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Contents (2008 - 392)
Poisons and Therapeutic Goods Regulation 2008
Current version for 1 July 2017 to date (accessed 23 November 2017 at 16:22)
Part 3
Part 3 Restricted substances (S4)
Division 1 Packaging and labelling
26   Packaging and labelling generally
(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. 80 applies, in accordance with that Order.
(2)  Despite subclause (1), an authorised practitioner who supplies a restricted substance must ensure that the substance is packaged in accordance with the requirements of subclause (1) but labelled in accordance with the requirements of Appendix A.
(3)  Despite subclause (1), a pharmacist who supplies a restricted substance on prescription, or as referred to in clause 45, or who supplies the restricted substance benzylpenicillin as referred to in clause 48, must ensure that the substance is packaged and labelled in accordance with the requirements of Appendix A.
(4)  Despite subclause (1), an authorised practitioner or pharmacist who supplies a restricted substance to a person who, in the opinion of the authorised practitioner or pharmacist, would suffer undue hardship through difficulty in opening a container that is packaged in accordance with Therapeutic Goods Order No. 80, is not required to package the substance in accordance with that Order.
Maximum penalty: 10 penalty units.
27   Misleading labelling of substances as restricted substances
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.
28   Exemptions
(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 a 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.
Division 2 Storage
29   Storage generally
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 food intended for consumption by humans or animals, and
(c)  in such a way that, if its container breaks or leaks, the substance cannot mix with or contaminate any food intended for consumption by humans or animals.
Maximum penalty: 15 penalty units.
30   Storage of prescribed restricted substances in hospital wards
(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.
31   Responsibility for storage in hospitals
(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 director of nursing of the hospital, or
(b)  the medical superintendent of the hospital,
as the chief executive officer of the hospital may determine.
(3)  The nurse or midwife in charge of a hospital ward is responsible for the storage of all restricted substances in the ward.
Division 3 Prescriptions
32   Prescriptions for restricted substances
(1)  A medical practitioner, dentist or veterinary practitioner may issue a prescription for a restricted substance.
(2)  A person must not issue a prescription for a restricted substance unless authorised to do so by or under the Act (including by an authority under Part 8).
Maximum penalty: 15 penalty units.
33   Prescriptions may be issued only for certain purposes
(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 midwife practitioner must not issue a prescription for a restricted substance otherwise than in the course of practising as a midwife practitioner.
(4)  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”.
(5)  An optometrist must not issue a prescription for a restricted substance otherwise than in the course of practising as an optometrist, and must endorse any such prescription with the words “FOR OPTOMETRICAL TREATMENT ONLY”.
(6)  A veterinary practitioner 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”.
(7)  A podiatrist must not issue a prescription for a restricted substance otherwise than in the course of practising as a podiatrist, and must endorse any such prescription with the words “FOR PODIATRY TREATMENT ONLY”.
Maximum penalty: 15 penalty units.
34   Quantity and purpose of prescriptions to be appropriate
An authorised practitioner 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: 20 penalty units or imprisonment for 6 months, or both.
34A   Medication chart prescriptions
(1)  The authority of a pharmacist to supply a restricted substance on prescription (other than for a special restricted substance or a substance listed in clause 37) extends, in the case of a medication chart prescription, to supply on a duplicate copy of the medication chart prescription.
(2)  Accordingly, a reference in this Regulation to a prescription (in the context of the supply on prescription of a restricted substance by a pharmacist) is a reference, in the case of supply on a medication chart prescription, to a duplicate copy of the prescription.
35   Form of prescription
(1)  A prescription for a restricted substance must include the following details:
(a)  the date on which it is issued,
(b)  if the treatment is for:
(i)  a patient—the name and address of the patient, or
(ii)  an animal—the species of animal and the name and address of the animal’s owner, or
(iii)  a patient’s partner and the prescription is for azithromycin for the treatment of chlamydia—the name and email address or mobile phone number of the partner,
(c)  the name, strength (if not readily apparent) and quantity of the substance to be supplied,
(c1)  the route of administration (if not readily apparent) 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 a special restricted 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.
