Poisons Act 1966 Poisons Regulation 1994 (1994-436) [GG No 108 of 26.8.1994] (NSW)

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1994—No. 436

POISONS ACT 1966—REGULATION

(Poisons Regulation 1994)

NEW SOUTH WALES

[Published in Gazette No. 108 of 26 August 1994]

HIS Excellency the Governor, with the advice of the Executive Council, and in pursuance of the Poisons Act 1966, has been pleased to make the Regulation set forth hereunder.

RON PHILLIPS

Minister for Health.

PART 1—PRELIMINARY

Citation

1. This Regulation may be cited as the Poisons Regulation 1994.

Commencement

2. This Regulation commences on 1 September 1994.

Definitions

3. (1) In this Regulation:

(a)

expressions that are defined in the dictionary at the end of this Regulation have the meanings given to them by the dictionary; and

(b)

expressions that are defined in the Uniform Standard have the meanings given to them by the Uniform Standard; and

(c)

expressions that are defined in the Uniform Standard and that are also defined in the Act or in this Regulation have the meanings given to them by the Act or this Regulation, respectively.

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(2) In this Regulation, a reference to a Form is a reference to a Form set out in Appendix G.

PART 2—POISONS (S1, S2, S3, S5, S6, S7)

Division 1—Packaging and labelling

Packaging and labelling generally

4. (1) A dealer must ensure that any poison supplied by the dealer is packaged and labelled:

(a) in accordance with the relevant provisions of the Uniform 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, 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) Any quantity of a Schedule 3 substance supplied by a pharmacist on prescription must be labelled in accordance with the requirements of Appendix A instead of the requirements of subclause (1).

Misleading labelling of poisons and other substances

5. A dealer must not supply any substance in a container that has a label that states or implies that:

(a) the substance is a poison, unless the substance is a poison; or

(b) a poison is a teratogenic or carcinogenic hazard, unless such warning:

(i)  has been recommended by the National Health and Medical Research Council; or

(ii) is otherwise authorised or required by law.

Packaging of camphor and naphthalene

6. 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.

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Schedule 1 or 3 substances supplied by retail dealers

7. A retail dealer must ensure that any Schedule 1 or 3 substance

supplied by the dealer is labelled with the dealer’s name and address.

Exemptions

8. (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.

Division 2—Storage

Storage generally

9. 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.

Schedule 1, 3 or 7 substances

10. A dealer who has possession of any Schedule 1, 3 or 7 substance must keep the substance in a room or enclosure to which the public does not have access.

Schedule 6 substances

11. (1) A retail 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;

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(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.

Division 3—Prescriptions

Unauthorised persons not to prescribe Schedule 3 substances

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

(2) A medical practitioner. dentist or veterinary surgeon may issue a prescription for a Schedule 3 substance, but only if he or she does so in accordance with this Division.

Certain Schedule 3 substances

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

dihydrocodeine
nicotine
nystatin
pseudoephedrine

(2) A prescription for a substance to which this clause applies must

comply with Division 3 of Part 3 as if the substance were a restricted

substance.

Quantity and purpose of prescriptions to be appropriate

14. A medical practitioner, dentist or veterinary surgeon must not issue a prescription for a Schedule 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.

Division 4—Supply

Schedule 1 substances to be supplied only to adults known to dealers

15. (1) A pharmacist must not supply a Schedule 1 substance:
(a) to any person who is under 18 years of age; or
(b) to any person who is unknown to the pharmacist.

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(2) Subclause (1) (b) does not prevent a pharmacist from supplying a Schedule 1 substance to a person who is unknown to the pharmacist if the substance 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.

(3) This clause does not apply to the supply of any substance: (a) to a medical practitioner, dentist or veterinary surgeon; or

(b)

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

Schedule 2 and 3 substances may be supplied by authorised persons

16. A person who is not a medical practitioner, dentist, veterinary surgeon or pharmacist may supply a Schedule 2 or 3 substance to another person if the person by whom the substance is supplied holds a licence or authority under Part 7 to supply the substance.

Schedule 3 substances to be supplied personally by pharmacists 17. (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, dentist or veterinary surgeon; or

(b)

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

Supply of dihydrocodeine

18. (1) This clause applies to dihydrocodeine, but only in so far as it is a Schedule 3 substance.

(2) Clause 15 applies to the supply of dihydrocodeine by a pharmacist as if it were a Schedule 1 substance.

Prescriptions for Schedule 3 substances to be endorsed

19. A prescription for a Schedule 3 substance that is supplied by a pharmacist must be endorsed in accordance with clause 43 as if it were a restricted substance.

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Schedule 7 substances to be supplied and used only under an authority

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

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

(a)

the dealer holds an authority under Part 7 to supply the substance; and

(b)

the person being supplied holds an authority under Part 7 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) This clause does not apply to:

(a) the supply to any person of a pesticide (within the meaning of the Pesticides Act 1978) or a stock medicine (within the meaning of Stock Medicines Act 1989); or
(b) the supply of a substance to any person in the course of wholesale dealing; or
(c) the supply of a substance to a scientifically qualified person in charge of a laboratory or other similar facility.

(5) The functions of the Director-General under Part 7 with respect to an authority under this clause may be exercised by:

(a) the Registrar of Pesticides; or

(b) the Director-General of the New South Wales Department of Agriculture; or

(c) the Permanent Head of the Commonwealth Department of Health. (6) This clause does not apply to any Schedule 7 substance that is a

drug precursor.

“Particular use” poisons may only be supplied in original containers

21. (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, 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.

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Supply of art materials, toys, furniture etc. containing poisons

22. (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 1, 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.

Quantity and purpose of supply to be appropriate
23. A medical 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.

Division 5—Records of supply

Registers of Schedule 1 substances

24. (1) A pharmacist who has possession of any Schedule 1 substance at any place for the purposes of supply must keep a separate register at that place.

(2) The register is to be in the form of a book whose pages:

(a) are consecutively numbered; and

(b) are so bound that they cannot be removed or replaced without trace; and
(c) contain provision for the inclusion of the particulars required to be entered in it.

(3) The Director-General may from time to time approve the keeping of the register in any other form.

(4) On the day on which a pharmacist supplies any Schedule 1 substance, the pharmacist must ensure that the following details are entered in the register:

(a) the name, strength and quantity of the substance supplied;
(b) the name, address and occupation of the person being supplied;

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(c) the purpose for which the person being supplied says that he or she intends to use the substance.

(5) The entry must be dated and signed by the pharmacist and must be countersigned by the person being supplied and (in the case of a sale to a person who is unknown to the pharmacist) by a witness to the sale who is known to the pharmacist and who knows the person being supplied.

(6) This clause does not apply to the supply of any substance: (a) to a medical practitioner, dentist or veterinary surgeon; or

(b)

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

Supply of certain Schedule 3 substances to be recorded

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

dihydrocodeine
nicotine
nystatin
pseudoephedrine

(2) Details of the supply on prescription of a substance to which this

clause applies must be recorded in accordance with clause 58 as if the
substance were a restricted substance.

(3) A pharmacist who supplies such a substance otherwise than on prescription must separately record the following particulars:

(a) the name, strength and quantity of the substance supplied;

(b) the date on which the substance was supplied;

(c)

if the substance is to be used in the treatment of a person, the name and address of the person to be treated;

(d)

if the substance is to be used in the treatment of an animal, the species of animal and the name and address of the animal’s owner.

