Poisons and Therapeutic Goods Regulation 2002

(1)  A dealer who supplies a poison must ensure that the poison is packaged and labelled:

(a)  in accordance with the relevant provisions of the current Poisons Standard, and

(b)  in the case of a poison to which Therapeutic Goods Order No 20 applies, in accordance with that Order.

(2)  This clause does not apply to the labelling of a substance that is supplied by a medical practitioner, nurse practitioner, dentist, veterinary surgeon or pharmacist so long as the substance is supplied in a package that is labelled in accordance with the requirements of Appendix A.

(3)  A pharmacist who supplies any quantity of a Schedule 2 or 3 substance on prescription must ensure that the substance is supplied in a package that is labelled in accordance with the requirements of Appendix A instead of in accordance with the requirements of subclause (1).

Maximum penalty: 10 penalty units.

A dealer must not supply any substance in a container that has a label that states or implies that the substance is a poison, unless the substance is a poison.

Maximum penalty: 10 penalty units.

A dealer must ensure that any camphor or naphthalene supplied by the dealer (being camphor or naphthalene packaged in block, disc, ball or pellet form suitable for domestic use) is packaged so that, in normal use, the contents of the package cannot be ingested or touched while the package remains unbroken.

Maximum penalty: 10 penalty units.

(1)  A dealer must ensure that any Schedule 3 substance supplied by the dealer is labelled with the dealer’s name and address.

Maximum penalty: 2 penalty units.

(2)  Subclause (1) does not apply to the supply of any Schedule 3 substance by wholesale.

(1)  The Director-General may, by order in writing, exempt any person or substance, or any class of persons or substances, from the requirements of this Division.

(2)  Such an exemption may be given unconditionally or subject to conditions.

(3)  Subject to subclause (4), any exemption in force under a law of the Commonwealth, or of another State or Territory, corresponding to this clause has the same effect as an exemption under this clause.

(4)  The Director-General may, by order published in the Gazette, declare that subclause (3) does not have effect with respect to an exemption specified in the order.

A dealer who has possession of any poison must keep the poison:

(a)  apart from human or animal food, and

(b)  in such a way that, if its container breaks or leaks, the poison cannot mix with or contaminate any human or animal food.

Maximum penalty: 10 penalty units.

A dealer who has possession of any Schedule 3 or 7 substance must keep the substance in a room or enclosure to which the public does not have access.

Maximum penalty: 10 penalty units.

(1)  A dealer who has possession of any Schedule 6 substance must keep that substance:

(a)  in a place to which the public does not have access, or

(b)  in a place that is at least 1.2 metres above the floor and at least 1.2 metres away from any step, stairway, ramp or escalator to which the public has access.

(2)  This clause does not apply to any of the following:

(a)  any therapeutic substance for internal use in animals,

(b)  any substance in a container that is fitted with a child-resistant closure,

(c)  any substance in a pressurised spray dispenser that is fitted with a cap that can be removed only by using a levering instrument applied through a slot in the cap,

(d)  any substance in a container that has a capacity of 5 litres or more or a weight (inclusive of its contents) of 5 kilograms or more,

(e)  any hair dye in a container that has a capacity of 50 millilitres or less,

(f)  any cockroach bait that is enclosed in a welded plastic labyrinth.

Maximum penalty: 10 penalty units.

(1)  A person must not issue a prescription for a Schedule 2 or 3 substance unless authorised to do so by this clause.

(2)  A medical practitioner, nurse practitioner, dentist or veterinary surgeon may issue a prescription for a Schedule 2 or 3 substance.

Maximum penalty: 10 penalty units.

(1)  This clause applies to the following substances, but only in so far as they are Schedule 3 substances:

pseudoephedrine

(2)  A person who issues a prescription for a substance to which this clause applies must ensure that the prescription complies with Division 3 of Part 3 as if the substance were a restricted substance.

Maximum penalty: 10 penalty units.

A medical practitioner, nurse practitioner, dentist or veterinary surgeon must not issue a prescription for a Schedule 2 or 3 substance in a quantity, or for a purpose, that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances.

Maximum penalty: 10 penalty units.

A person who is not a medical practitioner, nurse practitioner, dentist, veterinary surgeon or pharmacist may supply a Schedule 2 or 3 substance to another person if the supplier holds a licence or authority under Part 8 to supply the substance.

(1)  A pharmacist must not supply a Schedule 3 substance to any person unless the pharmacist:

(a)  personally hands the substance to the person, and

(b)  gives the person an opportunity to seek advice as to the use of the substance, including advice that the person may require in respect of the dosage, frequency of administration and general toxicity of the substance.

(2)  This clause does not apply to the supply of any substance:

(a)  to a medical practitioner, nurse practitioner, dentist or veterinary surgeon, or

(b)  to any other person on the prescription of a medical practitioner, nurse practitioner, dentist or veterinary surgeon.

(3)  This clause does not apply to the supply of salbutamol or terbutaline in metered aerosols for first aid purposes to a person who holds a current emergency asthma management certificate issued by an organisation approved by the Director-General for the purposes of this subclause.

(4)  This clause does not apply to the supply to the chief nurse of a nursing home of any substance in the manufacturer’s original pack, in accordance with a written order signed by the chief nurse, if the Director-General has determined that the substance may be supplied for emergency use at the nursing home in accordance with the authorisation of a medical practitioner, dentist or nurse practitioner who prescribes substances to the nursing home’s residents.

Maximum penalty: 10 penalty units.

A pharmacist who supplies a Schedule 2 or 3 substance on prescription must endorse the prescription for the substance in accordance with clause 40 as if the substance were a restricted substance.

Maximum penalty: 10 penalty units.

(1)  A person must not obtain or use a Schedule 7 substance unless the person holds an authority under Part 8 to obtain or use the substance.

(2)  A dealer must not supply a Schedule 7 substance to any other person unless:

(a)  the dealer holds an authority under Part 8 to supply the substance, and

(b)  the person being supplied holds an authority under Part 8 to obtain the substance.

(3)  A person being supplied with a Schedule 7 substance must surrender to the dealer the person’s authority to obtain the substance.

(4)  In the case of an authority:

(a)  that authorises multiple supplies of a Schedule 7 substance, or

(b)  that has been issued to a class of persons (as referred to in clause 166 (3)),

it is sufficient compliance with subclause (3) if the person being supplied surrenders a copy of the authority to the dealer.

(5)  The functions of the Director-General under Part 8 with respect to an authority under this clause may be exercised by the Permanent Head of the Commonwealth Department of Health.

Maximum penalty: 10 penalty units.

(6)  The Director-General may, by order in writing, exempt any person or substance, or any class of persons or substances, from the requirements of this clause.

(7)  Such an exemption may be given unconditionally or subject to conditions.

(8)  This clause does not apply to:

(a)  the supply by wholesale of any Schedule 7 substance, or

(b)  the use by a person of any Schedule 7 substance that is:

(i)  a pesticide (within the meaning of the Pesticides Act 1999), or

(ii)  a stock medicine (within the meaning of the Stock Medicines Act 1989),

or the supply to, or obtaining by, such a person of any such substance, or

(c)  the use by a person in charge of an institution or facility for scientific research, instruction, analysis or study of any Schedule 7 substance for use in that institution or facility, or the supply to, or obtaining by, such a person of any such substance for use in that institution or facility, or

(d)  the use by a person of any Schedule 7 substance (other than a highly dangerous substance) for non-domestic purposes, or the supply to, or obtaining by, a person of any such substance for use for non-domestic purposes.

(9)  In subclause (8) (d), highly dangerous substance means any of the following substances:

arsenic

cyanides

fluoroacetamide

fluoroacetic acid

hydrocyanic acid

4-hydroxybutanoic acid

strychnine

thallium

any Schedule 7 substance that is listed in Appendix C of the current Poisons Standard

(1)  This clause applies to any Schedule 5, 6 or 7 substance that is specified in the Poisons List as being a substance that is manufactured or supplied for a particular use.