(1A)  As an alternative to complying with subclause (1), a medication chart prescription authorising the supply of a substance that is not a special restricted substance or a substance listed in clause 37 must include the following details:
(a)  the date on which it is issued,
(b)  the name and address of the patient,
(c)  the name and form (if not readily apparent) of the substance to be supplied,
(d)  the strength (if not readily apparent) of the substance to be supplied,
(e)  the route of administration (if not readily apparent) of the substance to be supplied,
(f)  adequate directions for use,
(g)  the frequency or times at which the substance is to be administered or used,
(h)  the period during which the substance is to be used or administered (being a period that ends on a date that is no more than 4 months from the date of first use of the relevant chart for the resident),
(i)  the name and designation of the person by whom it is issued,
(j)  the name, address and telephone number of the relevant residential care facility.
(2)  The details referred to in subclause (1A) (b) and (j) can be made out by any person.
(2A)  The details referred to in subclause (1) or (1A) (a) or (c)–(i) 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.
(2B)  A prescription must be signed by the person by whom it is issued (whether it complies with subclause (1) or (1A)).
(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.
(5)  The Director-General may, by order in writing, exempt any person or restricted substance, or any class of persons or restricted substances, from any or all of the requirements of this clause.
(6)  Such an exemption may be given unconditionally or subject to conditions.
(7)  In this clause:
partner of a patient includes any of the following:
(a)  the patient’s spouse,
(b)  the patient’s de facto partner,
(c)  a person with whom the patient is or was in a sexual relationship.
(8)  Subclauses (1) (b) (iii) and (7) cease to have effect on 1 January 2018.
Maximum penalty: 15 penalty units.
36   Emergency prescriptions may be given by telephone or otherwise
(1)  In an emergency, an authorised practitioner 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 58.
Maximum penalty: 15 penalty units.
37   Authority required to prescribe certain restricted substances
(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 practitioner, 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 words that clearly indicate that the prescription has been issued under this clause.
Maximum penalty: 15 penalty units.
38   Records to be kept of certain prescriptions
(1)  An authorised practitioner 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 a special restricted 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.
Division 4 Supply
Subdivision 1 Supply on prescription
39   Prescriptions may be filled only if in proper form
(1)  A pharmacist must not supply a restricted substance on prescription unless the prescription is in the form required by Division 3.
(2)  This clause does not prevent a pharmacist from supplying a restricted substance on a prescription that otherwise complies with clause 35 (1) merely because:
(a)  the prescription fails to specify the maximum number of times the substance may be supplied, or
(b)  in the case of a prescription for a special restricted substance, the prescription fails to specify the intervals at which the substance may be supplied, or
(c)  the address shown on the prescription indicates that it has been issued by a veterinary practitioner from some other State or a Territory.
(2A)  This clause does not prevent a pharmacist from supplying a substance on a medication chart prescription that otherwise complies with clause 35 (1A) merely because the prescription fails to specify the maximum number of times that the substance may be supplied.
(3)  A pharmacist must not supply a restricted substance on a prescription referred to in subclause (2) (a) or (b) if it appears to the pharmacist that the substance has previously been supplied on the prescription, regardless of how many times the prescription purports to authorise the supply of the substance.
(4)  The Director-General may, by order in writing, exempt any person or restricted substance, or any class of persons or restricted substances, from any or all of the requirements of this clause.
(5)  Such an exemption may be given unconditionally or subject to conditions.
Maximum penalty: 15 penalty units.
40   Certain prescriptions not to be filled
(1)  A pharmacist must not supply a restricted substance on prescription:
(a)  if the prescription is marked “CANCELLED”, or
(b)  if the substance has already been supplied on the prescription the maximum number of times indicated by the prescription, or
(c)  if the interval of time that has elapsed since the substance was last supplied on the prescription is less than that indicated by the prescription as the minimum interval that must elapse between successive supplies of the substance, or
(d)  if the prescription is illegible or defaced, or
(e)  if the prescription appears to have been forged or fraudulently obtained, or
(f)  if the prescription appears to have been altered otherwise than by the authorised practitioner by whom it was issued, or
(g)  if the prescription is dated:
(i)  in the case of a medication chart prescription—more than 4 months before the date on which the supply is requested, or
(ii)  in the case of a prescription, other than a medication chart prescription, for a prescribed restricted substance—more than 6 months before the date on which the supply is requested, or
(iii)  in any other case—more than 12 months before the date on which the supply is requested, or
(h)  in the case of a medication chart prescription—where it appears to the pharmacist that a sufficient quantity of the substance has already been supplied to the resident for the period indicated on the prescription.
