with, and the quantity of the
medicine held following the dealing.
Details to be recorded under
section 540(1)(d) and (e) apply only if the dealing is supplying the
medicine. The details to be recorded under section 540(1)(f) apply if the
dealing is supplying the medicine on prescription. If the dealing is supplying
the medicine on a requisition, paragraph (g) of section 540(1) applies, and
if the dealing is supplying the medicine on a purchase order, it is paragraph
(h) that applies.
It is should also be noted that if section 53 of
the MPTG Act applies to the dealing being recorded in the register,
paragraph (i) states that the name of the person to whom the medicine is
administered must also be recorded. The only situations in which
paragraph (i) does not apply is where the controlled medicine is dispensed
in a dose administration aid for a patient at a residential aged care facility
or residential disability care facility, or a detainee at a correction centre or
a CYP detention place. In this regulation a CYP detention place is a detention
place under the ACT Children and Young People Act 2008.
Generally, the section requires that a dealing with a controlled
medicine be entered in the controlled medicines register that a person is
required to keep under this Chapter. However, with institutions it is possible
for there to be numerous controlled medicines registers, particularly if the
institution has a pharmacy and a number of wards. As such, this section
provides that if the dealing happens in a pharmacy at an institution the dealing
be entered into the controlled medicines register at the pharmacy. Whereas, if
the dealing happens in a ward at an institution the dealing must be recorded in
the controlled medicines register at the ward.
There may also be
situations where a person must keep a controlled medicines register for a
first-aid kit and another controlled medicines register. Subsection 3(c)
confirms that if the dealing with a controlled medicines related to the
first-aid kit must be recorded in the register for the first-aid kit, and all
other dealings will be recorded in the other register to be kept by the
person.
Section 544 Prescribed witnesses for administration of
controlled medicines
– Act, s 53 (a)
and (b)
Section 544 lists persons who are prescribed as
witnesses in relation to the administering of a controlled medicine.
Essentially, this provision enables a dentist, a doctor, a midwife, a nurse, a
nurse practitioner, or a pharmacist to be a prescribed witness to the
administering of a controlled medicine.
An intern doctor, or an
enrolled nurse registered under the Health Professionals Act 2004 in
the specialist area of medications, may also be prescribed witness to the
administering of a controlled medicine, unless the administering is being
performed by an intern doctor.
Section 545 Prescribed witnesses
for discarding of controlled medicines
– Act,
s 54 (a) and (b)
Section 545(1) lists persons who are
prescribed as witnesses in relation to the discarding of a controlled medicine.
However, section 545 also expressly excludes a person from being a
prescribed witness in relation to the discarding of a controlled medicine if the
person is related to, employed by, or a close friend of the person discarding
the controlled medicine.
Such persons are, by virtue of their relationship
with the person discarding the controlled medicine, potentially able to be
influenced by, or exert influence over, the person discarding the controlled
medicine. Accordingly, their suitability as a prescribed witness is thereby
diminished. For the same reason the supervisor of the person discarding the
controlled medicine cannot be a prescribed witness, nor can a person supervised
by the person discarding the controlled
medicine.
Section 546 Changes to entries in controlled medicines
registers – Act,
s 55 (2) (b)
Section 542 confirms that a controlled
medicines register may be kept in hardcopy form or electronically, and addresses
the form in which a controlled medicines register must be kept.
Understandably, from time to time situations may arise in which an entry
in a controlled medicines register needs to be changed, more often than not in
order to correct an entry. Changes to an entry in a controlled medicines
register is permissible, provided the requirements of this section are followed.
Subsection 1 relates to changes to an entry in a paper-based
controlled medicines register. The subsection permits the person who made the
entry to change the entry by signing and dating a marginal note or footnote that
gives the amendment details and the date the amendment is made.
If the
entry to be changed relates to the administering of a controlled medicine, the
amendment must be witnessed by a person listed in section 544, and the
witness must also sign the amendment to evidence that they witnessed the change.
It is not required that the person prescribed under section 544 that
witnessed the administering of the medicine be the same witness to the amendment
of the controlled medicines register. However, where it is possible it is
preferable.
Similarly, if the entry to be changed relates to the
discarding of a controlled medicine, the amendment must be witnessed by a person
listed in section 545, and the witness must also sign the amendment to
evidence that they witnessed the change. Again, it is not required that the
person prescribed under section 545 that witnessed the discarding of the
medicine be the same witness to the amendment of the controlled medicines
register, but it is still desirable where possible.
Subsection 2 of
the provision relates to changes to an entry in an electronic controlled
medicines register. Changes can be made by attaching or linking, by electronic
means, a document featuring the person’s signature, the date the details
of the amendment. Where the entry relates to the administering of a controlled
medicine, a prescribed witness under section 544 must also sign the
document to be attached or linked. Should the entry relate to the discarding of
a controlled medicine, the additional signature to be included is that of a
prescribed witness under section 545. Just as it is with a paper-based
register, the witness to the amendment need not be the original witness
identified in the entry, but where possible it is
desirable.
Chapter 13 Controlled medicines and appendix D
medicines approvals for human use
The medicines of most serious concern
within the SUSDP, and therefore the most tightly regulated by the MPTG
legislation, are controlled medicines and appendix D medicines. Controlled
medicines under the MPTG legislation are substances to which Schedule 8 of
the SUSDP apply and these medicines warrant additional restrictions to reduce
the likelihood of their misuse or dependence.
Approvals for human use of
these two types of medicines is the subject matter of Chapter 13. The
Chapter is divided into two Parts. Part 1 being approvals for controlled
medicines, and Part 2 being approvals for appendix D medicines.
Part 1 is further divided into four divisions, addressing standing
controlled medicines approvals, controlled medicines approvals by the Chief
Health Officer, endorsements to treat drug-dependency, and preliminary matters.
Part 13.1 Controlled medicines
approvals
Division 13.1.1 Preliminary
Preliminary matters
for Chapter 13 are contained within this Division. Section 550
establishes the meaning of controlled medicines approval for the purposes
of this Regulation, whereas section 551 assigns a meaning to designated
prescriber that applies to Part 13.1
only.
Division 13.1.2 Standing controlled medicines
approvals
Under this Division a designated prescriber, as defined in
Division 13.1.1, has a standing approval to prescribe a controlled medicine
for one of their patients where that patient is an in-patient at a
hospital.
A designated prescriber also has a standing approval to
prescribe a controlled medicine for one of their patients, provided that the
prescriber believes on reasonable grounds that the patient is not drug-dependent
and that the patient has not been prescribed a controlled medicine within the
preceding two month period. It is also a condition of that standing approval
that if the controlled medicine is prescribed, it is for no more than
2 months.
This Division also gives a standing approval to doctors
working at a correctional centre, CYP detention place, a hospital or an opioid
dependency treatment centre operated by the Territory. This standing approval,
which extends to intern doctors acting under the direct supervision of a doctor,
enables the prescription of buprenorphine or methadone for a patient at the
institution that the doctor works. Such a prescription must be in accordance
with the opioid dependency treatment guidelines, and requires the doctor to
apply.
This standing approval is effectively an interim approval for the
treatment of outpatients and others, as an application under section 560 of
this Regulation must be made within 72 hours of the buprenorphine or
methadone first being prescribed.
Division 13.1.3 Chief health
officer controlled medicines approvals
Through Division 13.1.3
applications may be made to the Chief Health Officer for approval to prescribe a
controlled medicine. Section 561 determines the requirements of an
application for approval to prescribe a controlled medicine, whereas
section 562 specifies the decisions on an application that the Chief Health
Officer can make. The Division permits the Chief Health Officer to impose
restrictions on an approval given, and a period for which an approval will
apply.
Should the Chief Health Officer think further information is
needed to decide the application, the applicant can be asked for that
information. If this occurs, the applicant must give the requested information
to the Chief Health Officer, who is not obliged to make a decision on the
application until the requested information is received.
Section 567
allows the Chief Health Officer to amend or revoke an approval that they have
given. The amendment or revocation may be made on the Chief Health
Officer’s own initiative, and without consultation with the Medicines
Advisory Committee. Should the Chief Health Officer amend or revoke an
approval, a written notice must be given to the approval-holder, and this
decision may also be reviewed by the Medicines Advisory Committee.
It should
also be noted that the Medicines Advisory Committee may also direct the Chief
Health Officer to amend or revoke an approval, irrespective of whether the
approval was given at the direction of the Medicines Advisory Committee.
Whatever the decision of the Chief Health Officer, a written notice of
the decision must be provided to the doctor no later than 7 days after the
decision is made. If the approval is refused, or an unfavourable decision is
made, the doctor has the right to seek a review of the decision, and the written
notice of the decision should explain that right.
The Division assigns
to the Medicines Advisory Committee the responsibility for reviewing a decision
by the Chief Health Officer. The Medicines Advisory Committee is established
under Part 15.2 of this
Regulation.
Division 13.1.4 Endorsements to treat
drug-dependency
This Division contains the framework under which the
Chief Health Officer can give an endorsement to a doctor to treat
drug-dependency. Within the Division, an endorsement is given by the Chief
Health Officer under section 582 to the prescribing of buprenorphine or
methadone to treat a person’s drug-dependency. It must be noted that an
endorsed doctor will also be required to have an approval to prescribe for an
individual patient under Division 13.1.3.
Through the operation of this
Division a doctor can apply to the Chief Health Officer, in writing, for an
endorsement. In addition to the doctor’s name, business address and
telephone number, the doctor is required to give their qualifications and
experience in treating drug-dependency. This information is critical as the
Chief Health Officer cannot give an endorsement unless satisfied that the doctor
possesses the necessary qualification and experience.
Should the Chief
Health Officer think further information is needed to decide the application,
the doctor can be asked for that information. If this occurs, the applicant
must give the requested information to the Chief Health Officer, who is not
obliged to make a decision on the application until the requested information is
received.
Whatever the decision of the Chief Health Officer, a written
notice of the decision must be provided to the doctor no later than 7 days
after the decision is made. If the decision is to give the endorsement, it must
include the doctor’s name, details of any conditions to which the
endorsement is subject, and an identifying number for the endorsement.
If
the endorsement is refused, the doctor has the right to seek a review of the
decision, and the written notice of the decision should explain that right.
The Division assigns to the Medicines Advisory Committee the
responsibility for reviewing a decision by the Chief Health Officer to refuse an
endorsement. The Medicines Advisory Committee is established under
Part 15.2 of this Regulation.
A doctor seeking a review has
28 days from the receipt of the notice of the Chief Health Officer’s
decision to apply for a review. An application for review must comply with
section 584(3). After considering an application the Medicines Advisory
Committee must make a decision, which will either be to confirm the decision of
the Chief Health Officer or to revoke the decision and give the
endorsement.