(2)  A dealer (other than a medical practitioner, nurse practitioner, dentist, veterinary surgeon or pharmacist) who supplies a substance to which this clause applies must supply the substance, unopened, in the container in which it was received by the dealer.

Maximum penalty: 10 penalty units.

(1)  A person must not supply any pencil, crayon, finger colour, poster paint, school pastel or show card colour or other such article or substance if the article or substance contains a Schedule 2, 3, 5, 6 or 7 substance.

(2)  Subclause (1) does not apply to the supply of artists’ oil colours.

(3)  A person must not supply any painted toy, furniture or other item of household goods if the paint contains a Schedule 6 or 7 substance.

Maximum penalty: 10 penalty units.

A medical practitioner, nurse practitioner, dentist, veterinary surgeon, pharmacist or retail dealer must not supply any poison:

(a)  in the case of a therapeutic substance, in a quantity, or for a purpose, that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances, or

(b)  in any other case, for a purpose other than that stated on its container or for a purpose other than that for which it is normally used.

Maximum penalty: 10 penalty units.

(1)  This clause applies to the following substances, but only in so far as they are Schedule 3 substances:

pseudoephedrine

(2)  A pharmacist who supplies a substance to which this clause applies, whether on prescription or otherwise, must record details of the supply in accordance with clause 54 as if the substance were a restricted substance.

Maximum penalty: 10 penalty units.

A person must not use or dispose of a poison in any place or in any manner likely to constitute a risk to the public.

Maximum penalty: 10 penalty units.

(1)  A dealer who supplies a restricted substance must ensure that the substance is packaged and labelled:

(a)  in accordance with the relevant provisions of the current Poisons Standard, and

(b)  in the case of a substance to which Therapeutic Goods Order No 20 applies, in accordance with that Order.

(2)  Despite subclause (1), a medical practitioner, dentist, veterinary surgeon or nurse practitioner who supplies a restricted substance must ensure that the substance is packaged in accordance with the requirements of that subclause but labelled in accordance with the requirements of Appendix A.

(3)  A pharmacist who supplies any quantity of a restricted substance on prescription, or in the circumstances referred to in clause 44 or 47, must ensure that the substance is supplied in a package that is labelled in accordance with the requirements of Appendix A instead of in accordance with the requirements of subclause (1).

Maximum penalty: 10 penalty units.

A dealer must not supply any substance in a container that has a label that states or implies that the substance is a restricted substance, unless the substance is such a substance.

Maximum penalty: 10 penalty units.

(1)  The Director-General may, by order in writing, exempt any person or substance, or any class of persons or substances, from the requirements of this Division.

(2)  Such an exemption may be given unconditionally or subject to conditions.

(3)  Subject to subclause (4), any exemption in force under a law of the Commonwealth, or of another State or Territory, corresponding to this clause has the same effect as an exemption under this clause.

(4)  The Director-General may, by order published in the Gazette, declare that subclause (3) does not have effect with respect to an exemption specified in the order.

A dealer who has possession of any restricted substance must keep the substance:

(a)  in a room or enclosure to which the public does not have access, and

(b)  apart from human or animal food, and

(c)  in such a way that, if its container breaks or leaks, the substance cannot mix with or contaminate any human or animal food.

Maximum penalty: 15 penalty units.

(1)  Prescribed restricted substances that are kept in a hospital ward must be stored apart from all other goods (other than drugs of addiction) in a separate room, safe, cupboard or other receptacle securely attached to a part of the premises and kept securely locked when not in immediate use.

(2)  This clause does not apply to the storage of prescribed restricted substances on an emergency trolley, anaesthetic trolley or operating theatre trolley.

Maximum penalty: 20 penalty units.

(1)  The chief pharmacist of a hospital is responsible for the storage of all restricted substances at the hospital other than those that have been supplied to a ward.

(2)  In the case of a hospital for which there is no pharmacist, the responsibilities of a chief pharmacist under this clause are instead the responsibilities of:

(a)  the chief nurse of the hospital, or

(b)  the medical superintendent of the hospital,

as the chief executive officer of the hospital may determine.

(3)  The nurse in charge of a hospital ward is responsible for the storage of all restricted substances in the ward.

(1)  A person must not issue a prescription for a restricted substance unless authorised to do so by this clause.

(2)  A medical practitioner, nurse practitioner, dentist or veterinary surgeon may issue a prescription for a restricted substance.

Maximum penalty: 15 penalty units.

(1)  A medical practitioner must not issue a prescription for a restricted substance otherwise than for medical treatment.

(2)  A nurse practitioner must not issue a prescription for a restricted substance otherwise than in the course of practising as a nurse practitioner.

(3)  A dentist must not issue a prescription for a restricted substance otherwise than for dental treatment, and must endorse any such prescription with the words “FOR DENTAL TREATMENT ONLY”.

(4)  A veterinary surgeon must not issue a prescription for a restricted substance otherwise than for veterinary treatment, and must endorse any such prescription with the words “FOR ANIMAL TREATMENT ONLY”.

Maximum penalty: 15 penalty units.

A medical practitioner, nurse practitioner, dentist or veterinary surgeon must not issue a prescription for a restricted substance in a quantity, or for a purpose, that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances.

Maximum penalty: 15 penalty units.

(1)  A prescription for a restricted substance must include the following details:

(a)  the date on which it is issued,

(b)  the name and address of the patient or (if the treatment is for an animal) the species of animal and the name and address of the animal’s owner,

(c)  the name, strength and quantity of the substance to be supplied,

(d)  adequate directions for use,

(e)  the maximum number of times the substance may be supplied on the prescription,

(f)  in the case of a prescription for an Appendix B substance, the intervals at which the substance may be supplied on the prescription,

(g)  if the prescription is issued at a hospital, the name and designation of the person by whom it is issued and the name, address and telephone number of the hospital,

(h)  if the prescription is issued elsewhere than at a hospital, the name and designation of the person by whom it is issued and the address and telephone number of the premises at which it is issued.

(2)  The details referred to in subclause (1) (a)–(f) must be made out:

(a)  in the handwriting of the person by whom the prescription is issued, or

(b)  in such other manner as may be approved for the time being by the Director-General,

and the prescription must be signed by the person by whom it is issued.

(3)  The person by whom the prescription is issued must confirm any dose that could be regarded as being dangerous or unusual by underlining the part of the prescription that specifies the intended dose and by initialling the prescription in the margin.

(4)  A person who issues a prescription for a restricted substance must ensure that the prescription complies with the requirements of this clause.

Maximum penalty: 15 penalty units.

(1)  In an emergency, a medical practitioner, nurse practitioner, dentist or veterinary surgeon may direct the supply of a restricted substance orally, by telephone, by electronic mail or by facsimile.

(2)  A person who so directs the supply of a restricted substance:

(a)  must immediately make out a prescription, and

(b)  must send the prescription without delay (and in any case within 24 hours) to the person to whom the direction was given.

(3)  A person who issues a prescription under this clause must ensure that the prescription is endorsed with words that indicate the prescription has been issued in confirmation of a direction under this clause.

(4)  This clause does not apply to a direction given under clause 57.

Maximum penalty: 15 penalty units.

(1)  This clause applies to the following restricted substances:

acitretin

clomiphene

cyclofenil

dinoprost

dinoprostone

etretinate

follitropin beta

isotretinoin for oral use

luteinising hormone

tretinoin for oral use

urofollitrophin (human follicle stimulating hormone)

(2)  A person must not prescribe a restricted substance to which this clause applies unless the person holds an authority under Part 8 to prescribe the substance.