(2)  Immediately on being requested to supply a prescribed restricted substance in either of the circumstances referred to in subclause (1) (e) or (f), a pharmacist must retain the prescription and cause notice of the request to be given to a police officer.
Maximum penalty: 15 penalty units.
41   Prescriptions to be endorsed
(1)  A pharmacist who supplies a restricted substance on prescription must (on each occasion the substance is supplied) endorse the following particulars (in ink) on the prescription:
(a)  the date on which the substance was supplied,
(b)  the address of the place at which the substance was supplied,
(c)  the prescription reference number.
Maximum penalty: 15 penalty units.
(2)  A person who supplies a substance on prescription must endorse (in ink) across the prescription the word “CANCELLED”:
(a)  if the maximum number of times the prescription is to be dispensed is not clearly specified, or
(b)  if (in the case of a prescription for a special restricted substance) the intervals at which the substance may be supplied are not clearly specified, or
(c)  if the prescription has reached the last occasion on which it can be supplied according to the maximum number of times specified on it.
Maximum penalty: 15 penalty units.
(3)  The Director-General may, by order in writing, exempt any person or substance, or any class of persons or substances, from any or all of the requirements of this clause.
(4)  Such an exemption may be given unconditionally or subject to conditions.
(5)  This clause does not apply to a medication chart prescription.
42   Prescriptions for certain substances to be kept
(1)  A pharmacist who supplies a special restricted substance on prescription must keep the prescription, whether or not the prescription authorises more than one supply of the substance.
Maximum penalty: 20 penalty units.
(2)  A pharmacist must keep prescriptions for special restricted substances separate from other prescriptions (other than prescriptions for drugs of addiction).
Maximum penalty: 20 penalty units.
(3)  The Director-General may, by order in writing, exempt any person or substance, or any class of persons or substances, from any or all of the requirements of this clause.
(4)  Such an exemption may be given unconditionally or subject to conditions.
Subdivision 2 Supply without prescription
43   Supply by certain health practitioners
(1)  A medical practitioner must not supply a restricted substance to any person otherwise than for medical treatment.
(2)  A nurse practitioner must not supply a restricted substance to any person otherwise than in the course of practising as a nurse practitioner.
(3)  A midwife practitioner must not supply a restricted substance to any person otherwise than in the course of practising as a midwife practitioner.
(4)  A dentist must not supply a restricted substance to any person otherwise than for dental treatment.
(5)  An optometrist must not supply a restricted substance to any person otherwise than in the course of practising as an optometrist.
(6)  A veterinary practitioner must not supply a restricted substance to any person otherwise than for veterinary treatment.
(7)  A podiatrist must not supply a restricted substance to any person otherwise than in the course of practising as a podiatrist.
Maximum penalty: 15 penalty units.
44   Emergency supply by pharmacists on direction of certain health practitioners
(1)  A pharmacist may supply a person with a restricted substance (including a prescribed restricted substance) in accordance with a direction given under clause 36.
(2)  A prescription that is subsequently sent in confirmation of the direction must be dealt with in accordance with clauses 41 and 42, and details of the supply must be recorded in accordance with clause 55, in the same way as if the restricted substance had been supplied on prescription.
(3)  If such a prescription is not received within 7 days after the substance is supplied, the pharmacist must report that fact to the Director-General.
Maximum penalty: 15 penalty units.
45   Emergency supply by pharmacists otherwise than on direction of health practitioner
(1)  A pharmacist may supply a person with a restricted substance (other than a prescribed restricted substance) if the pharmacist is satisfied:
(a)  that the person is undergoing treatment essential to the person’s well-being, and
(b)  that the substance has previously been prescribed for the treatment, and
(c)  that the person is in immediate need of the substance for continuation of the treatment, and
(d)  that, in the circumstances, it is not practicable for the person to obtain a prescription for the substance from an authorised practitioner.