Division 6—Miscellaneous

Poisons to be used or disposed of safely

26. 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.

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PART 3—RESTRICTED SUBSTANCES (S4)

Division 1—Packaging and labelling

Packaging and labelling generally

27. (1) A dealer must ensure that any restricted substance supplied by the dealer is packaged and labelled:

(a) in accordance with the relevant provisions of the Uniform Standard; and
(b) in the case of a substance to which Therapeutic Goods Order No. 20 applies, in accordance with that Order.

(2) If the quantity of restricted substance supplied is no more than that required for 3 days' treatment, a medical practitioner, dentist or veterinary surgeon may instead label the substance in accordance with the requirements of Appendix A.

(3) If the quantity of restricted substance supplied is more than that required for 3 days' treatment, a medical practitioner, dentist or veterinary surgeon must label the substance in accordance with the requirements of Appendix A.

(4) Any quantity of a restricted substance supplied by a pharmacist must be labelled in accordance with the requirements of Appendix A instead of the requirements of subclause (1).

Misleading labelling of restricted substances and other substances 28. A dealer must not supply any substance in a container that has a

label that states or implies that:

(a) the substance is a restricted substance, unless the substance is such a substance; or
(b) a restricted substance is a teratogenic or carcinogenic hazard, unless such a warning:

(i)  has been recommended by the National Health and Medical Research Council; or

(ii) is otherwise authorised or required by law.

Exemptions

29. (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.

1994—No. 436

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

Division 2—Storage

Storage generally
30. 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.

Storage of pentazocine elsewhere than in hospital wards

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

(2) This clause does not apply to the storage of pentazocine in a hospital ward.

Storage of prescribed restricted substances (including pentazocine) in hospital wards

32. Prescribed restricted substances (including pentazocine) 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.

Responsibility for storage in hospitals

33. (1) The chief pharmacist of a hospital is responsible for the storage of all restricted substances 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

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(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.

Division 3—Prescriptions

Unauthorised persons not to prescribe restricted substances 34. (1) A person must not issue a prescription for a restricted

substance unless authorised to do so by this clause.

(2) A medical practitioner, dentist or veterinary surgeon may issue a prescription for a restricted substance, but only if he or she does so in accordance with this Division.

Prescriptions may only be issued for certain purposes

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

(2) 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”.

(3) 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”.

Quantity and purpose of prescriptions to be appropriate

36. A medical 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.

Form of prescriptions
37. (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;

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(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 pentazocine or a substance referred to in Appendix B, 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) A prescription that is made out in a manner approved under subclause (2) (b) must be endorsed with the words “ISSUED UNDER CLAUSE 37 OF THE POISONS REGULATION 1994” or with other words that indicate that the prescription is issued under this clause.

(4) 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.

(5) A person must not issue a prescription that prescribes both pentazocine and another substance.

Emergency prescriptions may be given verbally or by telephone

38. (1) In an emergency, a medical practitioner, dentist or veterinary surgeon may direct the supply of a restricted substance verbally or by telephone or 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.

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(3) A prescription that is issued under this clause must be 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 an emergency direction given under clause 51.

Authority required to prescribe certain restricted substances

39. (1) This clause applies to the following restricted substances:
acitretin
clomiphene
cyclofenil
dinoprost
dinoprostone
etretinate
isotretinoin
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 7 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 prescriptions for the substance.

(4) A prescription that authorises the supply of a substance to which this clause applies:

(a)

in the case of a prescription that is issued in accordance with an authority under Part 7, must be endorsed with the reference number shown on the authority; or

(b)

in any other case, must be endorsed with the words “ISSUED UNDER CLAUSE 39 OF THE POISONS REGULATION 1994” or with other words that indicate that the prescription has been issued under this clause.

Records to be kept of certain prescriptions

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

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(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 pentazocine or a substance referred to in Appendix B, 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.

Division 4—Supply

Subdivision 1—Supply on prescription

Prescriptions may only be tilled if in proper form

41. (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 prescription 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 pentazocine or a substance referred to in Appendix B, 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 medical practitioner, dentist or veterinary surgeon from some other State or Territory.

(3) A prescription referred to in subclause (2) authorises the supply of a restricted substance once only, regardless of how many times it purports to authorise the supply of the substance.

Certain prescriptions not to be filled

42. (1) A pharmacist must not supply a restricted substance on prescription:

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(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 defaced; or

(e) if the prescription appears to have been forged or fraudulently obtained; or
(f) if (in the case of a prescription that is handwritten) the prescription appears to have been altered otherwise than by the medical practitioner by whom it was issued; or
(g) if (in the case of a prescription that is not handwritten) the prescription appears to have been altered; or
(h) if the prescription is dated more than 12 months (or, in the case of a prescription for a prescribed restricted substance, 6 months) before the date on which the supply is requested.

(2) A pharmacist must not supply pentazocine on a prescription directing the supply of both pentazocine and another substance.

Prescriptions to be endorsed
43. (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.

(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 pentazocine or a substance referred to in Appendix B) 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.

(3) If a prescription is required to be sent to a Commonwealth
Department for payment under the National Health Act 1953 of the

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Commonwealth or the Repatriation Act 1920 of the Commonwealth, the duplicate (and not the original) of the prescription must be endorsed in accordance with this clause.

Prescriptions for certain substances to be kept

44. (1) A pharmacist who supplies pentazocine or a substance referred to in Appendix B on prescription must keep the prescription, whether or not the prescription authorises more than one supply of the substance.

(2) Prescriptions for pentazocine or substances referred to in Appendix B must be kept apart from other prescriptions (other than prescriptions for drugs of addiction).

(3) If the prescription is required to be sent to a Commonwealth Department for payment under the National Health Act 1953 of the Commonwealth or the Repatriation Act 1920 of the Commonwealth, the pharmacist must instead keep the duplicate of the prescription.

Subdivision 2—Supply without prescription

Supply by medical practitioners, dentists and veterinary surgeons 45. (1) A medical practitioner must not supply a restricted substance to

any person otherwise than for medical treatment.
(2) A dentist must not supply a restricted substance to any person otherwise than for dental treatment.

(3) A veterinary surgeon must not supply a restricted substance to any person otherwise than for veterinary treatment.

Emergency supply by pharmacists on direction of medical practitioners

46. (1) A pharmacist may supply a person with a restricted substance (including a prescribed restricted substance) in accordance with a direction given under clause 38.

(2) A prescription that is subsequently sent in confirmation of the direction must be dealt with in accordance with clauses 43 and 44, and details of the supply must be recorded in accordance with clause 58, 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.

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Emergency supply by pharmacists otherwise than on direction of

medical practitioners

47. (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 medical treatment for a condition for which the substance has previously been prescribed; and
(b) that the person is in immediate need of the substance for the continuation of medical treatment essential to the person’s well being; and
(c) that, in the circumstances, it is impracticable for the person to obtain a prescription for the substance from a medical 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.

Supply by pharmacists in accordance with Commonwealth

entitlements

48. A pharmacist may supply a medical practitioner with a restricted substance (including a prescribed restricted substance) under the authority of an Emergency Drug (Doctor’s Bag) Order form that has been completed in accordance with the requirements of the National Health Act 1953 of the Commonwealth.

Subdivision 3—Supply in hospitals

Supply by pharmacists

49. A pharmacist at a hospital may supply a restricted substance:

(a) on a prescription issued in accordance with Division 3; or

(b)

on the written requisition of a medical practitioner or dentist or of the nurse in charge of the ward in which the substance is to be used or stored.