(3)  This clause does not apply to the prescription of a substance:

(a)  by a veterinary surgeon, or

(b)  by a person who is authorised by the Permanent Head of the Commonwealth Department of Health to issue a prescription for the substance.

(4)  A person who issues a prescription that authorises the supply of a substance to which this clause applies must ensure:

(a)  in the case of a prescription that is issued in accordance with an authority under Part 8 that was granted to a particular person (by means of an instrument in writing given to the person), that the prescription is endorsed with the reference number shown on the authority, or

(b)  in any other case, that the prescription is endorsed with the words “ISSUED UNDER CLAUSE 36 OF THE POISONS AND THERAPEUTIC GOODS REGULATION 2002” or with other words that indicate that the prescription has been issued under this clause.

Maximum penalty: 15 penalty units.

(1)  A medical practitioner, nurse practitioner, dentist or veterinary surgeon who prescribes a prescribed restricted substance must make a record of the following particulars:

(a)  the name, strength and quantity of the substance prescribed and the date on which it was prescribed,

(b)  if the substance is intended for the treatment of a person, the name and address of the person to be treated,

(c)  if the substance is intended for the treatment of an animal, the species of animal and the name and address of the animal’s owner,

(d)  the maximum number of times the substance may be supplied on the prescription,

(e)  in the case of a prescription for an Appendix B substance, the intervals at which the substance may be supplied on the prescription,

(f)  the directions for use, as shown on the prescription.

(2)  The record must be kept at the surgery, hospital or office of the person prescribing the substance.

Maximum penalty: 15 penalty units.

(1)  A pharmacist who supplies a restricted substance on prescription must record the following details in a manner approved by the Director-General:

(a)  the details required by clause 34 (1) to be included in the prescription,

(b)  a unique reference number for the prescription,

(c)  the date on which the substance was supplied,

(d)  the name of the person by whom the substance was supplied.

(2)  A prescription for the supply of a restricted substance in a hospital need not be recorded so long as the chief pharmacist of the hospital keeps the prescription or a copy of the prescription.

Maximum penalty: 15 penalty units.

A medical practitioner, nurse practitioner, dentist or veterinary surgeon who supplies a restricted substance in a quantity exceeding that required for 3 days’ treatment:

(a)  must record the name, strength and quantity of the substance supplied and the date on which it was supplied, and

(b)  must record the name and address of the patient or (if the treatment is for an animal) the species of animal and the name and address of the animal’s owner, and

(c)  must keep the record of the supply of the substance at the hospital, surgery or office of the person supplying the substance.

Maximum penalty: 15 penalty units.

A pharmacist who supplies a restricted substance as referred to in clause 44, or who supplies the restricted substance benzylpenicillin as referred to in clause 47, must record the following details of the supply in a manner approved by the Director-General:

(a)  a unique reference number for the supply,

(b)  the name and address of the patient or (if the treatment is for an animal) the species of animal and the name and address of the animal’s owner,

(c)  the name, strength and quantity of the substance,

(d)  the directions given by the pharmacist for the use of the substance,

(e)  in the case of a restricted substance supplied as referred to in clause 44, the name and address of the medical practitioner, dentist or nurse practitioner by whom it appears to the pharmacist that the substance was last prescribed,

(f)  the date on which the substance was supplied,

(g)  the name of the person by whom the substance was supplied.

Maximum penalty: 15 penalty units.

(1)  A person employed at a hospital must not administer a restricted substance to a patient in the hospital otherwise than on the direction of a medical practitioner, nurse practitioner or dentist.

(2)  Such a direction:

(a)  must be given in writing (otherwise than by electronic mail or facsimile) or in any other manner approved by the Director-General for the purposes of this paragraph, or

(b)  in an emergency, may be given:

(i)  by electronic mail or by facsimile, or

(ii)  orally, by telephone or in any other manner approved by the Director-General for the purposes of this subparagraph.

(3)  A medical practitioner, a nurse practitioner or a dentist who gives a direction under subclause (2) (b) (ii) must:

(a)  as soon as is practicable (and in any case within the next 24 hours) either:

(i)  sign an entry in the patient’s medical history confirming that he or she has given the direction, or

(ii)  confirm the direction by electronic mail or by facsimile, and

(b)  attend to review the patient as soon as he or she considers it appropriate in the circumstances of the case.

(4)  If confirmation is not received within 7 days after the restricted substance is administered, the person by whom the substance was administered must report that fact to the Director-General.

(5)  A medical practitioner, a nurse practitioner or a dentist who, by electronic mail or by facsimile, gives or confirms a direction for the administration of a restricted substance to a patient must attend to review the patient as soon as he or she considers it appropriate in the circumstances of the case.

(6)  Subclauses (3), (4) and (5) do not apply to the administration of a restricted substance to an inmate of a correctional centre (within the meaning of the Crimes (Administration of Sentences) Act 1999) if confirmation of the direction for the administration of the substance has been given in accordance with the requirements of a protocol approved by the Director-General.

Maximum penalty: 15 penalty units.

(1)  A person must not self-administer a prescribed restricted substance, or administer a prescribed restricted substance to any other person, otherwise than:

(a)  for the purposes of medical treatment prescribed by a medical practitioner, or

(b)  for the purposes of dental treatment prescribed by a dentist, or

(c)  for the purposes of treatment prescribed by a nurse practitioner in the course of practising as a nurse practitioner.

Maximum penalty: 20 penalty units.

(2)  For the purposes of subclause (1), it is sufficient if the treatment referred to in subclause (1) (a), (b) or (c) in relation to the self-administration of a prescribed restricted substance has been prescribed by the person by whom the substance is being self-administered.

(3)  This clause has effect for the purposes of Division 1 of Part 2 of the Drug Misuse and Trafficking Act 1985 in relation to any prescribed restricted substance that is included in Schedule 1 to that Act.

(1)  This clause applies to the following restricted substances:

acitretin

clomiphene

cyclofenil

dinoprost

dinoprostone

etretinate

follitropin beta

isotretinoin for oral use

luteinising hormone

tretinoin for oral use

urofollitrophin (human follicle stimulating hormone)

(2)  A person must not administer a restricted substance to which this clause applies unless the person holds an authority under Part 8 to administer the substance.

(3)  This clause does not apply to:

(a)  the administration to a patient of a substance whose administration has been prescribed or directed by a medical practitioner holding an authority under Part 8 to prescribe the substance, or

(b)  the administration of a substance to an animal by a veterinary surgeon or by a person acting under the general supervision of a veterinary surgeon.

Maximum penalty: 15 penalty units.

(1)  For the purposes of section 16 of the Act, the substances specified in Appendix D are prescribed restricted substances.

(2)  The substances specified in Appendix D are also restricted substances for the purposes of sections 9, 10, 11 and 18 of the Act, as referred to in paragraph (a) of the matter specified at the end of sections 9 (1), 10 (3), 11 (1) and 18 of the Act with respect to penalties.

(3)  For the purposes of section 18A (1) of the Act, the quantities specified in Appendix D are the prescribed quantities for the corresponding restricted substances specified in that Appendix.

For the purposes of section 16 (1) (e) of the Act, the following persons are authorised to obtain possession of prescribed restricted substances for the purposes of their profession or employment:

(a)  the chief nurse of a hospital that does not employ a chief pharmacist,

(b)  the master of a ship, in respect of a therapeutic substance that is required by law to be carried on the ship,

(c)  the holder of a licence under Part 8 to manufacture or supply drugs of addiction,

(d)  an analyst,

(e)  a scientifically qualified person in charge of a laboratory or department, being a person who is engaged in medical or scientific research or instruction, or in quality control or analysis,

(f)  a person acting under the direct personal supervision of a person referred to in paragraph (d) or (e).