Part 13.2 Appendix D medicines
approvals
An authorisation under section 33 of this Regulation is
subject to the condition that the prescriber have an approval under this Part,
referred to as an appendix D medicines approval. Appendix D medicines
approvals are made under either section 591 or 592 in this Part.
Through the joint application of section 591 and Schedule 3 of
this Regulation certain specialist doctors have a standing approval, which is an
enduring approval that always exists, in relation to certain appendix D
medicines provided that particular conditions are met. For example, a
specialist practising in a the specialist area of dermatology has a standing
approval for a number of appendix D medicines listed column 3 in
Part 3.2 of Schedule 3. However, column 4 in Part 3.2 of
Schedule 3 imposes conditions 1 and 2 on the standing approval
for some of those medicines, and conditions 1 and 4 for two of the
medicines. What constitutes conditions 1, 2, 3 and 4 is detailed in
Part 3.1 of Schedule 3.
If a doctor does not have a standing
approval for an appendix D medicine, under section 592 the doctor may
apply in writing to the Chief Health Officer for approval to prescribe an
appendix D medicine. However, an application must still relate to a
medicine and purpose listed column 3 in Part 3.2 of Schedule 3.
For example, an approval can be sought to prescribe clozapine for human use.
Applications must provide the name of the medicine, and the name, business
address and telephone number of the doctor. Specialist doctors must also
identify their area of speciality, whereas a doctor that is not a specialist
must provide information about their qualifications and experience in relation
to the medicine to which the application relates. Furthermore, if the Chief
Health Officer requests any other information for the purposes of deciding on
the application, that information is to be provided.
The Chief Health
Officer must either approve or refuse the application, having regard to matters
stated in section 593(3). Whatever the decision, written notice of the
decision is to be provided within 7 days of the decision being made. If the
decision is to grant an approval, the approval is subject to conditions stated
in section 593(2), and the approval must be in a form that meets the
requirements of section 594.
Chapter 14 Medicines
licences
In many instances it is adequate for authorisation to handle
certain types of medicines to be assigned by this regulation to categories of
persons, subject to prescribed but broadly applying conditions. However, in
other instances it is only appropriate to give authorisation to conduct certain
activities to persons through the use of licences. This requires a person, be
it an individual, company or institution, to apply for authorisation to perform
the licensed activity, and thereby enabling the suitability of that person for
that activity to be assessed. Licences also enable conditions to be imposed
specific to the person, or the circumstances, and provide further enforcement
methods in the event of improper use.
Licences for medicines are dealt
with through Chapter 14 and it’s six Parts. Controlled medicines
research and education program licences are addressed within Part 2.
Within the Part are sections regarding what must be included in an application
for a controlled medicines research and education program licence, the
restrictions imposed on such a licence, and additional information prescribed
for such a licence.
First-aid kit licensees are addressed in the third
Part of the Chapter. Like the previous Chapter, the Part is comprised of three
sections addressing what must be included in an application for a first-aid kit
licence, the restrictions imposed on such a licence, and additional information
prescribed for such a licence.
The application of Part 4 is in
regard to medicines wholesalers licences. Again, the Part consists of sections
addressing what must be included in an application for a licence under the Part,
the restrictions imposed on such a licence, and additional information
prescribed for such a licence.
The focus of the remaining Parts is upon
opioid dependency treatment licences and pharmacy medicines rural communities
licences. pharmacy medicines rural communities licences is a licence issued to a
person who is not a pharmacist to sell, by retail, pharmacy medicines. Such
licences were primarily contemplated to avoid disadvantaging rural communities
that are without a local pharmacist by providing another mechanism whereby
pharmacist only medicines could be made available for retail sale to the
community. Accordingly, such licences are referred to as a pharmacy medicines
rural communities licence.
Part 14.1 Medicines licences
generally
Section 600 Medicines licences that may be
issued – Act, s 78 (2)
Section 78(2) of
the MPTG provides that this Regulation may prescribe the types of licences that
may be issued under the MPTG Act. This provision identifies the licences for
medicines which may be issued under this Regulation, each of which are addressed
in greater detail in the other Parts of this Chapter.
Part 14.2 Controlled medicines research and education program
licences
Part 14.2 provides the governance structure for the issuing
of licences for research or education programs proposing to involve controlled
medicines. Section 605 contains the details for the lodging of an
application for such a licence and the information that must be provided to
support the application.
Applications must be in writing, and signed by
the applicant. Furthermore, an application must also be accompanied by a
written approval of the proposed program from the person in charge of either the
faculty or division of a recognised research institution at which the program
would be conducted, or from the person in charge of the institution itself.
Section 20(5) of the MPTG Act lists recognised research institutions, which
include the University of Canberra, the ANU, the Canberra Hospital, the CSIRO,
or any other entity prescribed by this Regulation.
Controlled medicines
research and education program licences are issued by the Chief Health Officer,
but only if the Chief Health Officer is satisfied as to the matters set out in
section 606. A key consideration for the Chief Health Officer is whether
the proposed program cannot be carried out without the use of the controlled
medicine, and whether the program will be adequately
supervised.
Section 88 of the MPTG Act sets out information that
must be included in all types of licences issued under the MPTG legislation.
Subsection 1(k) of that same section enables this Regulation to prescribe
additional information to be included on a licence. For a controlled medicines
research or education program licence that additional information is set out in
section 607.
Part 14.3 First-aid kit licences
The
governance structure for the issuing of first-aid kit licences is contained in
this Part. Section 610 contains the details for the lodging of an
application for such a licence and the information that must be provided to
support the application.
Applications must be in writing, and signed by
the applicant. Furthermore, an application must also be accompanied by evidence
that the applicant has successfully completed a course that qualifies the person
to be registered as a nurse or employed as an ambulance paramedic. A letter of
support from a doctor who will provide medical direction and support to the
applicant is also required.
First-aid kit licences are issued by the
Chief Health Officer, but only if the Chief Health Officer is satisfied as to
the matters set out in section 611. A key consideration for the Chief
Health Officer is whether the applicant and each person to be authorised by the
licence has successfully completed a course that qualifies the person to be
registered as a nurse or employed as an ambulance paramedic, and that the
applicant provides, or will be providing, first-aid services to the community
(eg at a workplace or under the Emergencies Act 2004). The Chief
Health Officer must also be satisfied that the medicines to which the licence
application relates are reasonably necessary to provide the first-aid
services.
Section 88 of the MPTG Act sets out information that must
be included in all types of licences issued under the MPTG legislation.
Subsection 1(k) of that same section enables this Regulation to prescribed
additional information to be included on a licence. For a first-aid kit licence
that additional information is set out in section 612.
Part 14.4 Medicines wholesalers licences
This Part
provides the governance structure for the issuing of licences for wholesale
suppliers proposing to supply medicines. Section 615 contains the details
for the lodging of an application for such a licence and the information that
must be provided to support the application.
Applications must be in
writing, and signed by the applicant. Furthermore, an application must also be
accompanied by a plan of the premises proposed to be used by the licensee that
shows where the medicines are proposed to be stored and the location and nature
of security devices at the premises.
Medicines wholesalers licences are
issued by the Chief Health Officer, but only if the Chief Health Officer is
satisfied as to the matters set out in section 616. A key consideration
for the Chief Health Officer is the suitability and qualifications of the
individual nominated to supervise the dealings to be authorised by the licence.
Section 88 of the MPTG Act sets out information that must be
included in all types of licences issued under the MPTG legislation.
Subsection 1(k) of that same section enables this Regulation to prescribed
additional information to be included on a licence. For a medicines wholesalers
licence section 617 requires that the licence also feature the name of the
person approved under section 616(1) to supervise the dealings authorised
by the licence.
Part 14.5 Opioid dependency treatment
licences
Section 600(d) of this Regulation enables a licence to be
issued for the treatment of opioid dependency with buprenorphine or methadone.
Section 620 Applications for opioid dependency treatment
licences
Section 620 contains the details for the lodging of an
application for such a licence and the information that must be provided to
support the application. Applications must be in writing, signed by the
applicant, and specifying the applicant’s full name and business
address.
Section 621 Restriction on opioid dependency treatment
licences - Act, s 85 (1) (a)
The Chief Health
Officer issues opioid dependency treatment licences, but may only do so to a
pharmacist at a community pharmacy. No other category of person may hold an
opioid dependency treatment licence under this
Regulation
Section 622 Witnessing not required for administration
under opioid dependency treatment licence - Act,
s 190 (1) (a)
This Regulation may, through the operation
of section 190(1)(a) of the MPTG Act, exempt persons, regulated things,
premises or even dealing with a regulated medicine, substance or therapeutic
good. Section 190(2) provides that such an exemption can be
conditional.
Division 4.2.2 of the MPTG Act contains offences
relating to registers for regulated substances. Amongst those is
section 53, which addresses the witnessing of administering of a medicine.
The section requires a number of elements to be met, otherwise an offence is
committed.
Section 622 exempts the administration of buprenorphine
or methadone under an opioid dependency treatment licence from the requirement
in section 53(e) of the MPTG Act, provided that the administration complies
with section 471 of this Regulation. Section 471 contains
authorisation conditions that apply to all opioid dependency treatment licences.
Accordingly, compliance with section 471 is mandatory even without the
application of section 622.
Part 14.6 Pharmacy medicines
rural communities licences
Section 600(e) of this Regulation enables
a licence to be issued to a person who is not a pharmacist to sell, by retail,
pharmacy medicines. Such licences were primarily contemplated to avoid
disadvantaging rural communities that are without a local pharmacist by
providing another mechanism whereby pharmacist only medicines could be made
available for retail sale to the community. Accordingly, such licences are
referred to as a pharmacy medicines rural communities licence. This Division
provides the governance structure for the issuing of such licences.
Section 625 Applications for pharmacy medicines rural
communities licences
Section 625 contains the details for the
lodging of an application for such a licence and the information that must be
provided to support the application. Applications must be in writing, and
signed by the applicant. Furthermore, an application must include the
applicant’s full name, business address and telephone number. The
pharmacy medicines that the applicant would propose to sell under the licence
must also be included.
Section 626 Restrictions on issuing of
pharmacy medicines rural communities licences - Act,
s 85 (1) (a)
Pharmacy medicines rural communities licences
are issued by the Chief Health Officer, but only if the Chief Health Officer is
satisfied as to the matters set out in section 626. In order to qualify
for a pharmacy medicines rural communities licence, the Chief Health Officer
needs to be satisfied that the premises from which the medicines will be sold is
more than 25 kilometres, using the shortest practical route, to the nearest
community pharmacy.
