MEDICINES, POISONS AND THERAPEUTIC GOODS REGULATION 2008 (NO 42 OF 2008) - REG 81 Information for CHO about controlled medicines supplied on supply

Australian Capital Territory Numbered Regulations

[Index] [Table] [Search] [Search this Regulation] [Notes] [Noteup] [Previous] [Next] [Download] [Help]

MEDICINES, POISONS AND THERAPEUTIC GOODS REGULATION 2008 (NO 42 OF 2008) - REG 81

Information for CHO about controlled medicines supplied on supply authorities—Act, s 31 (1) (b) and (4), def required information

(1) A person (the supplier ) who supplies a controlled medicine on a supply authority must, not later than 7 days after the end of the month when the medicine is supplied, give the chief health officer the following information in writing:

(a) the supplier's name, business address and telephone number;

(b) the name of the person who issued the supply authority;

(d) the name and address of the person to whom the medicine is supplied;

(e) the date of supply;

(f) the controlled medicine, and the form, strength and quantity of the medicine, supplied.

(2) However, this section does not apply to any of the following who report the supply of a controlled medicine on a supply authority to the Therapeutic Goods Administration:

(a) a medicines wholesalers licence-holder;

(b) a person who is authorised (however described) under a Commonwealth or State law to manufacture controlled medicines or supply controlled medicines by wholesale.

Part 4.1 Preliminary

100 Overview of supply authorisations for medicines

The following provisions of this chapter authorise a person to supply a medicine:

(a) section 110 (which is about supply authorisations set out in schedule 1, including dispensing on prescription, supply on requisition, purchase order and standing order and supply during consultations);

(b) section 251 (which is about authorisation of pharmacists to supply certain prescription only medicines without a prescription in emergencies);

Note A person may also be authorised to supply a medicine in a way mentioned in s 11 (2) (Overview of medicines authorisations under this regulation) (including under a licence, see pt 9.5).

Part 4.2 Medicines—supply authorisations under sch 1

Division 4.2.1 Sch 1 medicines supply authorisations

110 Authorisation under sch 1 to supply medicines—
Act, s 26 (1) (b) and (2) (b)

A person mentioned in schedule 1, column 2 is authorised to supply a medicine if—

(a) supplying the medicine is included in the schedule, column 3 in relation to the person; and

(b) the supply is consistent with any restriction for the supply mentioned in the schedule, column 3.

Note Supply includes dispense (see Act, s 24).

Division 4.2.2 Dispensing medicines

120 Authorisation conditions for dispensing medicines—Act, s 44 (1) (b) and (2) (b)

(1) A person's authorisation under section 110 to dispense a medicine is subject to the following conditions:

(a) the medicine is dispensed in accordance with the requirements of section 121;

Note Only a pharmacist may dispense a medicine (see sch 1).

(b) if the prescription is dispensed under section 121 (2), the pharmacist notes on the prescription the reasons that the pharmacist was satisfied that it was not practicable for a complying prescription to be issued for the medicine;

(c) if the prescription is changed by a pharmacist at the oral direction of the prescriber—the note of the change complies with section 122;

(d) the medicine is labelled in accordance with section 123;

(e) the dispensed prescription is marked in accordance with section 124;

(f) the dispensing of the prescription is recorded in accordance with section 125;

(g) if the prescription is an oral prescription for the dispensing of the medicine, or is faxed by a prescriber to a pharmacist, and the pharmacist does not receive an original of the prescription within 7 days after the day the prescription is given—the pharmacist must, within 24 hours after the end of the 7-day period, tell the chief health officer, in writing, of the failure to receive the original prescription;

(h) the prescription, if completed, and the record for paragraph (f), are kept at the pharmacy or, if the chief health officer approves in writing another place, the place approved by the chief health officer, for at least 2 years after the day the prescription becomes a completed prescription.

(2) However, subsection (1) (d), (e), (f) and (h) do not apply if the prescription is written for an in-patient at a hospital in the patient's medical records.

(3) In this section:

"completed"—a prescription is completed when—

(a) for a single prescription—the prescription is dispensed; or

(b) for a repeat prescription—the last repeat of the prescription is dispensed.

121 How medicines are dispensed

(1) The following are the requirements for dispensing a medicine:

(a) the prescription is issued by an authorised prescriber;

Note Authorised prescriber —see s (3).

(b) the prescription complies with the applicable provisions of division 3.1.2 (Prescriptions);

(c) the medicine is dispensed in accordance with the prescription (including the prescription as changed by a pharmacist at the oral direction of the prescriber).

Note 1 Dispensed in accordance with the prescription —see s (3).

Note 2 For changes to a prescription by the dispenser, see the Act, s 29 (3).

Note 3 Pharmacist does not include an intern pharmacist (see dict).

(2) However, a pharmacist may dispense a prescription that does not include all of the applicable provisions for subsection (1) (b) if—

(a) the prescription is issued by an authorised prescriber; and

(b) the medicine is—

(i) dispensed in accordance with the prescription; and

(ii) if the prescription is changed by a pharmacist at the oral direction of the prescriber—the prescription complies with section 122; and

Note Pharmacist does not include an intern pharmacist (see dict).

(d) the pharmacist is satisfied that, because of a circumstance affecting the prescriber or the person for whom the medicine is to be dispensed, it is not practicable for a complying prescription to be issued for the medicine.

(3) In this section:

"authorised prescriber", in relation to a prescription, means—

(a) a person who is authorised to issue the prescription under the Act or another territory law; or

(b) for a medicine other than a controlled medicine—a person who is—

(i) registered (however described) as a dentist, doctor, optometrist or veterinary surgeon (however described), other than a trainee dentist, intern doctor, trainee optometrist or trainee veterinary surgeon (however described), under a law of a State; and

Note State includes the Northern Territory (see Legislation Act, dict, pt 1).

(ii) authorised (however described) under a law of the State to prescribe the medicine.

Examples—authorised prescribers

1 A NSW registered doctor practising in Queanbeyan is authorised under a NSW law to prescribe medicines. The doctor gives a patient a prescription for a controlled medicine and another prescription for a prescription only medicine. The prescription only medicine can be dispensed in the ACT because the prescription is issued by a person who is authorised under a State law to prescribe the medicine. The prescription for the controlled medicine cannot be dispensed in the ACT because the doctor is not registered in the ACT.

2 If the doctor in example 1 is registered in both the ACT and NSW, the prescription for the controlled medicine can be dispensed in the ACT.

3 A special event exemption under the Health Professionals (Special Events Exemptions) Act 2000 authorises a visiting health professional to prescribe a medicine, including a controlled medicine. A Victorian registered doctor who is a visiting health professional within the meaning of that Act prescribes a controlled medicine. The prescription can be dispensed in the ACT.

Note 1 A reference to a health professional in sch 1 is a reference to a health professional who is registered under the Health Professionals Act 2004 . See, for example, the Legislation Act, dictionary, pt 1, def dentist .

Note 2 An example is part of the regulation, is not exhaustive and may extend, but does not limit, the meaning of the provision in which it appears (see Legislation Act, s 126 and s 132).

"dispensed in accordance with the prescription", for a prescribed medicine, includes dispensing another brand of the medicine that is a bioequivalent form of the prescribed medicine.

Note Bioequivalent —see the dictionary.

122 Noting changes to prescriptions on oral direction of prescriber—Act, s 27 (2) (b) (ii)

The following must be noted, in writing, on the prescription:

(a) the name of the prescriber giving the oral direction to change the prescription;

(b) the change to the prescription;

(d) the pharmacist's signature.

Note The notation must be made as soon as possible (see Legislation Act, s 151B).

123 Labelling dispensed medicines—Act, s 60 (1) (c) (i) and (2) (c) (i)

The dispensed medicine must have a label that includes the following:

(a) the name of the person for whom the medicine is dispensed;

(b) if the prescriber is a dentist—the words ‘for dental treatment only';

(d) if the prescriber is a veterinary surgeon—

(i) words to the effect of ‘for animal treatment only'; and

(ii) the species of the animal for which the medicine is dispensed; and

(iii) if a way of identifying the animal is stated on the prescription—the way of identifying the animal;

(e) the medicine's approved name and brand name;

Note Approved name —see the medicines and poisons standard, par 1 (1).

(f) the form, strength and quantity of the medicine dispensed;

(g) if the package of the dispensed medicine is not a manufacturer's pack—the relevant expiry date for the medicine;

(h) the date the medicine is dispensed;

(i) the name and the business address and telephone number of the pharmacy from which the medicine is dispensed;

(j) the initials or other identification of the dispensing pharmacist;

(k) a number that is different from the number given to each other prescription dispensed at the pharmacy;

(l) directions about the use of the medicine that are adequate to allow the medicine to be taken or administered safely, including any warning statement in the medicines and poisons standard, appendix K (Drugs required to be labelled with a sedation warning) applying to the medicine;

(m) words to the effect of ‘keep out of reach of children'.

Example—par (e) and par (f)

Warfarin tablets (Coumadin) 5mg 50

Note An example is part of the regulation, is not exhaustive and may extend, but does not limit, the meaning of the provision in which it appears (see Legislation Act, s 126 and s 132).

124 Marking dispensed prescriptions

(1) This section does not apply to a prescription for an in-patient at a hospital written in the patient's medical records.

(2) A dispensed paper-based prescription for a medicine must be marked with—

(a) if the prescription is a single prescription or the last repeat of a repeat prescription—the word ‘cancelled' on the front of the prescription; and

(b) the prescribed particulars.

(3) A dispensed electronic prescription for a medicine must be marked with—

(a) if the prescription is a single prescription or the last repeat of a repeat prescription—the word ‘cancelled'; and

(b) a link to an electronic document containing the prescribed particulars.

(4) In this section:

"paper-based prescription" includes a faxed copy of a prescription.

"prescribed particulars", for a dispensed prescription for a medicine, means—

(a) the date the medicine is dispensed; and

(b) the name and business address of the dispensing pharmacy; and

(c) if another brand of the medicine is dispensed for the prescribed medicine—the brand name of the medicine dispensed; and

(d) for a repeat prescription—the number of the repeat dispensed; and

(e) the prescription's number under section 123 (k); and

(f) the pharmacist's initials or signature.

"single prescription" means a prescription that is not a repeat prescription.

125 Recording dispensing of medicines

The dispensing pharmacist must ensure that a written record is made of the following information in relation to the dispensing of the medicine:

(a) the pharmacist's name;

(b) the date of the prescription;

(d) the date the prescription is dispensed;

(e) for a repeat prescription—the number of the repeat dispensed;

(f) the prescription's number under section 123 (k);

(g) the name and address of the person for whom the medicine is dispensed;

(h) the medicine's approved name and brand name;

Note Approved name —see the medicines and poisons standard, par 1 (1).

(i) the form, strength and quantity of the medicine dispensed.

Note Written includes in electronic form (see Act, dict).

Division 4.2.3 Supplying medicines on requisitions

Note For authorisation to issue a requisition, see s 50.

130 Authorisation conditions for supplying medicines on requisitions—Act, s 44 (1) (b) and (2) (b)

A person's authorisation under section 110 to supply a medicine on a requisition is subject to the following conditions:

(a) the medicine is supplied in accordance with the requirements under section 131;

(b) the medicine is supplied in a package that is labelled in accordance with section 132;

(d) the supply is recorded in accordance with section 134;

(e) the filled requisition and record under section 134 are kept at the institution where the medicine is supplied or, if the chief health officer approves in writing another place, the place approved by the chief health officer, for at least 2 years after the day the medicine is supplied.

131 Supplying medicines on requisitions

(1) The following are the requirements for the supply of a medicine on a requisition:

(a) the medicine is supplied in accordance with the requisition (including the requisition as changed by the person supplying the medicine at the oral direction of the person issuing the requisition);

Note For changes to a requisition by the person supplying a medicine on a requisition (see Act, s 29 (3)).

(b) if the requisition is a written requisition—the requisition complies with section 55 (General requirements for written requisitions) and section 56 (Particulars for requisitions);

(2) However, if the requisition does not comply with section 55 or section 56 (as appropriate), a pharmacist may supply the medicine on the requisition if satisfied that it is not practicable for a complying requisition to be issued for the medicine.

Note Pharmacist does not include an intern pharmacist (see dict).

(3) In this section:

"supplied in accordance with the requisition", for a requisitioned medicine, includes supplying another brand of the medicine that is a bioequivalent form of the requisitioned medicine.

Note Bioequivalent —see the dictionary.

132 Labelling medicines supplied on requisition—Act, s 60 (1) (c) (i) and (2) (c) (i)

The package of a medicine supplied on requisition to a ward for the supply to a patient must have a label that includes the following:

(a) the medicine's approved name or brand name;

Note Approved name —see the medicines and poisons standard, par 1 (1).

(b) the form, strength and quantity of the medicine;

(i) the batch number or numbers of the medicine; and

(ii) the relevant expiry date for the medicine;

(d) the name or other identifier of the pharmacy or ward from which the medicine is supplied;

(e) if the medicine is a controlled medicine—a number that is different from the number given to each other requisition supplied from the pharmacy or ward.

Examples—par (a) and par (b)

1 Warfarin tablets 5mg 50

2 Coumadin tablets 5mg 50

Note An example is part of the regulation, is not exhaustive and may extend, but does not limit, the meaning of the provision in which it appears (see Legislation Act, s 126 and s 132).

133 Marking filled requisitions

(1) A filled paper-based requisition for a medicine must be marked with—

(a) the name or other identifier of the pharmacy or ward from which the medicine is supplied; and

(b) if the medicine is a controlled medicine—the requisition's number under section 132 (e); and

(2) A filled electronic requisition for a medicine must be marked with a link to an electronic document containing—

(a) the name or other identifier of the pharmacy or ward from which the medicine is supplied; and

(b) if the medicine is a controlled medicine—the requisition's number under section 132 (e); and

(3) However, subsection (1) (a) and (2) (a) do not apply to a requisition filled at a pharmacy at an institution.

(4) In this section:

"paper-based requisition" includes a faxed copy of a requisition.

134 Recording supply of medicines on requisitions

A person who supplies a medicine to someone else on requisition must make a written record of the following information:

(a) the date of the requisition;

(b) the name of the person who issued the requisition;

(d) the medicine, and the form, strength and quantity of the medicine, supplied;

(e) the name or initials of the person supplying the medicine.

Note Written includes in electronic form (see Act, dict).

Division 4.2.4 Supplying medicines on purchase orders

Note For authorisation to issue a purchase order, see s 60.

140 Authorisation conditions for supplying medicines on purchase orders—Act, s 44 (1) (b) and (2) (b)

A person's authorisation under section 110 to supply a medicine on a purchase order is subject to the following conditions:

(a) the purchase order is a complying purchase order;

(b) the medicine is supplied in accordance with the requirements of section 141;

(d) if the supplier does not receive a document signed by the buyer acknowledging receipt of the medicine within 7 days after the day the medicine is delivered—the supplier must, within 24 hours after the end of the 7-day period, tell the chief health officer, in writing, of the failure to receive the document;

(e) the following are kept at the supplier's business premises or, if the chief health officer approves in writing another place, the place approved by the chief health officer, for at least 2 years after the day the medicine is supplied:

(i) the filled purchase order;

(ii) the delivery acknowledgement under paragraph (d) or section 141 (1) (d) (ii);

(iii) the record for section 142.

141 Supplying medicines on purchase orders

(1) The following are the requirements for the supply of a medicine on a purchase order:

(a) the medicine is supplied in manufacturer's packs that comply with—

(i) section 501 (Packaging of supplied manufacturer's packs of medicines—Act, s 59 (1) (c) (i) and (2) (c) (i)); or

(ii) an approval under the Act, section 193 (Approval of non-standard packaging and labelling);

(b) the manufacturer's packs are labelled in accordance with—

(i) section 502 (Labelling of supplied manufacturer's packs of medicines—Act, s 60 (1) (c) (i) and (2) (c) (i)); or

(ii) an approval under the Act, section 193;

(d) if the medicine is delivered in person by the supplier to the buyer—

(i) the medicine is delivered to an adult; and

(ii) the delivery is acknowledged by the adult signing and dating a copy of the purchase order;

(e) if the medicine is not delivered in person by the supplier to the buyer—the medicine is delivered to the buyer by a person whose procedures require the delivery of the medicine to be signed for by the buyer or an adult employee of the buyer.

(2) However, subsection (1) (a), (b) and (c) do not apply in relation to a medicine supplied by a pharmacist to a prescriber who is authorised to supply the medicine during a consultation if the medicine is supplied in a package that is labelled with the following particulars:

(a) the approved name and brand name of the medicine;

Note Approved name —see the medicine and poisons standard, par 1 (1).

(b) the form, strength and quantity of the medicine, supplied;

142 Recording supply of medicines on purchase orders

A person who supplies a medicine to someone else on a purchase order must make a written record of the following information:

(a) the date of the order;

(b) the issuer's authority to issue the order;

(d) the date the order is supplied;

(e) the medicine, and the form, strength and quantity of the medicine, supplied.

Note Written includes in electronic form (see Act, dict).

Division 4.2.5 Supplying medicines on standing orders

Note 1 For the issue of a standing order, see pt 3.4.

Note 2 Supply does not include administer (see Act, s 24).

150 Authorisation conditions for supplying medicines on standing orders—Act, s 44 (1) (b) and (2) (b)

(1) A person's authorisation under section 110 to supply a medicine on a standing order is subject to the following conditions:

(a) the medicine is supplied in accordance with the requirements of section 151;

(b) the supply is recorded in accordance with section 153;

(c) the record for section 153 is kept at the person's business premises or, if the chief health officer approves in writing another place, the place approved by the chief health officer, for at least 2 years after the day the medicine is supplied;

(d) if the supplier is not the person who would ordinarily have prescribed the medicine for the recipient, the required information is given in writing to—

(i) the prescriber (the usual prescriber ) who would ordinarily have prescribed the medicine for the recipient not later than 24 hours after supplying the medicine; or

(ii) if the recipient does not have a usual prescriber—the recipient.

(2) However, subsection (1) (c) and (d) do not apply if the record is made in a patient's medical records.

(3) In this section:

"required information", for the supply of a medicine on a standing order, means—

(a) the supplier's name; and

(b) the date the medicine is supplied; and

(d) the medicine's approved name and brand name; and

(e) the form, strength and quantity of the medicine supplied.

151 Supplying medicines on standing orders

The following are the requirements for the supply of a medicine on a standing order:

(a) the medicine is supplied in accordance with the standing order;

(b) the medicine is supplied in a package that is labelled in accordance with section 152.

152 Labelling medicines supplied on standing order—Act, s 60 (1) (c) (i) and (2) (c) (i)

The package of a medicine supplied on a standing order must have a label that includes the following:

(a) the name of the person to whom the medicine is to be supplied;

(b) the date the medicine is supplied;

(d) if the package of the dispensed medicine is not a manufacturer's pack—

(i) the batch number or numbers of the medicine; and

(ii) the relevant expiry date for the medicine;

(e) the supplier's name, business address and telephone number;

(f) directions about the use of the medicine that are adequate to allow the medicine to be taken or administered safely, including any warning statement in the medicines and poisons standard, appendix K (Drugs required to be labelled with a sedation warning) applying to the medicine;

(g) words to the effect of ‘keep out of reach of children'.

153 Recording supply of medicines on standing orders

(1) A person (the supplier ) who supplies a medicine to a person (the patient ) on a standing order must make a written record of the following information:

(a) the supplier's name;

(b) the patient's name and address;

(d) the medicine's approved name and brand name;

(e) the form, strength and quantity of the medicine;

(f) the date of the standing order.

Note Written includes in electronic form (see Act, dict).

(2) However, subsection (1) (b) does not apply if the record is made in the patient's medical records.

Division 4.2.6 Supplying medicines during consultations

Note Supply does not include administer (see Act, s 24).

160 Authorisation conditions for supplying medicines during consultations—Act, s 44 (1) (b) and (2) (b)

A prescriber's authorisation under section 110 to supply a medicine during a consultation is subject to the following conditions:

(a) the medicine is supplied in accordance with the Act, section 7 (Appropriate prescription and supply of medicines);

(b) if the medicine is a controlled medicine for human use—

(i) the prescriber complies with the additional requirements under section 163 (Additional requirements for supplying controlled medicines for human use during consultations) in relation to the supply; and

(ii) if the medicine is dronabinol—the prescriber has an authorisation under the Therapeutic Goods Act 1989 (Cwlth), section 19 to supply the medicine; and

Note Dronabinol cannot be prescribed for veterinary use because it is a prohibited substance (see medicine and poisons standard, sch 9, entry for tetrahydrocannabinols).