Supply in original containers: sec. 19

50. (1) A person who supplies a restricted substance to a patient in a
hospital, or to an inmate in an institution, pursuant to an authority under

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section 19 (1) (b) 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.

Subdivision—4 Administration

Administration by persons employed at a hospital

51. (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 or dentist.

(2) Such a direction must be given in writing, except in an emergency in which case it may be given verbally, by telephone or facsimile or in any other manner approved by the Director-General.

(3) A medical practitioner or dentist who gives a direction for the administration of a restricted substance to a patient otherwise than in writing must, within the next 24 hours, sign an entry in the patient's medical history confirming that he or she has given the direction.

(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) Subclauses (3) and (4) do not apply to the administration of a restricted substance to a patient in an institution conducted by the Corrections Health Service if the substance is administered in accordance with the requirements of a protocol approved by the Director-General.

Administration of prescribed restricted substances

52. (1) A person must not 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.

(2) A medical practitioner must not self-administer a prescribed

restricted substance otherwise than for the purposes of medical treatment.

(3) A dentist must not self-administer a prescribed restricted substance

otherwise than for the purposes of dental treatment.

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Authority required to administer certain restricted substances

53. (1) This clause applies to the following restricted substances:
acitretin
clomiphene
cyclofenil
dinoprost
dinoprostone
etretinate
isotretinoin
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 7 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 7 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.

Subdivision 5—General

Research drugs

54. (1) This clause applies to the following substances:

antibodies, antigens and immunoglobulins or conjugates thereof in

preparations for the diagnosis of human immunodeficiency virus

infection

thalidomide

(2) A dealer must not supply any other person with a substance to

which this clause applies unless the person being supplied holds an

authority under Part 7 to be supplied with the substance.

(3) This clause:

(a)

does not prohibit a dealer from supplying a substance to which this clause applies to another person, being 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 the substance; and

1994—No. 436

(b) does not prohibit a person holding an authority under Part 7 to be supplied with a substance to which this clause applies from supplying the substance to another person, being 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 7 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.

Authority required to supply certain restricted substances

55. (1) This clause applies to the following substances:
acitretin
clomiphene
cyclofenil
dinoprost
dinoprostone
etretinate
isotretinoin
urofollitrophin (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 7 to supply the substance.

(3) This clause does not apply to the supply of a substance:
(a) by way of wholesale dealing; or
(b) by a veterinary surgeon; or
(c) by a pharmacist on the prescription of

(i)  a medical practitioner holding an authority under Part 7 to prescribe the substance; or

(ii) a veterinary surgeon; or

(d)

by a person who is authorised by the Permanent Head of the Commonwealth Department of Health to supply the substance.

1994—No. 436

Restricted substances may be supplied by authorised persons

56. A person who is not a medical practitioner, dentist or veterinary surgeon may supply a restricted substance to another person if the person by whom the substance is supplied holds an authority under Part 7 to supply the substance.

Quantity and purpose of supply to be appropriate

57. A medical practitioner, dentist, veterinary surgeon 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.

Division 5—Records of supply

Supply on prescription to be recorded

58. (1) A pharmacist who supplies a restricted substance on prescription must record full details of the prescription in a manner approved by the Director-General.

(2) The details to be recorded must include the following:

(a) a unique reference number for the prescription;

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

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

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

(3) 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.

Records to be kept of supply of restricted substances by medical practitioners, dentists and veterinary surgeons

59. A medical 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)

if the substance is intended for the treatment of a person, must record the name and address of the person to be treated; and

(c)

if the substance is intended for the treatment of an animal, must record the species of animal and the name and address of the animal’s owner; and

1994—No. 436

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

Emergency supplies of restricted substances to be separately recorded

60. (1) A pharmacist who supplies a restricted substance as referred to in clause 47 must record full details of the supply in a manner approved by the Director-General.

(2) The details to be recorded must include the following:

(a)

the name and address of the person to whom the substance is supplied;

(b) the name, strength and quantity of the substance;

(c)

the directions given by the pharmacist for the use of the substance;

(d)

the name and address of the medical practitioner by whom it appears to the pharmacist that the substance was last prescribed;

(e) the date on which the substance was supplied.

Drug registers to be kept for pentazocine

61. Drug registers must be kept with respect to pentazocine in the same way as they must be kept under Division 5 of Part 4 with respect to drugs of addiction.

Division 6—Miscellaneous
Prescribed restricted substances: secs. 16, 18A

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

(2) For the purposes of section 18A (2) of the Act, the quantities specified in Appendix D are the prescribed quantities for the corresponding restricted substances specified in that Appendix.

Authorised persons: sec. 16 (1) (e)

63. 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;

1994—No. 436

(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 7 to manufacture or supply drugs of addiction;
(d) an analyst appointed under the Therapeutic Goods and Cosmetics Act 1972;
(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).

Disclosure of other prescribed restricted substances obtained or prescribed

64. (1) A person who asks a medical 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 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.

Delivery by carrier

65. 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.

Pentobarbitone sodium

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

(2) 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.

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

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

(6) 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.

Benzylpenicillin

67. (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.

(5) A pharmacist who supplies benzylpenicillin under this clause must make a record of that fact in the register of Schedule 1 substances kept under clause 24.

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Restricted substances to be used or disposed of safely

68. 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.

Destruction of pentazocine

69. Pentazocine must be destroyed in accordance with the provisions

of clauses 123 and 124 relating to the destruction of drugs of addiction.

Loss or theft of prescribed restricted substances

70. (1) A person must immediately notify the Director-General and a police officer if the person loses a prescribed restricted substance or if a prescribed restricted substance is stolen from him or her.

(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, dentist or veterinary surgeon.

Forfeiture of prescribed restricted substances

71. 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.

PART 4—DRUGS OF ADDICTION (S8)

Division 1—Packaging and labelling

Packaging and labelling generally

72. (1) A dealer must ensure that any drug of addiction supplied by the dealer is packaged and labelled in accordance with the relevant provisions of the Uniform Standard.

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

(3) Any quantity of a drug of addiction supplied by a pharmacist on prescription must be labelled in accordance with the requirements of Appendix A instead of the requirements of subclause (1).

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Misleading labelling of drugs of addiction and other substances

73. A dealer must not supply any substance in a container that has a label that states or implies that:

(a) the substance is a drug of addiction, unless the substance is such a drug; or
(b) a drug of addiction is a teratogenic or carcinogenic hazard, unless such a waning:

(i)  has been recommended by the National Health and Medical Research Council; or

(ii) is otherwise authorised or required by law.

Packages to be sealed so that broken seal is readily distinguishable 74. (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 nurse on the direction in writing of a medical practitioner or dentist.

Exemptions

75. (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.

Division 2—Storage

Storage generally

76. (1) A person who is in possession of drugs of addiction must keep
any such drug in his or her possession stored apart from all other goods

1994—No. 436

(other than pentazocine, 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.

Storage in hospitals

77. (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.

(4) 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.

(5) 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) the key:

(i)  is kept in the possession of a nurse whenever it is in the ward; and

(ii)  is removed from the ward whenever there is no nurse in the ward.

(6) The requirements of subclause (5) are satisfied if the key is kept in the ward in a separately locked safe.