The wording “by the shortest practical
route” recognises geographical realities. It may be possible for a
community pharmacy to be within a 25 kilometre radius of the
applicant’s business premises, but a trip to that pharmacy may be well in
excess of 25 kilometres as certain obstacles may need to be navigated.
For example, it could be that a river or bay separates the
applicant’s business and the nearest community pharmacy. The community
pharmacy may be only 20 kilometres away as the crow flies, but driving to
that community pharmacy may be a trip exceeding 25 kilometres due to the
trip around the bay or because of the location of the nearest bridge. In this
example the route from one point the other by boat may be less than
25 kilometres. Nevertheless, the route by boat would not be considered to
be “the shortest practical route” as travel by boat may not be
possible at certain times of day or in certain conditions, and it may be a means
of travel to which few people have access.
Additionally, the Chief
Health Officer must be satisfied that the applicant is carrying on a business of
selling goods by retail.
Chapter 15 Medicines – other
provisions
Part 15.1 Opioid dependency treatment
guidelines
This part contains a single section that enables the Minister
to approve, by notifiable instrument, guidelines for the treatment of opioid
dependency. If the Minister chooses to approve guidelines under this Part, the
guidelines may make provision for the prescribing, administration, or both, of
buprenorphine and methadone to drug-dependent people.
Part 15.2 Medicines advisory committee
Section 194
of the MPTG Act establishes the medicines advisory committee. Provisions about
the medicines advisory committee, its membership and operations, are contained
within this Part. The medicines advisory committee is comprised of 3 doctors,
one of which will serve as committee chair. Of the doctors on the committee,
section 635 requires the committee have a member with experience in the
teaching or practice of psychiatry, and a member that was nominated by the ACT
branch of the Australian Medical Association. It is possible for a single
member to fulfil both of these requirements, and may even fulfil both of these
requirements and be appointed as chair of the committee.
There are
provisions within the Chapter pertaining to the conduct of committee meetings,
voting, the necessary quorum for meetings and the disclosure of interests by
members. Section 644 of this regulation also gives the Minister the power
to end a member’s appointment in given circumstances, such as bankruptcy,
contravention of a law of the Territory and even
misbehaviour.
Part 15.3 Other medicines
provisions
Section 650 Advertising controlled
medicines – Act,
s 66 (3) (b)
Section 66 of the MPTG Act effectively
prohibits advertising controlled medicines, and does so through offences in
subsections (1) and (2). However, pursuant to subsection (3) of the
same provision the offences in subsections (1) and (2) do apply to an
advertisement prescribed under this regulation, or an advertisement by a
pharmacist prescribed by this regulation.
Section 650 operates to
prescribe a pricelist published by a pharmacist that includes a controlled
medicine for the purposes of section 66(3)(b) of the MPTG Act, provided
that the pricelist complies with the Price Information Code of Practice
published by the Therapeutic Goods
Administration.
Section 651 Advertising other
medicines
Section 66 of the MPTG Act contains offences for
advertising controlled medicines. This provision establishes offences for
advertising of declared medicines. The offences in this provision are less
serious than those in section 66 of the MPTG Act, and therefore carry a
lessor maximum penalty. As that maximum penalty is 30 penalty units the
offence in section 651 is appropriately located within this regulation
rather than the MPTG Act.
Section 651 also advises that the offences
within the provision do not apply in two circumstances. Similar to
section 650, a pricelist published by a pharmacist that includes a declared
medicine will not amount to an offence, provided that the pricelist complies
with the Price Information Code of Practice published by the Therapeutic
Goods Administration. The other exception is an advertisement for a declared
medicine in a publication that is published primarily for dentists, doctors,
pharmacists or veterinary surgeons.
Section 652 Prescribed
institutions – Act, dict, def institution,
par (b)
The definition of institution contained in the
dictionary of the MPTG Act states that an institution:
(a) means a hospital, residential aged care facility, residential disability care facility or other institution used for the accommodation, treatment and care of people suffering from mental or physical conditions; and
(b) includes a body prescribed by regulation as an institution.
This
section prescribes a correctional centre and a CYP detention place as an
institution for the purposes of paragraph (b) of the MPTG Act’s
dictionary definition. A correctional centre has its ordinary meaning.
However, for this regulation a CYP detention place is a detention place under
the ACT Children and Young People Act 2008.
Chapter 16 Low and moderate harm poisons
The MPTG Act
contains a number of offences for supplying improperly packaged or labelled
regulated substances. What amounts to appropriate packaging and labelling for
low and moderate harm poisons is the subject matter of this
Chapter.
Part 16.1 Preliminary
Section 660 Meaning
of relevant law – ch 16
For the purposes of
this Chapter, a law of another Australian State or Territory, referred to in the
MPTG legislation as a corresponding law, is a relevant law.
Additionally, the Commonwealth Agricultural and Veterinary Chemicals
Act 1997 and the Therapeutic Goods Act 1989 are also
relevant laws for Chapter 16.
Part 16.2 Authorisation to
supply low and moderate harm poisons
Section 661 Authorisation to
supply low and moderate harm poisons
– Act,
s 26 (1) (b) and (2) (b)
Through section 661 all
persons are authorised to supply a low or moderate harm poison. However, anyone
who chooses to supply a low or moderate harm poison must comply with the
conditions set out in section 662.
Section 662 Authorisation
condition for supplying low and moderate harm
poisons
– Act, s 44 (1) and
(2) (b)
Although anyone can, under section 661, supply a low or
moderate harm poison, the poison must be supplied in manufacturer’s packs.
Furthermore, the manufacturer’s pack must comply with section 665 of
this Regulation or with an approval given under section 193 of the MPTG
Act. The manufacturer’s pack must also be labelled in accordance with
either section 666 of this Regulation or an approval given under
section 193 of the MPTG Act.
Part 16.3 Authorisation to
manufacture low and moderate harm
poisons
Section 663 Authorisation to manufacture low and moderate
harm poisons
– Act, s 33 (b)
If a person
is authorised to manufacture a low or moderate harm poison under a relevant law,
as defined by section 660, then that person is also authorised under this
provision to manufacture the poison in the
ACT.
Section 664 Authorisation condition for manufacturing low
and moderate harm poisons
– Act, s 44 (1) and
(2) (b)
By virtue of this provision, if a relevant law as defined in
section 660 imposes a condition on a person manufacturing a poison, then
that condition is also a condition on an authorisation to manufacture a low or
moderate harm poison under section 661.
Part 16.4 Packaging
and labelling of low and moderate harm
poisons
Section 665 Packaging of supplied manufacturer’s
packs of low and moderate harm
poisons - Act,
s 59 (1) (c) (i) and (2) (c) (i)
Under
section 59 of the MPTG Act, a person authorised to supply a regulated
substance risks committing an offence if the substance supplied is not
appropriately labelled.
This section specifies that for the purposes of
section 59 of the MPTG Act, a manufacturer’s pack of a low or
moderate harm poison is packaged correctly if it is packaged in one of three
ways. The poison may also be packaged in accordance with an approval under
section 193 of the MPTG Act, or in accordance with either the
paragraphs 21 to 28 of the SUSDP. The third approved packaging method is
the supply of the substance in a container in which the poison may be sold under
a relevant law.
If the poison is camphor or naphthalene intended for
domestic use, the container in which the poison is sold under a relevant law
must also prevent the camphor or naphthalene from being removed from the
packaging, or ingested. Both camphor and naphthalene are routinely used in
domestic settings, and provided both are appropriately packaged they are safe
for such usages.
It should be noted that an approval for non-standard
packaging and labelling can be obtained under section 193 of the MPTG.
Where this has occurred, the person to whom the approval has been granted does
not need to comply with this section, provided that the terms of the approval
are adhered to.
Section 666 Labelling of supplied
manufacturer’s packs of low and moderate harm
poisons - Act, s 60 (1) (c) (i) and
(2) (c) (i)
Under section 60 of the MPTG Act, a person
authorised to supply a regulated substance risks committing an offence if the
substance that is supplied is not appropriately labelled.
This section
specifies that for the purposes of section 60 of the MPTG Act, a
manufacturer’s pack of a low or moderate harm poison is labelled correctly
if it is labelled in accordance with either the paragraphs 3 to 19 of the
SUSDP, a relevant law or an approval under section 193 of the MPTG
Act.
It should be noted that an approval for non-standard packaging and
labelling can be obtained under section 193 of the MPTG. Where this has
occurred, the person to whom the approval has been granted does not need to
comply with this section, provided that the terms of the approval are adhered
to.
Chapter 17 Dangerous poisons
authorisations
Part 17.1 Overview of dangerous poisons
authorisations
Section 670 General overview of authorisations for
dangerous poisons
This section reiterates that it is the MPTG Act that
prohibits dealing with a dangerous poison without an authorisation, and
section 20 of the MPTG Act sets out when a person is authorised to deal
with a regulated substance.
Section 671 Overview of dangerous
poisons authorisations under this regulation
Dangerous poisons
authorisations under this Regulation are listed in this section.
Section 672 General overview of authorisation conditions for
dangerous poisons
This section essentially reiterates that
section 44 of the MPTG Act requires a person authorised to deal with a
dangerous poison to comply with conditions to which the authorisation is
subject. The section also draws the reader’s attention to the fact that
conditions on authorisations are additional to other restrictions that may be
placed upon a person’s authorisation under the MPTG
legislation.
Part 17.2 Authorisations under dangerous poisons
licences
Division 17.2.1 Dangerous poisons manufacturers licence
authorisations
The governance structure for the issuing of dangerous
poisons manufacturers licences is contained in Part 18.2 of this
Regulation. This Division establishes what is authorised by a licence issued
under Part 18.2.
Section 675 authorises a licence-holder to
do a variety of things from the premises stated on the licence, including
possess the dangerous poison for sale by wholesale and, not unexpectedly,
manufacture the dangerous poison.
Of particular importance for a
dangerous poisons manufacturer’s licence, the Division authorises the sale
of dangerous poisons by wholesale, from the premises stated on the licence, to a
person that is authorised to issue a purchase order for the dangerous poison.
Furthermore, the licence-holder is authorised to sell by wholesale to a person
in another jurisdiction, including overseas, provided that person is lawfully
able to obtain the dangerous poison by wholesale.
It should be noted
that the authorisations under this Division apply to all the dangerous poisons
manufacturer’s licences, unless a licence expressly states that a
particular type of dealing is not authorised. In effect, this means that the
terms of an issued licence can overrule or contradict the authorisations in this
Division.
For example, a licence could be issued that states the licensee
is not authorised to supply by wholesale to a person in another country. Supply
by wholesale to a person in another country will also be prevented if the
dangerous poison to which the licence relates is a prohibited export under the
Commonwealth Customs Act 1901. In such circumstances the
authorisation to supply to a person in another country does not
apply.