(2)  A restricted substance may not be supplied to any person under this clause unless:
(a)  the quantity supplied is no more than that required for 3 days’ treatment, or
(b)  in the case of a liquid, aerosol, cream, ointment or anovulant tablet that is contained in a standard pack, the standard pack is the smallest standard pack in which that kind of liquid, aerosol, cream, ointment or anovulant tablet is generally available.
Maximum penalty: 15 penalty units.
45A   Supply by pharmacists in accordance with determination under National Health Act 1953 of Commonwealth
(1)  A pharmacist may supply a person with a restricted substance that is covered by the Continued Dispensing Determination under this clause if:
(a)  the supply is made in accordance with conditions that are specified in that determination, and
(b)  the supply is made in accordance with the document entitled Guidelines for the Continued Dispensing of eligible prescribed medicines by pharmacists, issued by the Pharmaceutical Society of Australia and as in force on 1 July 2012, and
(c)  the pharmacist is an approved pharmacist within the meaning of the National Health Act 1953 of the Commonwealth, and
(d)  the person is in immediate need of the substance for continuation of treatment.
(2)  In this clause, Continued Dispensing Determination means the National Health (Continued Dispensing) Determination 2012 of the Commonwealth, as in force on the commencement of the Poisons and Therapeutic Goods Amendment (Continued Dispensing) Regulation 2013.
46   Supply by pharmacists to health practitioners for emergency use
A pharmacist may supply an authorised practitioner with a restricted substance (including a prescribed restricted substance) for emergency use, but only on a written order signed and dated by the authorised practitioner.
47   Supply by pharmacists to nursing homes of stock for emergency use
(1)  The director of nursing of a nursing home is authorised to have possession of a restricted substance (including a prescribed restricted substance) that is approved by the Director-General for emergency use in that nursing home.
(2)  A retail pharmacist is authorised to supply a manufacturer’s original pack of a restricted substance (including a prescribed restricted substance) to the director of nursing of a nursing home but only if the substance is supplied:
(a)  at the premises of, and in the course of carrying on the business of, the pharmacy, and
(b)  in accordance with a written order signed by the director of nursing.
(3)  A director of nursing at a nursing home must not:
(a)  sign an order under this clause for a restricted substance unless the substance is approved by the Director-General for emergency use in that nursing home, or
(b)  allow any restricted substance in his or her possession to be used otherwise than for administration to a resident of the nursing home in accordance with an authorisation by a medical practitioner, nurse practitioner, podiatrist, dentist or optometrist who prescribes substances to the nursing home’s residents.
Maximum penalty: 15 penalty units.
(4)  An approval under this clause:
(a)  is to be by order in writing, and
(b)  may apply generally or may be limited to a particular nursing home or class of nursing homes, and
(c)  may apply generally or may be limited to a particular substance or class of substance, and
(d)  may be given unconditionally or subject to conditions.
48   Supply by pharmacists of benzylpenicillin for use in animals
(1)  This clause applies to benzylpenicillin, including procaine penicillin, in preparations for use by intramuscular injection in animals.
(2)  A pharmacist may supply benzylpenicillin otherwise than on prescription to a person who satisfies the pharmacist that it is needed for the urgent treatment of an animal and that, under the circumstances, it is not practicable to obtain a prescription authorising its supply.
(3)  A pharmacist must not supply benzylpenicillin:
(a)  to any person who is under 18 years of age, or
(b)  to any person who is unknown to the pharmacist.
(4)  Subclause (3) (b) does not prevent a pharmacist from supplying benzylpenicillin to a person who is unknown to the pharmacist if it is supplied in the presence of a person who is known to the pharmacist and who satisfies the pharmacist that he or she knows the person being supplied.
48A   Supply by pharmacists of influenza vaccine
(1)  A pharmacist may supply and administer an influenza vaccine to a person who is 18 years old or older at a retail pharmacy otherwise than on prescription if:
(a)  the pharmacist has completed a training course conducted by a provider of continuing professional development who is accredited by the Australian Pharmacy Council to provide the course, being a course that complies with any standards for the accreditation of programs to support pharmacist administration of vaccines that are published by the Australian Pharmacy Council from time to time, and
(b)  the pharmacist acts in accordance with any practice standards approved by the Director-General.