Storage in pharmacies

78. (1) The pharmacist for the time being in charge of a pharmacy
must keep any drug of addiction stored apart from other substances or

1994—No. 436

goods (other than pentazocine, 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) the key:

(i)  is kept in the possession of a pharmacist whenever it is on the same premises as the safe; and

(ii)  is removed from the premises whenever there is no pharmacist at those premises.

(4) The requirements of subclause (3) are satisfied if the key is kept on the premises in a separately locked safe.

1994—No. 436

Division 3—Prescriptions

Unauthorised persons not to prescribe drugs of addiction

79. (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, but only if he or she does so in accordance with this Division.

Prescriptions may only be issued for certain purposes

80. (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 dental treatment (for a period of not more than one month) of a hospital patient, and must endorse any such prescription with the words “FOR DENTAL TREATMENT ONLY”.

(3) 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”.

Quantity and purpose of prescriptions to be appropriate

81. 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.

Form of prescriptions
82. (1) A prescription for a drug of addiction 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 (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;

1994—No. 436

(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) A prescription that is made out in a manner approved under subclause (2) (b) must be endorsed with the words “ISSUED UNDER CLAUSE 82 OF THE POISONS REGULATION 1994” or with other words that indicate that the prescription is issued under this clause.

(4) 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.

(5) A person must not issue a prescription that prescribes more than

one drug of addiction or both a drug of addiction and another substance.

Emergency prescriptions may be given verbally or by telephone

83. (1) In an emergency, a medical practitioner, dentist or veterinary surgeon may direct the supply of a drug of addiction verbally or by telephone or 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 prescription that is issued under this clause must be 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 an emergency direction given under clause 100.

1994—No. 436

Records of prescriptions

84. (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.

Prescriptions for amphetamines

85. (1) This clause applies to the following substances:
amphetamine
dexamphetamine
methylamphetamine
methylphenidate
phendimetrazine
phenmetrazine
(2) A medical practitioner does not require an authority under section

29 of the Act to issue a prescription for dexamphetamine or methylphenidate to a person for the purpose of testing the suitability of the person to undergo a course of medical treatment involving the use of such a substance so long as the medical practitioner holds an authority under Part 7 to prescribe such a substance.

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

Exceptions to sec. 28 (a) and (b)

86. A medical practitioner is authorised to issue a prescription for a drug of addiction for a person referred to in section 28 (a) or (b) of the Act without an authority under section 29 of the Act:

1994—No. 436

(a)

if 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 hospital; and

(b)

if 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.

Division 4—Supply

Subdivision 1—Supply on prescription

Pharmacists may supply drugs of addiction on prescription

87. A pharmacist may supply a drug of addiction on prescription, but only if he or she does so in accordance with this Division.

Prescriptions may only be filled if in proper form

88. (1) A pharmacist must not supply a drug of addiction on
prescription unless the prescription is in the form required by Division 3.

(2) This clause does not prevent a pharmacist from supplying a drug of addiction on prescription merely because the prescription fails to specify the maximum number of times, or the intervals at which, the drug may be supplied.

(3) A prescription referred to in subclause (2) authorises the supply of a drug of addiction once only, regardless of how many times it purports to authorise the supply of the drug.

Certain prescriptions not to be filled

89. (1) A pharmacist must not supply a drug of addiction on prescription:

(a) if the prescription is marked “CANCELLED”; or

(b)

if the drug 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 drug 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 drug; or

(d) if the prescription is defaced; or

1994—No. 436

(e) if notice of an order prohibiting the person by whom the prescription was issued from issuing such a prescription has been published in the Gazette, unless the prescription contains a direction for the supply of the drug more than once and it appears that the drug has been supplied on the basis of the prescription at least once prior to the publication of the notice; or
(f) if the prescription appears to have been forged or fraudulently obtained; or
(g) if (in the case of a prescription that is handwritten) the prescription appears to have been altered otherwise than by the medical practitioner by whom it was issued; or
(h) if (in the case of a prescription that is not handwritten) the prescription appears to have been altered; or

(i)  if the prescription is dated more than 6 months before the date on which the supply is being requested.

(2) A pharmacist who is asked to supply a drug of addiction in the circumstances referred to in subclause (1) (e)–(g) must immediately cause notice of that fact to be given to a police officer.

(3) A pharmacist must not supply a drug of addiction on a prescription directing the supply of more than one drug of addiction or both a drug of addiction and another substance.

Prescriptions for certain drugs require verification

90. (1) This clause applies to the following substances:
dextromoramide
hydromorphone
methadone
morphine
oxycodone
pethidine

(2) A pharmacist must not supply such a substance on prescription

unless he or she:

(a)

is familiar with the handwriting of the person who issued the prescription; or

(b) knows the person for whom the drug is prescribed; or

(c)

has verified that the person who is purported to have issued the prescription has actually issued the prescription.

(3) This clause does not prevent a pharmacist who is otherwise
authorised to supply drugs of addiction from supplying on prescription a

1994—No. 436

substance to which this clause applies in a quantity sufficient for no more

than 2 days’ treatment.

Prescriptions to be endorsed

91. (1) A person who supplies a drug of addiction on prescription must (on each occasion the drug is supplied) endorse the following particulars (in ink) on the prescription:

(a) the date on which the drug was supplied;
(b) the address of the place at which the drug was supplied;
(c) the prescription reference number.

(2) A person who supplies a drug of addiction 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 the intervals at which the drug 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.

(3) If a prescription is required to be sent to a Commonwealth Department for payment under the National Health Act 1953 of the Commonwealth or the Repatriation Act 1920 of the Commonwealth, the duplicate (and not the original) of the prescription must be endorsed in accordance with this clause.

Prescriptions to be kept

92. (1) A pharmacist who supplies a drug of addiction on prescription must keep the prescription, whether or not the prescription authorises more than one supply of the drug.

(2) Prescriptions for drugs of addiction must be kept apart from other prescriptions (other than prescriptions for pentazocine and substances referred to in Appendix B).

(3) If the prescription is required to be sent to a Commonwealth Department for payment under the National Health Act 1953 of the Commonwealth or the Repatriation Act 1920 of the Commonwealth, the pharmacist must instead keep the duplicate of the prescription.

1994—No. 436

Supply by pharmacists of amphetamines

93. (1) This clause applies to the following substances:
amphetamine
dexamphetamine
methylamphetamine
methylphenidate
phendimetrazine
phenmetrazine

(2) A pharmacist must not supply such a substance on prescription

unless:

(a)

the authority to issue the prescription, given under section 29 of the Act, is attached to the prescription; or

(b)

the prescription includes the reference number shown on the authority.

(3) Subclause (2) does not apply if the person prescribing the substance
has been given a verbal authority under section 29 (5) (d) of the Act.

(4) A medical practitioner who issues a prescription for such a substance on a verbal authority must forward the confirming written authority to the pharmacist who supplied the substance, or notify the pharmacist of the reference number shown on the authority, without delay (and in any case within 24 hours) after receiving the written authority.

Exceptions to sec. 28 (a) and (b)

94. A medical practitioner is authorised to supply a drug of addiction to a person referred to in section 28 (a) or (b) of the Act without an authority under section 29 of the Act:

(a)

if 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 hospital; and

(b)

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

Subdivision 2—Supply without prescription

Supply to be on the basis of a written order

95. (1) A person who is authorised to supply drugs of addiction (whether by this Division or by an authority or licence under Part 7) may supply a drug of addiction:

1994—No. 436

(a) to any person who is authorised to have possession of such a drug of addiction; or
(b) to any other person if the other person is in possession of a certificate, signed by a person so authorised, to the effect that the other person is authorised to obtain the drug of addiction on behalf of the person so authorised.