(1)  A person who asks a medical practitioner, nurse practitioner or dentist:

(a)  to supply the person with a prescribed restricted substance, or

(b)  to give the person a prescription for a prescribed restricted substance,

must disclose to the medical practitioner, nurse practitioner or dentist the quantity of that and any other prescribed restricted substance with which the person has been supplied, or for which the person has been given prescriptions, within the last 2 months.

(2)  If the request is made on behalf of some other person, the person making the request is obliged only to furnish such information as is within that person’s knowledge.

Maximum penalty: 20 penalty units.

A carrier is authorised to be in possession of a package containing a prescribed restricted substance, but for the purpose only of delivering it to the person to whom it is addressed.

(1)  This clause applies to pentobarbitone sodium to the extent only to which it is a restricted substance, and not to the extent to which it is a drug of addiction.

(2)  An authorised person who uses pentobarbitone sodium for the destruction of animals must ensure that the requirements of this clause are complied with.

(3)  Pentobarbitone sodium must be kept separately from all other goods in a safe, cupboard or other receptacle:

(a)  that is securely attached to a part of the premises, and

(b)  that is kept securely locked except when in immediate use.

(4)  An authorised person must keep a separate register of all pentobarbitone sodium that is obtained or used by the authorised person.

(5)  On the day on which an authorised person obtains or uses any pentobarbitone sodium, the authorised person must enter in the register such of the following details as are relevant to the transaction:

(a)  the quantity that was obtained or used,

(b)  the name and address of the person from whom it was obtained,

(c)  the number and species of animals for which it was used,

(d)  the total quantity held by the authorised person after the entry is made.

(6)  Each entry must be dated and signed by the authorised person.

(7)  In this clause, authorised person means:

(a)  a person nominated by the council of a local government area, or

(b)  an officer of an animal welfare organisation nominated by the organisation,

being in either case a person who is authorised under section 16 (1) (d) of the Act to obtain possession of pentobarbitone sodium for the humane destruction of animals.

Maximum penalty: 20 penalty units.

A person must not use or dispose of a restricted substance in any place or in any manner likely to constitute a risk to the public.

Maximum penalty: 15 penalty units.

(1)  A person must immediately notify the Director-General if the person loses a prescribed restricted substance or if a prescribed restricted substance is stolen from the person.

(2)  This clause does not apply to the loss of any substance by, or the theft of any substance from, a person who has been supplied with the substance by, or on the prescription of, a medical practitioner, nurse practitioner, dentist or veterinary surgeon.

Maximum penalty: 20 penalty units.

The court before which a person is convicted of the illegal possession of a prescribed restricted substance may order that the substance be forfeited to the Crown, and may further order the forfeited substance to be destroyed or otherwise disposed of as the court thinks fit.

(1)  A dealer who supplies a drug of addiction must ensure that the drug is packaged and labelled:

(a)  in accordance with the relevant provisions of the current Poisons Standard, and

(b)  in the case of a drug of addiction to which Therapeutic Goods Order No 20 applies, in accordance with that Order.

(2)  Despite subclause (1), a medical practitioner, dentist or veterinary surgeon who supplies a drug of addiction must ensure that the drug is packaged in accordance with the requirements of that subclause but labelled in accordance with the requirements of Appendix A.

(3)  A pharmacist who supplies any quantity of a drug of addiction on prescription must ensure that the drug is supplied in a package that is labelled in accordance with the requirements of Appendix A instead of in accordance with the requirements of subclause (1).

Maximum penalty: 10 penalty units.

A dealer must not supply any substance in a container that has a label that states or implies that the substance is a drug of addiction, unless the substance is such a drug.

Maximum penalty: 10 penalty units.

(1)  A dealer who supplies any drug of addiction must ensure that the drug is packaged in such a way that:

(a)  its container is so sealed that, when the seal is broken, it is readily distinguishable from sealed containers, and

(b)  if several containers are enclosed in a single primary pack, the primary pack is so sealed that, when the seal is broken, it is readily distinguishable from sealed primary packs.

(2)  This clause does not apply to the supply of a drug of addiction:

(a)  by a medical practitioner, dentist or veterinary surgeon in the practice of his or her profession, or

(b)  by a pharmacist on the prescription of a medical practitioner, dentist or veterinary surgeon, or

(c)  by a pharmacist employed at a hospital, on the written requisition of a medical practitioner, a dentist or the nurse in charge of the ward in which the drug is to be used or stored, or

(d)  by a nurse on the direction in writing of a medical practitioner or dentist.

Maximum penalty: 20 penalty units.

(1)  The Director-General may, by order in writing, exempt any person or substance, or any class of persons or substances, from the requirements of this Division.

(2)  Such an exemption may be given unconditionally or subject to conditions.

(3)  Subject to subclause (4), any exemption in force under a law of the Commonwealth, or of another State or Territory, corresponding to this clause has the same effect as an exemption under this clause.

(4)  The Director-General may, by order published in the Gazette, declare that subclause (3) does not have effect with respect to an exemption specified in the order.

(1)  A person who is in possession of any drug of addiction must keep the drug in his or her possession stored apart from all other goods (other than cash or documents) in a separate room, safe, cupboard or other receptacle securely attached to a part of the premises and kept securely locked when not in immediate use.

(2)  A medical practitioner, dentist or veterinary surgeon is taken to comply with this clause if he or she keeps any drug of addiction (for use in an emergency only) in a bag that is in a room, or in a vehicle, kept locked when not occupied by the medical practitioner, dentist or veterinary surgeon.

Maximum penalty: 20 penalty units.

(1)  The chief pharmacist of a hospital is responsible for the storage of all drugs of addiction at a hospital other than those that have been supplied to a ward.

(2)  In the case of a hospital for which there is no pharmacist, the responsibilities of a chief pharmacist under this clause are instead the responsibilities of:

(a)  the chief nurse of the hospital, or

(b)  the medical superintendent of the hospital,

as the chief executive officer of the hospital may determine.

(3)  The nurse in charge of a hospital ward is responsible for the storage of all drugs of addiction in the ward.

(1)  Drugs of addiction that are kept in a hospital ward must be stored apart from all other goods (other than prescribed restricted substances) in a separate room, safe, cupboard or other receptacle securely attached to a part of the ward and kept securely locked when not in immediate use.

(2)  The nurse in charge of a hospital ward must ensure that:

(a)  the room, safe, cupboard or receptacle is kept securely locked when not in immediate use, and

(b)  any key or other device by means of which the room, safe, cupboard or receptacle may be unlocked:

(i)  is kept on the person of a nurse whenever it is in the ward, and is removed from the ward whenever there is no nurse in the ward, or

(ii)  is kept in a separately locked safe to which only a nurse has access, and

(c)  any code or combination that is required to unlock the room, safe, cupboard or receptacle is not divulged to any unauthorised person.

Maximum penalty: 20 penalty units.

(1)  The pharmacist for the time being in charge of a pharmacy must keep any drug of addiction stored apart from other substances or goods (other than cash or documents) in a separate safe.

(2)  Unless otherwise approved for the time being by the Director-General, such a safe must comply with the following requirements:

(a)  it must be made of black mild steel plate at least 9 millimetres thick with continuous welding along all edges,

(b)  it must be fitted with a door made of mild steel plate at least 9 millimetres thick, the door being flush fitting with a clearance around the door of not more than 1.5 millimetres,

(c)  it must have a fixed locking bar, welded to the inside face of the door near the hinged edge, that engages in a rebate in the safe body when the door is closed,

(d)  it must be fitted with a five lever key lock (or a locking mechanism providing at least equivalent security) securely fixed to the rear face of the door,

(e)  if mounted on a brick or concrete wall or floor, it must be attached to the wall or floor by means of suitably sized expanding bolts through holes 9 millimetres in diameter drilled in the rear or bottom of the safe,

(f)  if mounted on a timber framed wall or floor, it must be attached to the wall or floor frame by means of suitably sized coachscrews through holes 9 millimetres in diameter drilled in the rear or bottom of the safe,

(g)  if mounted on any other kind of wall or floor, it must be attached to the wall or floor in a manner approved for the time being by the Director-General.