(iii) the prescriber complies with section 164 (Information for CHO about controlled medicines supplied during consultations—Act, s 31 (2) (b) and (4), def required information );

(c) if the medicine is a designated appendix D medicine prescribed for a purpose mentioned in schedule 3 (Designated appendix D medicines—standing approvals), part 3.2, column 3 in relation to the medicine—

(i) the prescriber has an appendix D medicines approval to prescribe the medicine; and

(ii) the prescriber complies with each condition (if any) of the approval (including any conditions in the schedule, part 3.2, column 4 in relation to the medicine);

(d) the medicine is labelled in accordance with section 161;

(e) the supply is recorded in accordance with section 162;

(f) the record is kept at the prescriber's business premises or, if the chief health officer approves in writing another place, the place approved by the chief health officer, for at least 2 years after the day the medicine is supplied.

161 Labelling medicines supplied during consultations

The supplied medicine must have a label that includes the following:

(a) the name of the person to whom the medicine is supplied;

(b) the date the medicine is supplied;

(d) the medicine's approved name or brand name;

Note Approved name —see the medicines and poisons standard, par 1 (1).

(e) the form, strength and quantity of the medicine;

(f) if the package of the supplied medicine is not a manufacturer's pack—the relevant expiry date for the medicine;

(g) directions about the use of the medicine that are adequate to allow the medicine to be taken or administered safely, including any warning statement in the medicines and poisons standard, appendix K (Drugs required to be labelled with a sedation warning) applying to the medicine;

(h) words to the effect of ‘keep out of reach of children';

(i) if the prescriber is a dentist—the words ‘for dental treatment only';

(j) if the prescriber is an optometrist—the words ‘for optometry use only';

(k) if the prescriber is a veterinary surgeon—

(i) words to the effect of ‘for animal treatment only'; and

(ii) the species of the animal for which the medicine is supplied; and

(iii) if possible, a way of identifying the animal.

Examples—par (d) and par (e)

1 Warfarin tablets 5mg 50

2 Coumadin tablets 5mg 50

Note An example is part of the regulation, is not exhaustive and may extend, but does not limit, the meaning of the provision in which it appears (see Legislation Act, s 126 and s 132).

162 Recording medicines supplied during consultations

A prescriber who supplies a medicine during a consultation must make a written record of the following information in the medical records of the person to whom, or animal to which, the consultation related:

(a) the date the medicine is supplied;

(b) the medicine's approved name or brand name;

Note Approved name —see the medicines and poisons standard, par 1 (1).

(d) the directions given to the person for the use of the medicine.

Note Written includes in electronic form (see Act, dict).

163 Additional requirements for supplying controlled medicines for human use during consultations

The following are the additional requirements for supplying a controlled medicine for human use during a consultation:

(a) the prescriber has a controlled medicines approval to prescribe the medicine;

Note For controlled medicines approvals, see pt 13.1.

(b) if the approval is for a particular form of the medicine—the supply is for the form of the medicine approved or a bioequivalent form;

Note Bioequivalent —see the dictionary.

(c) if the approval is for a particular strength of the medicine—the supply is for the strength approved or a weaker strength;

(d) if the approval is for a particular quantity of the medicine—the supply is for not more than the quantity approved;

(e) the prescriber complies with each condition (if any) of the approval.

Example—par (b)

If a slow release form of a medicine is approved, the prescriber is not authorised to prescribe an immediate release form of the medicine.

Example—par (c) and par (d)

If a doctor is given an approval to prescribe 25 morphine 20mg capsules, the doctor may prescribe 5 20mg capsules and 10 15mg capsules. Later, if the approval is still in force, the doctor may prescribe not more than 10 morphine capsules of any strength up to and including 20mg.

Note An example is part of the regulation, is not exhaustive and may extend, but does not limit, the meaning of the provision in which it appears (see Legislation Act, s 126 and s 132).

164 Information for CHO about controlled medicines supplied during consultations—Act, s 31 (2) (b) and (4), def required information

(1) This section applies if a prescriber supplies a controlled medicine for human use during a consultation.

Note Supply does not include administer (see Act, s 24).

(2) The prescriber must, not later than 7 days after the end of the month when the controlled medicine is supplied, give the chief health officer the following information in writing:

(a) the prescriber's name, business address and telephone number;

(b) the name and address of the person to whom the medicine is supplied;

(d) the medicine, and the form, strength and quantity of the medicine, supplied.

Division 4.2.7 Selling pseudoephedrine by retail

170 Meaning of retail sale —div 4.2.7

In this division:

"retail sale" does not include supply on prescription.

171 Authorisation conditions for retail sale of pseudoephedrine—Act, s 44 (1) (b) and (2) (b)

A person's authorisation under section 110 to supply pseudoephedrine is subject to the following conditions if the pseudoephedrine is sold by retail sale:

(a) the pseudoephedrine is supplied in accordance with the Act, section 7 (Appropriate prescription and supply of medicines);

(b) the seller complies with section 172;

Note For how the record must be made, see the Act, s 46.

(d) the record is kept at the seller's business premises or, if the chief health officer approves in writing another place, the place approved by the chief health officer, for at least 2 years after the day the sale is made;

(e) if the buyer of the pseudoephedrine asks the seller to see the record during the period it is kept under paragraph (d), the seller—

(i) allows the buyer to see the record within a reasonable period of a request being made by the buyer; and

(ii) if satisfied that the record is incorrect, amends the record;

(f) the seller complies with—

(i) a request under section 174 (4) (b) (Failure to amend pseudoephedrine sales record); and

(ii) a direction under section 175 (Pseudoephedrine sales record—decision by CHO) to amend the record.

172 Requirement to tell buyer about pseudoephedrine sales record

(1) The authorised person selling pseudoephedrine by retail sale, must tell the buyer the following:

(a) the seller is required to make a record of the sale;

(b) the buyer may refuse to provide information for the record but, if the buyer refuses, the seller must not sell pseudoephedrine to the buyer;

(i) a police officer;

(ii) a public servant who is a member of the administrative unit to which the chief health officer belongs;

(iii) a Commonwealth or State public servant (however described) who is a member of an administrative unit (however described) that administers legislation about medicines;

Note State includes the Northern Territory (see Legislation Act, dict, pt 1).

(iv) anyone other than the seller who supplies pseudoephedrine to the public in Australia;

(v) the Pharmacy Guild of Australia;

(d) the buyer has the right to see the record and have any mistake corrected.

Note If a form is approved under the Act, s 198 for this provision, the form must be used.

(2) In this section:

"police officer "includes a member of a police force (however described) of a State.

173 Required information for pseudoephedrine sales records

(1) The following is the required information for a pseudoephedrine record:

(a) the date of sale;

(b) the brand name, form, strength and quantity of pseudoephedrine sold;

(d) a unique identification number for the buyer from—

(i) a photo identification document produced to the seller by the buyer; or

(ii) if the buyer does not produce a photo identification document—

(A) the buyer's birth certificate; or

(B) an Australian or New Zealand seniors card for the buyer;

(e) the kind of identification the buyer produces.

Example—unique identification number

a person's driver licence number

Note 1 If a form is approved under the Act, s 198 for this provision, the form must be used.

Note 2 An example is part of the regulation, is not exhaustive and may extend, but does not limit, the meaning of the provision in which it appears (see Legislation Act, s 126 and s 132).

(2) In this section:

"Australian student identification" card means a card issued to a person who is a student at an Australian secondary or tertiary education institution to identify the person as a student at the institution.

"birth certificate", for a person, means—

(a) the person's birth certificate, or a certified extract from the register about the person's birth, under the Births, Deaths and Marriages Registration Act 1997 ; or

(b) a document issued under a law of a State, an external Territory or New Zealand that corresponds to a birth certificate or extract mentioned in paragraph (a) if the document identifies the issuing jurisdiction and states its date of issue.

"photo identification document", for a person, means any of the following documents for the person if it is current and contains the person's photograph:

(a) an Australian driver licence or external driver licence within the meaning of the Road Transport (Driver Licensing) Act 1999 ;

(b) a passport, other than an Australian passport;

(d) an Australian student identification card.

"proof of age card" means a proof of age card issued under the Liquor Act 1975 , and includes a document corresponding to a proof of age card that has been issued under the law of a State, an external Territory or New Zealand.

174 Failure to amend pseudoephedrine sales record

(1) This section applies if the seller of pseudoephedrine does not amend a pseudoephedrine record in accordance with section 171 (e) (ii) (Authorisation conditions for retail sale of pseudoephedrine—Act, s 44 (1) (b) and (2) (b)).

(2) The buyer may, in writing, apply to the chief health officer for a direction to the seller to make the amendment.

(3) The application must give reasons why the buyer thinks the record is incorrect.

(4) The chief health officer must—

(a) give a copy of the application to the seller; and

(b) ask the seller to—

(i) make the amendment and tell the chief health officer; or

(ii) if the seller is satisfied that the amendment should not be made—send written reasons to the chief health officer not later than 10 working days after the day the seller receives the application why the amendment should not be made.

175 Pseudoephedrine sales record—decision by CHO

(1) After considering an application under section 174 (2) and any reasons given in accordance with the request under section 174 (4) (b) (ii), the chief health officer must—

(a) direct the seller to amend the pseudoephedrine record—

(i) in accordance with the application; or

(ii) in a stated way other than in accordance with the application; or

(b) refuse the application.

(2) The chief health officer must give the buyer and seller written notice of the decision.

Division 4.2.8 Supplying pharmacist only medicines

180 Authorisation conditions for supply of pharmacist only medicines—Act, s 44 (1) (b) and (2) (b)

(1) This section does not apply to the supply of a pharmacist only medicine—

(a) at an institution; or

(b) on a supply authority.

Note 1 Supply does not include administer (see Act, s 24).

Note 2 Supply authority includes a written prescription or requisition or a purchase order or standing order (see Act, s 23).

(2) A person's authorisation under section 110 to supply a pharmacist only medicine is subject to the following conditions:

(a) the person personally hands the medicine to a customer attending in person;

(b) the person gives the customer adequate instructions, either orally or in writing, for the medicine's use at the time of supply.

Part 4.3 Authorisation to supply without prescription in emergencies

250 Meaning of designated prescription only medicine —pt 4.3

In this part:

"designated prescription only medicine" means a prescription only medicine other than—

(a) an anabolic steroid; and

(b) a designated appendix D medicine; and

Note Prescription only medicine does not include a controlled medicine (see Act, s 11)

251 Authorisation to supply certain medicines without prescription in emergencies—Act, s 26 (1) (b)

A pharmacist is authorised to supply a designated prescription only medicine to someone else without a prescription if the pharmacist is satisfied that—

(a) the person is undergoing treatment essential to the person's health or wellbeing; and

(b) the designated prescription only medicine has previously been prescribed for the person's treatment by a prescriber; and

(d) because of an emergency, it is not practicable for the person to obtain a prescription for the medicine from a prescriber.

Note Pharmacist does not include an intern pharmacist (see dict).

252 Authorisation conditions for supplying of certain medicines without prescription in emergencies—Act, s 44 (1) (b) and (2) (b)

(1) A pharmacist's authorisation under section 251 to supply a designated prescription only medicine without a prescription is subject to the following conditions:

(a) the quantity supplied is—

(i) if the medicine is a liquid, aerosol, cream, ointment or anovulant tablet packaged in a manufacturer's pack—the smallest manufacturer's pack in which the medicine is generally available; or

(ii) in any other case—not more than the quantity required for 3 days treatment for the person;

(b) the medicine is supplied in a package that is labelled in accordance with section 253;

(d) the record of the supply is kept at the pharmacy or, if the chief health officer approves in writing another place, the place approved by the chief health officer, for at least 2 years after the day medicine is supplied;

(e) the pharmacist sends the prescriber who would have ordinarily prescribed the medicine for the recipient the required information for the supply in writing not later than 24 hours after supplying the medicine.

(2) In this section:

"required information", for the supply of a designated prescription only medicine, means—

(a) the pharmacist's name; and

(b) the name, business address and telephone number of the pharmacy from which the medicine is supplied; and

(d) the name and address of the person to whom the medicine is supplied; and

(e) the medicine's approved name or brand name; and

(f) the form, strength and quantity of the medicine supplied.

253 Labelling medicines supplied without prescription in emergencies—Act, s 60 (1) (c) (i) and (2) (c) (i)

The package of a designated prescription only medicine supplied to a person under section 251 must have a label that includes the following:

(a) the name of the person to whom the medicine is supplied;

(b) the date the medicine is supplied;

(d) the initials or other identification of the pharmacist supplying the medicine;

(e) the medicine's approved name and brand name;

Note Approved name —see the medicines and poisons standard, par 1 (1).

(f) the form, strength and quantity of the medicine;

(g) if the package of the supplied medicine is not a manufacturer's pack—the relevant expiry date for the medicine;

(h) directions about the use of the medicine that are adequate to allow the medicine to be taken or administered safely, including any warning statement in the medicines and poisons standard, appendix K (Drugs required to be labelled with a sedation warning) applying to the medicine;

(i) words to the effect of ‘keep out of reach of children'.

Example—par (e) and par (f)

Warfarin tablets (Coumadin) 5mg 3

Note An example is part of the regulation, is not exhaustive and may extend, but does not limit, the meaning of the provision in which it appears (see Legislation Act, s 126 and s 132).

254 Recording medicines supplied without prescription in emergencies

A pharmacist who supplies a designated prescription only medicine to a person under section 251 must make a written record of the following information in relation to the supply of the medicine:

(a) the pharmacist's name;

(b) the name of the prescriber who would ordinarily have prescribed the medicine;

(d) the name and address of the person to whom the medicine is supplied;

(e) the medicine's approved name and brand name;

(f) the form, strength and quantity of the medicine supplied.

Note Written includes in electronic form (see Act, dict).

Part 4.4 Authorisation to supply medicines for disposal

260 Authorisation to supply medicines to pharmacists for disposal—Act, s 26 (1) (b)

A person is authorised to supply a medicine to a pharmacist for disposal.

Note Pharmacist does not include an intern pharmacist (see dict).

261 Authorisation to supply medicines to commercial disposal operators for disposal—Act, s 26 (1) (b)

A person is authorised to supply a medicine to another person for disposal if the other person—

(a) holds an environmental authorisation for the disposal of the medicine; or

(b) is an adult acting for a person mentioned in paragraph (a).

Note For related authorisations, see pt 9.1.

Part 4.5 Wholesale supply of medicines under corresponding laws

270 Conditions for wholesalers supplying medicines under corresponding laws—Act, s 20 (4) (c)

The following conditions apply to a person who supplies medicines by wholesale under a corresponding law:

(a) the person must comply with, and must ensure that the person's agents and employees comply with—

(i) the Australian code of good wholesaling practice for therapeutic goods for human use; and

(ii) the medicines Australia code of conduct;

Note Australian code of good wholesaling practice for therapeutic goods for human use and medicines Australia code of conduct —see the dictionary.

(b) the person must not supply sample packs of a controlled medicine;

(i) the buyer is authorised to possess the medicine; and

(ii) the supply is in accordance with section 140 (Authorisation conditions for supplying medicines on purchase orders—Act, s 44 (1) (b) and (2) (b));

(d) the person must store medicines—

(i) within the manufacturer's recommended storage temperature range; and

(ii) in any other environmental condition that is necessary to preserve the medicine's stability and therapeutic quality.

Part 5.1 Authorisations for health-related occupations

350 Authorisation under sch 1 for people in health-related occupations to administer medicines—Act, s 37 (1) (b) and (3) (b)

A person mentioned in schedule 1, column 2 is authorised to administer a medicine if—

(a) administering the medicine is included in the schedule, column 3 in relation to the person; and

(b) the administration is consistent with any restriction for the administration mentioned in the schedule, column 3.

Note For authorisation to self-administer a medicine, see s 360.

351 Authorisation conditions for administration of medicines at institutions by people in health-related occupations—Act, s 44 (1) (b) and (2) (b)

(1) An authorisation under section 350 to administer a medicine is subject to the following conditions:

(a) if the medicine is administered under a standing order to a patient at an institution—the administration is recorded in the patient's medical records;

Note Institution includes a correctional centre and a CYP detention place (see s 652).

(b) if the medicine is a controlled medicine administered to a
patient at an institution—

(i) the medicine is not removed from a storage receptacle until immediately before its administration; and

(ii) the administration is witnessed by a prescribed administration witness or, if a prescribed administration witness is not reasonably available to witness the administration, the administration is witnessed by another person; and

Note The witness must sign the record of the administration as witness (see Act, s 53 (e)).

(iii) the administration is recorded in—

(A) the patient's medical records; and

(B) the applicable controlled medicines register mentioned in section 543 (3) (Making entries in controlled medicines registers—Act, s 51 (1) (b)).

(2) However, subsection (1) (b) does not apply in relation to a controlled medicine dispensed in a dose administration aid for—

(a) a patient at a residential aged care facility or residential disability care facility; or

(b) a detainee at a correctional centre; or

(3) In this section:

"prescribed administration witness" means a person prescribed under section 544 (Prescribed witnesses for administration of controlled medicines—Act, s 53 (a) and (b)) for the administration of a controlled medicine.

Part 5.2 Other administration authorisations

360 Authorisation for self-administration etc of medicines—Act, s 37 (2) (b) and (3) (b)

(1) This section applies in relation to a medicine obtained by a person from someone who is authorised to supply the medicine to the person.

(2) The following dealings by the person with the medicine are authorised:

(a) if the person is a prescriber and the medicine is a restricted medicine—self-administration of a medicine prescribed or supplied by another prescriber who is not—

(i) a trainee dentist or intern doctor; or

(ii) related to or employed by the person;

(b) if the person is a prescriber and the medicine is not a restricted medicine—self-administration of the medicine;

(c) if the person is not a prescriber and the medicine is supplied for the person's own use—self-administration of the medicine;

(d) if the person is the custodian of an animal and the medicine is supplied for the animal's use—administering the medicine to the animal.

Note Custodian , of an animal—see the dictionary.

(3) In this section:

"restricted medicine"—see section 30.

361 Authorisation for administration of medicines by assistants—Act, s 37 (1) (b)

(1) A person (the assistant ) is authorised to administer a medicine to someone else (the "assisted person") if—

(a) the medicine is obtained by or for the assisted person from someone who is authorised to supply the medicine to the assisted person; and

(b) the medicine is administered in accordance with the directions on the medicine's labelling; and

(c) if the assisted person is not a person under a legal disability—the assisted person asks for the assistant's help to take the medicine; and

(d) if the assisted person is a person under a legal disability—the assistant is authorised by the assisted person's parent or guardian to administer the medicine.

(2) In this section:

"impaired decision-making ability"—a person has impaired decision-making ability if the person's decision-making ability is impaired because of a physical, mental, psychological or intellectual condition or state, whether or not the condition or state is a diagnosable illness.

"person under a legal disability" means—

(a) a child; or

(b) a person with impaired decision-making ability in relation to a matter relating to the person's health.

370 Authorisation under sch 1 to obtain and possess medicines—Act, s 35 (1) (b), (2) (b) and s 36 (b)

(1) A person mentioned in schedule 1, column 2 is authorised to obtain a medicine if obtaining the medicine—

(a) is included in the schedule, column 3 in relation to the person; and

(b) is consistent with any restriction for obtaining the medicine mentioned in the schedule, column 3.

(2) A person mentioned in schedule 1, column 2 is authorised to possess a medicine if—

(a) possessing the medicine is included in the schedule, column 3 in relation to the person; and

(b) the possession is consistent with any restriction for the possession mentioned in the schedule, column 3.

371 Authorisation to obtain and possess medicines for certain personal use-related dealings—Act, s 35 (1) (b), (2) (b) and s 36 (b)

(1) A person is authorised to obtain or possess a medicine if the person obtains the medicine from someone who is authorised to supply the medicine to the person.

(2) Subsection (1) applies in relation to a person whether the medicine is obtained by the person for the person's own use or as an agent for someone else.

380 Authorisation under sch 1 to manufacture medicines—Act, s 33 (b)

A person mentioned in schedule 1, column 2 is authorised to manufacture a medicine if—

(a) manufacturing the medicine is included in the schedule, column 3 in relation to the person; and

(b) the manufacturing is consistent with any restriction for the manufacturing mentioned in the schedule, column 3.

390 Discarding controlled medicines—Act, s 34 (1) (a)

(1) A controlled medicine must be discarded in accordance with this section.

Note See also the Drugs of Dependence Act 1989 , div 11.4 about the disposal of seized substances.

(2) A prescribed discarding witness may discard a controlled medicine in the presence of another prescribed discarding witness.

(3) However, a person who is authorised to administer a controlled medicine may discard the residue of the medicine after administration in the presence of a person who is not a prescribed discarding witness if no other prescribed discarding witness is reasonably available to witness its discarding.

(4) A person complies with this section if the person destroys the medicine so that it is unable to be used.

(5) In this section:

"prescribed discarding witness" means a person prescribed under section 545 (Prescribed witnesses for discarding of controlled medicines—Act, s 54 (a) and (b)) for the discarding of a controlled medicine.