The authorisation to obtain a dangerous poison under this Division
is subject to the condition that the dangerous poison is purchased on a
complying purchase order. For a dangerous poison a complying purchase order is,
according to the dictionary in this Regulation, a purchase order pursuant to
section 721. Additionally, a dangerous poison may only be sold under a
wholesaler’s licence on a complying purchase order.
A further
condition is that dangerous poisons are only to be supplied under this Division
for non-household purposes. The condition means the dangerous poison may be
supplied for garden purposes, provided the garden is a non-household
garden.
As the condition applies to wholesalers, a dangerous poison may
only be supplied to a person who has an authority to possess a dangerous poison,
and that the supply conforms with section 720 of this Regulation.
A
special condition also exists where the dangerous poison is a liquid containing
paraquat. In such circumstances the poison must be coloured blue or green and
must have an offensive smell. These visual and olfactory indicators are
necessary to identify the danger associated with this particular poison.
Section 676(e) also contemplates that the licence-holder will
receive a document from a buyer to whom a dangerous poison was supplied. This
document, acknowledging receipt of the dangerous poison, should be provided
within 7 days of the dangerous poison being delivered. Should this not
occur, the licence-holder must, within 24 hours after the end of the
7 day period, advise the Chief Health Officer in writing.
There is
also a requirement for certain records to be kept at the licence-holders
business premises, or another location if approved in writing by the Chief
Health Officer. Those records include the filled purchase order, the delivery
acknowledgement, and a record that satisfies section 722 of this
Regulation.
Division 17.2.2 Dangerous
poisons - research and education program licence
authorisations
This Division specifies the types of dealings for which a
dangerous poisons research and education program licence-holder is authorised,
as well as the conditions that apply to all such licences. Additionally, the
program supervisor and anyone participating in the program are authorised to
deal with the dangerous poison to which the licence relates, provided that the
dealing occurs, for the purposes of the program, at the premises stated in the
licence.
A dangerous poisons research and education program
licence-holder is authorised to obtain dangerous poisons in accordance with the
terms of their licence. It is a further condition on a licence-holder’s
authorisation that all dangerous poisons purchased under the licence are done so
through a complying purchase order. For a dangerous poison a complying purchase
order is, according to the dictionary in this Regulation, a purchase order
pursuant to section 721.
Division 17.2.3 Dangerous poisons
suppliers licence authorisations
The governance structure for the issuing
of dangerous poisons suppliers licences is contained in Part 18.4 of this
Regulation. This Division establishes what is authorised by a licence issued
under Part 18.4.
Section 685 authorises a licence-holder to
do a variety of things from the premises stated on the licence, including
issuing purchase orders for a dangerous poison, obtaining a dangerous poison
through a purchase order for sale, and possessing the dangerous poison for
sale.
Of particular importance for a dangerous poisons suppliers licence,
the Division authorises the sale of dangerous poisons on a purchase order, from
the premises stated on the licence, to a person that is authorised to issue a
purchase order for the dangerous poison. Furthermore, the licence-holder is
authorised to sell a dangerous poison to a person in another jurisdiction,
including overseas, provided that person is lawfully able to obtain the
dangerous poison.
It should be noted that the authorisations under this
Division apply to all supplier’s licences, unless a licence expressly
states that a particular type of dealing is not authorised. In effect, this
means that the terms of an issued licence can overrule or contradict the
authorisations in this Division. For example, a licence could be issued that
states the licensee is not authorised to supply to a person in another country.
Supply to a person in another country will also be prevented if the dangerous
poison to which the licence relates is a prohibited export under the
Commonwealth Customs Act 1901. In such circumstances the
authorisation to supply to a person in another country does not apply.
It
is a condition under section 686 of this Regulation that all dealings with
a dangerous poison take place under the supervision of an individual approved
under section 716(1).
All dangerous poisons sold under the licence
must be sold under a purchase order that meets the requirements of
section 720. However, if a dangerous poison is subject to condition 3
in appendix J of the SUSDP that poison must not be supplied to a person
unless they are allowed to use that poison under condition 3 of
appendix J.
A further condition is that dangerous poisons are only
to be supplied under this Division for non-household purposes. The condition
means the dangerous poison may be supplied for garden purposes, provided the
garden is a non-household garden.
A special condition also exists where
the dangerous poison is a liquid containing paraquat. In such circumstances the
poison must be coloured blue or green and must have an offensive smell. These
visual and olfactory indicators are necessary to identify the danger associated
with this particular poison.
Section 686(e) also contemplates that
the licence-holder will receive a document from a buyer to whom a dangerous
poison was supplied. This document, acknowledging receipt of the dangerous
poison, should be provided within 7 days of the dangerous poison being
delivered. Should this not occur, the licence-holder must, within 24 hours
after the end of the 7 day period, advise the Chief Health Officer in
writing.
There is also a requirement for certain records to be kept at
the licence-holders business premises, or another location if approved in
writing by the Chief Health Officer. Those records include the filled purchase
order, the delivery acknowledgement, and a record that satisfies
section 722 of this Regulation.
Part 17.3 Other dangerous
poisons authorisations
Division 17.3.1 Authorisations for
manufacturing etc purposes
Section 690 in this Division directs that
a person mentioned in column 2 in Schedule 4 of this Regulation is
authorised for a relevant dealing with a dangerous poison mentioned in
column 3 of Schedule 4. However, the authorisation is on the proviso
that the poison is for the purpose mentioned in column 4 in Schedule 4
and the dealing is consistent with any condition or restriction mentioned in
column 3. Furthermore, where the dealing is issuing a purchase order for
the poison, the purchase order must comply with section 720 of this
Regulation,
Under this Division, the types of dealings that are regarded
as relevant dealings include the issuing of a purchase order, obtaining
the poison, possessing the poison and discarding the poison.
Division 17.3.2 Authorisations for delivery people and
commercial disposal operators
Division 17.3.2 gives authorisations
to delivery people and commercial disposal operators so that the handling of
medicines by such persons in the ordinary course of their employment is
authorised and lawful under the MPTG legislation.
Division 17.3.3 Authorisations for dangerous poisons research
and education programs by scientifically qualified people
The provisions
in Division 17.3.3 give authorisations for dangerous poisons for research
and education program purposes. The provisions in this Division enable
scientifically qualified persons employed a recognised research institution to
handle dangerous poisons without contravening the MPTG legislation.
A
scientifically qualified person is, according to the dictionary in this
Regulation, a dentist, doctor, pharmacist or veterinary surgeon, excluding
trainees and interns. A person who has been awarded a doctorate for scientific
studies is also considered a scientifically qualified
person.
Section 20(5) of the MPTG Act lists recognised research
institutions, which include the University of Canberra, the ANU, the Canberra
Hospital, the CSIRO, or any other entity prescribed by this
Regulation.
Chapter 18 Dangerous poisons
licences
Part 18.1 Dangerous poisons licences
generally
Section 700 Dangerous poisons licences that may be
issued - Act, s 78 (2)
Section 78(2) of the MPTG
provides that this Regulation may prescribe the types of licences that may be
issued under the MPTG Act. This provision identifies the licences for dangerous
poisons which may be issued under this Regulation, each of which are addressed
in greater detail in the other Parts of this Chapter.
Part 18.2 Dangerous poisons manufacturers licences
This
Part provides the governance structure for the issuing of manufacturers licences
for dangerous poisons. Section 705 contains the details for the lodging of
an application for such a licence and the information that must be provided to
support the application.
Applications must be in writing, and signed by
the applicant. Furthermore, an application must also be accompanied by a plan
of the premises proposed to be used by the licensee. The plan submitted must
show the locations where dangerous poisons are proposed to be stored,
irrespective of whether those poisons are those manufactured under the licence
sought or are precursor dangerous poisons.
The plan must also reflect each
part of the premises where a manufacturing process is proposed to be carried out
and the nature of the process, as well as the location and nature of security
devices at the premises.
Dangerous poisons manufacturers licences are
issued by the Chief Health Officer, but only if the Chief Health Officer is
satisfied as to the matters set out in section 706. A key consideration
for the Chief Health Officer is the suitability and qualifications of the
individual nominated to supervise the dealings to be authorised by the licence.
Section 88 of the MPTG Act sets out information that must be
included in all types of licences issued under the MPTG legislation.
Subsection 1(k) of that same section enables this Regulation to prescribed
additional information to be included on a licence. For a dangerous poisons
manufacturers licences section 707 requires that the licence also feature
the name of the person approved under section 706(1) to supervise the
dealings authorised by the licence.
Part 18.3 Dangerous poisons
research and education program licences
This Part provides the governance
structure for the issuing of licences for research or education programs
proposing to involve dangerous poisons. Section 710 contains the details
for the lodging of an application for such a licence and the information that
must be provided to support the application.
Applications must be in
writing, and signed by the applicant. Furthermore, an application must also be
accompanied by a written approval of the proposed program from the person in
charge of either the faculty or division of a recognised research institution at
which the program would be conducted, or from the person in charge of the
institution itself. Section 20(5) of the MPTG Act lists recognised
research institutions, which include the University of Canberra, the ANU, the
Canberra Hospital, the CSIRO, or any other entity prescribed by this
Regulation.
Dangerous poisons research and education program licences are
issued by the Chief Health Officer, but only if the Chief Health Officer is
satisfied as to the matters set out in section 711. A key consideration
for the Chief Health Officer is whether the proposed program cannot be carried
out without the use of the dangerous poison, and whether the program will be
adequately supervised.
Section 88 of the MPTG Act sets out
information that must be included in all types of licences issued under the MPTG
legislation. Subsection 1(k) of that same section enables this Regulation
to prescribed additional information to be included on a licence. For a
dangerous poisons research or education program licence that additional
information is set out in section 712.
Part 18.4 Dangerous
poisons suppliers licences
This Part provides the governance structure
for the issuing of dangerous poisons supplier licences. Section 715
contains the details for the lodging of an application for such a licence and
the information that must be provided to support the application.
Applications must be in writing, and signed by the applicant.
Furthermore, an application must also be accompanied by a plan of the premises
proposed to be used by the licensee that shows where the dangerous poisons are
proposed to be stored and the location and nature of security devices at the
premises.
Licences to supply dangerous poisons are issued by the Chief
Health Officer, but only if the Chief Health Officer is satisfied as to the
matters set out in section 716. A key consideration for the Chief Health
Officer is the suitability and qualifications of the individual nominated to
supervise the dealings to be authorised by the licence.
Section 88
of the MPTG Act sets out information that must be included in all types of
licences issued under the MPTG legislation. Subsection 1(k) of that same
section enables this Regulation to prescribed additional information to be
included on a licence. For a dangerous poisons supplier licence
section 717 requires that the licence also feature the name of the person
approved under section 716(1) to supervise the dealings authorised by the
licence.