(3)  The pharmacist must ensure that:

(a)  the safe is kept securely locked when not in immediate use, and

(b)  any key or other device by means of which the safe may be unlocked:

(i)  is kept on the person of a pharmacist whenever it is on the same premises as the safe, and is removed from the premises whenever there is no pharmacist at those premises, or

(ii)  is kept in a separately locked safe to which only a pharmacist has access, and

(c)  any code or combination that is required to unlock the safe is not divulged to any unauthorised person.

(4)  This clause applies to a hospital pharmacy as well as to a retail pharmacy.

Maximum penalty: 20 penalty units.

(1)  A person must not issue a prescription for a drug of addiction unless authorised to do so by this clause.

(2)  A medical practitioner, dentist or veterinary surgeon may issue a prescription for a drug of addiction.

Maximum penalty: 20 penalty units.

(1)  A person who issues a prescription for a drug of addiction must ensure that the prescription includes the following details:

(a)  the date on which it is issued,

(b)  the name and address of the patient or (if the treatment is for an animal) the species of animal and the name and address of the animal’s owner,

(c)  the name, strength and quantity (expressed in both words and figures) of the drug to be supplied,

(d)  adequate directions for use,

(e)  the maximum number of times the drug may be supplied on the prescription,

(f)  the intervals at which the drug may be supplied on the prescription,

(g)  if the prescription is issued at a hospital, the name and designation of the person by whom it is issued and the name, address and telephone number of the hospital,

(h)  if the prescription is issued elsewhere than at a hospital, the name and designation of the person by whom it is issued and the address and telephone number of the premises at which it is issued.

(2)  The details referred to in subclause (1) (a)–(f) must be made out:

(a)  in the handwriting of the person by whom the prescription is issued, or

(b)  in such other manner as may be approved for the time being by the Director-General,

and the prescription must be signed by the person by whom it is issued.

(3)  The person by whom the prescription is issued must confirm any dose that could be regarded as being dangerous or unusual by underlining the part of the prescription that specifies the intended dose and by initialling the prescription in the margin.

(4)  A person must not issue a prescription that includes:

(a)  more than one preparation containing a drug of addiction, or

(b)  both a preparation containing a drug of addiction and another preparation.

Maximum penalty: 20 penalty units.

(1)  A medical practitioner must not issue a prescription for a drug of addiction otherwise than for medical treatment.

(2)  A dentist must not issue a prescription for a drug of addiction otherwise than for the dental treatment (for a period not exceeding one month’s continuous treatment) of a patient and must endorse any such prescription with the words “FOR DENTAL TREATMENT ONLY”.

(3)  If the patient is in a hospital, the dentist may issue a prescription for any drug of addiction.

(4)  If the patient is not in a hospital, the dentist may issue a prescription only:

(a)  for pentazocine, or

(b)  for any drug of addiction included in the list of preparations that may be prescribed by participating dental practitioners for dental treatment only set out in the Schedule of Pharmaceutical Benefits issued by the Commonwealth Department of Health, as that Schedule is in force from time to time.

(5)  A veterinary surgeon must not issue a prescription for a drug of addiction otherwise than for veterinary treatment, and must endorse any such prescription with the words “FOR ANIMAL TREATMENT ONLY”.

Maximum penalty: 20 penalty units.

A medical practitioner, dentist or veterinary surgeon must not issue a prescription for a drug of addiction in a quantity, or for a purpose, that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances.

Maximum penalty: 20 penalty units.

(1)  In an emergency, a medical practitioner, dentist or veterinary surgeon may direct the supply of a drug of addiction orally, by telephone, by electronic mail or by facsimile.

(2)  A person who so directs the supply of a drug of addiction:

(a)  must immediately make out a prescription, and

(b)  must send the prescription without delay (and in any case within 24 hours) to the person to whom the direction was given.

(3)  A person who issues a prescription under this clause must ensure that the prescription is endorsed with words that indicate the prescription has been issued in confirmation of a direction under this clause.

(4)  This clause does not apply to a direction given under clause 119.

Maximum penalty: 20 penalty units.

(1)  A medical practitioner, dentist or veterinary surgeon who prescribes a drug of addiction must make a record of the following particulars:

(a)  the name, strength and quantity of the drug prescribed and the date on which it was prescribed,

(b)  if the drug is intended for the treatment of a person, the name and address of the person to be treated,

(c)  if the drug is intended for the treatment of an animal, the species of animal and the name and address of the animal’s owner,

(d)  the maximum number of times the drug may be supplied on the prescription,

(e)  the intervals at which the substance may be supplied on the prescription,

(f)  the directions for use, as shown on the prescription.

(2)  The record must be kept at the surgery, hospital or office of the person prescribing the substance.

Maximum penalty: 20 penalty units.

(1)  A medical practitioner is authorised to issue a prescription for a drug of addiction for a person without an authority under section 29 of the Act if:

(a)  the medical practitioner is of the opinion that the person requires the use of the drug in the course of treatment as an in-patient in a public or private hospital, and

(b)  the prescription is for a course of treatment for a period of not more than 14 days following the person’s admission as an in-patient.

(2)  A medical practitioner is authorised to issue a prescription for a drug of addiction for a person for continuous therapeutic use by that person for a period of up to 12 months without an authority under section 29 of the Act if:

(a)  the medical practitioner is of the opinion that the person requires the drug for the relief of pain associated with cancer, and

(b)  a medical practitioner (whether or not the medical practitioner referred to in paragraph (a)) whose qualifications in the diagnosis and treatment of cancer are recognised by the National Specialist Qualification Advisory Committee of Australia, or who is approved by the Director-General for the purposes of this paragraph, has made the diagnosis of cancer, and

(c)  either the medical practitioner referred to in paragraph (a) or a medical practitioner referred to in paragraph (b) has estimated the person’s life expectancy to be 12 months or less.

(3)  Subclause (2) does not authorise a medical practitioner to prescribe the following drugs of addiction in the circumstances referred to in that subclause:

dextromoramide (all forms)

fentanyl (all forms, except transdermal patches)

pethidine (parenteral forms only)

(4)  A medical practitioner is authorised to prescribe methadone or buprenorphine for the treatment of a person without an authority under section 29 of the Act if:

(a)  the medical practitioner is a person approved under section 28A of the Act as a prescriber of drugs of addiction, and

(b)  at the time the prescription is issued the person is, or at some time during the preceding 21 days was, an inmate in a correctional centre (within the meaning of the Crimes (Administration of Sentences) Act 1999), and

(c)  the prescription is for methadone or buprenorphine in oral dosage form for use by the person as a course of treatment:

(i)  while an inmate, or

(ii)  during a period of not more than 21 days after release, and

(d)  immediately before the person became an inmate, a medical practitioner had an authority under section 29 of the Act to prescribe methadone or buprenorphine for the person, or supply methadone or buprenorphine to the person, and

(e)  the prescription is issued for the purpose of continuing the treatment that the person was receiving or was about to receive immediately before the person became an inmate.

(5)  A medical practitioner is authorised to issue a prescription for a drug of addiction for a person without an authority under section 29 of the Act if:

(a)  the person is the subject of such an authority, and

(b)  the medical practitioner is practising at the same premises as the holder of that authority, and

(c)  the prescription is issued in accordance with any conditions to which that authority is subject.

cl 82: Am 2004 No 37, Sch 6 [1].