Note A medicine must not be discarded in a way that creates a risk to the health or safety of people or is likely to cause damage to property or the environment (see Act, s 34 (3)).

Part 9.1 Authorisations for delivery people and commercial disposal operators

400 Authorisations to deliver medicines under supply authorities—Act, s 26 (1) (b), (2) (b), s 35 (1) (b), (2) (b) and s 36 (b)

(1) This section applies to an adult (the delivery person ), other than a health professional at an institution, who is—

(a) engaged to transport and deliver a medicine supplied on a supply authority; or

(b) acting for a person mentioned in paragraph (a).

Note For health professionals at institutions, see sch 1.

(2) The delivery person is authorised to—

(a) obtain and possess the medicine for the purposes of transporting and delivering the medicine as engaged; and

(b) supply the medicine to the entity named as the recipient in the supply authority or the entity's agent.

Examples—delivery person

1 a hospital employee who is not a health professional

2 an employee of a courier service

Example—agent

the guardian of a child for a prescription dispensed for the child

Note 1 Entity includes a person (see Legislation Act, dict, pt 1).

Note 2 An example is part of the regulation, is not exhaustive and may extend, but does not limit, the meaning of the provision in which it appears (see Legislation Act, s 126 and s 132).

401 Authorisations for commercial disposal operators—Act, s 26 (1) (b) and (2) (b), s 35 (1) (b) and (2) (b) and s 36 (b)

(1) This section applies to a person who—

(a) holds an environmental authorisation for the disposal of a medicine; or

(b) is an adult acting for a person mentioned in paragraph (a).

(2) The person is authorised to obtain and possess the medicine for the purposes of disposing of the medicine as engaged.

Part 9.2 Emergency supply and administration of adrenaline and salbutamol

410 Authorisations to supply and administer adrenaline and salbutamol—Act, s 26 (1) (b) and s 37 (1) (b)

(1) A person is authorised to do 1 or more of the following for someone else (the assisted person ) who is in immediate need of adrenaline or salbutamol:

(a) supply authorised adrenaline or authorised salbutamol to the assisted person;

(b) supply authorised adrenaline or authorised salbutamol to someone else for immediate administration to the assisted person;

(2) In this section:

"authorised adrenaline" means adrenaline in a single use automatic injector delivering not more than 0.3mg adrenaline.

"authorised salbutamol" means salbutamol in, or for, a metered inhaler.

Part 9.3 Medicines authorisations for corrections functions

420 Authorisations for CYP authorised people—Act, s 26 (1) (b), s 35 (1) (b), (2) (b), s 36 (b) and s 37 (1) (b)

A CYP authorised person is authorised, within the scope of the person's employment, to do any of the following in relation to a medicine supplied for a young detainee by a person who is authorised to supply the medicine:

(a) obtain the medicine;

(b) possess the medicine (including possess the medicine outside a CYP detention place for the purpose of administering the medicine to a young detainee while the young detainee is lawfully outside the place);

(d) supply the medicine to a person who is authorised to obtain the medicine for the young detainee.

Example—young detainee lawfully outside CYP detention place

the detainee is on local leave escorted by a CYP authorised person

Note 1 CYP authorised person and CYP detention place —see the dictionary.

Note 2 Young detainee —see the Children and Young People Act 2008 , s 95.

Note 3 An example is part of the regulation, is not exhaustive and may extend, but does not limit, the meaning of the provision in which it appears (see Legislation Act, s 126 and s 132).

421 Authorisations for corrections officers—Act, s 26 (1) (b), s 35 (1) (b), (2) (b), s 36 (b) and s 37 (1) (b)

A corrections officer is authorised, within the scope of the officer's employment, to do any of the following in relation to a medicine supplied for a detainee by a person who is authorised to supply the medicine:

(a) obtain the medicine;

(b) possess the medicine (including possess the medicine outside a correctional centre for the purpose of administering the medicine to a detainee while the detainee is lawfully outside the centre);

(d) supply the medicine to a person who is authorised to obtain the medicine for the detainee.

Note 1 See the example and notes to s 420.

Note 2 Detainee —see the Corrections Management Act 2007 , s 6.

422 Authorisations for court and police cell custodians—Act, s 26 (1) (b), s 35 (1) (b), (2) (b), s 36 (b) and s 37 (1) (b)

(1) A custodian is authorised, within the scope of the custodian's employment, to do any of the following in relation to a medicine supplied for a person in custody at court cells or police cells by someone who is authorised to supply the medicine:

(a) obtain the medicine at the cells;

(b) possess the medicine at the cells;

(d) supply the medicine to someone who is authorised to obtain the medicine for the person in custody.

(2) In this section:

"court cell"—see the Corrections Management Act 2007 , section 29.

"custodian" means—

(a) a person in charge of a court cell or police cell; or

(b) a person acting under the direct supervision of the person in charge.

"person in custody" means—

(a) a detainee; or

(b) a young detainee; or

(d) a person detained at a court cell under the Corrections Management Act 2007 , section 33.

"police cell"—see the Corrections Management Act 2007 , section 29.

Part 9.4 Authorisations for medicines research and education program purposes other than controlled medicines

Note A licence is required for research and education programs in relation to controlled medicines (see pt 14.2).

430 Authorisations for non-controlled medicines research and education—Act, s 26 (1) and (2) (b)

(1) A scientifically qualified person employed at a recognised research institution (other than the Canberra Hospital) is authorised to do the following for the purposes of an authorised activity at the institution:

(a) issue a purchase order for a relevant medicine;

(b) obtain on a purchase order a relevant medicine;

(d) supply a relevant medicine to a person (a relevant person ) who is taking part in the authorised activity at the institution.

Note 1 Scientifically qualified person —see the dictionary.

Note 2 Recognised research institution —see the Act, s 20 (5).

(2) A scientifically qualified person employed at the Canberra Hospital is authorised to do the following for the purposes of an authorised activity at the hospital:

(a) issue a written requisition for a relevant medicine;

(b) obtain on a written requisition a relevant medicine;

(d) supply a relevant medicine to a person (also a relevant person ) who is taking part in the authorised activity at the hospital.

(3) A relevant person is authorised to do the following in relation to a relevant medicine for the purposes of an authorised activity:

(a) obtain the medicine from the scientifically qualified person for the activity;

(b) possess the medicine for the purposes of the activity;

(4) In this section:

"authorised activity", in relation to a relevant medicine at a recognised research institution, means the conduct of any of the following if it does not involve the administration of the medicine to a person:

(a) medical or scientific research in relation to the medicine at the institution;

(b) instruction involving the medicine at the institution;

"relevant medicine" means a medicine other than a controlled medicine.

431 Authorisation conditions for non-controlled medicines research and education—Act, s 44 (1) (b) and (2) (b)

A scientifically qualified person's authorisation under section 430 is subject to the following conditions:

(a) the person has written approval for the conduct of the authorised activity from the person in charge of—

(i) the recognised research institution; or

(ii) a faculty or division of the institution;

(b) if the recognised research institution employing the person is the Canberra Hospital—

(i) a requisition for the relevant medicine issued by the person complies with section 55 (General requirements for written requisitions) and section 56 (Particulars for requisitions); and

(ii) the requisition is for an amount of the medicine approved in writing by the person in charge; and

(iii) the requisition is for an amount of the medicine used solely for the purpose approved in writing by the person in charge;

(i) a purchase order for the relevant medicine complies with section 62; and

(ii) the purchase order is for an amount of the medicine approved in writing by the person in charge;

(d) the medicine is obtained from someone who is authorised to supply the medicine to the person.

Part 9.5 Authorisations under medicines licences

Division 9.5.1 Controlled medicines research and education program licence authorisations

Note 1 For authorisation for research and education for other medicines, see pt 9.4.

Note 2 For other provisions about controlled medicines research and education program licences, see pt 14.2.

440 Authorisations under controlled medicines research and education program licences—Act, s 20 (1) (a)

(1) A controlled medicines research and education program licence (other than for a program conducted at the Canberra Hospital) authorises—

(a) the licence-holder to—

(i) issue a purchase order for a controlled medicine (the licensed controlled medicine ) stated in the licence for the program stated in the licence; and

(ii) obtain a licensed controlled medicine on a purchase order for the program; and

(iii) possess a licensed controlled medicine for the program at the premises to which the licence relates; and

(iv) supply a licensed controlled medicine to anyone taking part in the program for the program; and

(b) the program supervisor, and anyone taking part in the program, to deal with the licensed controlled medicine as authorised by the licence at the premises stated in the licence.

(2) A controlled medicines research and education program licence for a program conducted at the Canberra Hospital authorises—

(a) the licence-holder to—

(i) issue a written requisition for a controlled medicine (the licensed controlled medicine ) stated in the licence for the program stated in the licence; and

(ii) obtain a licensed controlled medicine on a written requisition for the program; and

(iii) possess a licensed controlled medicine for the program at the premises to which the licence relates; and

(iv) supply a licensed controlled medicine to anyone taking part in the program for the program; and

(b) the program supervisor, and anyone taking part in the program, to deal with the licensed controlled medicine as authorised by the licence at the hospital.

441 Authorisation condition for controlled medicines research and education program licences—Act, s 44 (1) (b) and (2) (b)

A licence-holder's authorisation to obtain a controlled medicine under a controlled medicines research and education program licence is subject to the condition that the medicine is—

(a) if the licence is for a program conducted at the Canberra Hospital—obtained on a requisition that complies with section 55 (General requirements for written requisitions) and section 56 (Particulars for requisitions); or

(b) in any other case—purchased on a complying purchase order.

Note For licence conditions, see the Act, s 89.

Division 9.5.2 First-aid kit licence authorisations

Note For other provisions about first-aid kit licences, see pt 14.3.

450 Authorisations under first-aid kit licences—Act, s 20 (1) (a)

(1) In this section:

"authorised medicine", for a first-aid kit, means—

(a) a medicine stated in the first-aid kit licence for the kit; and

(b) a pharmacy medicine or pharmacist only medicine for the kit.

(2) A first-aid kit licence authorises—

(a) the licence-holder to—

(i) issue a purchase order for an authorised medicine for the first-aid kit; and

(ii) obtain on a purchase order an authorised medicine for the first-aid kit; and

(b) the licence-holder, and anyone else authorised to deal with a medicine by the licence, to—

(i) possess an authorised medicine as part of the first-aid kit for the emergency treatment of a person's medical condition; and

(ii) supply an authorised medicine to someone else who is authorised under the licence to administer the medicine; and

(iii) administer an authorised medicine in the first-aid kit if the person believes on reasonable grounds that the administration of the medicine is necessary for the emergency treatment of a person's medical condition.

451 Authorisation condition for first-aid kit licences—Act, s 44 (1) (b) and (2) (b)

A licence-holder's authorisation to obtain a medicine under a first-aid kit licence is subject to the condition that the medicine is purchased on a complying purchase order.

Note For licence conditions, see the Act, s 89.

Division 9.5.3 Wholesalers licence authorisations

Note For other provisions about wholesalers licences, see pt 14.4.

460 Authorisations under medicines wholesalers licences—Act, s 20 (1) (a)

(1) A medicines wholesalers licence authorises the licence-holder to do any of the following in relation to a medicine (the licensed medicine ) stated in the licence at the premises (the licensed premises ) stated in the licence:

(a) issue a purchase order for a licensed medicine;

(b) obtain a licensed medicine on a purchase order for sale by wholesale from the licensed premises;

(d) sell a licensed medicine by wholesale (whether or not for resale) from the licensed premises to—

(i) a person authorised to issue a purchase order for the medicine; or

(ii) someone in another State who may obtain the medicine by wholesale under the law of the other State; or

(iii) someone in another country who may lawfully obtain the medicine by wholesale in the other country;

Note The medicines must be sold on a purchase order in accordance with s 140 (see s 461).

(e) unless the licensed medicine is a controlled medicine—supply the medicine in accordance with the medicines Australia code of conduct provisions for product starter packs.

Note Medicines Australia code of conduct —see the dictionary.

(2) However, an authorisation under subsection (1) does not apply if the licence states that it does not apply.

(3) Also, subsection (1) (d) (iii) does not apply in relation to a licensed medicine that is a prohibited export under the Customs Act 1901 (Cwlth).

461 Authorisation conditions for medicines wholesalers licences—Act, s 44 (1) (b) and (2) (b)

A licence-holder's authorisation under a medicines wholesalers licence is subject to the following conditions:

(a) the dealings with a medicine authorised by the licence will be carried out under the supervision of an individual approved under section 616 (1) (Restrictions on issuing of medicines wholesalers licences—Act, s 85 (1) (a));

(b) the licence-holder must comply with, and the licence-holder must ensure that the licence-holder's agents and employees comply with—

(i) the Australian code of good wholesaling practice for therapeutic goods for human use; and

(ii) the medicines Australia code of conduct;

Note Australian code of good wholesaling practice for therapeutic goods for human use and medicines Australia code of conduct —see the dictionary.

(d) a medicine sold under the licence is sold on a complying purchase order in accordance with section 141 (Supplying medicines on purchase orders).

Note For licence conditions, see the Act, s 89.

Division 9.5.4 Opioid dependency treatment licence authorisations

Note For other provisions about opioid dependency treatment licences, see pt 14.5.

470 Authorisations under opioid dependency treatment licences—Act, s 20 (1) (a)

(1) An opioid dependency treatment licence issued to a pharmacist authorises the licence-holder, and any other pharmacist at the community pharmacy (the licensed pharmacy ) to which the licence relates, to do any of the following for the purpose of treating a person's drug-dependency:

(a) issue a purchase order for buprenorphine or methadone;

(b) obtain buprenorphine or methadone on a purchase order for administration at the licensed pharmacy;

(d) dispense buprenorphine and methadone in accordance with a prescription;

(e) supply buprenorphine and methadone to a nurse at the licensed pharmacy for administration at the pharmacy under the supervision of a pharmacist;

(f) administer buprenorphine and methadone at the licensed pharmacy in accordance with a prescription (including the prescription as changed by a pharmacist at the oral direction of the prescriber).

(2) An opioid dependency treatment licence issued to a pharmacist authorises a nurse to administer buprenorphine and methadone at the licensed pharmacy under the supervision of a pharmacist and in accordance with a prescription (including the prescription as changed by a pharmacist at the oral direction of the prescriber).

Note 1 Nurse does not include an enrolled nurse (see Legislation Act, dict, pt 1).

Note 2 Pharmacist does not include an intern pharmacist (see dict).

(3) To remove any doubt, an authorisation under this section does not, by implication, limit a pharmacist's or nurse's authorisations under schedule 1 (Medicines—health-related occupations authorisations) in relation to other dealings with buprenorphine and methadone.

471 Authorisation condition for opioid dependency treatment licences—Act, s 44 (1) (b) and (2) (b)

(1) A licence-holder's authorisation under an opioid dependency treatment licence is subject to the following conditions:

(a) the licence-holder must ensure that a person to whom buprenorphine or methadone is administered under the licence signs a written acknowledgement in accordance with subsection (2) that the medicine has been administered to the person;

(b) a purchase order issued by the licence-holder to obtain buprenorphine or methadone under the licence is a complying purchase order.

Note 1 Written includes in electronic form (see Act, dict).

Note 2 For licence conditions, see the Act, s 89.

(2) For subsection (1) (a), the acknowledgement must include the following:

(a) the approved name or brand name of the medicine administered;

(b) the form, strength and quantity of the medicine administered;

Division 9.5.5 Pharmacy medicines rural communities licences

Note For other provisions about pharmacy medicines rural communities licences, see pt 14.6.

480 Authorisations under pharmacy medicines rural communities licences—Act, s 20 (1) (a)

A pharmacy medicines rural communities licence authorises—

(a) the licence-holder to—

(i) issue a purchase order for a pharmacy medicine (the licensed medicine ) stated in the licence for retail sale from the premises (the licensed premises ) stated in the licence; and

(ii) obtain the licensed medicine on a purchase order for retail sale from the licensed premises; and

(iii) possess the licensed medicine at the licensed premises for retail sale from the licensed premises; and

(iv) sell the licensed medicine by retail from the licensed premises to customers attending in person at the licensed premises; and

(b) an employee of the licence-holder to—

(i) possess the medicine at the licensed premises for retail sale from the licensed premises; and

(ii) sell the medicine by retail from the licensed premises to customers attending in person at the licensed premises.

Examples—sales to which par (a) (iv) and par (b) (ii) do not apply

sales over the internet or by mail

Note 1 For other requirements in relation to medicines sold under rural communities licences—see s 500 (3), s 502 (4) and s 522.

Note 2 An example is part of the regulation, is not exhaustive and may extend, but does not limit, the meaning of the provision in which it appears (see Legislation Act, s 126 and s 132).

481 Authorisation conditions for pharmacy medicines rural communities licences—Act, s 44 (1) (b) and (2) (b)

A licence-holder's authorisation under a pharmacy medicines rural communities licence is subject to the following conditions:

(a) a pharmacy medicine obtained under the licence is purchased on a complying purchase order;

(b) the pharmacy medicines to which the licence relates are sold in the manufacturer's packs;

(i) section 502 (Labelling of supplied manufacturer's packs of medicines—Act, s 60 (1) (c) (i) and (2) (c) (i)); or

(ii) an approval under the Act, section 193 (Approval of non-standard packaging and labelling);

(d) the pharmacy medicines to which the licence relates are sold from the premises stated in the licence to customers attending in person.

Note For licence conditions, see the Act, s 89.

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)

(1) In this section:

"health professional" does not include—

(a) a pharmacist, or intern pharmacist, at a hospital; and

(b) a prescriber who supplies a medicine during a consultation.

"supply" does not include dispense.

(2) A health professional, or an employee acting under the direction of a health professional, must supply a pharmacy medicine or pharmacist only medicine in a whole manufacturer's pack of the medicine.

(3) A pharmacy medicines rural communities licence-holder, or an employee acting under the direction of the licence-holder, must sell a pharmacy medicine stated in the licence in a whole manufacturer's pack of the medicine.

501 Packaging of supplied manufacturer's packs of medicines—Act, s 59 (1) (c) (i) and (2) (c) (i)

A manufacturer's pack of a medicine supplied must be packaged—

(a) in accordance with the medicines and poisons standard, paragraphs 21 to 27; or

(b) in a container in which the medicine may be sold under a corresponding law.

Note A manufacturer's pack of a medicine supplied may also be packaged in accordance with an approval under the Act, s 193 (Approval of non-standard packaging and labelling) (see Act, s 59 (1) (c) (ii) and (2) (c) (ii)).

502 Labelling of supplied manufacturer's packs of medicines—Act, s 60 (1) (c) (i) and (2) (c) (i)

(1) In this section:

"supply", a medicine, does not include—

(a) dispense the medicine; or

(b) supply the medicine on a requisition or standing order.

(2) A manufacturer's pack of a supplied medicine must be labelled in accordance with—

(a) the medicines and poisons standard, paragraphs 3 to 19; or

(b) a corresponding law.

Note A manufacturer's pack of a medicine supplied may also be labelled in accordance with an approval under the Act, s 193 (Approval of non-standard packaging and labelling) (see Act, s 60 (1) (c) (ii) and (2) (c) (ii)).

(3) A manufacturer's pack of a pharmacist only medicine sold by retail at a community pharmacy must be labelled with the pharmacy's name, business address and telephone number.

(4) A manufacturer's pack of a pharmacy medicine sold at premises licensed under a pharmacy medicines rural communities licence must be labelled with the licence-holder's name, business address and telephone number.

Part 11.1 Preliminary

510 Meaning of prescribed person —ch 11

For this chapter, each of the following is a prescribed person :

(a) a dentist, doctor, optometrist, podiatrist or veterinary surgeon;

Note Dentist , doctor and veterinary surgeon does not include an intern or trainee (see defs of these terms in dict).

(b) a pharmacist responsible for the management of a community pharmacy;

(d) a medicines wholesalers licence-holder;

(e) a pharmacy medicines rural communities licence-holder;

(f) an approved analyst;

Note Approved analyst —see the dictionary.

(g) a medicines and poisons inspector (including a police officer);

(h) a controlled medicines research and education program licence-holder;

(i) a person in charge of any of the following:

(i) an ambulance service (whether or not operated by the Commonwealth, the Territory or a State);

(ii) a correctional centre;

(iii) a CYP detention place;

(iv) a health centre operated by the Territory;

(v) a residential aged care facility without a pharmacy;

(vi) a residential disability care facility without a pharmacy;

(vii) a ward (including an opioid dependency treatment centre operated by the Territory).

Note 1 CYP detention place —see the dictionary.

Note 2 Residential aged care facility and residential disability care facility —see the Act, dictionary.

Note 3 State includes a territory (see Legislation Act, dict, pt 1).

511 Meaning of key —ch 11

In this chapter:

"key" includes an electronic swipe card or electronic proximity device.