Chapter 19 Dangerous poisons – other
provisions
Part 19.1 Dangerous poisons purchase
orders
Section 720 Supplying dangerous poisons on purchase
orders
The supply of a dangerous poison on a purchase order must meet
certain requirements, which are set out in this section. Dangerous poisons to
be supplied on a purchase order must be supplied in manufacturer’s packs
that are properly labelled in accordance with section 732, properly
packaged in accordance with section 731, and are securely wrapped and
packed. The provision imposes requirements in regard to the delivery of the
dangerous poison, which differ depending on whether or not the supplier is
delivering the poison in person. Which ever method is used, the poison can only
be delivered to an adult, and that person must sign for the
delivery.
Section 721 General requirements for dangerous poisons
purchase orders
- Act,
s 38 (2) (c)
Purchase orders for dangerous poisons must,
under this section, be signed by the person issuing the order. Furthermore, if
the person issuing the purchase order amends the order at any stage, the person
must record their initials and the date along side the
amendment.
Subsection 2 specifies what information must be included
in a purchase order for a dangerous poison, such as the form, strength and
quantity of the dangerous poison supplied.
Section 722 Recording supply of dangerous poisons on purchase
orders
Under this section, a person who supplies a dangerous poison to
someone else on a purchase order is required to make a written record of the
supply. The information required to be kept under this provision includes the
date of the order, the date the order is supplied, and the form, strength and
quantity of the dangerous poison supplied. For obvious reasons, the details of
the person to whom the dangerous poison was supplied is also required to be
recorded.
Through a comparison of the record made under this section with
the purchase order to which the supply relates, discrepancies and variations
should be identifiable. Identification of such variances and discrepancies may
enable the identification of dangerous poisons being misused, redirected or
unusual supply patterns. Therefore, the keeping of such records is invaluable
from a regulatory perspective.
Under section 11 of the Electronic
Transactions Act 2001 records can be kept in an electronic format
provided certain criteria can be met. Accordingly, a requirement to keep a
written record is met if the record is kept in an electronic
form.
Part 19.2 Wholesale supply of dangerous poisons under
corresponding laws
Section 725 Conditions for wholesalers
supplying dangerous poisons under corresponding laws – Act,
s 20 (4) (c)
This provision imposes conditions upon all
persons who supply, under authority assigned by a corresponding law, dangerous
poisons by wholesale. Through this provision, dangerous poisons are only to be
supplied for non-household purposes. The condition means the dangerous poison
may be supplied for garden purposes, provided the garden is a non-household
garden.
As the condition applies to wholesalers, a dangerous poison may
only be supplied to a person who has an authority to possess a dangerous poison,
and that the supply conforms with section 686 of this Regulation.
A
special condition also exists where the dangerous poison is a liquid containing
paraquat. In such circumstances the poison must be coloured blue or green and
must have an offensive smell. These visual and olfactory indicators are
necessary to identify the danger associated with this particular poison.
Part 19.3 Packaging and labelling of dangerous
poisons
Section 730 Meaning of relevant
law – pt 19.3
For the purposes of this Part, a
law of another Australian State or Territory, referred to in the MPTG
legislation as a corresponding law, is a relevant law. Additionally, the
Commonwealth Agricultural and Veterinary Chemicals Act 1997 and the
Therapeutic Goods Act 1989 are also relevant laws for this
Part.
Section 731 Packaging of supplied manufacturer’s
packs of dangerous poisons
- Act,
s 59 (1) (c) (i) and (2) (c) (i)
The
packaging requirements of a manufacturer’s pack of a dangerous poison is
set out in this section. Manufacturer’s pack must be packaged in
accordance with paragraphs 21 through to 27 of the SUSDP. Alternatively, a
manufacturer’s pack may be packaged in a container approved under
section 193 of the MPTG or in a container in which the dangerous poison may
be sold under a corresponding law.
Section 732 Labelling of
supplied manufacturer’s packs of dangerous poisons
- Act,
s 60 (1) (c) (i) and (2) (c) (i)
Under
section 60 of the MPTG Act, a person authorised to supply a regulated
substance risks committing an offence if the substance that is supplied is not
appropriately labelled.
This section specifies that for the purposes of
section 60 of the MPTG Act, a manufacturer’s pack of a dangerous
poison is labelled correctly if it is labelled in accordance with
paragraphs 3 to 19 of the SUSDP or a relevant law.
It should be
noted that an approval for non-standard packaging and labelling can be obtained
under section 193 of the MPTG. Where this has occurred, the person to whom
the approval has been granted does not need to comply with this section,
provided that the terms of the approval are adhered
to.
Part 19.4 Storage of dangerous
poisons
Section 735 Storage of dangerous poisons - Act,
s 61 (b) and (c)
Dangerous poisons must, under this
provision, be stored in a part of the premises to which the public does not have
access. Additionally, such dangerous poisons must be stored so that only a
prescribed person, or a person under the direct supervision of a prescribed
person, has access to the poison. Persons listed in column 2 of
Table 740 who possess dangerous poisons are prescribed
persons.
Part 19.5 Dangerous poisons
registers
Section 740 Keeping of dangerous poisons registers by
certain people
– Act, s 48 (a) and
s 50 (1) (b) and (2) (b)
Within this provision is
Table 740 that lists, in column 2, prescribed persons who must keep a
dangerous poisons register for all dangerous poisons in their possession.
Column 3 of the same table specifies where the register is to be kept.
Section 741 Form of dangerous poisons
registers – Act, s 49 (1) (b)
Under this
section, each page in a dangerous poisons register must relate to a
single form and strength of a dangerous poison. This means that if a single
dangerous poison were possessed, but in different strength, each strength
requires its own page in the register.
Where a dangerous poisons register
is kept electronically, which is permissible, a separate record must be used for
each form and strength of dangerous poison
kept.
Section 742 Making entries in dangerous poisons
registers – Act, s 51 (1) (b)
Under
section 51 of the MPTG Act a person who must keep a register for a
regulated substance commits an offence unless that person ensures that the
details prescribed by this Regulation are recorded.
In regard to a
dangerous poison, the details required to be recorded under section 51 of
the MPTG Act are listed in this provision. Amongst the details for dealing with
a dangerous poison that must be recorded are the nature of the dealing
itself, the date of the dealing, and the form, strength and quantity of the
poison dealt with, and the quantity of the poison held following the
dealing.
Details to be recorded under section 742(1)(d) applies only
if the dealing is receiving the poison. The details to be recorded under
section 742(1)(e) applies if the dealing is supplying the poison.
This provision also makes it expressly clear that a dealing with a
dangerous poison must be entered in the dangerous poisons register
that a person is required to keep under this Chapter.
Section 743 Prescribed witnesses for discarding of dangerous
poisons
– Act, s 54 (a)
and (b)
Adults are prescribed by section 743(1) as witnesses in
relation to the disposal of a dangerous poison. However, section 743 also
expressly excludes a person from being a prescribed witness in relation to the
disposal of a dangerous poison if the person is related to, employed by, or a
close friend of the person disposing of the poison. Such persons are, by virtue
of their relationship with the person disposing of the dangerous poison,
potentially able to be influenced by, or exert influence over, that person.
Accordingly, their suitability as a prescribed witness is thereby diminished.
For the same reason the supervisor of the person disposing of the dangerous
poison cannot be a prescribed witness, nor can a person supervised by the person
disposing of the dangerous poison.
Section 744 Changes to entries
in dangerous poisons registers – Act,
s 55 (2) (b)
Section 741 confirms that a dangerous
poison register may be kept in hardcopy form or electronically, and addresses
the form in which a dangerous poison register must be kept.
Understandably, from time to time situations may arise in which an entry
in a dangerous poisons register needs to be changed, more often than not in
order to correct an entry. Changes to an entry in a dangerous poisons register
is permissible, provided the requirements of this section are followed.
Subsection 1 relates to changes to an entry in a paper-based
dangerous poisons register. The subsection permits the person who made the
entry to change the entry by signing and dating a marginal note or footnote that
gives the amendment details and the date the amendment is made.
If the
entry to be changed relates to the disposing of a dangerous poison, the
amendment must be witnessed by a person listed in section 743, and the
witness must also sign the amendment to evidence that they witnessed the change.
It is not required that the person prescribed under section 743 that
witnessed the disposal of the dangerous poison be the same witness to the
amendment of the dangerous poisons register. However, where it is possible it
is preferable.
Chapter 20 Paints
There are some paints
that contain certain substances and poisons that can be highly toxic or
dangerous, and thereby have the potential to be harmful if contacted directly or
to contaminate food, water or even the surrounding environment. Nevertheless,
some of these paints may still have special or specific, all be it limited,
applications. This Chapter contains some sections that determine what usages
certain paints can be used for, and some sections that instruct usages for which
certain paints must not be used for. Each section within this Chapter links
back to an offence contained within the MPTG
Act.
Section 750 Manufacture, supply and use of paints containing
white lead
- Act, s 70 (1) (b), (2) (b) and
(3) (b)
Section 70 of the MPTG Act contains offences for
manufacturing, supplying or using paint containing white lead, also known as
basic lead carbonate, unless that paint is manufactured, supplied or used in
accordance with this regulation.
The only purpose permitted by this
regulation for which paint containing white lead may be used is as a mirror
backing, provided certain criteria are met. The first requirement is a
limitation on the percentage of lead within the non-volatile content of the
paint. Should the amount of lead exceed 15% of the non-volatile content, the
paint does not comply with this section, and this therefore illegal and very
unsafe.
Another requirement is that the paint is not applied more than
40 microns thick. This is also a requirement to minimise the danger that
the applied paint may present. Should the applied paint be greater than
40 microns thick the paint does not comply with this section, and this
therefore illegal and very unsafe. The final requirement is for the applied
paint that contains the white lead to be further coated by a paint that does not
contain lead. This requirement is intended to create a barrier between the
lead-based paint that can be harmful and any person who may handle the
mirror.
These requirements apply not just to persons using the paint to
create the mirror, but to persons supplying the paint containing white lead. As
such, if the supplier is not certain that the paint containing white lead will
be used as a mirror backing, they must not supply the paint. Similarly, if the
supplier suspects that the person to whom the paint is to be supplied cannot
comply with the requirements of this section the paint must not be
supplied.
Section 751 Manufacture, supply and use of paints for
certain purposes
- Act, s 71 (1) and
(3)
Section 15 of the MPTG Act establishes what is the medicines and
poisons standard, and the medicines and poisons standard defines what is a first
schedule paint and what is a third schedule paint.