(1)  This clause applies to the following substances:

amphetamine

dexamphetamine

methylamphetamine

methylphenidate

phendimetrazine

phenmetrazine

(2)  A medical practitioner is authorised to issue a prescription for dexamphetamine or methylphenidate for a person without an authority under section 29 of the Act:

(a)  for the purpose of testing the suitability of the person to undergo a course of medical treatment involving the use of such a substance, or

(b)  for the purpose of treating the person for attention deficit disorder (ADD) or attention deficit hyperactivity disorder (ADHD),

so long as the medical practitioner holds an authority under Part 8 to prescribe such a substance.

(3)  A dentist or veterinary surgeon must not issue a prescription for a substance to which this clause applies.

Maximum penalty: 20 penalty units.

(1)  A person employed at a hospital must not administer a drug of addiction to a patient in the hospital otherwise than on the direction of a medical practitioner or dentist.

(2)  Such a direction:

(a)  must be given in writing (otherwise than by electronic mail or facsimile) or in any other manner approved by the Director-General for the purposes of this paragraph, or

(b)  in an emergency, may be given:

(i)  by electronic mail or by facsimile, or

(ii)  orally, by telephone or in any other manner approved by the Director-General for the purposes of this subparagraph.

(3)  A medical practitioner or a dentist who gives a direction under subclause (2) (b) (ii) must:

(a)  as soon as is practicable (and in any case within the next 24 hours) either:

(i)  sign an entry in the patient’s medical history confirming that he or she has given the direction, or

(ii)  confirm the direction by electronic mail or by facsimile, and

(b)  attend to review the patient as soon as he or she considers it appropriate in the circumstances of the case.

(4)  If confirmation is not received within 7 days after the drug of addiction is administered, the person by whom the drug was administered must report that fact to the Director-General.

(5)  A medical practitioner or a dentist who, by electronic mail or by facsimile, gives or confirms a direction for the administration of a drug of addiction to a patient must also attend to review the patient as soon as he or she considers it appropriate in the circumstances of the case.

(6)  Subclauses (3), (4) and (5) do not apply to the administration of a drug of addiction to an inmate of a correctional centre (within the meaning of the Crimes (Administration of Sentences) Act 1999) if confirmation of the direction for the administration of the substance has been given in accordance with the requirements of a protocol approved by the Director-General.

Maximum penalty: 20 penalty units.

(1)  For the purposes of Division 1 of Part 2 of the Drug Misuse and Trafficking Act 1985:

(a)  a medical practitioner is authorised to self-administer a drug of addiction, but only if the medical practitioner does so for the purposes of medical treatment, and

(b)  a dentist is authorised to self-administer a drug of addiction, but only if the dentist does so for the purposes of dental treatment.

(2)  Subclause (1) does not authorise a medical practitioner or dentist to self-administer a drug of addiction for more than 7 days.

(3)  However, a medical practitioner may self-administer a drug of addiction for more than 7 days if the medical practitioner does so in accordance with an authority issued under section 29 of the Act.

For the purposes of section 28 (c) of the Act, the following substances are prescribed drugs of addiction:

amphetamine

dexamphetamine

methylamphetamine

methylphenidate

phendimetrazine

phenmetrazine

A person who is authorised to be in possession of drugs of addiction must immediately notify the Director-General if the person loses a drug of addiction or if a drug of addiction is stolen from him or her.

Maximum penalty: 20 penalty units.

(1)  A person who is authorised to be in possession of a drug of addiction must not wilfully destroy the drug or allow the drug to be destroyed.

(2)  This clause does not apply to the destruction of a drug of addiction carried out:

(a)  by or under the direct personal supervision of a police officer or an inspector or by or under the direct personal supervision of a person authorised, whether generally or in a particular case, by an authority under Part 8 held by the person, or

(b)  by or under the direct personal supervision of a person who is in charge of a laboratory, or who is an analyst, but only if the destruction is carried out in accordance with an authority under Part 8 held by the person, or

(c)  by a person to whom the drug has been supplied by, or in accordance with the prescription of, a medical practitioner, dentist or veterinary surgeon, or

(d)  in accordance with clause 124 or 125.

Maximum penalty: 20 penalty units.

(1)  The nurse in charge of a ward in a public hospital having responsibility for a drug of addiction that becomes unusable must immediately notify the chief pharmacist of the hospital of the fact and of the circumstances under which the drug became unusable.

(2)  A pharmacist employed in a public hospital:

(a)  may (but only in the presence of a nurse) destroy the drug of addiction, and

(b)  in that event, must record the fact of the destruction of the drug in the ward register.

(3)  The entry must be dated and signed by the pharmacist and countersigned by the nurse who witnessed the destruction of the drug.

(4)  In the case of a public hospital for which there is no pharmacist, the functions of a chief pharmacist or pharmacist under this clause are instead the functions of:

(a)  the chief nurse of the hospital, or

(b)  the medical superintendent of the hospital,

as the chief executive officer of the hospital may determine.

Maximum penalty: 20 penalty units.

(1)  A retail pharmacist who is engaged in the supply of restricted substances or drugs of addiction:

(a)  to a private hospital, nursing home or day procedure centre, or

(b)  to a patient in a private hospital, nursing home or day procedure centre,

is authorised to destroy any unwanted drug of addiction on the premises of that private hospital, nursing home or day procedure centre.

(2)  Subclause (1) applies only where the drug is destroyed in the presence of:

(a)  where the private hospital, nursing home or day procedure centre is the holder of a licence under Division 2 of Part 8, the person who is named on the licence as being responsible for the storage of drugs of addiction, or

(b)  in any other case, the chief nurse of the private hospital, nursing home or day procedure centre.

(3)  A pharmacist who destroys a drug of addiction in accordance with this clause:

(a)  must record the fact of the destruction of the drug by an entry in the drug register maintained by the private hospital, nursing home or day procedure centre, and

(b)  must ensure that the entry is dated and signed by the pharmacist, and is countersigned by a person who witnessed the destruction of the drug.

Maximum penalty: 20 penalty units.

This Division applies to all therapeutic goods, and all substances used in the preparation of therapeutic goods, that are unpackaged or otherwise susceptible to contamination (in this Division referred to as exposed substances).

A medical practitioner, nurse practitioner, dentist, veterinary surgeon, pharmacist or practitioner of alternative medicine must ensure that:

(a)  all exposed substances that are prepared or handled on his or her business premises are free from any contamination and from anything that is likely to render them harmful or to have an adverse effect on their efficacy, and

(b)  all persons that he or she employs in the preparation or handling of exposed substances comply with the requirements of this Division.

Maximum penalty: 20 penalty units.

A person who is involved in the preparation or handling of exposed substances:

(a)  must be clean and must wear clean clothing, and

(b)  must clean his or her hands (by means of soap or detergent and water or by some other suitable cleaning process) before starting work and before resuming work after using the toilet.

Maximum penalty: 10 penalty units.

A person who is involved in the preparation or handling of exposed substances, or who is in a place that is used for preparing or handling exposed substances, must not:

(a)  urinate, defecate or spit, or

(b)  use, smoke or chew tobacco or any other similar substance, or

(c)  sit, walk, stand or lie on any surface used for the purpose of preparing or handling exposed substances.

Maximum penalty: 10 penalty units.

A person who is involved in the preparation or handling of exposed substances:

(a)  must not have any unnecessary human contact with any such substance, and

(b)  must not handle any such substance with his or her fingers, but must use a suitable implement to do so, and

(c)  must not touch his or her mouth, eye, ear, nose or scalp while handling any such substance, and

(d)  must not wipe his or her hands otherwise than with a clean towel, and

(e)  must not place, so that it can come into contact with any such substance, any ticket, label or other article that is unclean or liable to contaminate any such substance or that has been in contact with the person’s mouth, and

(f)  must not place in his or her pockets any implement used in preparing or handling any such substance.

Maximum penalty: 10 penalty units.

A person who is involved in the preparation or handling of exposed substances must not apply to his or her mouth any implement used for preparing or handling any such substance.

Maximum penalty: 10 penalty units.