Part 11.2 Storage requirements for medicines generally

515 Storage of medicines generally—Act, s 61 (b) and (c)

(1) A prescribed person must ensure that a medicine in the person's possession is stored—

(a) within the manufacturer's recommended storage temperature range; and

(b) in any other environmental condition that is necessary to preserve the medicine's stability and therapeutic quality.

Note Possess includes having control over disposition (see Act, s 24).

(2) To remove any doubt, this section does not apply to a prescribed person mentioned in section 510 (i) if the person does not have control over the disposition of the medicine.

Example—person not having control over disposition of medicine

a medicine in the personal possession of a resident of a residential aged care facility who is in an independent living unit within the facility

Note An example is part of the regulation, is not exhaustive and may extend, but does not limit, the meaning of the provision in which it appears (see Legislation Act, s 126 and s 132).

Part 11.3 Additional storage requirements for medicines other than controlled medicines

520 Storage of medicines other than controlled medicines in community pharmacies—Act, s 61 (b) and (c)

(1) The pharmacist responsible for the management of a community pharmacy must ensure that each pharmacy medicine at the pharmacy is stored—

(a) if the medicine is for retail sale—within 4m of, and in sight of, the pharmacy's dispensary; and

(b) in any other case—so that public access to the medicine is restricted.

(2) The pharmacist responsible for the management of a community pharmacy must ensure that each pharmacist only medicine and prescription only medicine at the pharmacy is stored—

(a) in a part of the premises to which the public does not have access; and

(b) so that only a pharmacist, or a person under the direct supervision of a pharmacist, has access to the medicine.

Note Pharmacist does not include an intern pharmacist (see dict).

521 Storage of medicines other than controlled medicines by other people—Act, s 61 (b) and (c)

(1) In this section:

"prescribed person" does not include a pharmacist responsible for the management of a community pharmacy.

(2) A prescribed person must ensure that a medicine (other than a controlled medicine) in the person's possession is stored so that public access to it is restricted.

Note Possess includes having control over disposition (see Act, s 24).

(3) To remove any doubt, this section does not apply to a prescribed person mentioned in section 510 (i) if the person does not have control over the disposition of the medicine.

Example—person not having control over disposition of medicine

a medicine in the personal possession of a resident of a residential aged care facility who is in an independent living unit within the facility

Note An example is part of the regulation, is not exhaustive and may extend, but does not limit, the meaning of the provision in which it appears (see Legislation Act, s 126 and s 132).

522 Storage of pharmacy medicines by pharmacy medicines rural communities licence-holders—Act, s 61 (b) and (c)

A pharmacy medicines rural communities licence-holder must store a pharmacy medicine for retail sale so that public access to the medicine is restricted.

Part 11.4 Additional storage requirements for controlled medicines

530 Meaning of personal custody —pt 11.4

In this part:

"personal custody", of a key by a person, includes keeping the key in a combination-operated key safe, the combination of which the person keeps confidential.

531 Storage of controlled medicines by wholesalers licence-holders—Act, s 61 (b) and (c)

(1) A wholesalers licence-holder must store a controlled medicine in the person's possession (other than a controlled medicine required for immediate supply) in a vault that—

(a) complies with, or is more secure than a vault that complies with, the requirements for a vault in schedule 5, section 5.8 (Requirements for vaults); and

(b) is fitted with an alarm system.

(2) However, if the chief health officer is satisfied that the total amount of controlled medicine held by the licence-holder at any time is not large enough to need to be stored in a vault, the chief health officer may approve, in writing, the storage of the controlled medicine in a safe or strong room.

(3) If the chief health officer gives an approval under subsection (2)—

(a) if the approval is for a safe—the safe must comply with, or be more secure than a safe that complies with, the requirements for a safe in schedule 5, section 5.6 (Requirements for safes); and

(b) if the approval is for a strong room—the strong room must comply with, or be more secure than a strong room that complies with, the requirements for a strong room in schedule 5, section 5.7 (Requirements for strong rooms); and

532 Storage of controlled medicines for certain health-related occupations—Act, s 61 (b) and (c)

(1) In this section:

"designated person" means—

(a) a dentist, doctor or veterinary surgeon (other than a dentist, doctor or veterinary surgeon at an institution); or

(b) an ambulance officer employed by the Commonwealth, the Territory or a State; or

Note 1 Dentist , doctor and veterinary surgeon does not include an intern or trainee (see defs of these terms in dict).

Note 2 State includes a territory (see Legislation Act, dict, pt 1).

(2) A designated person who possesses a controlled medicine must store the controlled medicine as follows:

(a) the person must ensure that the controlled medicine is stored in—

(i) a locked container that prevents ready access to the container's contents and is securely attached to a building; or

(ii) a locked drawer, cupboard, room or vehicle;

(b) if the medicine is kept in a container that is unlocked by a combination lock—the person must keep the combination confidential;

(d) if the medicine is kept in a drawer, cupboard, room or vehicle—the person must keep personal custody of the key to the drawer, cupboard, room or vehicle.

(3) However, subsection (2) does not apply to a controlled medicine if—

(a) the controlled medicine is being carried by a designated person in—

(i) a locked first-aid kit; or

(ii) an unlocked first-aid kit that is in immediate use; and

(b) the person keeps personal custody of the key to the first-aid kit.

533 Storage of controlled medicines by certain other prescribed people—Act, s 61 (b) and (c)

(1) In this section:

"excluded person "means—

(a) a dentist, doctor or veterinary surgeon at an institution; or

(b) the person in charge of a residential aged care facility or residential disability care facility in relation to a controlled medicine dispensed in a dose administration aid for a patient at the facility; or

(c) the person in charge of a correctional centre in relation to a controlled medicine dispensed for a detainee in a dose administration aid; or

(d) the person in charge of a CYP detention place in relation to a controlled medicine dispensed for a young detainee in a dose administration aid.

Note 1 CYP detention place —see the dictionary.

Note 2 Correctional centre — see the Legislation Act, dictionary, pt 1.

Note 3 Detainee —see the Corrections Management Act 2007 , s 6.

Note 4 Young detainee —see the Children and Young People Act 2008 , s 95.

(2) This section applies to a prescribed person, other than an excluded person, in relation to a controlled medicine in the person's possession if the medicine is not for immediate administration.

Note Possess includes having control over disposition (see Act, s 24).

(3) The person must ensure that—

(a) the controlled medicine is stored in a medicines cabinet, safe, strong room or vault (a storage receptacle ) that complies with, or is more secure than a storage receptacle that complies with, the requirements for the receptacle in schedule 5 (Requirements for storage receptacles); and

(b) the storage receptacle is kept securely locked when not in immediate use; and

(d) if the storage receptacle is unlocked by a key—the person keeps personal custody of the key; and

(e) if the prescribed person is the chief pharmacist at an institution—the storage receptacle is fitted with an alarm system.

(4) To remove any doubt, this section does not apply to a prescribed person mentioned in section 510 (i) if the person does not have control over the disposition of the medicine.

Example—person not having control over disposition of medicine

a medicine in the personal possession of a resident of a residential aged care facility who is in an independent living unit within the facility

Note An example is part of the regulation, is not exhaustive and may extend, but does not limit, the meaning of the provision in which it appears (see Legislation Act, s 126 and s 132).

540 Keeping of controlled medicines registers by certain people—Act, s 48 (a) and s 50 (1) (b) and (2) (b)

(1) A person mentioned in table 540, column 2 who possesses a controlled medicine must keep a controlled medicines register.

Note Also, a pharmacist responsible for the management of a community pharmacy must keep a controlled medicines register for controlled medicines kept at the pharmacy (see Act, s 48).

(2) However, subsection (1) does not apply to the person in relation to—

(a) a controlled medicine in a first-aid kit kept by the person; or

(b) if the person is the person in charge of a residential aged care facility or residential disability care facility—a controlled medicine dispensed for the patient in a dose administration aid; or

(c) if the person is the person in charge of a correctional centre—a controlled medicine dispensed for a detainee in a dose administration aid; or

(d) if the person is the person in charge of a CYP detention place—a controlled medicine dispensed for a young detainee in a dose administration aid.

Note 1 CYP detention place —see the dictionary.

Note 2 Correctional centre — see the Legislation Act, dictionary, pt 1.

Note 3 Detainee —see the Corrections Management Act 2007 , s 6.

Note 4 Young detainee —see the Children and Young People Act 2008 , s 95.

Note 5 For keeping controlled medicines in a first-aid kit, see s 541.

(3) A person to whom subsection (1) applies must keep a controlled medicines register for a controlled medicine at the place prescribed in table 540, column 3 for the person.

(4) A pharmacist responsible for the management of a community pharmacy at which controlled medicines are kept must keep the controlled medicines register for the controlled medicines at the pharmacy.

Note For the requirement for a controlled medicine register to be kept for a community pharmacy, see the Act, s 48.

Table 540 Keeping controlled medicines registers

column 1

item

column 2

prescribed person

column 3

place where register to be kept

1

person in charge of ambulance service

the premises where the controlled medicine is kept

2

approved analyst

the analyst's laboratory

3

person in charge of correctional centre

the correctional centre

4

person in charge of CYP detention place

the detention place

5

dentist

the dentist's surgery

6

doctor

the doctor's surgery

7

medicines wholesalers licence-holder

the licensed premises under s 460

8

medicines and poisons inspector (other than police officer)

the place directed in writing by the chief health officer

9

person in charge of residential aged care facility without pharmacy

the facility

10

person in charge of residential disability care facility without pharmacy

the facility

11

supervisor of program under controlled medicines research and education program licence

the premises where program is being conducted

12

veterinary surgeon

the veterinary surgeon's surgery

13

person in charge of ward (including an opioid dependency treatment centre operated by the Territory)

the ward

column 1 item	column 2 prescribed person	column 3 place where register to be kept
1	person in charge of ambulance service	the premises where the controlled medicine is kept
2	approved analyst	the analyst's laboratory
3	person in charge of correctional centre	the correctional centre
4	person in charge of CYP detention place	the detention place
5	dentist	the dentist's surgery
6	doctor	the doctor's surgery
7	medicines wholesalers licence-holder	the licensed premises under s 460
8	medicines and poisons inspector (other than police officer)	the place directed in writing by the chief health officer
9	person in charge of residential aged care facility without pharmacy	the facility
10	person in charge of residential disability care facility without pharmacy	the facility
11	supervisor of program under controlled medicines research and education program licence	the premises where program is being conducted
12	veterinary surgeon	the veterinary surgeon's surgery
13	person in charge of ward (including an opioid dependency treatment centre operated by the Territory)	the ward

541 Keeping of controlled medicines registers by first-aid kit holders—Act, s 48 (a) and s 50 (1) (b) and (2) (b)

(1) In this section:

"designated person" means—

(a) a dentist, doctor or veterinary surgeon; or

(b) an ambulance officer employed by the Commonwealth, the Territory or a State; or

Note 1 Dentist , doctor and veterinary surgeon does not include an intern or trainee (see defs of these terms in dict).

Note 2 State includes a territory (see Legislation Act, dict, pt 1).

(2) A designated person who possesses a first-aid kit containing a controlled medicine must keep the controlled medicines register for the controlled medicine with the first-aid kit.

542 Form of controlled medicines registers—Act, s 49 (1) (b) and (2) (b)

(1) Each page in a controlled medicines register must relate to a single form and strength of a controlled medicine.

(2) If a controlled medicines register is kept electronically, a separate record must be used for each form and strength of controlled medicine kept.

543 Making entries in controlled medicines registers—Act, s 51 (1) (b)

(1) The following details for a dealing with a controlled medicine are prescribed:

(a) the nature of the dealing;

(b) the date of the dealing;

(d) if the dealing is receiving the medicine—the name and address of the supplier;

(e) if the dealing is supplying the medicine—the name and address of the person to whom it is supplied;

(f) if the medicine is supplied on a prescription—the prescriber's name and suburb and the prescription's number under section 123 (k) (Labelling dispensed medicines—Act, s 60 (1) (c) (i) and (2) (c) (i));

(g) if the medicine is supplied on a requisition—the requisition's number under section 132 (e) (Labelling medicines supplied on requisition—Act, s 60 (1) (c) (i) and (2) (c) (i));

(h) if the medicine is supplied on a purchase order—the date of the purchase order;

(i) if the Act, section 53 (Registers—witnessing administration of medicines) applies to the dealing—the name of the person to whom the medicine is administered;

(j) the quantity of the medicine held after the dealing.

(2) However, subsection (1) (i) does not apply in relation to a controlled medicine dispensed in a dose administration aid for—

(a) a patient at a residential aged care facility or residential disability care facility; or

(b) a detainee at a correctional centre; or

(3) A dealing with a controlled medicine must be entered in—

(a) if the dealing happens in a pharmacy at an institution—the controlled medicines register kept at the pharmacy; or

(b) if the dealing happens in a ward at an institution—the controlled medicines register kept at the ward; or

(c) if the person must keep both a controlled medicines register for a first-aid kit and another controlled medicines register—

(i) for a dealing with a controlled medicine to which the first-aid kit relates—the controlled medicines register for the kit; or

(ii) for any other dealing by the person—the other controlled medicines register; or

(d) in any other case—the controlled medicines register the person must keep.

544 Prescribed witnesses for administration of controlled medicines—Act, s 53 (a) and (b)

The following people are prescribed as witnesses in relation to the administration of a controlled medicine:

(a) if the medicine is administered by an intern doctor—a dentist, doctor, midwife, nurse, nurse practitioner or pharmacist;

(b) if the medicine is administered by a person who is not an intern doctor—

(i) a person prescribed under paragraph (a); or

(ii) an intern doctor or enrolled nurse (medications).

Note Dentist , doctor and "pharmacist" does not include an intern or trainee (see defs of these terms in dict).

545 Prescribed witnesses for discarding of controlled medicines—Act, s 54 (a) and (b)

(1) The following people are prescribed as witnesses in relation to the discarding of a controlled medicine:

(a) an ambulance officer employed by the Commonwealth, the Territory or a State;

(b) an approved analyst;

(d) a doctor;

(e) a medicines and poisons inspector;

(f) a midwife;

(g) a nurse;

(h) a nurse practitioner;

(i) a pharmacist;

(j) a veterinary surgeon.

Note 1 Approved analyst —see the dictionary.

Note 2 Dentist , doctor , "pharmacist" and veterinary surgeon does not include an intern or trainee (see defs of these terms in dict).

Note 3 Nurse does not include an enrolled nurse (see Legislation Act, dict, pt 1).

Note 4 See s 390 for the discarding of the residue of a controlled medicine left after administration.

(2) However, a person mentioned in subsection (1) must not be a prescribed witness to the discarding of a controlled medicine if the person is—

(a) related to, a close friend of or employed by the person discarding the medicine; or

(b) the supervisor of the person discarding the medicine; or

546 Changes etc to entries in controlled medicines registers—Act, s 55 (2) (b)

(1) An entry in a paper-based controlled medicines register may be amended by the person who made the entry by—

(a) the person signing and dating a marginal note or footnote that gives the date of the amendment and the amended details; and

(b) if the entry relates to administering a controlled medicine—

(i) the amendment being witnessed by a person prescribed under section 544 (Prescribed witnesses for administration of controlled medicines—Act, s 53 (a) and (b)); and

(ii) the witness signing the amendment as witness; and

(i) the amendment being witnessed by a person prescribed under section 545 (Prescribed witnesses for discarding of controlled medicines—Act, s 54 (a) and (b)); and

(ii) the witness signing the amendment as witness.

(2) An entry in an electronic controlled medicines register may be amended by the person who made the entry by the person attaching or linking, by electronic means, a document that includes—

(a) the person's signature, the date and the amended details; and

(b) if the entry relates to administering a controlled medicine—the signature as witness of a person prescribed under section 544; and

(c) if the entry relates to the discarding of a controlled medicine—the signature as witness of a person prescribed under section 545.

Part 13.1 Controlled medicines approvals

Note It is a condition of an authorisation to prescribe a controlled medicine for human use that the prescriber has an approval under this part (see s 31 (d)).

Division 13.1.1 Preliminary

550 Meaning of controlled medicines approval

In this regulation:

"controlled medicines approval" means an approval to prescribe a controlled medicine under—

(a) division 13.1.2 (Standing controlled medicines approvals); or

(b) division 13.1.3 (Chief health officer controlled medicines approvals).

551 Meaning of designated prescriber —pt 13.1

In this part:

"designated prescriber" means a prescriber (other than a veterinary surgeon or trainee veterinary surgeon) in relation to whom prescribing a controlled medicine is included in schedule 1, column 3.

Division 13.1.2 Standing controlled medicines approvals

555 Standing approval to prescribe controlled medicines for hospital in-patients

A designated prescriber is approved to prescribe a controlled medicine for a patient of the prescriber if the patient is an in-patient at a hospital.

Note A hospice is a hospital (see The Macquarie Dictionary , 4th ed).

556 Standing approval to prescribe controlled medicines for short-term treatment

A designated prescriber is approved to prescribe a controlled medicine for a patient of the prescriber if—

(a) the prescriber believes on reasonable grounds that the patient is not a drug-dependant person in relation to a controlled medicine or prohibited substance; and

(b) the prescriber believes on reasonable grounds that the patient has not been prescribed a controlled medicine within the 2-month period before the prescriber prescribes the medicine; and

Note For long-term prescribing, see div 13.1.3.

557 Standing approval to prescribe buprenorphine and methadone for patients of certain institutions

(1) In this section:

"doctor" includes an intern doctor acting under the direct supervision of a doctor.

(2) A doctor is approved (the interim approval ) to prescribe buprenorphine or methadone if—

(a) the doctor is working at any of the following institutions:

(i) a correctional centre;

(ii) a CYP detention place;

(iii) a hospital;

(iv) an opioid dependency treatment centre operated by the Territory; and

Note Institution includes a correctional centre and a CYP detention place (see s 652).

(b) the doctor prescribes the buprenorphine or methadone for a patient of the institution; and

Note Opioid dependency treatment guidelines —see the dictionary.

(d) the doctor makes an application under section 560 to prescribe the medicine not later than 72 hours after the doctor first prescribes buprenorphine or methadone for the patient.

(3) The interim approval ends—

(a) if the chief health officer approves the application under division 13.1.3—when the doctor is given notice of the approval; or

(b) if the application under section 560 is withdrawn—on the withdrawal of the application; or

(c) if the chief health officer refuses to approve the application and the 7-day period mentioned in section 565 (2) (Applications for review of unfavourable CHO decisions for approvals) ends without an application for review being made—at the end of the 7-day period; or

(d) if the chief health officer refers the application to the medicines advisory committee or an application is made to the committee under section 565—when the doctor is given notice of the chief health officer's decision under section 573 (Medicines advisory committee—directions to CHO).

Division 13.1.3 Chief health officer controlled medicines approvals

560 Applications for CHO controlled medicines approvals

(1) A designated prescriber may apply to the chief health officer for approval to prescribe a controlled medicine.

(2) An application under subsection (1) must—

(a) be for approval to prescribe a controlled medicine for a single individual; and

(b) be made in a way determined by the chief health officer.

Examples

telephone, email and fax

Note 1 If a form is approved under the Act, s 198 for this provision, the form must be used.

Note 2 An example is part of the regulation, is not exhaustive and may extend, but does not limit, the meaning of the provision in which it appears (see Legislation Act, s 126 and s 132).

(3) An application under subsection (1) may be made—

(a) on the applicant's own behalf; or

(b) on the applicant's own behalf and on behalf of 1 or more other named designated prescribers; or

Example

the doctors practising at a suburban medical practice so that if a person's usual doctor is unavailable another doctor at the practice can, under the approval, prescribe the controlled medicine

(4) A determination under subsection (2) (b) is a notifiable instrument.

Note A notifiable instrument must be notified under the Legislation Act.

561 Requirements for CHO controlled medicines approval applications

(1) An application by a designated prescriber for an approval to prescribe a controlled medicine for a patient must include the following:

(a) the designated prescriber's name and address;

(b) if the application is made on behalf of a group of designated prescribers—the names of the designated prescribers or a description of the group;

Note For morphine or oxycodone for a terminally ill person, see s (2).

(d) the daily dose of the medicine and, if more than 1 form or strength of the medicine is to be prescribed, the dose for each form or strength;

(e) the patient's name and home address;

(f) the condition from which the patient is suffering that, in the designated prescriber's opinion, requires treatment with the medicine;

(g) whether, in the designated prescriber's opinion, based on reasonable grounds, the patient is a drug-dependent person in relation to a controlled medicine or prohibited substance.

(2) However, for subsection (1) (c), if the controlled medicine is morphine or oxycodone for a person with a terminal illness, the application may be made for all forms, strengths and quantities of the medicine.

(3) To remove any doubt, the application may include any other information the designated prescriber considers relevant.

(4) The chief health officer may ask the designated prescriber for any other information reasonably required to decide the application, including, for example, further information about the patient's treatment.