Section 71(1) of
the MPTG Act contains an offence for manufacturing, supplying or using a first
schedule paint in a manner prescribed by this regulation. Section 751(1)
contains the usages of a first schedule paint that are prohibited through
section 71(1) of the MPTG Act. Those usages include application to roofs
or other surfaces that may be used for the collection or storage of potable
water.
Also included is application to furniture and to fences, walls,
posts, gates and to buildings, with the exception of a building that is used
only for industrial purposes, for mining, or as an oil terminal. Application to
premises used for the manufacture, processing, preparation, packing or serving
of products for human or animal consumption is also prohibited. These
prescribed applications reflect the danger of first schedule paints, and the
high risk of contamination that first schedule paints
pose.
Similarly, section 71(3) of the MPTG Act contains an offence
for manufacturing, supplying or using a third schedule paint in a manner
prescribed by this regulation. Section 751(2) contains the usages of a
first schedule paint that are prohibited through section 71(3) of the MPTG
Act. Those usages include application to roofs or other surfaces that may be
used for the collection or storage of potable water. Also included is
application to furniture and to buildings, fences, walls, posts, gates, bridges,
pylons, pipelines, storage tanks or similar structures. Application to
premises, equipment or utensils used for the manufacture, processing,
preparation, packing or serving of products for human or animal consumption is
also prohibited. These prescribed applications reflect just how dangerous
schedule 3 paints are, and the extreme risk of contamination that third
schedule paints present.
The elevation in maximum penalties from
section 71(1) to section 71(3) of the MPTG Act is indicative of the
escalating danger between first schedule paints and third schedule
paints.
Both subsections in this provision apply to manufacture, supply
and use. As such, it not just an offence to use a first schedule or third
schedule paint on furniture, but is also an offence to supply or manufacture
such paints for application to furniture. Accordingly, a manufacturer of a
third schedule paint that represents that the third schedule paint is suitable
for use on furniture will breach section 71(3) of the MPTG Act. Indeed, if
the manufacturer does not indicate that the third schedule paint must not be
applied to furniture they may even contravene section 71(3) of the MPTG
Act.
Similarly, a person who supplies a first schedule paint to person
knowing it will be applied to furniture will breach section 71(1) of the
MPTG Act. However, the supplier may also have committed the offence under
section 71(1) if the supplier is reckless as to how the paint will be
applied, or even if the supplier fails to give warnings about improper
applications of a first schedule paint.
Section 752 Manufacture,
supply and use of paints for toys - Act, s 72 (b)
Due
to several major recalls, the safety of paints used in toys has been the subject
of much media and public attention in the years prior to the introduction of the
MPTG legislation. The Australian and New Zealand Standard
AS/NZS ISO 8124.3:2003 is a standard for safety requirements for
Children’s Toys. AS/NZS ISO 8124.3:2003 contains standards for
children’s toys in regard to general requirements, construction and, in
Part 3, toxicological attributes, such as coating materials.
Accordingly, this provision permits a paint that complies with
specifications for coating materials for toys contained in
AS/NZS ISO 8124.3:2003 to be manufactured, supplied or used for
application to toys. As the provision applies to the Standard in force from
time to time, any amendment to the Standard is immediately applicable under this
section.
The application of this section will have relevance to other
ACT legislation. By virtue of this provision, a paint used on a toy that does
not conform to AS/NZS ISO 8124.3:2003 also does not conform with this
regulation, and thereby contravenes the offence contained in section 72 of
the MPTG Act. By implication, a toy made with, or coated in a paint that does
not conform with AS/NZS ISO 8124.3:2003 will most likely be regarded
as manufactured in an unsafe manner, and may contravene the ACT Fair Trading
legislation.
Section 753 Manufacture, supply and use of paints
containing pesticides
- Act, s 73 (b)
Under
section 73 of the MPTG Act it is an offence to manufacture, supply or use a
paint that contains a pesticide prescribed in this regulation. This section
states the pesticides that are prescribed, and therefore effectively prohibited,
by the MPTG Act. What constitutes a pesticide is, for the purposes of the MPTG
legislation, set out in the SUSDP.
However, subsection 2 provides
an exception to the general prohibition effected by section 73 of the MPTG
Act. If a paint that contains a pesticide listed in section 753 of this
regulation is for human therapeutic use, then subsection 1 of this
provision, and therefore the offence in section 73 of the MPTG Act, do not
apply.
Chapter 21 Prohibited and appendix C
substances
The substances of most serious concern within the SUSDP, and
therefore the most tightly regulated by the MPTG legislation, are prohibited
substances and appendix C substances.
Substances to which
Schedule 9 of the SUSDP applies are generally illegal substances that are
subject to abuse. For this reason such substances are prohibited substances
under the MPTG legislation. Appendix C substances are substances that
Appendix C of the SUSDP applies. The sale, supply and use of these
substances are prohibited because of the degree of danger to health that they
represent.
Part 21.1 Preliminary
Section 760 Meaning of
prohibited substance – ch 21
For the purposes of
Chapter 21 of this regulation, an appendix C substance is included in
the meaning of prohibited substance. Appendix C substances and prohibited
substances are defined in section 13 of the MPTG
Act.
Section 761 Prohibited substances
licences – Act, s 78 (2)
Section 78(2) of
the MPTG provides that this Regulation may prescribe the types of licences that
may be issued under the MPTG Act. Licences for a program of research or
education relating to a prohibited substance may, through the operation of
section 761, be issued.
Part 21.2 Prohibited substances
research and education program licences
Division 21.2.1 Issue of
prohibited substances research and education program licences
This
Division provides the governance structure for the issuing of licences for
research or education programs proposing to involve prohibited substance.
Section 765 contains the details for the lodging of an application for such
a licence and the information that must be provided to support the application.
Applications must be in writing, and signed by the applicant.
Furthermore, an application must also be accompanied by a written approval of
the proposed program from the person in charge of either the faculty or division
of a recognised research institution at which the program would be conducted, or
from the person in charge of the institution itself. Section 20(5) of the
MPTG Act lists recognised research institutions, which include the University of
Canberra, the ANU, the Canberra Hospital, the CSIRO, or any other entity
prescribed by this Regulation.
Prohibited substances research and
education program licences are issued by the Chief Health Officer, but only if
the Chief Health Officer is satisfied as to the matters set out in
section 766. A key consideration for the Chief Health Officer is whether
the proposed program cannot be carried out without the use of the prohibited
substance, and whether the program will be adequately
supervised.
Section 88 of the MPTG Act sets out information that
must be included in all types of licences issued under the MPTG legislation.
Subsection 1(k) of that same section enables this Regulation to prescribed
additional information to be included on a licence. For a prohibited substances
research or education program licence that additional information is set out in
section 767.
Division 21.2.2 Prohibited substances
research and education program authorisations
This Division specifies the
types of dealings for which a prohibited substances research and education
program licence-holder is authorised, as well as the conditions that apply to
all such licences. Additionally, the program supervisor and anyone
participating in the program are authorised to deal with the prohibited
substance to which the licence relates, provided that the dealing occurs at the
premises stating in the licence.
A prohibited substances research and
education program licence-holder is authorised to obtain prohibited substances
in accordance with the terms of their licence. It is a further condition on a
licence-holder’s authorisation that all prohibited substances purchased
under the licence are done so through a complying purchase order. For an
Appendix C or prohibited substance a complying purchase order is, according
to the dictionary in this Regulation, a purchase order pursuant to
section 772.
Division 21.2.3 Other
provisions - prohibited substances research and education
program
licences
Section 770 Approvals of dealings for
prohibited substances research and education program
licences – Act, s 20 (1) (c)
Under this
provision, the Chief Health Officer can grant an approval to a person to deal
with a prohibited substance for a research and education licence. The types of
dealings that can approved under this provision are limited to obtaining the
substance, possessing the substance, issuing a purchase order for the substance,
and supplying the substance on a complying purchase order to the
licence-holder.
For an Appendix C or prohibited substance a
complying purchase order is, according to the dictionary in this Regulation, a
purchase order pursuant to section 772.
An approval under this
section must be in writing. Such an approval may also be conditional, or for a
stated period or until a stated event transpires.
Section 771 Authorisation condition for
approval-holders – Act, s 44 (1) (b)
and (2) (b)
An approval-holder’s authorisation under
section 770 is subject the condition that filled purchase orders and
records required under section 773 are kept. These records are to be kept
for at two years from the date of supply, at the approval-holder’s
business premises.
The Chief Health Officer also has the power, under
this provision, to give written approval for the records to be kept at an
alternative location. This recognises commercial practicalities. For example,
it may not be possible to keep the volume of records at the business
premises.
Section 772 General requirements for prohibited
substances purchase orders
– Act,
s 38 (2) (c)
Purchase orders for prohibited substances
must, under this section, be signed by the person issuing the order.
Furthermore, if the person issuing the purchase order amends the order at any
stage, the person must record theirs initials and the date along side the
amendment.
Subsection 2 specifies what information must be included
in a purchase order for a prohibited substance, such as the form, strength and
quantity of the prohibited substance supplied.
Section 773 Recording supply of prohibited substances on
purchase orders
Under this section, a person who supplies a prohibited
substance to someone else on a purchase order is required to make a written
record of the supply. The information required to kept under this provision
includes the date of the order, the date the order is supplied, and the form,
strength and quantity of the prohibited substance supplied. For obvious
reasons, the details of the person to whom the prohibited substance was supplied
is also required to be recorded.
Through a comparison of the record made
under this section with the purchase order to which the supply relates,
discrepancies and variations should be identifiable. Identification of such
variances and discrepancies may enable the identification of prohibited
substances being misused, redirected or unusual supply patterns. Therefore, the
keeping of such records is essential from a regulatory perspective.
Under
section 11 of the Electronic Transactions Act 2001 records can
be kept in an electronic format provided certain criteria can be met.
Accordingly, a requirement to keep a written record is met if the record is kept
in an electronic form.
Section 774 Information for CHO about
supplied prohibited substances research and education program
licences – Act,
s 31 (1) (a) (ii), (1) (b), (2) (a) (ii),
(2) (b) and (4)
Section 774 applies if a person supplies a
prohibited substance to a prohibited substances research and education program
licence-holder. The section requires certain information to be given, in
writing to the Chief Health Officer. The information includes the date of the
supply, the name of the person to whom the substance was supplied, and the form,
strength and quantity of the prohibited substance supplied. The information to
be given to the CHO must be provided within 7 days of the end of the
calendar month in which the supply took place.
This provision reflects
the seriousness and level of public health concern associated with prohibited
substances. The effect of the section is to enable the Chief Health Officer,
through the information required to be provided, to monitor the details, such as
quantities, of prohibited substances being used by a research and education
program licence-holder.