A person who is wearing an unclean bandage or a medicated or absorbent bandage must not prepare or handle exposed substances, or use any appliance, article or fitting for preparing or handling exposed substances, unless the bandage is protected and covered with a waterproof covering.

Maximum penalty: 10 penalty units.

(1)  A person who is suffering from an infectious disease, or who has any exposed cut, sore, wound or skin eruption, must not prepare or handle exposed substances, or use any appliance, article or fitting for preparing or handling exposed substances.

Maximum penalty: 10 penalty units.

(2)  This clause does not apply to an activity carried out by a person if the Director-General has certified in writing that the person may carry out that activity and the person complies with any conditions contained in the certificate.

(1)  A person who is involved in the preparation or handling of exposed substances must not use any appliance, article or fitting for preparing or handling any such substance unless the appliance, article or fitting:

(a)  is designed and constructed so as to be easily cleaned, and

(b)  is kept clean.

Maximum penalty: 10 penalty units.

(2)  A person who is involved in the preparation or handling of exposed substances must not cause or allow any such substance to come into contact with any surface used for preparing or handling any such substance unless the surface:

(a)  is designed and constructed so as to be easily cleaned, and

(b)  is kept clean.

Maximum penalty: 10 penalty units.

A person must not use any premises for preparing, handling or supplying therapeutic goods unless the premises are clean and free from vermin.

Maximum penalty: 10 penalty units.

(1)  A person who uses any premises for preparing, handling or supplying therapeutic goods must not cause or permit any animal or bird to be in those premises.

Maximum penalty: 10 penalty units.

(2)  This clause does not apply to the premises of a veterinary surgeon.

(1)  This clause applies to all therapeutic goods that are not therapeutic devices and are not included in a Schedule of the Poisons List (in this clause referred to as unscheduled therapeutic substances).

(2)  A medical practitioner, nurse practitioner, dentist, veterinary surgeon, pharmacist or practitioner of alternative medicine must ensure that any unscheduled therapeutic substances that are supplied from his or her business premises for therapeutic use are labelled in accordance with the requirements of Appendix A.

Maximum penalty: 10 penalty units.

(3)  This clause does not apply to the supply of a substance by a person referred to in subclause (2) if:

(a)  the substance is supplied, unopened, in the container in which it was received by the person, and

(b)  the container is labelled in accordance with the requirements of the Commonwealth therapeutic goods laws.

(1)  An inspector who seizes a portion or sample of regulated goods for analysis:

(a)  must immediately notify the person from whom the portion or sample was taken of the inspector’s intention to submit it for analysis, and

(b)  must divide the portion or sample into 3 parts and properly fasten and seal each part or (if that is impracticable) properly fasten and seal the whole portion or sample.

(2)  If the portion or sample is divided into 3 parts, the inspector:

(a)  must return one part to the person from whom it was taken, and

(b)  must forward another part for analysis, and

(c)  must retain the remaining part.

(3)  If the portion or sample is not divided into 3 parts, the inspector must forward the whole of it for analysis.

(4)  For the purposes of this clause, a portion or sample is properly fastened and sealed if:

(a)  it is put into a container, and

(b)  the container is marked with the name and address of the person from whom it was taken, and

(c)  the container is fastened and sealed so as to prevent the container from being opened, or the name and address being removed, without the seal’s being broken.

Payment for a portion or sample of regulated goods that is seized for analysis is to be made by the State, at current market value:

(a)  to the person from whom those goods were taken, or

(b)  if the person was not the owner of those goods, to the owner.

(1)  Seized goods are to be released at the end of the period of 6 months after they were seized unless, before the end of that period, a Magistrate makes an order under this Division directing them to be forfeited to the State.

(2)  This clause does not prevent seized goods from being released before the expiration of that period.

(3)  Seized goods may be released:

(a)  by or at the direction of the inspector who seized them or by or at the direction of the Director-General, and

(b)  to the owner of the goods or the person in whose possession, care, custody or control they were at the time of the seizure.

(4)  This clause does not require the release of any goods that have been damaged or destroyed in the course of analysis.

(5)  A Magistrate may, in any particular case, extend the period referred to in subclause (1).

(1)  A Magistrate may order that seized goods specified in the order be forfeited to the State on the expiration of any period so specified.

(2)  Such an order does not have effect in respect of any goods that have been released under this Division.

(3)  Before a Magistrate makes an order under this clause, the Magistrate may require such notice as he or she thinks fit to be given to such persons as he or she considers appropriate.

(1)  A Magistrate may order that a person from whom goods have been seized under section 43 of the Act (being a person who has been convicted of an offence in connection with those goods) must pay to the Director-General such amount (not exceeding $500) as the Magistrate considers appropriate to cover the reasonable costs of:

(a)  seizing the goods, and

(b)  dealing with them under this Division, and

(c)  conducting any analysis for which they have been submitted.

(2)  Before a Magistrate makes an order under this clause, the Magistrate may require such notice as he or she thinks fit to be given to such persons as he or she considers appropriate.

(3)  An order under this clause operates as an order under the Local Courts (Civil Claims) Act 1970, and is enforceable as such an order under the provisions of that Act.

(1)  Subject to any direction of the Director-General, seized goods may be kept or stored:

(a)  at the premises at which they were seized, or

(b)  at such other place as the inspector who seized them considers appropriate.

(2)  A person must not remove, alter or interfere in any way with seized goods without the authority of an inspector or the Director-General.

Maximum penalty: 20 penalty units.

If the owner of seized goods or the person in whose possession, care, custody or control they were at the time of their seizure consents in writing to their forfeiture, the goods are, by virtue of that consent, forfeited to the State.

Any goods forfeited under this Division may be disposed of in such manner as the Director-General may direct, either generally or in any particular case or class of cases.

(1)  Any person who conducts, or proposes to conduct, a retail shop may apply for a licence to supply Schedule 2 substances from the shop.

(2)  The application:

(a)  must be in the form approved by the Director-General, and

(b)  must be accompanied by an application fee of $60, and

(c)  must be lodged with the Director-General.

(3)  The Director-General may require an applicant to furnish such further information as is necessary to enable the Director-General to determine the application.

cll 151: Am 5.9.2003.

(1)  After considering an application under this Division, the Director-General may issue the licence for which the application is made or may refuse the application.

(2)  In particular, the Director-General may refuse an application if of the opinion that the applicant is not a fit and proper person to hold the licence for which the application is made.

(3)  A licence may not be issued or renewed unless:

(a)  in the case of premises the subject of an existing licence issued before 7 April 1989 that is in force, the Director-General is satisfied that the premises to which the application relates are at least 6.5 kilometres (measured along the shortest practicable route) from the premises of the nearest retail pharmacist, or

(b)  in any other case, the Director-General is satisfied that the premises to which the application relates are at least 20 kilometres (measured along the shortest practicable route) from the premises of the nearest retail pharmacist.

(4)  The application fee is to be refunded if the application is refused.

(1)  A licence is to be in the form for the time being approved by the Director-General.

(2)  A licence remains in force until suspended, cancelled or surrendered.

(3)  A licence is not transferable.

(1)  A licence is subject to such conditions as the Director-General may endorse on the licence and to such further conditions as the Director-General may from time to time impose by order in writing served on the holder of the licence.

(2)  The Director-General may from time to time vary or revoke any condition of a licence by means of a further order in writing served on the holder of the licence.

(3)  A licence is ineffective unless its conditions are complied with.

The holder of a licence under this Division must, on or before 31 March in each year following that in which the licence was issued, pay to the Director-General an annual licence fee of $60.

cll 155: Am 5.9.2003.

(1)  Any person may apply to the Director-General for a licence to supply by wholesale any poisons or restricted substances.

(2)  The application:

(a)  must be in the form approved by the Director-General, and

(b)  must be accompanied by the relevant application fee, and

(c)  must be lodged with the Director-General.