Note An example is part of the regulation, is not exhaustive and may extend, but does not limit, the meaning of the provision in which it appears (see Legislation Act, s 126 and s 132).

562 CHO decision on applications to prescribe controlled medicines

(1) On application under section 560, the chief health officer must—

(a) approve the application in the terms applied for; or

(b) approve the application in terms different from those applied for; or

(d) refer the application to the medicines advisory committee.

Note 1 An approval may include conditions (see s 570).

Note 2 For the form of a controlled medicines approval by the chief health officer, see s 571.

(2) However, the chief health officer need not decide the application if the chief health officer has asked for information under section 561 (4) and the information has not been given.

(3) The chief health officer must give the applicant written notice of the chief health officer's decision not later than 7 days after the day the decision is made.

(4) If the decision is made under subsection (1) (b) or (c), the notice must include information about the applicant's right to seek review of the decision under section 565 (Applications for review of unfavourable CHO decisions for approvals).

563 Restrictions on CHO power to approve applications for approvals

In making a decision under section 562, the chief health officer—

(a) must comply with any applicable guidelines made under section 574 (Medicines advisory committee—guidelines for CHO decisions on applications); and

(b) must not approve an application to prescribe all forms, strengths and quantities of morphine or oxycodone for the treatment of a person who is terminally ill unless satisfied—

(i) a specialist has diagnosed the person as being terminally ill; and

(ii) the medicine is for use by the person for therapeutic purposes only; and

(c) must not approve an application to prescribe buprenorphine or methadone to treat a drug-dependent person's drug-dependency unless the applicant is—

(i) a doctor who is working at an institution mentioned in section 557 (2) (a) (Standing approval to prescribe buprenorphine and methadone for patients of certain institutions); or

(ii) an intern doctor who is working at an institution mentioned in section 557 (2) (a) who is acting under the direct supervision of a doctor at the institution; or

(iii) a doctor who holds an endorsement under section 582 (CHO decisions on applications for endorsement to treat drug-dependency).

Note Doctor does not include an intern doctor (see dict).

564 Term of CHO controlled medicines approvals

A controlled medicines approval under this division is for the period (not longer than 1 year) stated in the approval.

565 Applications for review of unfavourable CHO decisions for approvals

(1) This section applies if, under section 562, the chief health officer—

(a) approves an application for a controlled medicines approval in terms different from those applied for; or

(b) refuses to approve the application for an approval.

(2) The applicant for the approval may, not later than 7 days after the day the person receives written notice of the decision, apply to the medicines advisory committee for review of the decision.

(3) The application for review—

(a) must be in writing signed by the applicant; and

(b) must set out the grounds for the application; and

566 Medicines advisory committee—referred applications and review of unfavourable CHO decisions

(1) This section applies to an application—

(a) for approval to prescribe a controlled medicine referred to the medicines advisory committee under section 562 (1) (d); or

(b) under section 565 for review of a decision of the chief health officer on an application for a controlled medicines approval.

(2) The medicines advisory committee may, in writing, ask the applicant to give the committee further information about the treatment of the person to whom the application relates not later than a stated reasonable time.

(3) After considering the application and any further information provided in accordance with a notice under subsection (2), the medicines advisory committee must—

(a) for an application for review of a decision by the chief health officer—

(i) direct the chief health officer to confirm the decision made; or

(ii) do both of the following:

(A) direct the chief health officer to revoke the decision made;

(B) give the chief health officer a direction under paragraph (b) (i), (ii) or (iii); or

(b) direct the chief health officer—

(i) to approve the application to prescribe a controlled medicine in the terms applied for; or

(ii) to approve the application in terms different from those applied for; or

(iii) to refuse to approve the application.

Note 1 The medicines advisory committee may direct the chief health officer to include conditions in the approval (see s 570 (2)).

Note 2 The chief health officer must comply with a direction (see s 573).

(4) A direction must be in writing.

567 Amendment and revocation of controlled medicines approvals

(1) The chief health officer may amend or revoke a controlled medicines approval on the chief health officer's own initiative and without consulting the medicines advisory committee.

(2) The medicines advisory committee may direct the chief health officer to amend or revoke a controlled medicines approval, whether or not the approval was given at the direction of the committee.

Note The chief health officer must comply with a direction (see s 573).

(3) A direction under subsection (2) must be in writing.

(4) The chief health officer must send the approval-holder written notice of the chief health officer's decision not later than 7 days after the day the decision is made.

(5) If the decision is to amend or revoke a controlled medicines approval under subsection (1), the notice must include information about the approval-holder's right to seek review of the decision under section 568.

(6) In this section:

"amend", a controlled medicines approval, includes imposing a condition on, or changing a condition of, the approval.

568 Application for review of amendment and revocation on CHO initiative

(1) This section applies if the chief health officer amends or revokes a controlled medicines approval under section 567 (1).

(2) The person to whom the approval was given may, not later than 7 days after the day the person is given written notice of the amendment or revocation, apply to the medicines advisory committee for review of the decision.

(3) The application for review—

(a) must be in writing signed by the applicant; and

(b) must set out the grounds for the application; and

(4) To remove any doubt, the decision to which the application relates continues to operate despite the making of the application until the day the chief health officer's decision on direction under section 569 (3) takes effect.

569 Medicines advisory committee—review of amendment or revocation on CHO initiative

(1) This section applies if an application is made to the medicines advisory committee under section 568 to review a decision (the original decision ) of the chief health officer to amend or revoke a controlled medicines approval.

(2) The medicines advisory committee may, in writing, ask the designated prescriber to give the committee further information about the treatment of the person to whom the application relates not later than a stated reasonable time.

(3) After considering the application for review and any further information provided in accordance with a notice under subsection (2), the medicines advisory committee must direct the chief health officer to—

(a) confirm the original decision; or

(b) revoke the original decision; or

Note 1 The medicines advisory committee may direct the chief health officer to include conditions in the approval (see s 570 (2)).

Note 2 The chief health officer must comply with a direction (see s 573).

(4) A direction must be in writing.

570 Conditional controlled medicines approvals

(1) The chief health officer may include conditions for the safe or proper use of a controlled medicine in a controlled medicines approval.

(2) The medicines advisory committee may direct the chief health officer to include conditions for the safe or proper use of a controlled medicine in a controlled medicines approval.

Note The chief health officer must comply with a direction (see s 573).

571 Form of CHO controlled medicines approvals

(1) A controlled medicines approval given by the chief health officer must include the following:

(a) the name of the controlled medicine to which the approval relates;

(b) the maximum quantity of the medicine that may be prescribed under the approval;

Note 1 For morphine or oxycodone for a person with a terminal illness, see s (2).

Note 2 For buprenorphine or methadone for a drug-dependent person, see s (3).

Note Other forms and strengths may be prescribed in accordance with s 32.

(d) the period when the medicine may be prescribed under the approval or when the approval ends;

(e) an identifying number for the approval;

(f) any condition to which the approval is subject.

Note If the approval is an oral approval, the prescriber must send the chief health officer a written application (see s 31 (d) (ii)).

(2) However, for subsection (1) (b) and (c), if the controlled medicines approval relates to the treatment of a person with a terminal illness, the approval may provide that all forms, strengths and quantities of morphine or oxycodone are approved.

(3) Also, for subsection (1) (b), if the controlled medicines approval relates to the treatment of a drug-dependent person with buprenorphine or methadone for their drug-dependency, the approval may state the maximum daily dose that may be prescribed for the person.

572 When controlled medicines approvals etc take effect

(1) A controlled medicines approval takes effect when the applicant receives notice of the approval or, if the approval states a later day, on the later day.

(2) An amendment or revocation of a controlled medicines approval takes effect when the approval-holder receives notice of the amendment or revocation or, if the notice of the amendment or revocation states a later day, on the later day.

573 Medicines advisory committee—directions to CHO

(1) This section applies if the medicines advisory committee directs the chief health officer to make a decision in relation to—

(a) an application for a controlled medicines approval; or

(b) a controlled medicines approval; or

(2) The chief health officer must—

(a) make the decision in accordance with the direction; and

(b) send the applicant or approval holder written notice of the decision not later than 7 days after the day the chief health officer makes the decision.

574 Medicines advisory committee—guidelines for CHO decisions on applications

(1) The medicines advisory committee may issue guidelines for the chief health officer in relation to decisions on applications under section 560 (Applications for CHO controlled medicines approvals).

Note The chief health officer must comply with any applicable guidelines (see s 563 (a)).

(2) A guideline is a notifiable instrument.

Note A notifiable instrument must be notified under the Legislation Act.

Division 13.1.4 Endorsements to treat drug-dependency

580 Meaning of endorsement —div 13.1.4

In this division:

"endorsement" means an endorsement under section 582 to prescribe buprenorphine and methadone to treat a drug-dependent person's drug-dependency.

Note An endorsement is not required by doctors and certain intern doctors who are working at particular institutions, see s 563 (c).

581 Applications for CHO endorsement to treat drug-dependency

(1) A doctor may, in writing, apply to the chief health officer for an endorsement.

Note Doctor does not include an intern doctor (see dict).

(2) The application must include the following:

(a) the doctor's name and business address and telephone number;

(b) the doctor's qualifications and experience in treating drug-dependency.

Note If a form is approved under the Act, s 198 for this provision, the form must be used.

(3) The chief health officer may ask the doctor for any other information reasonably required to decide the application.

582 CHO decisions on applications for endorsement to treat drug-dependency

(1) The chief health officer must give, or refuse to give, an endorsement to a doctor who applies under section 581.

(2) The chief health officer must not give a doctor an endorsement unless satisfied that the doctor has the qualifications and experience to treat drug-dependency.

(3) An endorsement is subject to any condition included in the endorsement by the chief health officer.

(4) The chief health officer must give the doctor written notice of the chief health officer's decision not later than 7 days after the day the decision is made.

(5) If the chief health officer refuses the application, the notice must include information about the doctor's right to seek review of the decision under section 584.

583 Form of CHO endorsements to treat drug-dependency

An endorsement by the chief health officer must include the following:

(a) the doctor's name;

(b) an identifying number for the endorsement;

584 Medicines advisory committee—review of CHO decisions to refuse endorsements to treat drug-dependency

(1) This section applies if the chief health officer refuses under section 582 to give an endorsement to a doctor.

(2) The doctor may, not later than 28 days after the day the doctor receives written notice of the decision, apply to the medicines advisory committee for review of the decision.

(3) The application for review—

(a) must be in writing signed by the doctor; and

(b) must set out the grounds for the application; and

(4) The medicines advisory committee may, in writing, ask the doctor to give the committee further information that the committee reasonably needs to decide the application.

(5) After considering the application and any further information provided in accordance with a notice under subsection (4), the medicines advisory committee must—

(a) direct the chief health officer to confirm the decision made; or

(b) direct the chief health officer to revoke the decision made and approve the application as directed by the committee.

Note The chief health officer must comply with a direction (see s 573).

(6) A direction must be in writing.

Part 13.2 Appendix D medicines approvals

Note It is a condition of an authorisation to prescribe a designated appendix D medicine for the prescriber to have an approval under this part (see s 33 (a)).

590 Meaning of appendix D medicines approval

In this regulation:

"appendix D medicines approval" means an approval under section 591 or section 593.

591 Standing approval to prescribe designated appendix D medicines

A doctor is approved to prescribe a designated appendix D medicine for a purpose mentioned in schedule 3 (Designated appendix D medicines—standing approvals), part 3.2, column 3 in relation to the medicine if—

(a) the medicine is mentioned in the schedule, part 3.2, column 3 in relation to the doctor; and

(b) if the schedule, part 3.2, column 4 contains a condition in relation to the medicine—the doctor prescribes the medicine in accordance with the condition.

Example—par (b)

If sch 3, pt 3.2, col 4 includes a condition requiring a doctor to advise a woman of child-bearing age to avoid becoming pregnant during or for a certain period after the completion of treatment, the doctor is authorised to prescribe the medicine only if the doctor gives the patient the advice.

Note 1 Doctor does not include an intern doctor (see dict).

Note 2 An example is part of the regulation, is not exhaustive and may extend, but does not limit, the meaning of the provision in which it appears (see Legislation Act, s 126 and s 132).

592 Applications for CHO approval to prescribe designated appendix D medicines

(1) A doctor may, in writing, apply to the chief health officer for approval to prescribe a designated appendix D medicine for a purpose mentioned in schedule 3 (Designated appendix D medicines—standing approvals), part 3.2, column 3 in relation to the medicine.

Note Doctor does not include an intern doctor (see dict).

(2) The application must include the following:

(a) the medicine's name;

(b) the doctor's name, business address and telephone number;

(d) if the doctor is not a specialist—the doctor's qualifications and experience in relation to the medicine.

Note If a form is approved under the Act, s 198 for this provision, the form must be used.

(3) The chief health officer may ask the doctor for any other information reasonably required to decide the application.

593 CHO decisions on applications to prescribe designated appendix D medicines

(1) The chief health officer must approve, or refuse to approve, an application by a doctor under section 592 for approval to prescribe a designated appendix D medicine.

(2) An approval under subsection (1) to prescribe a designated appendix D medicine is subject to the following conditions:

(a) that the doctor complies with any conditions in schedule 3, part 3.2, column 4 in relation to the medicine;

(b) any other condition included in the approval by the chief health officer.

Example—par (a)

Note An example is part of the regulation, is not exhaustive and may extend, but does not limit, the meaning of the provision in which it appears (see Legislation Act, s 126 and s 132).

(3) For this section, the chief health officer—

(a) must have regard to the specialist area (if any) in which the doctor practises and the requirements (if any) stated in the medicines and poisons standard, appendix D for the medicine to which the application relates; and

(b) may have regard to anything else the chief health officer considers appropriate.

(4) The chief health officer must send the doctor written notice of the chief health officer's decision not later than 7 days after the day the decision is made.

594 Form of CHO appendix D medicines approvals

An appendix D medicines approval given by the chief health officer must include the following:

(a) the doctor's name;

(b) the name of the medicine to which the approval relates;

(d) any condition included in the approval by the chief health officer.

Part 14.1 Medicines licences generally

600 Medicines licences that may be issued—Act, s 78 (2)

The following licences for medicines may be issued:

(a) a licence for a program of research or education in relation to a controlled medicine (a controlled medicines research and education program licence );

(b) a licence for medicines for first-aid kits (a first-aid kit licence );

(d) a licence for the treatment of opioid dependency with buprenorphine or methadone (an opioid dependency treatment licence );

(e) a licence for the sale by retail of pharmacy medicines by a person who is not a pharmacist (a pharmacy medicines rural communities licence ).

Note Other medicines licences may also be issued (see Act, s 78 (3)).

Part 14.2 Controlled medicines research and education program licences

Note For research and education activities in relation to other medicines, see pt 9.4.

605 Applications for controlled medicines research and education program licences

(1) An application for a controlled medicines research and education program licence for a controlled medicine must be in writing, signed by the applicant, and include the following:

(a) the full name, address and academic, professional or other relevant qualifications of—

(i) the person who is to supervise the program; and

(ii) the person who is to conduct the program;

(b) the name of the recognised research institution at or under which the program is proposed to be conducted;

Note Recognised research institution —see the Act, s 20 (5).

(d) the premises where the program will be conducted;

(e) the controlled medicine, and the form and strength of the medicine, for which the licence is sought;

(f) the maximum quantity of the medicine that would be possessed under the licence at any time;

(g) a description of the program, including an explanation of why the program cannot be carried out satisfactorily without the use of the medicine;

(h) the supervision arrangements for the program;

(i) the period for which the licence is sought.

Note 1 If a form is approved under the Act, s 198 for this provision, the form must be used.

Note 2 A fee may be determined under the Act, s 197 for this provision.

(2) The application must be accompanied by a written approval of the program by the person in charge of—

(a) the recognised research institution; or

(b) a faculty or division of the institution.

606 Restrictions on issuing of controlled medicines research and education program licences—Act, s 85 (1) (a)

The chief health officer must not issue a controlled medicines research and education program licence to a person unless—

(a) the program to which the licence relates will be conducted at, or under the authority of, a recognised research institution; and

(b) the program is approved by a person mentioned in section 605 (2); and

(i) cannot be carried out without the use of the controlled medicine to which the licence application relates; and

(ii) will be adequately supervised.

607 Additional information for controlled medicines research and education program licences—Act, s 88 (1) (k)

The following additional information is prescribed for a controlled medicines research and education program licence:

(a) the research or education program for which the licence is issued;

(b) the name of the program's supervisor;

(d) the premises where the program will be conducted;

(e) the maximum quantity of the controlled medicine that may be possessed at any time for the program;

(f) the total quantity of the controlled medicine that may be possessed for the program during the period of the licence;

(g) the form and strength of the controlled medicine that may be obtained and possessed for the program.

Part 14.3 First-aid kit licences

Note This part is not applicable to a health professional who is authorised elsewhere under this regulation to possess etc medicines for a first-aid kit.

610 Applications for first-aid kit licences

(1) An application for a first-aid kit licence must be in writing, signed by the applicant, and include the following:

(a) the full name, address and occupation of the applicant;

(b) the full name, address and occupation of each other person proposed to be authorised to deal with a medicine under the licence;

(c) the prescription only medicines and controlled medicines (each of which are relevant medicines ), and the form and strength of the relevant medicines, for which the licence is sought;

Note Pharmacy medicines and pharmacist only medicines are authorised for the kit under s 450.

(d) the maximum quantity of the relevant medicines that would be possessed under the licence at any time;

(e) the first-aid services provided, or proposed to be provided, to the community by the applicant;

(f) the situations in which it is proposed the medicines in the first-aid kit will be used;

(g) the period for which the licence is sought.

Note 1 If a form is approved under the Act, s 198 for this provision, the form must be used.

Note 2 A fee may be determined under the Act, s 197 for this provision.

(2) The application must be accompanied by—

(a) evidence of the qualifications mentioned in section 611 (a) for the applicant and each person included in the application under subsection (1) (b); and

(b) a letter of support from a doctor who will provide medical direction and support to the applicant.

Note Doctor does not include an intern doctor (see dict).

611 Restrictions on issuing of first-aid kit licences—Act, s 85 (1) (a)

The chief health officer must not issue a first-aid kit licence to a person unless—

(a) each person to be authorised under the licence has successfully completed a course that qualifies the person to be registered as a nurse or employed as an ambulance paramedic; and

(b) the chief health officer is satisfied that the person provides, or will be providing, first-aid services to the community, for example, at a workplace or as part of a privately operated ambulance service approved under the Emergencies Act 2004 , part 4.6 (Other approved providers); and

Note An example is part of the regulation, is not exhaustive and may extend, but does not limit, the meaning of the provision in which it appears (see Legislation Act, s 126 and s 132).

612 Additional information for first-aid kit licences—Act, s 88 (1) (k)

(1) The following additional information is prescribed for a first-aid kit licence:

(a) the full name and residential address of each person who is authorised to deal with a medicine under the licence;

(b) the maximum quantity of each relevant medicine that may be possessed under the licence at any time;

(d) the form and strength in which each relevant medicine may be obtained, possessed and administered under the licence.

(2) In this section:

"relevant medicines"—see section 610.

Part 14.4 Medicines wholesalers licences

Note This part is applicable to an interstate wholesaler only if the Act, s 20 (4) does not apply to the wholesaler.

615 Applications for medicines wholesalers licences

(1) An application for a medicines wholesalers licence must be in writing, signed by the applicant, and include the following:

(a) the medicines to which the application relates;

(b) the full name of the applicant;

(d) if the applicant is a corporation—the corporation's ACN;

(e) the location of the premises where the applicant proposes to deal with the medicines under the licence;

(f) the security arrangements proposed for the premises;

(g) the name of an individual who is to supervise the dealings to be authorised under the licence.

Note 1 If a form is approved under the Act, s 198 for this provision, the form must be used.

Note 2 A fee may be determined under the Act, s 197 for this provision.

(2) The application must be accompanied by a plan of the premises that shows—

(a) where it is proposed to store the medicines; and

(b) the location and nature of security devices.

616 Restrictions on issuing of medicines wholesalers licences—Act, s 85 (1) (a)

(1) The chief health officer must not issue a medicines wholesalers licence to a person unless dealings with medicines under the licence will be supervised by an individual nominated by the applicant and approved, in writing, by the chief health officer.

(2) The chief health officer must not approve the nominated individual unless satisfied that the individual—

(a) is a suitable person to hold a medicines wholesalers licence; and

(b) has qualifications in chemistry, pharmacy or pharmacology or experience appropriate for the sale of medicines.

Note For changes of nominated individuals, see the Act, s 93.

(3) In this section:

"suitable person", to hold a licence—see the Act, section 81.

617 Additional information for medicines wholesalers licences—Act, s 88 (1) (k)

The name of the person approved under section 616 (1) to supervise the dealings with medicines authorised by the licence is prescribed for a medicines wholesalers licence.