(2) A supplier may supply drugs of addiction under this clause on the basis of a written order signed by a person so authorised or on the basis of an order received from such a person by telephone, lettergram or facsimile.

(3) A person who orders a drug of addiction by telephone, lettergram or facsimile must, within 24 hours after doing so, send written confirmation of the order to the supplier.

(4) If a supplier who supplies a drug of addiction on the basis of an order received by telephone, lettergram or facsimile does not receive written confirmation of the order within 7 days after the drug was supplied, the supplier must report that fact to the Director-General.

(5) A person who supplies a drug of addiction in accordance with this clause must keep and cancel the relevant order and (if the drug is supplied as referred to in subclause (1) (b)) the relevant certificate.

Emergency supply by pharmacists

96. (1) A pharmacist may supply a person with a drug of addiction in accordance with a direction given under clause 83.

(2) A pharmacist who supplies a drug of addiction in accordance with this clause:

(a)

must keep and cancel the prescription that is subsequently sent in confirmation of the direction; or

(b)

if such a prescription is not received within 7 days after the drug is supplied, must report that fact to the Director-General.

Supply by pharmacists in accordance with Commonwealth

entitlements

97. A pharmacist may supply a medical practitioner with a drug of addiction under the authority of an Emergency Drug (Doctor’s Bag) Order form that has been completed in accordance with the requirements of the National Health Act 1953 of the Commonwealth.

1994—No. 436

Supply of amphetamines

98. (1) This clause applies to the following substances:
amphetamine
dexamphetamine
methylamphetamine
methylphenidate
phendimetrazine
phenmetrazine
(2) A medical practitioner does not require an authority under section

29 of the Act to supply dexamphetamine or methylphenidate to a person for the purpose of testing the suitability of the person to undergo a course of medical treatment involving the use of such a substance so long as the medical practitioner holds an authority under Part 7 to supply such a substance.

(3) A dentist or veterinary surgeon is not authorised to supply any substance to which this clause applies.

(4) This clause does not prevent a veterinary surgeon from supplying methylphenidate (in solid dosage form) to a person for the treatment of an animal.

Subdivision 3—Supply in hospitals

Supply by pharmacists
99. (1) A pharmacist employed at a hospital may supply a drug of addiction from the pharmacy department of the hospital:

(a) on a prescription issued in accordance with Division 3; or

(b) on the written requisition of a medical practitioner or dentist or of the nurse in charge of the ward in which the drug is to be used or stored.

(2) The person delivering a drug of addiction to a ward from the pharmacy department of the hospital must obtain a receipt, dated and signed, from the person to whom the drug is delivered.

Subdivision 4—Administration

Administration by persons employed at a hospital

100. (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.

1994—No. 436

(2) Such a direction must be given in writing, except in an emergency in which case it may be given verbally, by telephone or facsimile or in any other manner approved by the Director-General.

(3) A medical practitioner or dentist who gives a direction for the administration of a drug of addiction to a patient otherwise than in writing must, within the next 24 hours, sign an entry in the patient’s medical history confirming that he or she has given the direction.

(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) Subclauses (3) and (4) do not apply to the administration of a drug of addiction to a patient in an institution conducted by the Corrections Health Service if the drug is administered in accordance with the requirements of a protocol approved by the Director-General.

Self-administration by medical practitioners and dentists

101. (1) For the purposes 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.

Subdivision 5—General

Unauthorised manufacture and supply of drugs of addiction prohibited

102. (1) A person must not manufacture or supply a drug of addiction unless the person is authorised to do so by this Division or by an authority or licence under Part 7.

(2) This Division does not authorise a person to manufacture or supply drugs of addiction in contravention of any prohibition or restriction to which the person is otherwise subject.

1994—No. 436

Possession of drugs of addiction by medical practitioners, dentists, veterinary surgeons, hospital pharmacists

103. (1) The following persons are authorised to have possession of, and to supply, drugs of addiction:

(a) a medical practitioner, dentist or veterinary surgeon;

(b)

the chief pharmacist of, and any pharmacist employed in dispensing medicines at, any public hospital or other public institution;

(c) the nurse in charge of a ward in a public hospital;

(d)

a nurse employed in a Community Health Centre in a place or locality approved for the time being by the Director-General;

(e)

any other nurse, but for the purpose only of administering doses of such drugs to individual patients in a hospital;

(f) a person:

(i)  who is employed by the Ambulance Service of New South Wales as an ambulance officer or as an air ambulance flight nurse; and

(ii)  who is approved for the time being by the Ambulance Service of New South Wales for the purposes of this clause.

(2) The following persons are authorised to have possession of (but not to supply) drugs of addiction:

(a) a person in charge of a laboratory used for the purpose of analysis, research or instruction, being a person who is approved for the time being by the Director-General for the purposes of this clause;
(b) an analyst appointed under the Therapeutic Goods and Cosmetics Act 1972;
(c) a person acting under the direct personal supervision of a person referred to in paragraph (a) or (b).

(3) This clause authorises a person referred to in subclause (1) or (2) to have possession of, or to supply, drugs of addiction for the purpose only of the lawful practice of the person’s profession or occupation.

(4) This clause does not authorise any person to have possession of, or to supply, hallucinogens.
(5) This clause does not authorise a dentist or veterinary surgeon to have possession of, or to supply, any of the following substances:

amphetamine
dexamphetamine
methylamphetamine
methylphenidate (other than methylphenidate in solid dosage form)

1994—No. 436

phendimetrazine

phenmetrazine

Possession of drugs of addiction by retail pharmacists

104. (1) A retail pharmacist is authorised:

(a) to have possession of drugs of addiction; and

(b)

to manufacture drugs of addiction and any preparation, admixture or extract of a drug of addiction; and

(c) to supply a drug of addiction:

(i) to a person who has a prescription for the drug; or

(ii) to the chief nurse of a private hospital or nursing home,

but only if he or she does so at the premises of, and in the course of
carrying on the business of, the pharmacy.

(2) This clause does not authorise a retail pharmacist to have possession of, or to manufacture or supply, hallucinogens.

Possession of drugs of addiction by chief nurses of private hospitals

105. (1) The chief nurse of a private hospital or nursing home is authorised to have possession of the following drugs of addiction in the following quantities:

(a) no more than 5 ampoules of morphine sulphate (15 milligrams in 1 millilitre);
(b) no more than 5 ampoules of pethidine hydrochloride (100 milligrams in 2 millilitres).

(2) The chief nurse must not allow any such drug of addiction to be used otherwise than for administration to a patient in accordance with the directions of a medical practitioner or dentist.

(3) This clause does not limit the power of a chief nurse to have possession of drugs of addiction, or to supply drugs of addiction to patients, in accordance with a licence under Part 7.

Possession of drugs of addiction by masters of ships

106. (1) The master of a ship is authorised to have possession of drugs of addiction that are required by law to be carried on the ship.

(2) A pharmacist may supply drugs of addiction to the master of a ship
if the pharmacist is authorised to do so by an authority under Part 7.