(3)  The relevant application fee is:

(a)  $50, in the case of an application by a public institution, or

(b)  $345, in any other case.

(4)  The Director-General may require an applicant to furnish such further information as is necessary to enable the Director-General to determine the application.

cll 156: Am 5.9.2003.

(1)  After considering an application under this Division, the Director-General may issue the licence for which the application is made or may refuse the application.

(2)  In particular, the Director-General may refuse an application if of the opinion that the applicant is not a fit and proper person to hold the licence for which the application is made.

(3)  A licence may not be issued unless the Director-General is satisfied that the premises to which the application relates are appropriate for the supply of the poisons or restricted substances concerned.

(4)  The application fee is to be refunded if the application is refused.

(1)  A licence is to be in a form for the time being approved by the Director-General.

(2)  A licence remains in force until suspended, cancelled or surrendered.

(3)  A licence is not transferable.

(1)  A licence is subject to such conditions as the Director-General may from time to time impose by order in writing served on the holder of the licence.

(2)  The Director-General may from time to time vary or revoke any condition of a licence by means of a further order in writing served on the holder of the licence.

(3)  A licence is ineffective unless its conditions are complied with.

The holder of a licence under this Division must, on or before 30 September in each year following that in which the licence was issued, pay to the Director-General an annual licence fee of:

(a)  $50, if the holder is a public institution, or

(b)  $345, in any other case.

cll 160: Am 5.9.2003.

(1)  Any person may apply to the Director-General for a licence to manufacture drugs of addiction at, or to supply drugs of addiction from, any premises.

(2)  The application:

(a)  must be in the form approved by the Director-General, and

(b)  must be accompanied by the relevant application fee, and

(c)  must be lodged with the Director-General.

(3)  The relevant application fee for a licence to manufacture drugs of addiction is:

(a)  $50, in the case of an application by a public institution, or

(b)  $460, in any other case.

(4)  The relevant application fee for a licence to supply drugs of addiction is:

(a)  $10, in the case of an application by a charitable organisation, or

(b)  $50, in the case of an application by a public institution (other than a charitable organisation), or

(c)  $230, in any other case.

(5)  The Director-General may require an applicant to furnish such further information as is necessary to enable the Director-General to determine the application.

cll 161: Am 5.9.2003.

(1)  After considering an application under this Division, the Director-General may issue the licence for which the application is made or may refuse the application.

(2)  In particular, the Director-General may refuse an application if of the opinion that the applicant is not a fit and proper person to hold the licence for which the application is made.

(3)  A licence may not be issued unless the Director-General is satisfied that the premises to which the application relates are appropriate for the manufacture or supply of drugs of addiction.

(4)  The application fee is to be refunded if the application is refused.

(1)  A licence is to be in the form for the time being approved by the Director-General.

(2)  A licence to manufacture drugs of addiction authorises the manufacturer to supply drugs that are manufactured under the licence, subject to the conditions of the licence.

(3)  A licence remains in force until suspended, cancelled or surrendered.

(4)  A licence is not transferable.

(1)  A licence is subject to such conditions as the Director-General may endorse on the licence and to such further conditions as the Director-General may from time to time impose by order in writing served on the holder of the licence.

(2)  The Director-General may from time to time vary or revoke any condition of a licence by means of a further order in writing served on the holder of the licence.

(3)  A licence is ineffective unless its conditions are complied with.

(1)  The holder of a licence to manufacture drugs of addiction must, on or before 30 September in each year following that in which the licence was issued, pay to the Director-General an annual licence fee of:

(a)  $50, if the holder is a public institution, or

(b)  $460, in any other case.

(2)  The holder of a licence to supply drugs of addiction must, on or before 30 September in each year following that in which the licence was issued, pay to the Director-General an annual licence fee of:

(a)  $10, if the holder is a charitable organisation, or

(b)  $50, if the holder is a public institution (other than a charitable organisation), or

(c)  $230, in any other case.

cll 165: Am 5.9.2003.

(1)  The Director-General may issue authorities for the purposes of the Act and this Regulation.

(2)  The Director-General may require a person seeking an authority to furnish such information as is necessary to enable the Director-General to determine the issuing of the authority.

(3)  An authority may be issued to a particular person (by means of an instrument in writing given to the person) or to a specified class of persons (by means of an instrument published in a manner approved by the Director-General).

(4)  In particular, the Director-General may refuse to issue an authority to a person if of the opinion that the person is not a fit and proper person to hold the authority.

(5)  An authority that is issued to a particular person remains in force until it is suspended, cancelled or surrendered.

(6)  An authority that is issued to a particular person is not transferable.

(7)  In this Regulation, a reference to a person who holds an authority under this Part includes a reference to a person who belongs to a class of persons specified in an instrument referred to in subclause (3).

(1)  The exercise of the functions conferred on a person by an authority is subject to such conditions as the Director-General may specify in the instrument by which the authority is issued and to such further conditions as the Director-General may from time to time impose by order in writing served on that person.

(2)  The Director-General may from time to time vary or revoke any condition of an authority by means of a further order in writing served on the holder of the authority.

(3)  An authority is ineffective unless its conditions are complied with.

(1)  The Director-General must suspend or cancel a licence or authority in the event of one or more of the following:

(a)  the holder of the licence or authority requests or agrees in writing to the suspension or cancellation of the licence or authority,

(b)  the holder of the licence or authority is convicted of a serious offence against the Drug Misuse and Trafficking Act 1985 or any regulation in force under that Act,

(c)  the Director-General forms the opinion that the holder of the licence or authority is no longer a fit and proper person to hold the licence or authority,

(d)  in the case of a licence or authority to supply methadone or buprenorphine, the Director-General forms the opinion that the supply of methadone has a significant adverse effect on the amenity of the area in which the premises from which it is being supplied are situated.

(2)  The Director-General may, at the Director-General’s discretion, suspend or cancel a licence or authority on any one or more of the following grounds:

(a)  the holder of the licence or authority contravenes any condition of the licence or authority,

(b)  the holder of the licence or authority is convicted of an offence against the Act or this Regulation, or of an offence (not being a serious offence) against the Drug Misuse and Trafficking Act 1985 or any regulation in force under that Act,

(c)  an order is made under section 10 (1) of the Crimes (Sentencing Procedure) Act 1999 relating to the holder of the licence or authority in respect of an offence against the Act or this Regulation, or an offence against the Drug Misuse and Trafficking Act 1985 or any regulation in force under that Act,

(d)  the annual fee for the licence is not duly paid.

(3)  In this clause, serious offence means an offence that is punishable by imprisonment for life or for a term of 5 years or more.

(1)  Before suspending or cancelling a licence or authority (otherwise than at the request of its holder), the Director-General:

(a)  must cause written notice of the proposed suspension or cancellation, and of the grounds for the proposed suspension or cancellation, to be served on the holder of the licence or authority, and

(b)  must give the holder of the licence or authority a reasonable opportunity to make representations with respect to the proposed suspension or cancellation, and

(c)  must take any such representations into consideration.

(2)  Suspension or cancellation of a licence or authority takes effect on the date on which written notice of the suspension or cancellation is served on its holder or on such later date as is specified in the notice.

(3)  The Director-General may, by a further notice in writing served on the holder of a licence or authority that is suspended, revoke the suspension or vary the period of the suspension.

(1)  This clause applies to circumstances to which the Therapeutic Goods Act 1989 of the Commonwealth applies by reason of section 31 of the Poisons and Therapeutic Goods Act 1966.

(2)  Part 2 of the Therapeutic Goods Regulations of the Commonwealth is modified in its application to circumstances to which this clause applies to the extent that the Director-General may, by order in writing, exempt any person or substance, or any class of persons or substances, from the requirements of that Part.

(3)  Such an exemption may be given unconditionally or subject to conditions.