Part 14.5 Opioid dependency treatment licences

620 Applications for opioid dependency treatment licences

An application for an opioid dependency treatment licence must be in writing, signed by the applicant, and include the applicant's full name and business address.

Note 1 If a form is approved under the Act, s 198 for this provision, the form must be used.

Note 2 A fee may be determined under the Act, s 197 for this provision.

621 Restriction on issuing of opioid dependency treatment licences—Act, s 85 (1) (a)

The chief health officer must not issue an opioid dependency treatment licence to a person unless the person is a pharmacist at a community pharmacy.

Note Pharmacist does not include an intern pharmacist (see dict).

622 Witnessing not required for administration under opioid dependency treatment licence—Act, s 190 (1) (a)

The Act, section 53 (e) (Registers—witnessing administration of medicines) does not apply to the administration of buprenorphine or methadone under an opioid dependency treatment licence if section 471 is complied with in relation to the administration.

Part 14.6 Pharmacy medicines rural communities licences

625 Applications for pharmacy medicines rural communities licences

An application for a pharmacy medicines rural communities licence must—

(a) be in writing signed by the applicant; and

(b) include—

(i) the applicant's full name, business address and telephone number; and

(ii) the pharmacy medicines proposed to be sold under the licence.

Note 1 If a form is approved under the Act, s 198 for this provision, the form must be used.

Note 2 A fee may be determined under the Act, s 197 for this provision.

626 Restrictions on issuing of pharmacy medicines rural communities licences—Act, s 85 (1) (a)

The chief health officer must not issue a pharmacy medicines rural communities licence to a person unless—

(a) the person is carrying on the business of selling goods by retail; and

(b) the premises from which the medicines will be sold under the licence is more than 25km by the shortest practical route to the nearest community pharmacy.

Part 15.1 Opioid dependency treatment guidelines

630 Guidelines for treatment of opioid dependency

(1) The Minister may approve guidelines for the treatment of opioid dependency.

(2) Without limiting subsection (1), approved guidelines may make provision in relation to the prescribing and administration of buprenorphine and methadone to drug-dependent people.

(3) An approval is a notifiable instrument.

Note A notifiable instrument must be notified under the Legislation Act.

Part 15.2 Medicines advisory committee

Note The medicines advisory committee is established under the Act, s 194.

635 Medicines advisory committee—membership

(1) The medicines advisory committee consists of the following members appointed by the Minister:

(a) a chair;

(b) 2 other members.

Note 1 For the making of appointments (including acting appointments), see the Legislation Act, pt 19.3.

Note 2 Certain Ministerial appointments require consultation with an Assembly committee and are disallowable (see Legislation Act, div 19.3.3).

(2) A person is not eligible for appointment to the medicines advisory committee unless the person is a doctor.

Note Doctor does not include an intern doctor (see dict).

(3) The medicines advisory committee must include—

(a) at least 1 member who has had experience in the teaching or practice of psychiatry; and

(b) 1 member nominated by the Australian Capital Territory Branch of the Australian Medical Association.

(4) The instrument appointing, or evidencing the appointment of, a medicines advisory committee member must state whether the person is appointed as the chair, or as another member, of the committee.

636 Medicines advisory committee—term of appointments

The appointment of a medicines advisory committee member must be for not longer than 3 years.

Note A person may be reappointed to a position if the person is eligible to be appointed to the position (see Legislation Act, s 208 and dict, pt 1, def appoint ).

637 Medicines advisory committee—conditions of appointments

The conditions of appointment of a medicines advisory committee member are the conditions agreed between the Minister and the member, subject to any determination under the Remuneration Tribunal Act 1995 .

638 Medicines advisory committee—time and place of meetings

(1) Meetings of the medicines advisory committee are to be held when and where the committee decides.

(2) The chair of the medicines advisory committee may at any time call a meeting.

(3) The chair must give the other members reasonable notice of the time and place of a meeting called by the chair.

(4) The medicines advisory committee may adjourn a proceeding, for any reason it considers appropriate, to a time and place decided by the committee.

639 Medicines advisory committee—presiding member

(1) The chair presides at a meeting of the medicines advisory committee.

(2) If the chair is absent, the member chosen by the members present presides.

640 Medicines advisory committee—quorum

Business may be carried out at a meeting of the medicines advisory committee only if at least 2 members are present.

641 Medicines advisory committee—voting

(1) At a meeting of the medicines advisory committee each member has a vote on each question to be decided.

(2) A question is decided by a majority of the votes of members present and voting but, if the votes are equal, the presiding member has the deciding vote.

642 Medicines advisory committee—conduct of meetings

(1) The medicines advisory committee may conduct its meetings as the committee considers appropriate.

(2) A meeting of the medicines advisory committee may be held using a method of communication, or a combination of methods of communication, that allows each member taking part to hear what each other member taking part says without the members being in each other's presence.

Examples

a phone link, a satellite link, an internet or intranet link

Note An example is part of the regulation, is not exhaustive and may extend, but does not limit, the meaning of the provision in which it appears (see Legislation Act, s 126 and s 132).

(3) A medicines advisory committee member who takes part in a meeting conducted under subsection (2) is taken to be present at the meeting.

(4) A resolution is a valid resolution of the medicines advisory committee, even if it is not passed at a meeting of the committee, if all members agree to the proposed resolution in writing.

Note Written includes in electronic form (see Act, dict).

(5) The medicines advisory committee must keep minutes of its meetings.

643 Medicines advisory committee—disclosure of interests by members

(1) If a medicines advisory committee member has a material interest in an issue being considered, or about to be considered, by the committee, the member must disclose the nature of the interest at a committee meeting as soon as possible after the relevant facts have come to the member's knowledge.

(2) The disclosure must be recorded in the medicines advisory committee's minutes and, unless the committee otherwise decides, the member must not—

(a) be present when the medicines advisory committee considers the issue; or

(b) take part in a decision of the committee on the issue.

Example

David, Emile and Fiona are members of the medicines advisory committee. They have an interest in an issue being considered at a committee meeting and they disclose the interest as soon as they become aware of it. David's and Emile's interests are minor but Fiona has a direct financial interest in the issue.

The medicines advisory committee considers the disclosures and decides that because of the nature of the interests:

• David may be present when the committee considers the issue but not take part in the decision

• Emile may be present for the consideration and take part in the decision.

The medicines advisory committee does not make a decision allowing Fiona to be present or take part in the committee's decision. Accordingly, Fiona cannot be present for the consideration of the issue or take part in the decision.

Note An example is part of the regulation, is not exhaustive and may extend, but does not limit, the meaning of the provision in which it appears (see Legislation Act, s 126 and s 132).

(3) Any other medicines advisory committee member who also has a material interest in the issue must not be present when the committee is considering its decision under subsection (2).

(4) In deciding under subsection (2) whether a member may be present when the medicines advisory committee decides the issue or take part in a decision of the committee on the issue, and despite section 640 (Medicines advisory committee—quorum), the committee may consist of 1 member.

Example

if 2 members are present at a meeting and 1 member discloses a material interest, the other member may decide whether the member who made the disclosure can take part in a decision by the committee

(5) In this section:

"associate", of a person, means—

(a) the person's business partner; or

(b) a close friend of the person; or

"executive officer", of a corporation, means a person (however described) who is concerned with, or takes part in, the corporation's management (whether or not the person is a director of the corporation).

"indirect interest"—without limiting the kind of indirect interest a person may have, a person has an indirect interest in an issue if any of the following has an interest in the issue:

(a) an associate of the person;

(b) a corporation with not more than 100 members that the person, or an associate of the person, is a member of;

(d) a corporation that the person, or an associate of the person, is an executive officer of;

(e) the trustee of a trust that the person, or an associate of the person, is a beneficiary of;

(f) a member of a firm or partnership that the person, or an associate of the person, is a member of;

(g) someone else carrying on a business if the person, or an associate of the person, has a direct or indirect right to participate in the profits of the business.

"material interest"—a medicines advisory committee member has a material interest in an issue if the member has—

(a) a direct or indirect financial interest in the issue; or

(b) a direct or indirect interest of any other kind if the interest could conflict with the proper exercise of the member's functions in relation to the committee's consideration of the issue.

644 Medicines advisory committee—ending appointments

(1) The Minister may end the appointment of a medicines advisory committee member—

(a) if the member contravenes a territory law; or

(b) for misbehaviour; or

(d) if the member is convicted, in the ACT, of an offence punishable by imprisonment for at least 1 year; or

(e) if the member is convicted outside the ACT, in Australia or elsewhere, of an offence that, if it had been committed in the ACT, would be punishable by imprisonment for at least 1 year; or

(f) if the member contravenes section 643 (Medicines advisory committee—disclosure of interests by members).

Note A member's appointment also ends if the member resigns (see Legislation Act, s 210).

(2) The Minister must end the appointment of a medicines advisory committee member—

(a) if the member ceases to be a doctor; or

(b) if, on 3 consecutive occasions, the member fails, without the chair's agreement, to make himself or herself available for a proposed meeting of the committee; or

(c) if the member fails to take all reasonable steps to avoid being placed in a position where a conflict of interest arises during the exercise of the member's functions; or

(d) for physical or mental incapacity, if the incapacity substantially affects the exercise of the member's functions.

Part 15.3 Other medicines provisions

650 Advertising controlled medicines—Act, s 66 (3) (b)

A pricelist published by a pharmacist that includes a controlled medicine is prescribed if the pricelist complies with the Price Information Code of Practice , published by the Therapeutic Goods Administration, as in force from time to time.

Note The code is accessible at www.tga.gov.au/meds/vipicop.htm.

651 Advertising other medicines

(1) A person commits an offence if—

(a) the person publishes an advertisement; and

(b) the advertisement promotes or encourages the use of a declared medicine.

Maximum penalty: 30 penalty units.

(2) A person commits an offence if—

(a) the person publishes an advertisement; and

(b) the advertisement indicates that someone is willing or authorised to supply a declared medicine.

Maximum penalty: 30 penalty units.

(3) This section does not apply to—

(a) an advertisement for a declared medicine in a publication published primarily for dentists, doctors, pharmacists or veterinary surgeons; or

(b) a pricelist published by a pharmacist that includes a declared medicine if the pricelist complies with the Price Information Code of Practice , published by the Therapeutic Goods Administration, as in force from time to time.

(4) In this section:

"advertisement"—see the Act, section 66.

"declared medicine" means—

(a) a pharmacist only medicine other than a pharmacist only medicine to which the medicines and poisons standard, appendix H applies; or

(b) a prescription only medicine.

652 Prescribed institutions—Act, dict, def institution , par (b)

The following are prescribed:

(a) a correctional centre;

(b) a CYP detention place.

Part 16.1 Preliminary

660 Meaning of relevant law —ch 16

In this chapter:

"relevant law" means—

(a) a corresponding law; or

(b) the Agricultural and Veterinary Chemicals Act 1994 (Cwlth); or

Note 1 Corresponding law includes a law of a State that corresponds, or substantially corresponds, to the Act (see Act, dict).

Note 2 State includes a territory (see Legislation Act, dict, pt 1).

Part 16.2 Authorisation to supply low and moderate harm poisons

661 Authorisation to supply low and moderate harm poisons—Act, s 26 (1) (b) and (2) (b)

Anyone is authorised to supply a low harm poison or moderate harm poison.

662 Authorisation condition for supplying low and moderate harm poisons—Act, s 44 (1) (b) and (2) (b)

A person's authorisation under section 661 to supply a low harm poison or moderate harm poison is subject to the following conditions:

(a) the poison is supplied in manufacturer's packs that comply with—

(i) section 665 (Packaging of supplied manufacturer's packs of low and moderate harm poisons—Act, s 59 (1) (c) (i) and (2) (c) (i)); or

(ii) an approval under the Act, section 193 (Approval of non-standard packaging and labelling);

(b) the manufacturer's packs are labelled in accordance with—

(i) section 666 (Labelling of supplied manufacturer's packs of low and moderate harm poisons—Act, s 60 (1) (c) (i) and (2) (c) (i)); or

(ii) an approval under the Act, section 193.

Part 16.3 Authorisation to manufacture low and moderate harm poisons

663 Authorisation to manufacture low and moderate harm poisons—Act, s 33 (b)

A person is authorised to manufacture a low harm poison or moderate harm poison if the person is authorised to manufacture the poison under a relevant law.

664 Authorisation condition for manufacturing low and moderate harm poisons—Act, s 44 (1) (b) and (2) (b)

A person's authorisation under section 663 to manufacture a low harm poison or moderate harm poison is subject to the condition that, if a condition or restriction applies to the person under the relevant law, the person manufactures the poison in accordance with the condition and restriction.

Part 16.4 Packaging and labelling of low and moderate harm poisons

665 Packaging of supplied manufacturer's packs of low and moderate harm poisons—Act, s 59 (1) (c) (i) and (2) (c) (i)

(1) A manufacturer's pack of a supplied low harm poison or moderate harm poison must be packaged—

(a) in accordance with the medicines and poisons standard, paragraphs 21 to 27; or

(b) in a container in which the poison may be sold under a relevant law.

Note A manufacturer's pack of a low or moderate harm poison supplied may also be packaged in accordance with an approval under the Act, s 193 (Approval of non-standard packaging and labelling) (see Act, s 59 (1) (c) (ii) and (2) (c) (ii)).

(2) However, if the poison is camphor or naphthalene for domestic use, it must also be packaged in a way that, in normal use, prevents—

(a) removal of the camphor or naphthalene from the packaging; or

(b) ingestion of the camphor or naphthalene.

666 Labelling of supplied manufacturer's packs of low and moderate harm poisons—Act, s 60 (1) (c) (i) and (2) (c) (i)

A manufacturer's pack of a supplied low harm poison or moderate harm poison must be labelled in accordance with—

(a) the medicines and poisons standard, paragraphs 3 to 19; or

(b) a relevant law.

Note A manufacturer's pack of a low or moderate harm poison supplied may also be labelled in accordance with an approval under the Act, s 193 (Approval of non-standard packaging and labelling) (see Act, s 60 (1) (c) (ii) and (2) (c) (ii)).

Part 17.1 Overview of dangerous poisons authorisations

670 General overview of authorisations for dangerous poisons

(1) The Act requires that a person must not deal with a dangerous poison in a particular way unless the person is authorised to deal with the poison.

Example

the Act, s 35 about obtaining certain substances (which include dangerous poisons)

Note 1 The Act, s 19 sets out when a person deals with a dangerous poison.

Note 2 An example is part of the regulation, is not exhaustive and may extend, but does not limit, the meaning of the provision in which it appears (see Legislation Act, s 126 and s 132).

(2) The Act, section 20 sets out when a person is authorised to deal with a dangerous poison.

(3) This regulation authorises certain dealings with dangerous poisons.

Note An authorisation is not required to deal with the following:

• a substance excluded from the medicines and poisons standard by the standard, par 1 (2) (see s 6);

• a substance mentioned in the medicines and poisons standard, sch 7 if the schedule does not apply to the substance because of an exception in the standard.

(4) An authorisation under this regulation may be subject to limitations.

Example

a purchase order issued by a person mentioned in sch 4, col 2 must comply with s 721 (see s 690 (2) (c))

Note For the power to impose other restrictions, see the Act, ch 8.

671 Overview of dangerous poisons authorisations under this regulation

Dangerous poisons authorisations under this regulation are given by the following provisions:

(a) section 675 (which is about authorisations under dangerous poisons manufacturers licences);

(b) section 680 (which is about authorisations under dangerous poisons research and education program licences);

(d) section 690 (which is about authorisations for manufacturing and other purposes);

(e) section 692 (which is about authorisation to deliver dangerous poisons under purchase orders);

(f) section 693 (which is about authorisation for commercial disposal operators for disposal of dangerous poisons);

(g) section 695 (which is about authorisations for dangerous poisons research and education programs by scientifically qualified people).

672 General overview of authorisation conditions for dangerous poisons

(1) The Act, section 44 requires a person who is authorised to deal with a dangerous poison to comply with any condition to which the authorisation is subject.

Example

Section 676 sets out the authorisation conditions for an authorised person to manufacture a dangerous poison.

Note An example is part of the regulation, is not exhaustive and may extend, but does not limit, the meaning of the provision in which it appears (see Legislation Act, s 126 and s 132).

(2) The conditions are additional to other restrictions on an authorised person's authority to deal with a dangerous poison.

Note Conditions may also be imposed under other provisions of the Act including, for example, s 89 which sets out conditions on licences.

Part 17.2 Authorisations under dangerous poisons licences

Division 17.2.1 Dangerous poisons manufacturers licence authorisations

Note For other provisions about dangerous poisons manufacturers licences, see pt 18.2.

675 Authorisations under dangerous poisons manufacturers licences—Act, s 20 (1) (a)

(1) A dangerous poisons manufacturers licence authorises the holder to do any of the following in relation to a dangerous poison (the licensed dangerous poison ) stated in the licence at the premises (the licensed premises ) stated in the licence:

(a) manufacture the licensed dangerous poison;

(b) possess the licensed dangerous poison for sale by wholesale from the licensed premises;

(i) a person authorised to issue a purchase order for the dangerous poison; or

(ii) someone in another State who may obtain the dangerous poison by wholesale under the law of the other State; or

(iii) someone in another country who may lawfully obtain the dangerous poison by wholesale in the other country;

Note The dangerous poison must be sold on a purchase order in accordance with s 720 (see s 676).

(d) obtain a dangerous poison, other than a licensed dangerous poison, for manufacturing a licensed dangerous poison at the licensed premises;

(e) possess a dangerous poison, other than a licensed dangerous poison, at the licensed premises for manufacturing a licensed dangerous poison.

(2) However, an authorisation under subsection (1) does not apply if the licence states that it does not apply.

(3) Also, subsection (1) (c) (iii) does not apply in relation to a licensed dangerous poison that is a prohibited export under the Customs Act 1901 (Cwlth).

676 Authorisation conditions for dangerous poisons manufacturers licences—Act, s 44 (1) (b) and (2) (b)

A licence-holder's authorisation under a dangerous poisons manufacturers licence is subject to the following conditions:

(a) the dealings with a dangerous poison authorised by the licence will be carried out under the supervision of an individual approved under section 706 (1) (Restrictions on issuing of dangerous poisons manufacturers licences—Act, s 85 (1) (a));

(b) a dangerous poison obtained under the licence is purchased on a complying purchase order;

(d) a dangerous poison sold under the licence will be sold on a purchase order in accordance with section 720 (Supplying dangerous poisons on purchase orders);

(e) if the supplier does not receive a document signed by the buyer acknowledging receipt of the dangerous poison within 7 days after the day the dangerous poison is delivered—the supplier must, within 24 hours after the end of the 7-day period, tell the chief health officer, in writing, of the failure to receive the document;

(f) the following are kept at the supplier's business premises or, if the chief health officer approves in writing another place, the place approved by the chief health officer, for at least 2 years after the day the poison is supplied:

(i) the filled purchase order;

(ii) the delivery acknowledgement under paragraph (e) or section 720 (d) (ii);

(iii) the record for section 722;

(g) if a dangerous poison sold under the licence is liquid containing paraquat—the poison is coloured blue or green and has an offensive smell.

Note For licence conditions, see the Act, s 89.

Division 17.2.2 Dangerous poisons—research and education program licence authorisations

Note 1 For authorisation for research and education programs by scientifically qualified people, see div 17.3.3.

Note 2 For other provisions about dangerous poisons research and education program licences, see pt 18.3.

680 Authorisations under dangerous poisons research and education program licences—Act, s 20 (1) (a)

A dangerous poisons research and education program licence authorises—

(a) the licence-holder to—

(i) issue a purchase order for a dangerous poison (the licensed dangerous poison ) stated in the licence for the program stated in the licence; and

(ii) obtain a licensed dangerous poison on a purchase order for the program; and

(iii) possess a licensed dangerous poison for the program at the premises to which the licence relates; and

(iv) supply a licensed dangerous poison to anyone taking part in the program for the program; and

(b) the program supervisor, and anyone taking part in the program, to deal with the licensed dangerous poison as authorised by the licence at the premises stated in the licence.

681 Authorisation condition for dangerous poisons research and education program licences—Act, s 44 (1) (b) and (2) (b)

A licence-holder's authorisation to obtain a dangerous poison under a dangerous poisons research and education program licence is subject to the condition that the poison is purchased on a complying purchase order.

Note For licence conditions, see the Act, s 89.

Division 17.2.3 Dangerous poisons suppliers licence authorisations

Note For other provisions about dangerous poisons suppliers licences, see pt 18.4.

685 Authorisations under dangerous poisons suppliers licences—Act, s 20 (1) (b)

(1) A dangerous poisons suppliers licence authorises the holder to do any of the following in relation to a dangerous poison (the licensed dangerous poison ) stated in the licence at the premises (the licensed premises ) stated in the licence:

(a) issue a purchase order for a licensed dangerous poison;

(b) obtain a licensed dangerous poison on a purchase order for sale from the licensed premises;

(d) sell a licensed dangerous poison on a purchase order to—

(i) someone authorised to issue a purchase order for the dangerous poison; or

(ii) someone in another State who may obtain the dangerous poison under the law of the other State; or

(iii) someone in another country who may lawfully obtain the dangerous poison in the other country.