1994—No. 436

(3) A person must not supply a drug of addiction to the master of a ship unless the person receives:

(a)

a written order for the drug (in duplicate) signed by the master of the ship; and

(b)

a written statement (in duplicate) signed by the master of the ship, being a statement to the effect that the drug is required by law to be carried on the ship; and

(c)

a certificate, issued by the ship’s agent in New South Wales, to the effect that the signatures appearing on the order and statement are those of the master of the ship.

(4) A person who supplies a drug of addiction in accordance with this

clause: (a) must keep and cancel the relevant order and statement; and

(b) must cancel the duplicate copies of the order and statement and forward them to the Director-General, together with the certificate issued by the ship’s agent, within 24 hours.

(5) This clause does not authorise the master of a ship to have possession of, or to supply, hallucinogens.

Possession of hallucinogens

107. A person must not obtain possession of a hallucinogen unless the

person is authorised to do so by an authority or licence under Part 7.

Authorities to possess and administer drugs of addiction

108. (1) The following persons are authorised to have possession of drugs of addiction, but only if authorised to do so by an authority under Part 7:

(a) a person in an isolated locality;

(b) a person in charge of a first aid post;

(c) a person representing an organisation established for search and rescue;

(d) any other person the Minister may from time to time approve. (2) A person who is so authorised to have possession of a drug of

addiction is also authorised to administer the drug to another person in an

emergency.

Mode of delivery

109. (1) A person who supplies drugs of addiction must do so personally, by security post or by carrier.

1994—No. 436

(2) A person who supplies a drug of addiction personally:

(a) must deliver it to the person being supplied at the premises of the supplier or at the premises of the person being supplied; and
(b) must obtain a receipt, dated and signed, from the person to whom it is delivered.

(3) A person who supplies a drug of addiction by security post must obtain and keep written evidence of postage of the drug.

(4) A person who supplies a drug of addiction by carrier must obtain and keep written evidence of the consignment of the drug.

(5) A person who supplies a drug of addiction must not deliver a drug of addiction by carrier otherwise than under an arrangement under which the carrier undertakes:

(a)

to obtain a receipt, dated and signed, from the person to whom the drug is delivered; and

(b) to deliver the receipt to the supplier.

Delivery by carrier

110. (1) A carrier is authorised to be in possession of a package containing a drug of addiction, but for the purpose only of delivering it to the person to whom it is addressed.

(2) A dealer (other than a medical practitioner, dentist, veterinary

surgeon or pharmacist) who supplies a drug of addiction by post or by

carrier must ensure that:

(a)

the drug is contained in a package that has at least one opaque covering; and

(b) no other goods are contained in the package; and
(c) the package contains a document:

(i) listing the contents of the package; and

(ii)  bearing the words “SCHEDULE EIGHT—CHECK CAREFULLY” in bold face sans serif capital letters with a letter height of at least 12.5 millimetres; and

(d) the outside of the package does not indicate that it contains a drug of addiction; and
(e) the package is properly addressed to the person to whom the drug is being supplied.

(3) This clause does not prevent a dealer from supplying a drug of addiction by means of a separately wrapped inner package within an outer package containing other goods so long as:

1994—No. 436

(a)

a document listing the contents of the inner package is contained in the inner package; and

(b)

the inner package is marked with the words “SCHEDULE EIGHT—CHECK CAREFULLY” in bold face sans serif capital letters with a letter height of at least 12.5 millimetres; and

(c)

the outside of the outer package does not indicate that it contains a drug of addiction; and

(d)

the outer package is properly addressed to the person to whom the drug is being supplied.

Anabolic steroidal agents not otherwise specified in this Appendix

when included in Schedule 4 of the Poisons List ........... Androisoxazole

5.0 grams

..................................................................... 5.0 grams

Barbituric acid derivatives not otherwise specified in this

Appendix ..................................................................... 50.0 grams

Benzodiazepine derivatives not otherwise specified in this

Appendix ..................................................................... 0.5 gram
Benzphetamine ................................................................... 5.0 grams
Bolandiol ............................................................................. 5.0 grams
Bolasterone .......................................................................... 5.0 grams
Boldenone ........................................................................... 2.5 grams
Bolmantalate ........................................................................ 5.0 grams
Bromazepam ...................................................................... 5.0 grams
Butobarbitone ..................................................................... 50.0 grams
Calusterone .......................................................................... 30.0 grams
Cathine .............................................................................. 5.0 grams
Chlorandrostenolone .............................................................. 5.0 grams
Chlordiazepoxide ................................................................ 5.0 grams
Chloroxydienone. .................................................................. 5.0 grams
Chloroxymesterone ............................................................... 5.0 grams
Clobazam ........................................................................... 2.5 grams
Clonazepam ....................................................................... 0.5 gram
Clorazepate ........................................................................ 3.0 grams
Clostebol ............................................................................ 2.0 grams
Cyclobarbitone ................................................................... 50.0 grams

Dextropropoxyphene when included in Schedule 4 of the Poisons

List ............................................................................ 15.0 grams

1994—No. 436

Diazepam ........................................................................... 2.5 prams
Diethylpropion .................................................................... 5.0 grams
Dihydrolone ......................................................................... 5.0 grams
Dimethandrostanolone ........................................................... 5.0 grams
5.0 grams
Dimethazine .........................................................................

Doxapram

..........................................................................

2.0 grams 2.0 grams

Drostanolone ......................................................................

5.0 grams

Ephedrine ..........................................................................

50.0 grams

Ethchlorvynol .....................................................................
Ethinamate ......................................................................... 50.0 grams
5.0 grams
Ethyldienolone .....................................................................
Ethyloestrenol
..................................................................... 1.0 gram

Fencamfamin

.......................................................................

1.0 gram 1.0 gram

Fenproporex .......................................................................

0.5 gram

Flunitrazepam .....................................................................
Fluoxymesterone ................................................................. 2.0 grams
Flurazepam ....................................................................... 10.0 grams
Formebolone ....................................................................... 1.0 gram
Formyldienolone .................................................................. 1.0 gram
Furazabol ........................................................................... 0.5 gram
Glutethimide ...................................................................... 50.0 grams
Hydroxystenozol .................................................................. 5.0 grams
Lorazepam ........................................................................ 1.0 gram
Mazindol .......................................................................... 0.5 gram
Medazepam ....................................................................... 2.5 grams
Mefenorex ......................................................................... 5.0 grams
Meprobamate ..................................................................... 100.0 grams
Mesabolone ......................................................................... 5.0 grams
Mestanolone. ....................................................................... 5.0 grams
Mesterolone ........................................................................ 10.0 grams
Methandienone .................................................................... 1.0 gram
Methandriol ........................................................................ 20.0 grams

1994—No. 436

Methenolone ........................................................................ 2.0 grams
Methylandrostanolone ............................................................ 5.0 grams
Methylclostebol .................................................................... 5.0 grams
Methyltestosterone ................................................................ 20.0 grams
Methyltrienolone ................................................................... 5.0 grams
Methyprylone .................................................................... 40.0 grams
Mibolerone ........................................................................ 0.01 gram
Midazolam ......................................................................... 0.5 gram
Nalbuphine ........................................................................ 0.5 gram
Nandrolone ....................................................................... 1.0 gram
Nitrazepam ........................................................................ 1.0 gram
Norandrostenolone ............................................................... 1.0 gram
Norbolethone ...................................................................... 5.0 grams
Norethandrolone ................................................................. 4.0 grams
Normethandrone .................................................................. 0.5 gram
Oxabolone .......................................................................... 0.5 gram
Oxandrolone ...................................................................... 1.0 gram
Oxazepam ......................................................................... 10.0 grams
Oxymesterone .................................................................... 4.0 grams
Oxymetholone ................................................................... 40.0 grams
Paraldehyde ....................................................................... 250 millilitres
Pentazocine ....................................................................... 20.0 grams
Pentobarbitone ................................................................... 50.0 grams
Phentermine ...................................................................... 10.0 grams