Part 21.3 Prohibited substances
registers
Section 775 Keeping prohibited substances registers by
certain people
– Act, s 48 (a) and
s 50 (1) (b) and (2) (b)
Within this provision is
Table 775 that lists, in column 2, prescribed persons who must keep a
prohibited substance register for all prohibited substance in their possession.
Column 3 of the same table specifies where the register is to be kept.
Section 776 Form of prohibited substances
registers – Act, s 49 (1) (b)
Under this
section, each page in a prohibited substances register must relate to a single
form and strength of a prohibited substance. This means that if a single
prohibited substance were possessed, but in different sizes, each size requires
its own page in the register.
Where a prohibited substances register is
kept electronically, which is permissible, a separate record must be used for
each form and strength of prohibited substance
kept.
Section 777 Making entries in prohibited substances
registers – Act, s 51 (1) (b)
Under
section 51 of the MPTG Act a person who must keep a register for a
regulated substance commits an offence unless that person ensures that the
details prescribed by this Regulation are recorded.
In regard to a
prohibited substance, the details required to be record under section 51 of
the MPTG Act are listed in this provision. Amongst the details for dealing with
a prohibited substance that must be recorded are the nature of the dealing
itself, the date of the dealing, and the form, strength and quantity of the
substance dealt with, and the quantity of the substance held following the
dealing.
Details to be recorded under section 777(1)(d) applies only
if the dealing is receiving the substance. The details to be recorded under
section 777(1)(e) applies if the dealing is supplying the substance.
This provision also makes it expressly clear that a dealing with a
prohibited substance must be entered in the prohibited substance register that a
person is required to keep under this Chapter.
Section 778 Prescribed witnesses for discarding of prohibited
substances
– Act, s 54 (a)
and (b)
Section 778(1) lists persons who are prescribed as
witnesses in relation to the disposal of a prohibited substance. However,
section 778 also expressly excludes a person from being a prescribed
witness in relation to the disposal of a prohibited substance if the person is
related to, employed by, or a close friend of the person disposing of the
prohibited substance. Such persons are, by virtue of their relationship with
the person disposing of the prohibited substance, potentially able to be
influenced by, or exert influence over, that person. Accordingly, their
suitability as a prescribed witness is thereby diminished. For the same reason
the supervisor of the person disposing of the prohibited substance cannot be a
prescribed witness, nor can a person supervised by the person disposing of the
prohibited substance.
Section 779 Changes to entries in
prohibited substances registers – Act,
s 55 (2) (b)
Section 776 confirms that a prohibited
substances register may be kept in hardcopy form or electronically, and
addresses the form in which a prohibited substances register must be kept.
Understandably, from time to time situations may arise in which an entry
in a prohibited substances register needs to be changed, more often than not in
order to correct an entry. Changes to an entry in a prohibited substances
register is permissible, provided the requirements of this section are followed.
Subsection 1 relates to changes to an entry in a paper-based
prohibited substances register. The subsection permits the person who made the
entry to change the entry by signing and dating a marginal note or footnote that
gives the amendment details and the date the amendment is made.
If the
entry to be changed relates to the disposing of a prohibited substance, the
amendment must be witnessed by a person listed in section 778, and the
witness must also sign the amendment to evidence that they witnessed the change.
It is not required that the person prescribed under section 778 that
witnessed the disposal of the prohibited substance be the same witness to the
amendment of the prohibited substances register. However, where it is possible
it is preferable.
Chapter 22 Therapeutic goods
As the
title of the legislation suggest, the MPTG Act and this Regulation cover
therapeutic goods in addition to medicines and poisons. In many instances the
ramifications of misuse, intentional or otherwise, or improper supply of a
therapeutic good will not be as serious as those for a medicine or poison.
Nevertheless, the misuse or improper supply of a therapeutic good may result in
harm, so it is appropriate to regulate therapeutic goods through the MPTG
legislation.
Section 800 Definitions – ch 22
For
the purposes of this Chapter, corrective contact lenses, correct lenses for
spectacles and plano lenses are optical devices. Plano lenses are
non-corrective contact lenses. A definition of prescription specific to this
Chapter is also included.
Section 801 Prescribed regulated
therapeutic goods
– Act, s 14, def regulated
therapeutic good, par (b)
Section 14 of the Act defines
what constitutes a regulated therapeutic good. The effect of paragraph (b)
of that section is to include in the meaning of a regulated therapeutic good
anything prescribed by this regulation. The purpose of section 801 is to
prescribe optical devices for the purposes of section 14(b) of the MPTG
Act. In this regard, the definition of an optical device under section 800
of this Chapter is applicable.
Section 802 Authorisation to
supply optical devices – Act, s 74 (1) (b) and
(2) (b)
Under section 74 of the MPTG Act it is an offence to
supply a regulated therapeutic good to another person, or oneself, unless the
person is authorised to supply the regulated therapeutic good under this
regulation. What constitutes a regulated therapeutic good is defined in
section 14 of the MPTG Act. Through the operation of section 800 of
this regulation, optical devices are a regulated therapeutic good.
This
provision gives optometrists and opticians authorisation to supply optical
devices, on prescription issued by an optometrist or a doctor. The
authorisation is limited to the extent necessary to practice, and if the
optometrist or optician is employed, that the supply is within the scope of
their employment.
Provided it is within the scope of their employment,
section 802 also authorises an employee of an optometrist to sell and
deliver optical devices being supplied by an authorised optometrist or optician.
Determining what is and what is not within the scope of employment will
be determined based on any documented procedures and rules within a work place,
a person’s job description, and established practices within a workplace.
Also relevant will be any orders or instructions, oral or written, issued to the
employee. Some of these considerations may contradict others. For example,
established practices within a workplace may not actually conform to documented
procedures. In such circumstances, evaluating whether a person acted outside of
the scope of their employment will require an assessment of what workplace rules
and instructions prevail or dominate.
Section 803 Authorisation
conditions for supplying optical devices – Act,
s 75 (1) (b)
An optometrist’s or optician’s
authorisation under section 802 of this regulation, as it applies to
corrective contact lenses and corrective lenses for spectacles. is subject to
conditions stated in section 803. This provision essentially operates to
require that corrective lenses, be it for contacts or spectacles, are only
supplied on a written prescription, and that the prescription is not more than a
year old. A definition of prescription specific to the Chapter is contained in
section 800.
Chapter 23 Notification and review of
decisions
Chapter 9 of the Act, in conjunction with Schedule 1
of the MPTG Act, provides for the review of decisions under the MPTG Act by the
Chief Health Officer . This Chapter of the Regulation provides for the review
of decisions made under this Regulation.
Section 850 Meaning
of reviewable decision – ch 23
Pursuant to
this section, a decision of a kind listed in column 3 of Table 850,
made by the Chief Health Officer pursuant to a section of this Regulation listed
in column 2 of Table 850, is a reviewable decision. The entity that
may apply for a review of the decision mentioned in column 3 of
Table 850 is listed in column 4 of the same Table.
Section 851 Notice of reviewable
decisions
Section 851 operates to require a person, when making a
reviewable decision, to give a written notice of the decision to each entity
listed in column 4 of Table 850.
Section 852 Applications for review
Section 852
makes it expressly clear that in addition to the entities listed in
column 4 of Table 850, any other person who interests are affected by
the decision may apply for a review of a reviewable decision.
Chapter 24 Miscellaneous
This Chapter contains some
miscellaneous provisions, concerning such matters as authorisations for public
employees and containers not to be used for human use.
Section 860 Authorisations for public
employees
– Act, s 26 (1) (b),
(2) (b), s 35(1) (b), (2) (b) and
s 36 (b)
Under section 860 a public employee may lawfully
obtain a regulated substance and possess a regulated substance to the extent
necessary for public employee to exercise a function that the person may have
under the MPTG Act.
Similarly, to the extent necessary for a public
employee to exercise a function under the MPTG Act, a public employee may supply
a regulated substance or regulated therapeutic good to a law enforcement officer
for law enforcement purposes.
The section also operates to lawfully
permit a public employee to supply a regulated substance, or regulated
therapeutic good, to another person for the purposes of discarding the regulated
substance or regulated therapeutic good. However, the person to whom regulated
substance or regulated therapeutic good is supplied must be authorised to obtain
it. Again, the authority provided by this section is limited to the extent
necessary for public employee to exercise a function that the person may have
under the MPTG Act.
The Legislation Act 2001 defines who is
a public employee. In the majority of cases a public employee is a public
servant. However, a public employee also includes a person employed by a
territory instrumentality, a statutory office-holder, or a person employed by a
statutory office-holder. Accordingly, it is through this provision that certain
public servants are lawfully able to handle a regulated substance through the
course of their employment.
Section 861 Other authorisations for
public employees
– Act, s 20 (1) (a),
(2) (a) and s 74 (1) (b)
Section 861 operates to
enable the Chief Health Officer to issue a permit to a public employee enabling
that person to lawfully deal with a regulated substance or regulated therapeutic
good, provided the dealing is in accordance with the permit. Such permits may
identify the public employee by name, or by position held.
A permit
issued by the Chief Health Officer must be in writing and contain a unique
identifying number, the full name of the permit holder, and conditions to which
the authorisation given by the permit is subject. The type, or types of
regulated substance or regulated therapeutic goods authorised to be dealt with
must also be stated on the permit, together with the types of dealings. An
expiry term for the permit is also mandated.
The meaning of deal
in regard to a regulated substance is defined by section 19 of the MPTG
Act.
The Legislation Act 2001 defines who is a public
employee. In the majority of cases a public employee is a public servant.
However, a public employee also includes a person employed by a territory
instrumentality, a statutory office-holder, or a person employed by a statutory
office-holder. Accordingly, it is through this provision that certain public
servants are lawfully able to handle a regulated substance through the course of
their employment.
Section 862 Certain containers not to be used
for human-use substances
– Act,
s 63 (1) (b)
Section 63 of the MPTG Act contains an
offence for supplying a human use substance in a container where that container
is prescribed by this Regulation. This section instructs that containers of a
kind mentioned in paragraphs 21, 22 or 23 of the SUSDP are prescribed for
the purposes of section 63 of the MPTG Act. Accordingly, it is an offence
to supply a human use substance in such a
container.
Section 863 Displacement of Legislation Act,
s 47 (6)
Through this provision, the normal operation of
section 47(6) of the Legislation Act 2001 is displaced in
regard to Australian and New Zealand Standard AS/NZS ISO 8124.3:2003.
Accordingly, AS/NZS ISO 8124.3:2003 does not need to be placed on the
ACT Legislation Register as a notifiable instrument. This avoids issues around
copyright infringement that might arise from the reproduction of the standard on
the ACT Legislation Register.