Note The dangerous poison must be sold on a purchase order in accordance with s 720 (see s 686).

(2) However, an authorisation under subsection (1) does not apply if the licence states that it does not apply.

(3) Also, subsection (1) (d) (iii) does not apply in relation to a licensed dangerous poison that is a prohibited export under the Customs Act 1901 (Cwlth).

686 Authorisation conditions for dangerous poisons suppliers licences—Act, s 44 (1) (b) and (2) (b)

A licence-holder's authorisation under a dangerous poisons suppliers licence is subject to the following conditions:

(a) the dealings with a dangerous poison authorised by the licence will be carried out under the supervision of an individual approved under section 716 (1) (Restrictions on issuing of dangerous poisons suppliers licences—Act, s 85 (1) (a));

(b) a dangerous poison sold under the licence will be sold on a purchase order in accordance with section 720 (Supplying dangerous poisons on purchase orders);

(c) a dangerous poison sold under the licence will be supplied for a non-household (including a non-household garden) purpose only;

(d) if a dangerous poison sold under the licence is subject to the medicines and poisons standard, appendix J (Conditions for availability and use of Schedule 7 poisons), condition 3—the poison will be supplied only to a person who is allowed to use the poison under the condition;

Note Condition 3 relates to a dangerous poison that is not to be used except by or in accordance with the directions of an accredited government vermin control officer.

(i) the filled purchase order;

(ii) the delivery acknowledgement under paragraph (e) or section 720 (d) (ii);

(iii) the record for section 722;

(g) if a dangerous poison sold under the licence is liquid containing paraquat—the poison is coloured blue or green and has an offensive smell.

Note For licence conditions, see the Act, s 89.

Part 17.3 Other dangerous poisons authorisations

Division 17.3.1 Authorisations for manufacturing etc purposes

690 Manufacturing etc authorisations for dangerous poisons—Act, s 20 (2) (a)

(1) In this section:

"relevant dealing", with a dangerous poison, means any of the following:

(a) issuing a purchase order for the poison;

(b) obtaining the poison;

(d) issuing a purchase order for the poison;

(e) discarding the poison.

(2) A person mentioned in schedule 4 (Dangerous poisons— manufacturing etc authorisations), column 2 is authorised for a relevant dealing with a dangerous poison mentioned in column 3 in relation to the person if—

(a) the poison is for a purpose mentioned in column 4 in relation to the person; and

(b) the dealing is consistent with any condition or restriction for the dealing mentioned in column 3; and

(c) if the dealing is issuing a purchase order for the poison—the purchase order complies with section 721 (General requirements for dangerous poisons purchase orders—Act, s 38 (2) (c)).

Note A purchase order must be in writing (see Act, dict, def purchase order ).

Division 17.3.2 Authorisations for delivery people and commercial disposal operators

692 Authorisations to deliver dangerous poisons under purchase orders—Act, s 26 (1) (b) and (2) (b), s 35 (1) (b), (2) (b) and s 36 (b)

(1) This section applies to an adult (the delivery person ) who is—

(a) engaged to transport and deliver a dangerous poison supplied on a purchase order; or

(b) acting for a person mentioned in paragraph (a).

(2) The delivery person is authorised to—

(a) obtain and possess the dangerous poison for the purpose of transporting and delivering the dangerous poison as engaged; and

(b) supply the dangerous poison to the entity named as the recipient in the purchase order or the entity's agent.

Example—delivery person

an employee of a courier service

Note 1 Entity includes a person (see Legislation Act, dict, pt 1).

Note 2 An example is part of the regulation, is not exhaustive and may extend, but does not limit, the meaning of the provision in which it appears (see Legislation Act, s 126 and s 132).

693 Authorisation to supply dangerous poisons to commercial disposal operator for disposal—Act, s 26 (1) (b)

A person is authorised to supply a dangerous poison for disposal to another person if the other person—

(a) holds an environmental authorisation for the disposal of the dangerous poison; or

(b) is an adult acting for a person mentioned in paragraph (a).

Note For related authorisations, see pt 9.1.

694 Authorisations for commercial disposal operators—Act, s 26 (1) (b) and (2) (b), s 35 (1) (b) and (2) (b) and s 36 (b)

(1) This section applies to a person who—

(a) holds an environmental authorisation for the disposal of a dangerous poison; or

(b) is an adult acting for a person mentioned in paragraph (a).

(2) The person is authorised to obtain and possess the dangerous poison for disposing of the poison as engaged.

Division 17.3.3 Authorisations for dangerous poisons research and education programs by scientifically qualified people

Note A licence is required for research and education programs in relation to an administration-related dealing for human use (see Act, s 20 (3)).

695 Authorisations for dangerous poisons research and education—Act, s 26 (1) and (2) (b)

(1) A scientifically qualified person employed at a recognised research institution is authorised to do the following for the purposes of an authorised activity at the institution:

(a) issue a purchase order for a dangerous poison;

(b) obtain on a purchase order a dangerous poison;

(d) supply a dangerous poison to a person (a relevant person ) who is taking part in the authorised activity at the institution.

Note 1 Scientifically qualified person —see the dictionary.

Note 2 Recognised research institution —see the Act, s 20 (5).

(2) A relevant person is authorised to do the following in relation to a dangerous poison for the purposes of an authorised activity:

(a) obtain the poison from the scientifically qualified person for the activity;

(b) possess the poison for the purposes of the activity;

(3) In this section:

"administration-related dealing", in relation to a dangerous poison—see the Act, section 20 (5).

"authorised activity", in relation to a dangerous poison at a recognised research institution, means the conduct of any of the following if it does not involve an administration-related dealing of the poison for human use:

(a) medical or scientific research in relation to the poison at the institution;

(b) instruction involving the poison at the institution;

696 Authorisation conditions for dangerous poisons research and education—Act, s 44 (1) (b) and (2) (b)

A scientifically qualified person's authorisation under section 695 is subject to the following conditions:

(a) the person has written approval for the conduct of the authorised activity from the person in charge of—

(i) the recognised research institution; or

(ii) a faculty or division of the institution;

(b) a dangerous poison is purchased on a complying purchase order;

(d) the dangerous poison is obtained from someone who is authorised to supply the poison to the person.

Part 18.1 Dangerous poisons licences generally

700 Dangerous poisons licences that may be issued—Act, s 78 (2)

The following licences for dangerous poisons may be issued:

(a) a licence for the manufacture of a dangerous poison (a dangerous poisons manufacturers licence );

(b) a licence for a program of research or education in relation to a dangerous poison (a dangerous poisons research and education program licence );

Note Other dangerous poisons licences may also be issued (see Act, s 78 (3)).

Part 18.2 Dangerous poisons manufacturers licences

705 Applications for dangerous poisons manufacturers licences

(1) An application for a dangerous poisons manufacturers licence must be in writing, signed by the applicant, and include the following:

(a) the dangerous poisons to which the application relates;

(b) the full name of the applicant;

(d) if the applicant is a corporation—the corporation's ACN;

(e) the location of the premises where the applicant proposes to deal with the poisons under the licence;

(f) the security arrangements proposed for the premises;

(g) the name of an individual who is to supervise the dealings to be authorised under the licence.

Note 1 If a form is approved under the Act, s 198 for this provision, the form must be used.

Note 2 A fee may be determined under the Act, s 197 for this provision.

(2) The application must be accompanied by a plan of the premises that shows—

(a) each part of the premises where a process in the manufacture of the dangerous poisons is proposed to be carried out and the nature of the process; and

(b) where it is proposed to store the dangerous poisons to which the application relates and any other dangerous poisons obtained for the manufacture of those dangerous poisons; and

706 Restrictions on issuing of dangerous poisons manufacturers licences—Act, s 85 (1) (a)

(1) The chief health officer must not issue a dangerous poisons manufacturers licence to a person unless dealings with dangerous poisons under the licence will be supervised by an individual nominated by the applicant and approved, in writing, by the chief health officer.

(2) The chief health officer must not approve the nominated individual unless satisfied that the individual—

(a) is a suitable person to hold a dangerous poisons manufacturers licence; and

(b) has qualifications in chemistry, pharmacy or pharmacology or experience appropriate for the manufacture of dangerous poisons.

Note For changes of nominated individuals, see the Act, s 93.

(3) In this section:

"suitable person", to hold a licence—see the Act, section 81.

707 Additional information for dangerous poisons manufacturers licences—Act, s 88 (1) (k)

The name of the person approved under section 706 (1) to supervise the dealings with dangerous poisons authorised by the licence is prescribed for a dangerous poisons manufacturers licence.

Part 18.3 Dangerous poisons research and education program licences

710 Applications for dangerous poisons research and education program licences

(1) An application for a dangerous poisons research and education program licence for a dangerous poison must be in writing, signed by the applicant, and include the following:

(a) the full name, address and academic, professional or other relevant qualifications of—

(i) the person who is to supervise the program; and

(ii) the person who is to conduct the program;

(b) the name of the recognised research institution at or under which the program is proposed to be conducted;

Note Recognised research institution —see the Act, s 20 (5).

(d) the premises where the program will be conducted;

(e) the dangerous poison, and the form and strength of the poison, for which the licence is sought;

(f) the maximum quantity of the dangerous poison that would be possessed under the licence at any time;

(g) a description of the program, including an explanation of why the program cannot be carried out satisfactorily without the use of the dangerous poison;

(h) the supervision arrangements for the program;

(i) the period for which the licence is sought.

Note 1 If a form is approved under the Act, s 198 for this provision, the form must be used.

Note 2 A fee may be determined under the Act, s 197 for this provision.

(2) The application must be accompanied by a written approval of the program by the person in charge of—

(a) the recognised research institution; or

(b) a faculty or division of the institution.

711 Restrictions on issuing of dangerous poisons research and education program licences—Act, s 85 (1) (a)

The chief health officer must not issue a dangerous poisons research and education program licence to a person unless—

(a) the program to which the licence relates will be conducted at, or under the authority of, a recognised research institution; and

(b) the program is approved by a person mentioned in section 710 (2); and

(i) cannot be carried out without the use of the dangerous poison to which the licence application relates; and

(ii) will be adequately supervised.

712 Additional information for dangerous poisons research and education licences—Act, s 88 (1) (k)

The following additional information is prescribed for a dangerous poisons research and education licence:

(a) the research or education program for which the licence is issued;

(b) the name of the program's supervisor;

(d) the premises where the program will be conducted;

(e) the maximum quantity of the dangerous poison that may be possessed at any time for the program;

(f) the total quantity of the dangerous poison that may be possessed for the program during the period of the licence;

(g) the form and strength of the dangerous poison that may be obtained and possessed for the program.

Part 18.4 Dangerous poisons suppliers licences

715 Applications for dangerous poisons suppliers licences

(1) An application for a dangerous poisons suppliers licence must be in writing, signed by the applicant, and include the following:

(a) the dangerous poisons to which the application relates;

(b) the full name of the applicant;

(d) if the applicant is a corporation—the corporation's ACN;

(e) the location of the premises where the applicant proposes to deal with the poisons under the licence;

(f) the security arrangements proposed for the premises;

(g) the name of an individual who is to supervise the dealings to be authorised under the licence.

Note 1 If a form is approved under the Act, s 198 for this provision, the form must be used.

Note 2 A fee may be determined under the Act, s 197 for this provision.

(2) The application must be accompanied by a plan of the premises that shows—

(a) where it is proposed to store the dangerous poisons; and

(b) the location and nature of security devices.

716 Restrictions on issuing of dangerous poisons suppliers licences—Act, s 85 (1) (a)

(1) The chief health officer must not issue a dangerous poisons suppliers licence to a person unless dealings with dangerous poisons under the licence will be supervised by an individual nominated by the applicant and approved, in writing, by the chief health officer.

(2) The chief health officer must not approve the nominated individual unless satisfied that the individual—

(a) is a suitable person to hold a dangerous poisons suppliers licence; and

(b) has qualifications in chemistry, pharmacy or pharmacology or experience appropriate for the sale of dangerous poisons.

Note For changes of nominated individuals, see the Act, s 93.

(3) In this section:

"suitable person", to hold a licence—see the Act, section 81.

717 Additional information for dangerous poisons suppliers licences—Act, s 88 (1) (k)

The name of the person approved under section 716 (1) to supervise the dealings with dangerous poisons authorised by the licence is prescribed for a dangerous poisons suppliers licence.

Part 19.1 Dangerous poisons purchase orders

720 Supplying dangerous poisons on purchase orders

The following are the requirements for the supply of a dangerous poison on a purchase order:

(a) the dangerous poison is supplied in manufacturer's packs that comply with—

(i) section 731 (Packaging of supplied manufacturer's packs of dangerous poisons—Act, s 59 (1) (c) (i) and (2) (c) (i)); or

(ii) an approval under the Act, section 193 (Approval of non-standard packaging and labelling);

(b) the manufacturer's packs are labelled in accordance with—

(i) section 732 (Labelling of supplied manufacturer's packs of dangerous poisons—Act, s 60 (1) (c) (i) and (2) (c) (i)); or

(ii) an approval under the Act, section 193;

(d) if the dangerous poison is delivered in person by the supplier to the buyer—

(i) the poison is delivered to an adult; and

(ii) the delivery is acknowledged by the adult signing and dating a copy of the purchase order;

(e) if the dangerous poison is not delivered in person by the supplier to the buyer—the poison is delivered to the buyer by a person whose procedures require the delivery of the poison to be signed for by the buyer or an adult employee of the buyer.

721 General requirements for dangerous poisons purchase orders—Act, s 38 (2) (c)

(1) A purchase order for a dangerous poison must be—

(a) signed by the person (the issuer ) issuing the order; and

Note The purchase order must be signed with the issuer's usual signature (see Act, dict, def signs ).

(b) if the issuer amends the order—initialled and dated by the issuer beside the amendment.

(2) A purchase order for a dangerous poison must include the following:

(a) the issuer's name and business address and telephone number;

(b) the issuer's authority to issue the order;

722 Recording supply of dangerous poisons on purchase orders

A person who supplies a dangerous poison to someone else on a purchase order must make a written record of the following information:

(a) the date of the order;

(b) the issuer's authority to issue the order;

(d) the date the order is supplied;

(e) the dangerous poison, and the form, strength and quantity of the poison, supplied.

Note Written includes in electronic form (see Act, dict).

Part 19.2 Wholesale supply of dangerous poisons under corresponding laws

725 Conditions for wholesalers supplying dangerous poisons under corresponding laws—Act, s 20 (4) (c)

The following conditions apply to a person who supplies dangerous poisons by wholesale under a corresponding law:

(a) the person must not supply a dangerous poison to someone else (the "buyer") unless—

(i) the buyer is authorised to possess the poison; and

(ii) the supply is in accordance with section 686 (Authorisation conditions for dangerous poisons suppliers licences—Act, s 44 (1) (b) and (2) (b));

(b) the poison is supplied for a non-household (including a non-household garden) purpose only;

Note 1 A purchase order must be in writing (see Act, dict, def purchase order ).

Note 2 See pt 19.1 for other requirements in relation to supply of dangerous poisons on purchase orders.

Part 19.3 Packaging and labelling of dangerous poisons

730 Meaning of relevant law —pt 19.3

In this part:

"relevant law" means—

(a) a corresponding law; or

(b) the Agricultural and Veterinary Chemicals Act 1994 (Cwlth); or

Note 1 Corresponding law includes a law of a State that corresponds, or substantially corresponds, to the Act (see Act, dict).

Note 2 State includes a territory (see Legislation Act, dict, pt 1).

731 Packaging of supplied manufacturer's packs of dangerous poisons—Act, s 59 (1) (c) (i) and (2) (c) (i)

A manufacturer's pack of a supplied dangerous poison must be packaged—

(a) in accordance with the medicines and poisons standard, paragraphs 21 to 27; or

(b) in a container in which the poison may be sold under a relevant law.

Note A manufacturer's pack of a dangerous poison supplied may also be packaged in accordance with an approval under the Act, s 193 (Approval of non-standard packaging and labelling) (see Act, s 59 (1) (c) (ii) and (2) (c) (ii)).

732 Labelling of supplied manufacturer's packs of dangerous poisons—Act, s 60 (1) (c) (i) and (2) (c) (i)

A manufacturer's pack of a supplied dangerous poison must be labelled in accordance with—

(a) the medicines and poisons standard, paragraphs 3 to 19; or

(b) a relevant law.

Note A manufacturer's pack of a dangerous poison supplied may also be labelled in accordance with an approval under the Act, s 193 (Approval of non-standard packaging and labelling) (see Act, s 60 (1) (c) (ii) and (2) (c) (ii)).

Part 19.4 Storage of dangerous poisons

735 Storage of dangerous poisons—Act, s 61 (b) and (c)

(1) A person mentioned in table 740, column 2 who possesses a dangerous poison is prescribed.

(2) The dangerous poison must be kept—

(a) in a part of the premises to which the public does not have access; and

(b) so that only the prescribed person, or a person under the supervision of the prescribed person, has access to the poison.

Part 19.5 Dangerous poisons registers

740 Keeping of dangerous poisons registers by certain people—Act, s 48 and s 50 (1) (b) and (2) (b)

(1) A person mentioned in table 740, column 2 who possesses a dangerous poison must keep a dangerous poisons register.

(2) A person to whom subsection (1) applies must keep a dangerous poisons register for a dangerous poison at the place prescribed in table 740, column 3 for the person.

Table 740 Keeping dangerous poisons registers

column 1

item

column 2

prescribed person

column 3

place where register to be kept

1

approved analyst

the analyst's laboratory

2

dangerous poisons manufacturers licence-holder

the licensed premises under s 675

3

dangerous poisons suppliers licence-holder

the licensed premises under s 685

4

medicines and poisons inspector (other than police officer)

the place directed in writing by the chief health officer

5

person mentioned in sch 4, col 2

the person's business premises

6

supervisor of program under dangerous poisons research and education program licence

the premises where program is being conducted

7

supervisor of program under dangerous poisons research and education authorisation under div 17.3.3

the premises where program is being conducted

column 1 item	column 2 prescribed person	column 3 place where register to be kept
1	approved analyst	the analyst's laboratory
2	dangerous poisons manufacturers licence-holder	the licensed premises under s 675
3	dangerous poisons suppliers licence-holder	the licensed premises under s 685
4	medicines and poisons inspector (other than police officer)	the place directed in writing by the chief health officer
5	person mentioned in sch 4, col 2	the person's business premises
6	supervisor of program under dangerous poisons research and education program licence	the premises where program is being conducted
7	supervisor of program under dangerous poisons research and education authorisation under div 17.3.3	the premises where program is being conducted

741 Form of dangerous poisons registers—Act, s 49 (1) (b)

(1) Each page in a dangerous poisons register must relate to a single form and strength of a dangerous poison.

(2) If a dangerous poisons register is kept electronically, a separate record must be used for each form and strength of dangerous poison kept.

742 Making entries in dangerous poisons registers—Act, s 51 (1) (b)

(1) The following details for a dealing with a dangerous poison are prescribed:

(a) the nature of the dealing;

(b) the date of the dealing;

(d) if the dealing is receiving the poison—the name and address of the supplier;

(e) if the dealing is supplying the poison—the name and address of the person to whom it is supplied;

(f) if the poison is supplied on a purchase order—the date of the purchase order;

(g) the quantity of the poison held after the dealing.

(2) A dealing with a dangerous poison must be entered in the dangerous poisons register the person must keep.

743 Prescribed witnesses for discarding of dangerous poisons—Act, s 54 (a) and (b)

(1) An adult is prescribed as a witness in relation to the disposal of a dangerous poison.

(2) However, a person mentioned in subsection (1) must not be a prescribed witness to the discarding of a dangerous poison if the person is—

(a) related to, a close friend of or employed by the person discarding the poison; or

(b) the supervisor of the person discarding the poison; or

744 Changes to entries in dangerous poisons registers—Act, s 55 (2) (b)

(1) An entry in a paper-based dangerous poisons register may be amended by the person who made the entry by—

(a) the person signing and dating a marginal note or footnote that gives the date of the amendment and the amended details; and

(b) if the entry relates to disposing of a dangerous poison—

(i) the amendment being witnessed by a person mentioned in section 743; and

(ii) the witness signing the amendment as witness.

(2) An entry in an electronic dangerous poisons register may be amended by the person who made the entry by the person attaching or linking, by electronic means, a document that includes—

(a) the person's signature, the date and the amended details; and

(b) if the entry relates to disposing of a dangerous poison—

(i) the amendment being witnessed by a person mentioned in section 743; and

(ii) the witness signing the amendment as witness.