Pipradrol except in compounded preparations containing 0.01 per

cent or less of pipradrol .............................................. 1.0 gram
Prasterone ........................................................................... 1.0 gram
Prazepam .......................................................................... 2.5 grams
Propylhexedrine ................................................................. 5.0 grams
Pseudoephedrine when included in Schedule 4 of the Poisons List 20.0 grams
Pyrovalerone ..................................................................... 1.0 gram
Quinalbarbitone ................................................................ 50.0 grams
Quinbolone ........................................................................ 3.0 grams
1994—No. 436
Secbutobarbitone ................................................................ 50.0 grams
Silandrone .......................................................................... 5.0 grams
Stanolone .......................................................................... 10.0 grams
Stanozolol ......................................................................... 2.0 grams
Stenbolone .......................................................................... 5.0 grams
Temazepam ....................................................................... 5.0 grams
Testolactone ........................................................................ 100.0 grams

Testosterone except when included in Schedule 6 of the Poisons

List ............................................................................ 20.0 grams
Thiomesterone ..................................................................... 5.0 grams

Trenbolone except when included in Schedule 6 of the Poisons

List ............................................................................ 5.0 grams
Trestolone ......................................................................... 5.0 grams
Triazolam .......................................................................... 0.05 gram
Zolazepam ........................................................................ 2.5 grams

1994—No. 436

APPENDIX E—WHOLESALE DEALING

(CI. 125)

Medical superintendents of hospitals

The medical superintendent of a hospital is authorised to be in possession of any Schedule 1, 2, 3, 4, 5 or 6 substance.

Persons licensed to manufacture or supply drugs of addiction

The holder of a licence under Part 7 to manufacture or supply drugs of addiction is authorised to be in possession of any Schedule 1 , 2, 3. 4, 5 or 6 substance.

Scientifically qualified persons

A scientifically qualified person in charge of a laboratory or department is authorised
to be in possession of any Schedule 1, 2, 3, 4, 5 or 6 substance for use in the conduct of

medical or scientific research or instruction or the conduct of quality control or analysis.

Masters of ships

The master of a ship is authorised to be in possession of any Schedule 1, 2, 3, 4, 5 or 6 substance that is required by law to be carried on the ship.

Miscellaneous trades and industries

A person who is engaged in any of the following activities is authorised to be in possession of any Schedule 1, 2, 3. 5 or 6 substance for use in connection with that activity:

(a) jewellery manufacture;
(b) electroplating;
(c) paint manufacture;
(d) ferrous hardening;
(e) commercial pest control;

( f ) mining gold or other precious metals;

(g) refining non-ferrous metals.

Optometrists

A person who holds a certificate under Part 4A of the Optometrists Act 1930 is authorised to be in possession of any substance referred to in the Table to this clause so long as the substance is in the form of eyedrops containing not more than the maximum concentration set out in that Table opposite that substance.

1994—No. 436

TABLE

Substance Maximum
concentration
Adrenaline .......................................................................... 0.1 per cent
Amethocaine hydrochloride ...................................................
0. 5 per cent
Cyclopentolate hydrochloride .................................................. 1 per cent
Ephedrine hydrochloride ....................................................... 5 per cent
Homatropine hydrobromide ................................................... 2 per cent
Oxybuprocaine hydrochloride ................................................ 0.4 per cent
Physostigmine hydrochloride ................................................. 0.5 per cent
Pilocarpine hydrochloride ...................................................... 2 per cent
Pilocarpine nitrate ................................................................ 2 per cent
Proxymetacaine hydrochloride ................................................. 0.5 per cent
Tetrahydrozoline .................................................................. 0.05 per cent
Tropicamide ........................................................................ 1 per cent
Podiatrists

A registered podiatrist (within the meaning of the Podiatrists Act 1989) is authorised to be in possession of synthetic cocaine substitutes (prepared for parenteral use) for use in connection with podiatry.

Dental therapists

(1) A dental therapist is authorised to be in possession of the following substances for use in connection with dental therapy:

benzocaine lignocaine mepivacaine

prilocaine

procaine

tetracycline (in preparations for treatment of dental pulp)

triamcinolone (in preparations for treatment of dental pulp)

(2) In this clause, “dental therapist” means a person who has such training, and performs such part of the practice of dentistry, as is prescribed under section 57 (4) (c) of the Dentists Act 1989.

1994—No. 436

Emergency medical treatment by ambulance officers

A person:

(a) who is employed by the Ambulance Service of New South Wales as an ambulance officer or as an air ambulance flight nurse; and
(b) who is approved for the time being by the Ambulance Service of New South Wales for the purposes of this clause,

is authorised to be in possession of such Schedule 1, 2, 3, 4. 5 or 6 substances as are approved by the Ambulance Service of New South Wales for use by such persons in the carrying out of emergency medical treatment.

Emergency medical treatment of divers

A person:

(a) who is a dive medical technician within the Police Service; and

(b)

whose duties include the carrying out (under the supervision of a medical practitioner who is qualified in underwater medicine) of emergency medical treatment on divers,

is authorised to be in possession of the substances specified in the Table to this clause.

TABLE

Substance Form Strength
adrenaline .............................. ampoule not more than 0.01 per cent

amoxycillin with clavulanic acid

tablet

not more than 500 milligrams (amoxycillin) and 125 milligrams (clavulanic acid)

atropine ................................. ampoule not more then 600 micrograms per
ampoule
dexamethasone with framycetin ear drops not more than 500 micrograms

and

gramicidin .........................

(dexamethasone), 5 milligrams (framycetin) and 50 micrograms (gramicidin)

diazepam ................................. ampoule not more than 10 milligrams per
ampoule
diclofenac ................................ tablet not more than 50 milligrams
frusemide ................................ ampoule not more than 20 milligrams per
ampoule
heparin .................................... ampoule not more than 25,000 units per 5
millilitres
lignocaine ................................ ampoule not more than 1 per cent
lignocaine with chlorhexidine .... ampoule not more than 2 per cent

1994—No. 436

metronidazole ........................... tablet not more than 200 milligrams
naloxone.. ................................ ampoule not more than 400 micrograms per
ampoule
piroxicam ................................ gel not more than 0.5 per cent
prochlorperazine ....................... ampoule not more than 12.5 milligrams per
ampoule
prochlorperazine ....................... tablet not more than 5 milligrams
trimethoprim with
sulfamethoxazole ...................... tablet not more than 160 milligrams
(trimethoprim) and 800
milligrams (sulfamethaxozole)
Industrial first aid

A person who is in control of an industrial first aid post is authorised to be in possession of any Schedule 2 substance in connection with the carrying out of industrial first aid.

Registered nurses involved in vaccination programs

A person who is a registered nurse and who is employed in connection with a vaccination program carried out in a public institution or place of work is authorised to be in possession of vaccines for use in humans.

Ski rescue

A ski patroller who holds a valid first aid certificate issued by the Australian Ski Patrol Association for use in ski patrol duties is authorised to be in possession of methoxyflurane, nitrous oxide and trichloroethylene for use in connection with the carrying out of ski rescues.