(2)  A pharmacist who supplies an influenza vaccine to a person in accordance with this clause must record the following details:
(a)  the person’s name, address, date of birth and contact details,
(b)  the name and contact details of the person’s primary medical practitioner,
(c)  the brand, batch number and expiry date of the vaccine,
(d)  the part of the body to which the vaccine was administered,
(e)  the date on which the vaccine was administered,
(f)  the pharmacist’s name and contact details and his or her certificate of accreditation number,
(g)  the address of the pharmacy at which the vaccination was administered,
(h)  a unique reference number for the supply and administration.
Maximum penalty: 15 penalty units.
Subdivision 3 Supply in hospitals
49   Supply by pharmacists
A pharmacist employed at a hospital may supply a restricted substance:
(a)  on a prescription issued in accordance with Division 3, or
(b)  on the authorisation (whether in writing, by electronic mail, by facsimile or by any other form of electronic communication approved by the Director-General) of an authorised practitioner (other than a veterinary practitioner), where that authorisation is entered on a patient’s medication chart, or
(c)  on the requisition (whether in writing, by electronic mail, by facsimile or by any other form of electronic communication approved by the Director-General) of an authorised practitioner (other than a veterinary practitioner) or the nurse or midwife in charge of the ward in which the substance is to be used or stored.
50   Supply in original containers
(1)  A person who supplies a restricted substance to a patient in a hospital, or to an inmate in an institution, in accordance with section 10 (4) (c) of the Act must supply the substance, unopened, in the container in which it was received by the person.
(2)  This clause does not prevent the person from supplying an individual dose of the substance to the patient or inmate.
Maximum penalty: 15 penalty units.
Subdivision 4 Supply generally
51   Research drugs
(1)  This clause applies to thalidomide other than as registered goods.
(2)  A dealer must not supply thalidomide unless the person being supplied holds an authority under Part 8 to be supplied with thalidomide.
(3)  This clause:
(a)  does not prohibit a dealer from supplying thalidomide to a person who has the approval in writing of the Permanent Head of the Commonwealth Department of Health to import, buy, obtain or otherwise be supplied with thalidomide, and
(b)  does not prohibit a person holding an authority under Part 8 to be supplied with thalidomide from supplying thalidomide to a person under his or her general supervision, for the purpose of enabling that other person to carry out medical diagnosis, or medical or scientific research or analysis (including the conduct of clinical trials), and
(c)  does not prohibit a medical practitioner holding an authority under Part 8 to be supplied with thalidomide from supplying thalidomide to another person for the purpose of treating that other person in accordance with the authority.
(4)  A person being supplied with thalidomide (otherwise than as referred to in subclause (3) (c)) must surrender his or her authority to the dealer.
(5)  A dealer must keep any authority surrendered to the dealer under this clause.
Maximum penalty: 15 penalty units.
52   Authority required to supply certain restricted substances
(1)  This clause applies to the following substances:
acitretin
clomiphene
cyclofenil
dinoprost
dinoprostone
etretinate
follitropin beta
isotretinoin for oral use
luteinising hormone
tretinoin for oral use
urofollitropin (human follicle stimulating hormone)
(2)  A person must not supply a substance to which this clause applies unless the person holds an authority under Part 8 to supply the substance.
(3)  This clause does not apply to the supply of a substance:
(a)  by wholesale, or
(b)  by a veterinary practitioner, or
(c)  by a pharmacist on the prescription of:
(i)  a medical practitioner holding an authority under Part 8 to prescribe the substance, or
(ii)  a veterinary practitioner, or
(d)  by a person who is authorised by the Permanent Head of the Commonwealth Department of Health to supply the substance.
Maximum penalty: 15 penalty units.
53   Restricted substances may be supplied by authorised persons
A person who is not an authorised practitioner may supply a restricted substance to another person if the person by whom the substance is supplied holds an authority under Part 8 to supply the substance.
54   Quantity and purpose of supply to be appropriate
An authorised practitioner or pharmacist must not supply any 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: 20 penalty units or imprisonment for 6 months, or both.
Division 5 Records of supply
55   Supply on prescription to be recorded
(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 35 (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.
Maximum penalty: 15 penalty units.
(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.
(3)  The Director-General may, by order in writing, exempt any person or restricted substance, or any class of persons or restricted substances, from the requirements of this clause.
(4)  Such an exemption may be given unconditionally or subject to conditions.