750 Manufacture, supply and use of paints containing white lead—Act, s 70 (1) (b), (2) (b) and (3) (b)

A paint containing basic lead carbonate (white lead) may be manufactured, supplied or used for application as a mirror backing if the paint—

(a) contains not more than 15% lead in the non-volatile content of the paint; and

(b) is applied not more than 40µm thick; and

Note µm is the symbol for micron (see National Measurement Regulations 1999 (Cwlth), sch 1, pt 4).

751 Manufacture, supply and use of paints for certain purposes—Act, s 71 (1) and (3)

(1) A first schedule paint must not be manufactured, supplied or used for application to—

(a) a roof or other surface to be used for the collection or storage of potable water; or

(b) furniture; or

(c) a fence, wall, post, gate or building (including the interior of a building), other than a building that is used only for industrial purposes or mining or as an oil terminal; or

(d) premises used for the manufacture, processing, preparation, packing or serving of products intended for human or animal consumption.

Note First schedule paint —see the medicines and poisons standard, par 1 (1).

(2) A third schedule paint must not be manufactured, supplied or used for application to—

(a) a roof or other surface to be used for the collection or storage of potable water; or

(b) furniture; or

(c) a fence, wall, post, gate, building (including the interior of a building), bridge, pylon, pipeline, storage tank or similar structure; or

(d) premises, equipment or utensils used for the manufacture, processing, preparation, packing or serving of products intended for human or animal consumption.

Note Third schedule paint —see the medicines and poisons standard, par 1 (1).

752 Manufacture, supply and use of paints for toys—Act, s 72 (b)

A paint that complies with the specification for coating materials in AS/NZS ISO 8124.3:2003 ( Safety of toys - Migration of certain elements ), as in force from time to time, may be manufactured, supplied or used for application to toys.

753 Manufacture, supply and use of paints containing pesticides—Act, s 73 (b)

(1) The following pesticides are prescribed:

(a) an algicide;

(b) an antifouling agent;

(d) a fungicide.

Note Pesticide —see the medicines and poisons standard, par 1 (1).

(2) However, subsection (1) does not apply in relation to a paint for human therapeutic use.

Part 21.1 Preliminary

760 Meaning of prohibited substance —ch 21

In this chapter:

"prohibited substance" includes an appendix C substance.

Note Appendix C substance and prohibited substance —see the Act, s 13.

761 Prohibited substances licences—Act, s 78 (2)

A licence for a program of research or education in relation to a prohibited substance (a prohibited substances research and education program licence ) may be issued.

Note Other prohibited substances licences may also be issued (see Act, s 78 (3)).

Part 21.2 Prohibited substances research and education program licences

Division 21.2.1 Issue of prohibited substances research and education program licences

765 Applications for prohibited substances research and education program licences

(1) An application for a prohibited substances research and education program licence for a prohibited substance must be in writing, signed by the applicant, and include the following:

(a) the full name, address and academic, professional or other relevant qualifications of—

(i) the person who is to supervise the program; and

(ii) the person who is to conduct the program;

(b) the name of the recognised research institution at or under which the program is proposed to be conducted;

Note Recognised research institution —see the Act, s 20 (5).

(d) the premises where the program will be conducted;

(e) the prohibited substance, and the form and strength of the substance, for which the licence is sought;

(f) the maximum quantity of the prohibited substance that would be possessed under the licence at any time;

(g) a description of the program, including an explanation of why the program cannot be carried out satisfactorily without the use of the prohibited substance;

(h) the supervision arrangements for the program;

(i) the period for which the licence is sought.

Note 1 If a form is approved under the Act, s 198 for this provision, the form must be used.

Note 2 A fee may be determined under the Act, s 197 for this provision.

(2) The application must be accompanied by a written approval of the program by the person in charge of—

(a) the recognised research institution; or

(b) a faculty or division of the institution.

766 Restrictions on issuing of prohibited substances research and education program licences—Act, s 85 (1) (a)

The chief health officer must not issue a prohibited substances research and education program licence to a person unless—

(a) the program to which the licence relates will be conducted at, or under the authority of, a recognised research institution; and

(b) the program is approved by a person mentioned in section 765 (2); and

(i) cannot be carried out without the use of the prohibited substance to which the licence application relates; and

(ii) will be adequately supervised.

767 Additional information for prohibited substances research program and education licences—Act, s 88 (1) (k)

The following additional information is prescribed for a prohibited substances research and education licence:

(a) the research or education program for which the licence is issued;

(b) the name of the program's supervisor;

(d) the premises where the program will be conducted;

(e) the maximum quantity of the prohibited substance that may be possessed at any time for the program;

(f) the total quantity of the prohibited substance that may be possessed for the program during the period of the licence;

(g) the form and strength of the prohibited substance that may be obtained and possessed for the program.

Division 21.2.2 Prohibited substances research and education program authorisations

768 Authorisations under prohibited substances research and education program licences—Act, s 20 (1) (a)

A prohibited substances research and education program licence authorises—

(a) the licence-holder to—

(i) issue a purchase order for a prohibited substance (the licensed prohibited substance ) stated in the licence for the program stated in the licence; and

(ii) obtain a licensed prohibited substance on a purchase order for the program; and

(iii) possess a licensed prohibited substance for the program at the premises to which the licence relates; and

(iv) supply a licensed prohibited substance to anyone taking part in the program for the program; and

(b) the program supervisor, and anyone taking part in the program, to deal with the licensed prohibited substance as authorised by the licence at the premises stated in the licence.

769 Authorisation condition for prohibited substances research and education program licences—Act, s 44 (1) (b) and (2) (b)

A licence-holder's authorisation to obtain a prohibited substance under a prohibited substances research and education program licence is subject to the condition that the substance is obtained on a complying purchase order.

Note For licence conditions, see the Act, s 89.

Division 21.2.3 Other provisions—prohibited substances research and education program licences

770 Approvals of dealings for prohibited substances research and education program licences—Act, s 20 (1) (c)

(1) In this section:

"relevant dealing", with a prohibited substance for a prohibited substances research and education program licence, means any of the following:

(a) obtaining the substance;

(b) possessing the substance;

(d) supplying the substance on a complying purchase order to the licence-holder.

(2) The chief health officer may approve a person for a relevant dealing with a prohibited substance to which a prohibited substances research and education program licence relates.

(3) An approval—

(a) must be in writing; and

(b) may be conditional; and

771 Authorisation condition for approval-holders—Act, s 44 (1) (b) and (2) (b)

An approval-holder's authorisation under section 770 is subject to the condition that the following are kept at the approval-holder's business premises or, if the chief health officer approves in writing another place, the place approved by the chief health officer, for at least 2 years after the day a prohibited substance is supplied:

(a) the filled purchase order;

(b) the record for section 773.

772 General requirements for prohibited substances purchase orders—Act, s 38 (2) (c)

(1) A purchase order for a prohibited substance must be—

(a) signed by the person (the issuer ) issuing the order; and

Note The purchase order must be signed with the issuer's usual signature (see Act, dict, def signs ).

(b) if the issuer amends the order—initialled and dated by the issuer beside the amendment.

(2) A purchase order for a prohibited substance must include the following:

(a) the issuer's name and business address and telephone number;

(b) the issuer's authority to issue the order;

773 Recording supply of prohibited substances on purchase orders

A person who supplies a prohibited substance to someone else on a purchase order must make a written record of the following information:

(a) the date of the order;

(b) the issuer's authority to issue the order;

(d) the date the order is supplied;

(e) the prohibited substance, and the form, strength and quantity of the substance, supplied.

Note Written includes in electronic form (see Act, dict).

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)

(1) This section applies if a person supplies a prohibited substance to a prohibited substances research and education program licence-holder.

(2) The person must, not later than 7 days after the end of the month when the prohibited substance is supplied, give the chief health officer the following information in writing:

(a) the person's name, business address and telephone number;

(b) the name of the person who issued the supply authority;

(d) the name and address of the person to whom the substance is supplied;

(e) the date of supply;

(f) the substance, and the form, strength and quantity of the substance, supplied.

Part 21.3 Prohibited substances registers

775 Keeping of prohibited substances registers by certain people—Act, s 48 and s 50 (1) (b) and (2) (b)

(1) A person mentioned in table 775, column 2 who possesses a prohibited substance must keep a prohibited substances register.

(2) A person to whom subsection (1) applies must keep a prohibited substances register for a prohibited substance at the place prescribed in table 775, column 3 for the person.

Table 775 Keeping prohibited substances registers

column 1

item

column 2

prescribed person

column 3

place where register to be kept

1

approved analyst

the analyst's laboratory

2

medicines and poisons inspector (other than police officer)

the place directed in writing by the chief health officer

3

supervisor of program under prohibited substances research and education program licence

the premises where program is being conducted

column 1 item	column 2 prescribed person	column 3 place where register to be kept
1	approved analyst	the analyst's laboratory
2	medicines and poisons inspector (other than police officer)	the place directed in writing by the chief health officer
3	supervisor of program under prohibited substances research and education program licence	the premises where program is being conducted

776 Form of prohibited substances registers—Act, s 49 (1) (b)

(1) Each page in a prohibited substances register must relate to a single form and strength of a prohibited substance.

(2) If a prohibited substances register is kept electronically, a separate record must be used for each form and strength of prohibited substance kept.

777 Making entries in prohibited substances registers—Act, s 51 (1) (b)

(1) The following details for a dealing with a prohibited substance are prescribed:

(a) the nature of the dealing;

(b) the date of the dealing;

(d) if the dealing is receiving the substance—the name and address of the supplier;

(e) if the dealing is supplying the substance—the name and address of the person to whom it is supplied;

(f) the quantity of the substance held after the dealing.

(2) A dealing with a prohibited substance must be entered in the prohibited substances register the person must keep.

778 Prescribed witnesses for discarding of prohibited substances—Act, s 54 (a) and (b)

(1) The following people are prescribed as witnesses in relation to the disposal of a prohibited substance:

(a) an approved analyst;

(b) a medicines and poisons inspector.

Note Approved analyst —see the dictionary.

(2) However, a person mentioned in subsection (1) must not be a prescribed witness to the discarding of a prohibited substance if the person is—

(a) related to, a close friend of or employed by the person discarding the substance; or

(b) the supervisor of the person discarding the substance; or

779 Changes to entries in prohibited substances registers—Act, s 55 (2) (b)

(1) An entry in a paper-based prohibited substances register may be amended by the person who made the entry by—

(a) the person signing and dating a marginal note or footnote that gives the date of the amendment and the amended details; and

(b) if the entry relates to disposing of a prohibited substance—

(i) the amendment being witnessed by a person mentioned in section 743; and

(ii) the witness signing the amendment as witness.

(2) An entry in an electronic prohibited substances register may be amended by the person who made the entry by the person attaching or linking, by electronic means, a document that includes—

(a) the person's signature, the date and the amended details; and

(b) if the entry relates to disposing of a prohibited substance—

(i) the amendment being witnessed by a person mentioned in section 743; and

(ii) the witness signing the amendment as witness.

800 Definitions—ch 22

In this chapter:

"optical device" means any of the following:

(a) corrective contact lenses;

(b) corrective lenses for spectacles;

"prescription", in relation to an optical device, means a written direction (other than a purchase order) to a person who is authorised to supply the optical device to dispense the optical device.

801 Prescribed regulated therapeutic goods—Act, s 14, def regulated therapeutic good , par (b)

Optical devices are prescribed.

802 Authorisation to supply optical devices—Act, s 74 (1) (b) and (2) (b)

(1) To the extent necessary to practise optometry and, if employed, within the scope of employment, an optometrist is authorised to supply optical devices on prescription issued by an optometrist or doctor.

Note Supply includes dispense (see Act, s 24).

(2) To the extent necessary to practise as an optician and, if employed, within the scope of employment, an optician is authorised to supply optical devices on prescription issued by an optometrist or doctor.

(3) Within the scope of employment, an employee of an optometrist is authorised to sell and deliver optical devices supplied under subsection (1) or (2).

803 Authorisation conditions for supplying optical devices—Act, s 75 (1) (b)

An optometrist's, and optician's, authorisation under section 802 in relation to optical devices is subject to the following conditions:

(a) the optical devices are supplied on a written prescription by an optometrist or doctor;

(b) if the prescription is for contact lenses (whether corrective or plano)—the prescription is issued not more than 1 year before the date the lenses are supplied;

(c) if the prescription is for corrective lenses for spectacles—the prescription is issued not more than 2 years before the date the lenses are supplied.

850 Meaning of reviewable decision— ch 23

In this chapter:

"reviewable decision" means a decision mentioned in table 850, column 3 under a provision of this regulation mentioned in column 2 in relation to the decision.

Table 850 Reviewable decisions—chief health officer

column 1

item

column 2

section

column 3

decision

column 4

entity

1

120 (1) (h)

refuse approval of other premises

applicant for approval

2

130 (e)

refuse approval of other premises

applicant for approval

3

140 (e)

refuse approval of other premises

applicant for approval

4

150 (1) (c)

refuse approval of other premises

applicant for approval

5

160 (f)

refuse approval of other premises

applicant for approval

6

171 (d)

refuse approval of other premises

applicant for approval

7

175 (1) (a) (ii) and (b)
amend pseudoephedrine record in way other than in accordance with application/refuse application

applicant for amendment

8

252 (1) (d)

refuse approval of other premises

applicant for approval

9

531 (2)

refuse approval to store a controlled medicine in a safe or strongroom

applicant for approval

10

616 (1)

refuse approval of nominated individual for medicines wholesales licence

applicant for licence
11

676 (f)

refuse approval of other premises

applicant for approval

12

686 (f)

refuse approval of other premises

applicant for approval

13

706 (1)

refuse approval of nominated individual for dangerous poisons manufacturers licence

applicant for licence

14

716 (1)

refuse approval of nominated individual for dangerous poisons suppliers licence

applicant for licence

15

771

refuse approval of other premises

applicant for approval

column 1 item	column 2 section	column 3 decision	column 4 entity
1	120 (1) (h)	refuse approval of other premises	applicant for approval
2	130 (e)	refuse approval of other premises	applicant for approval
3	140 (e)	refuse approval of other premises	applicant for approval
4	150 (1) (c)	refuse approval of other premises	applicant for approval
5	160 (f)	refuse approval of other premises	applicant for approval
6	171 (d)	refuse approval of other premises	applicant for approval
7	175 (1) (a) (ii) and (b)	amend pseudoephedrine record in way other than in accordance with application/refuse application	applicant for amendment
8	252 (1) (d)	refuse approval of other premises	applicant for approval
9	531 (2)	refuse approval to store a controlled medicine in a safe or strongroom	applicant for approval
10	616 (1)	refuse approval of nominated individual for medicines wholesales licence	applicant for licence
11	676 (f)	refuse approval of other premises	applicant for approval
12	686 (f)	refuse approval of other premises	applicant for approval
13	706 (1)	refuse approval of nominated individual for dangerous poisons manufacturers licence	applicant for licence
14	716 (1)	refuse approval of nominated individual for dangerous poisons suppliers licence	applicant for licence
15	771	refuse approval of other premises	applicant for approval

Note For AAT review of other decisions in relation to licences, see the Act, ch 9 and sch 1.

851 Notice of reviewable decisions

(1) If a person makes a reviewable decision, the person must give written notice of the decision to each entity mentioned in table 850, column 4 in relation to the decision.

(2) A notice under subsection (1) must be in accordance with the requirements of the code of practice in force under the Administrative Appeals Tribunal Act 1989 , section 25B (1).

852 Applications for review

The following may apply to the administrative appeals tribunal for a review of a reviewable decision:

(a) an entity mentioned in table 850, column 4 in relation to the decision;

(b) any other person whose interests are affected by the decision.

860 Authorisations for public employees—Act, s 26 (1) (b), (2) (b), s 35 (1) (b), (2) (b) and s 36 (b)

(1) This section applies to a public employee who is exercising a function under the Act.

Note Function includes authority, duty and power (see Legislation Act, dict, pt 1).

(2) To the extent necessary to exercise the function and within the scope of employment, the public employee is authorised to do any of the following:

(a) obtain a regulated substance;

(b) possess a regulated substance;

(c) supply a regulated substance or regulated therapeutic good to a person for discarding if the person is authorised to obtain the substance or good;

Example—person authorised to obtain

a person who holds an environmental authorisation for the disposal of the substance (see, eg s 693)

Note An example is part of the regulation, is not exhaustive and may extend, but does not limit, the meaning of the provision in which it appears (see Legislation Act, s 126 and s 132).

(d) supply a regulated substance or regulated therapeutic good, for law enforcement purposes, to—

(i) someone else who is authorised to obtain the substance or good; or

(ii) a law enforcement officer.

Note Public employee —see the Legislation Act, dictionary, pt 1.

(3) In this section:

"law enforcement officer"—see the Criminal Code, section 700.

861 Other authorisations for public employees—Act, s 20 (1) (a), (2) (a) and s 74 (1) (b)

(1) A public employee is authorised to deal with a regulated substance, or regulated therapeutic good, in accordance with a permit issued by the chief health officer to the employee.

(2) The permit must be in writing and include the following information:

(a) the dealings with regulated substances or regulated therapeutic goods authorised by the permit;

(b) the regulated substances or regulated therapeutic goods to which the permit relates;

(d) any condition included in the permit by the chief health officer to which the permit is subject;

(e) a unique identifying number;

(f) when the permit ends.

(3) For subsection (2) (c), the permit may identify a public employee authorised under the permit by—

(a) naming the employee; or

(b) nominating the occupant of a position (however described), at a particular time or from time to time.

862 Certain containers not to be used for human-use substances—Act, s 63 (1) (b)

A container of a kind mentioned in the medicines and poisons standard, paragraph 21, 22 or 23 is prescribed.

863 Displacement of Legislation Act, s 47 (6)

The Legislation Act, section 47 (6) does not apply to AS/NZS ISO 8124.3:2003 ( Safety of toys - Migration of certain elements ).

Note 1 The text of an applied, adopted or incorporated instrument, whether applied as in force at a particular time or from time to time, is taken to be a notifiable instrument if the operation of the Legislation Act, s 47 (5) or (6) is not disapplied (see s 47 (7)).

Note 2 A reference to an Act includes a reference to the statutory instruments made or in force under the Act, including any regulation (see Legislation Act, s 104).

864 Legislation amended—sch 6

The Health Professionals Regulation 2004 is amended in schedule 6.

1000 Definitions—ch 30

In this chapter:

"DODA" means the Drugs of Dependence Act 1989 .

"PADA" means the Poisons and Drugs Act 1978 .

1001 DODA wholesaler's licences—Act, s 520 (2)

A wholesaler's licence under DODA for a controlled medicine is taken to be a medicines wholesalers licence for the medicine.

1002 Poisons Act licences—Act, s 520 (2)

A licence (the old licence ) under the Poisons Act 1933 is taken to be a licence under this Act to obtain and possess for sale, and sell, the regulated substance to which the old licence applies.

1003 PADA licences—Act, s 520 (2)

(1) A manufacture's licence under PADA for a dangerous poison is taken to be a dangerous poisons manufacturers licence for the poison.

(2) A vendor's licence under PADA for a dangerous poison is taken to be a dangerous poisons suppliers licence for the poison.

1004 DODA authorisations—Act, s 522 (2)

(1) An authorisation under DODA, section 33 (Authorisation (research or education)—grant) for a controlled medicine is taken to be a controlled medicines research and education program licence for the medicine.

Note A licence is not required for other kinds of medicines (see pt 9.4).

(2) An authorisation under DODA, section 33 (Authorisation (research or education)—grant) for a prohibited substance is taken to be a prohibited substances research and education program licence for the substance.

(3) An authorisation under DODA, section 43 (Authorisation (first-aid)—grant) for a medicine is taken to be a first-aid kit licence for the medicine.

(4) An authorisation under DODA, section 200 (Possession by officials) for a controlled medicine or prohibited substance is taken to be an authorisation under section 861 for the medicine or substance.

1005 PADA authorisations—Act, s 522 (2)

An authorisation under PADA, section 26 (Grant of authorisation) for a dangerous poison is taken to be a dangerous poisons research and education program licence for the poison.

1006 Public Health (Prohibited Drugs) Act authorisations—Act, s 522 (2)

An authorisation under the Public Health (Prohibited Drugs) Act 1957 , section 6A (Authority to possess prohibited drugs for research purposes) is taken to be a prohibited substances research and education program licence for the regulated substance to which the authorisation related.

1007 DODA approvals to prescribe drugs of dependence—Act, s 531 (2)

An approval under DODA, section 69 (Powers of chief health officer) is taken to be a controlled medicines approval under division 13.1.3 (Chief health officer controlled medicines approvals) for the controlled medicine to which the approval related.

1008 Expiry—ch 30

This chapter expires on 31 March 2010.

AustLII: Copyright Policy | Disclaimers | Privacy Policy | Feedback