Section 864 Amendments of Health
Professionals Regulation 2004
This provision directs that
consequential amendments to the Health Professionals Regulation 2004 are
made as set out in Schedule 6 of this
Regulation.
Chapter 30 Transitional
Given the complexity
of reforming a number of Acts and regulations and the necessity of allowing
licences and authorisations made under those Acts to continue until replaced by
new licences and authorisations, transitional provisions have been included in
the MPTG Act.
Part 14.3 (Transitional – licences and
authorisations) of the MPTG Act provides that licences that were in force under
the Drugs of Dependence Act 1989, the Poisons Act 1933
and the Poisons and Drugs Act 1978 immediately prior to the
commencement of the MPTG Act are to be regarded as a licence under the MPTG Act
as prescribed by this Regulation. This enables a smooth transition from the
various pieces of legislation being repealed and replaced to the new
legislation, and avoids the need for the reissue of a plethora of licences
immediately upon the commencement of the new Act.
This Chapter contains
transitional provisions that link back to Part 14.3 of the MPTG
Act.
Section 1000 Definitions – ch 30
This
provision simply specifies that within Chapter 30 of this Regulation a
reference to DODA means the ACT Drugs of Dependence Act 1989, and a
reference to the Poisons and Drugs Act means the ACT Poisons and Drugs
Act 1978.
Section 1001 DODA wholesaler’s
licences – Act, s 520 (2)
Pursuant to this
provision, a wholesaler’s licence for a controlled medicine under the ACT
Drugs of Dependence Act 1989 will continue to operate under the MPTG
legislation as if it were a medicines wholesalers licence.
Where an
expiry date or term on the licence is stipulated, the licence will continue
under the MPTG legislation for the same period. Where no expiry or term on the
licence is stated, the licence will remain in force for a period of six months
from the date of commencement of the MPTG Act. The MPTG clearly instructs that
licences preserved by these transitional provisions continue to be subject to
any condition to which the licence was subject immediately before the
commencement of the MPTG legislation. Such conditions remain in force unless the
condition ceases to have effect, or the condition is removed or varied under the
MPTG Act.
Section 1002 Poison’s Act
licences – Act, s 520 (2)
Pursuant to this
provision, a licence under the Poisons Act 1933 will continue to
operate under the MPTG legislation as if it were a licence to possess for sale
and to sell the regulated substance stated on the licence under the Poisons
Act 1933.
Where an expiry date or term on the licence is
stipulated, the licence will continue under the MPTG legislation for the same
period. Where no expiry or term on the licence is stated, the licence will
remain in force for a period of six months from the date of commencement of the
MPTG Act. The MPTG clearly instructs that licences preserved by these
transitional provisions continue to be subject to any condition to which the
licence was subject immediately before the commencement of the MPTG legislation.
Such conditions remain in force unless the condition ceases to have effect, or
the condition is removed or varied under the MPTG
Act.
Section 1003 Poisons and Drugs Act
licences – Act, s 520 (2)
A
manufacturer’s licence under the ACT Poisons and Drugs Act 1978
for a dangerous poison will continue to operate under the MPTG legislation
as if it were a dangerous poisons manufacturer’s licence. Similarly, a
vendor’s licence under the ACT Poisons and Drugs Act 1978 for
a dangerous poison will continue to operate under the MPTG legislation as if it
were a dangerous poisons supplier’s licence.
Where an expiry date
or term on the licence is stipulated, the licence will continue under the MPTG
legislation for the same period. Where no expiry or term on the licence is
stated, the licence will remain in force for a period of six months from the
date of commencement of the MPTG Act. The MPTG clearly instructs that licences
preserved by these transitional provisions continue to be subject to any
condition to which the licence was subject immediately before the commencement
of the MPTG legislation. Such conditions remain in force unless the condition
ceases to have effect, or the condition is removed or varied under the MPTG
Act.
Section 1004 DODA authorisations – Act,
s 522 (2)
An authorisation for a controlled medicine under
section 33 of the ACT Drugs of Dependence Act 1989 will, by
virtue of this section, be taken to be a controlled medicines research and
education program licence for the same medicine, or medicines, under the MPTG
legislation.
Where an expiry date or term on the authorisation issued
under the ACT Drugs of Dependence Act 1989 is stipulated, the new
licence will continue under the MPTG legislation for the same period. Where no
expiry or term on the authorisation is stated, the new licence will remain in
force for a period of six months from the date of commencement of the MPTG Act.
The MPTG clearly instructs that authorisations that become licences under the
MPTG through these transitional provisions continue to be subject to any
condition to which the authorisation was subject immediately before the
commencement of the MPTG legislation. Such conditions remain in force unless
the condition ceases to have effect, or the condition is removed or varied under
the MPTG Act.
Section 1005 Poisons and Drugs Act
authorisations – Act, s 522 (2)
An
authorisation for a dangerous poison under section 26 of the ACT Poisons
and Drugs Act 1978 will, by virtue of this section, be taken to be a
dangerous poison research and education program licence for the same poison, or
poisons, under the MPTG legislation.
Where an expiry date or term on the
authorisation issued under the ACT Poisons and Drugs Act 1978 is
stipulated, the new licence will continue under the MPTG legislation for the
same period. Where no expiry or term on the authorisation is stated, the new
licence will remain in force for a period of six months from the date of
commencement of the MPTG Act.
The MPTG clearly instructs that authorisations
that become licences under the MPTG through these transitional provisions
continue to be subject to any condition to which the authorisation was subject
immediately before the commencement of the MPTG legislation. Such conditions
remain in force unless the condition ceases to have effect, or the condition is
removed or varied under the MPTG Act.
Section 1006 Public Health
(Prohibited Drugs) Act authorisations – Act,
s 522 (2)
An authorisation under section 6A of the ACT
Public Health (Prohibited Drugs) Act 1957 will, by virtue of this
section, be taken to be a prohibited substances research and education program
licence for the same regulated substance, or substances, under the MPTG
legislation.
Where an expiry date or term on the authorisation issued
under the ACT Public Health (Prohibited Drugs) Act 1957 is
stipulated, the new licence will continue under the MPTG legislation for the
same period. Where no expiry or term on the authorisation is stated, the new
licence will remain in force for a period of six months from the date of
commencement of the MPTG Act. The MPTG clearly instructs that authorisations
that become licences under the MPTG through these transitional provisions
continue to be subject to any condition to which the authorisation was subject
immediately before the commencement of the MPTG legislation. Such conditions
remain in force unless the condition ceases to have effect, or the condition is
removed or varied under the MPTG Act.
Section 1007 DODA approvals
to prescribe drugs of dependence – Act,
s 531 (2)
An approval under section 69 of the Drugs of
Dependence Act 1989 will, by virtue of this section, be taken to be a
controlled medicines approval under Division 13.1.3 of the MPTG Act for the
controlled medicine to which the approval relates.
The new approval will
continue under the MPTG legislation for the unexpired period of the original
approval. The MPTG clearly instructs that the approval will continue to be
subject to any condition to which the approval was subject immediately before
the commencement of the MPTG legislation. Such conditions remain in force
unless the condition ceases to have effect, or the condition is removed or
varied under the MPTG
Act.
Section 1008 Expiry – ch 30
Section 1008
provides that Chapter 30 expires on 31 March 2010. The purpose
of this provision is to ensure that transitional provisions are not retained on
the statute books for longer than is
necessary.
Schedule 1 Medicines – health related
occupations authorisations
It is through Schedule 1 that the various
health-related occupations are assigned authorisation to deal with
medicines.
There are 13 Parts to Schedule 1, each dealing with a
different health-related occupation. These range from ambulance services and
officers in Part 1.1, to doctors (Part 1.3) through to optometrists
(Part 1.8) and finally to veterinary surgeons and their employees at
Part 1.13. Even opioid dependence treatment centres operated by the
Territory are addressed in the Schedule.
Under each Part the person
authorised is listed in column 2, and what that person is authorised to do
is specified in column 3.
Schedule 2 Optometry
medicines
Part 1.8 of Schedule 1 of this Regulation sets out
the authorisations relating to optometrists and employees of optometrists.
Several of those authorisations are subject to conditions to which this Schedule
relates.
Schedule 2 contains two tables; Table 2.1 and
Table 2.2. Table 2.1 identifies general optometry medicines and the
prescribed purposes for which those medicines may be used. Table 2.2 sets
out restricted optometry medicines and the medicine groups into which those
restricted optometry medicines fall.
Schedule 3 Designated
appendix D medicines – standing approvals
The focus
of Schedule 3 is standing approvals for designated Appendix D
medicines. The Schedule consists of two Parts. Part 3.1 of the Schedule
defines the four different approval conditions that are then placed upon certain
specialist doctors by Part 3.2. Appendix D medicines are listed in
the SUSDP.
Schedule 4 Dangerous
poisons – manufacturing etc authorisations
Column 3
of Schedule 4 identifies a range of dangerous poisons. The people who may
have a legitimate reason to access that dangerous poison are listed in
column 2, and the prescribed purpose for which those persons may access the
dangerous poison can be found in column 4. For example, there can be
little argument that cyanides are a dangerous poison. However, cyanides are
used in the manufacturing of gold jewellery and as such access to this dangerous
poison is necessary for jewellers.
It is through this Schedule and
section 690 of this Regulation that persons listed in column 2 of
Schedule 4 are duly authorised to deal with the corresponding dangerous
poison in column 3.
Schedule 5 Requirements for storage
receptacles
Part 11.4 of this Regulation imposes additional
requirements on certain persons in regard to the storage of controlled
medicines, be it within medicine cabinets, safes, strong rooms and
vaults.
This Schedule sets out requirements for the construction and
installation of medicine cabinets, safes, strong rooms and vaults for persons
who are required by Part 11.4 to keep controlled medicines safely and
securely stored.
Schedule 5 is specific in regard to matters such as
lock requirements for medicine cabinets, the thickness of the doors and body of
medicine cabinets, and even the length of time in which a medicine vaults should
be able to withstand attempts to enter it using tools, torches or explosives.
Schedule 6 Amendments of Health Professionals
Regulation 2004
This Schedule sets out a number of consequential
amendments to be made to the Health Professionals Regulation 2004,
primarily to Schedules 5, 11 and 15. Amongst the changes is a new
definition of community pharmacy to replace the definitions of
community pharmacy and institution currently existing in the
Health Professional Regulation 2004.
Dictionary
The
Dictionary contains definitions of terms used throughout the Regulation.
Definitions within the Dictionary include bioequivalent, disability care,
in-patient, trainee and young detainee. Terms that frequently appear
for which dictionary definitions are provided include CYP detention place,
first-aid kit, intern, and manufacturer’s pack.