55A   Records relating to medication chart prescriptions
(1)  A pharmacist who supplies any substance to a person on a medication chart prescription must keep the prescription.
Maximum penalty: 15 penalty units.
(2)  A pharmacist who supplies any substance to a person on a medication chart prescription must endorse the following particulars (in ink) on the prescription on each occasion on which the substance is dispensed:
(a)  the date on which the substance was supplied,
(b)  the address of, or number identifying, the pharmacy from which the substance was supplied,
(c)  the prescription reference number,
(d)  the quantity supplied.
Maximum penalty: 15 penalty units.
(3)  The operator of a residential care facility in which medication charts are used must ensure that an employee of the facility makes a record in the medication chart of a resident of the facility of the administration of any restricted substance to the resident.
Maximum penalty: 15 penalty units.
56   Records to be kept of certain supply of restricted substances
(1)  An authorised practitioner who supplies a restricted substance:
(a)  must record the name, strength and quantity of the substance supplied and the date on which it was supplied, and
(b)  must record:
(i)  if the supply of the restricted substance is for a patient—the name and address of the patient, or
(ii)  if the supply of the restricted substance is for an animal—the species of the animal and the name and address of the animal’s owner, or
(iii)  if the restricted substance is azithromycin and the supply is for a patient’s partner for the treatment of chlamydia—the name and email address or mobile phone number of the partner, 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: 20 penalty units or imprisonment for 6 months, or both.
(2)  In this clause:
partner of a patient includes any of the following:
(a)  the patient’s spouse,
(b)  the patient’s de facto partner,
(c)  a person with whom the patient is or was in a sexual relationship.
(3)  Subclauses (1) (b) (iii) and (2) cease to have effect on 1 January 2018.
57   Certain supplies of restricted substances to be separately recorded
(1)  A pharmacist who supplies a restricted substance as referred to in clause 45, or who supplies the restricted substance benzylpenicillin as referred to in clause 48, 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 45, the name and address of the authorised 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.
(2)  A pharmacist who supplies a restricted substance as referred to in clause 46 or 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 person supplied,
(c)  the name, strength and quantity of the substance,
(d)  the date on which the substance was supplied,
(e)  the name of the person by whom the substance was supplied.
Maximum penalty: 15 penalty units.
Division 6 Administration
58   Administration by persons employed at a hospital
(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 an authorised practitioner (other than a veterinary practitioner).
(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)  An authorised practitioner 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)  An authorised practitioner 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.
59   Administration of prescribed restricted substances
(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:
(i)  a nurse practitioner in the course of practising as a nurse practitioner, or
(ii)  a midwife practitioner in the course of practising as a midwife practitioner, or
(iii)  an optometrist in the course of practising as an optometrist, or
(iv)  a podiatrist in the course of practising as a podiatrist.
Maximum penalty: 20 penalty units.
(2)  For the purposes of subclause (1), it is sufficient if the treatment referred to in subclause (1) (a) or (b) 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.
60   Authority required to administer certain restricted substances
(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
urofollitropin (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 practitioner or by a person acting under the general supervision of a veterinary practitioner.
Maximum penalty: 15 penalty units.
Division 7 Miscellaneous
61   Prescribed restricted substances
(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.
62   Authorised persons
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 director of nursing of a hospital that does not employ a chief pharmacist,
(b)  the nurse or midwife in charge of a ward in a public hospital,
(c)  a nurse or midwife who is approved for the time being by the Director-General for the purposes of this clause, or who belongs to a class of nurses or a class of midwives so approved,
(d)  any other nurse or midwife, but for the purpose only of administering doses of such substances to individual patients in a hospital,
(e)  an analyst, or a person acting under the direct personal supervision of an analyst.
63   Disclosure of other prescribed restricted substances obtained or prescribed
(1)  A person who asks an authorised practitioner (other than a veterinary practitioner):
(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 authorised practitioner 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.
64   Delivery by carrier
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.
65   Pentobarbitone sodium
(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.
66   Restricted substances to be used or disposed of safely
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.
67   Loss or theft of prescribed restricted substances
(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, an authorised practitioner.
Maximum penalty: 20 penalty units.
68   Forfeiture of prescribed restricted substances
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.