Bee keeping

A person:

(a) who is registered as a beekeeper under the Apiaries Act 1985; and

(b) who holds a written authority (issued by the Director-General of the Department of Agriculture) recommending the use, by that person, of that substance for that purpose,

is authorised to be in possession of oxytetracycline in the form of a stock medicine registered under the Stock Medicines Act 1989 for use in the treatment or prevention of European Foulbrood disease in bees.

Animal feedstulf production

(1) A person who is authorised under this Regulation to obtain a Schedule 1, 2, 3 or 4 substance is authorised to be in possession of the substance for use in connection with the commercial production of animal feedstuffs or feedstuff premixes.

1994—No. 436

(2) In this clause, a reference to an animal feedstuff or feedstuff premix is a reference

to a feedstuff or feedstuff premix containing a Schedule 1. 2. 3 or 4 s ubstance at such a
level, or in such a form:

(a) that Schedule 6 to the Poisons List applies to the substance; or

(b) that the substance is not a poison.

APPENDIX F—RESIDENTIAL CENTRES FOR DISABLED PERSONS

(Dictionary)

Balgownie Centre (Mount View), Wollongong
Baringa Centre, Fairy Meadow
Grosvenor Centre, Summer Hill
John Williams Centre, Warringah
Kanangra Centre, Morisset
Lachlan Centre, North Ryde
Marsden Centre, Westmead
Marsden Rehabilitation Centre, Parramatta
Peat Island Centre, Peat Island
Pennant Hills Hostel, Pennant Hills
Riverside Centre, Orange
Rydalmere Centre, Rydalmere
Stockton Centre, Stockton
Strathallen Centre, Goulburn
Tomaree Centre, Shoal Bay
Woodstock Centre, AIbury
York Road Cottages, Bondi Junction

1994—No. 436

APPENDIX G—FORMS

Form 1

(Cl. 157)

APPLICATION FOR AUTHORITY TO PRESCRIBE A DRUG OF

ADDICTION

(Section 29 of the Poisons Act 1966)

The Medical Officer,
Pharmaceutical Services Section,

Department of Health, New South Wales,

I. Dr ................................................................ SPECIALITY ............................

(Name in block letters) (if any)

of ................................................................ TEL. NO. ( ) ..........................

(Address in block letters)

hereby apply for permission to prescribe or continue treatment with the drug(s)—name.

strength and dosage form:

(1) .................................................................................................................
(2) .................................................................................................................

at a dosage and frequency of (1) .....................................................................

(2) ......................................................................

(If dosage is P.R.N. indicate approximate

weekly or monthly usage)

for Mr/Mrs/Ms ................................................................. D.O.B. .....................

(FULL name of patient in block letters)

of ..................................................................................................................

(Patient’s address in block letters)

who is suffering from ......................................................................................

(Please include prognosis—if applicable)

I consider this patient *IS an addict (as ( ) lick appropriate
defined below) box
*IS NOT an addict ( )
........................................................ ........................................................
(Signature) (Date)

NOTE: Copies of relevant hospital/specialist reports (if available) will facilitate the application.

1994—No. 436

DICTIONARY

(Cl . 3 )

charitable organisation means an organisation or association that holds an authority under Part 2 of the Charitable Fundraising Act 1991 or that is referred to in section 7 of that Act as an organisation or association to which that Act does not apply.

child-resistant closure means (in the case of a can) a lid of the design known as “double-tight” or “triple-tight” or (in any other case) a closure that is resistant to opening by children and that complies with:

(a) a design specified and described in Part 1 of Schedule 3 to Therapeutic Goods Order No. 20; or
(b) a design approved for the time being by the Director-General.

Commonwealth Department of Health means the Commonwealth Department of Human Services and Health.

day procedure centre means premises licensed as a day procedure centre under the Private Hospitals and Day Procedure Centres Act 1988.

dealer, in relation to a substance, means a person who supplies the substance as a manufacturer, as an importer or exporter or as a wholesale or retail dealer, and includes a medical practitioner, dentist, veterinary surgeon or pharmacist in his or her capacity as a supplier of the substance.

Director-General means the Director-General of the Department of

Health.

function includes a power, authority and duty; exercise a function

includes perform a duty; confer a function includes impose a duty.

hallucinogen means any of the following drugs of addiction:

(a) etorphine;

(b)

lysergic acid, lysergide, bufotenine, N:N-dimethyl- tryptamine, psilocin, psilocybin and any of their derivatives having hallucinogenic properties;

(c) mescaline and other substances structurally derived from
methoxyphenylethylamine, being substances having
hallucinogenic properties and not otherwise specified in
Schedule 8 of the Poisons List;

(d) phencyclidine;
(e) tetrahydrocannabinol.

1994—No. 436

hospital means a public hospital, public institution, private hospital, nursing home, day procedure centre or residential centre for disabled persons.

inspector means a person authorised by the Director-General to exercise the powers conferred by section 43 of the Act (Powers of entry and search).
nurse means a person who is registered as a nurse under the Nurses Act 1991.
nursing home means premises licensed as a nursing home under the Nursing Homes Act 1988.
pharmacist includes pharmacy trainee.

prescribed restricted substance means a substance listed in Appendix

D.

prescription reference number means the unique reference number for the prescription recorded under clause 58 or 115.

private hospital means premises licensed as a private hospital under the Private Hospitals and Day Procedure Centres Act 1988.

public hospital means:

(a) an incorporated hospital or a separate institution within the meaning of the Public Hospitals Act 1929, premises controlled by an associated organisation within the meaning of that Act or a hospital specified in the Fifth Schedule to that Act; or
(b) a hospital or other institution under the control of an area health service constituted under the Area Health Services Act 1986.

residential centre for disabled persons means a residential centre for disabled persons specified in Appendix F.

retail pharmacist means a pharmacist who is employed in premises approved under section 24A of the Pharmacy Act 1964 as suitable for carrying on the business of a pharmacist.

scientifically qualified person means:

(a)

a medical practitioner, dentist or veterinary surgeon or pharmacist; or

(b)

a person who is the holder of a degree or diploma approved for the time being by the Director-General; or

(c)

a person approved for the time being by the Director-General.

the Act means the Poisons Act 1966.

1994—No. 436

Therapeutic Goods Order No. 20 means the order of that name, as in force from time to time under Part 2 of the Therapeutic Goods Act 1989 of the Commonwealth.

therapeutic substance means a substance that is manufactured for therapeutic use within the meaning of the Uniform Standard.

Uniform Standard means the Standard for the Uniform Scheduling of Drugs and Poisons published by the Australian Health Ministers’ Advisory Council, as in force from time to time.

ward of a hospital includes any theatre, laboratory or department of the

hospital, other than the pharmacy department.

NOTES

TABLE OF PROVISIONS

PART 1—PRELIMINARY

1. Citation

2. Commencement

3. Definitions

PART 2—POISONS (S1, S2. S3, S5. S6. S7)

Division 1—Packaging and labelling

4. Packaging and labelling generally

5. Misleading labelling of poisons and other substances

6. Packaging of camphor and naphthalene
7. Schedule 1 or 3 substances supplied by retail dealers

8. Exemptions

Division 2—Storage

9. Storage generally

10. Schedule 1, 3 or 7 substances

11. Schedule 6 substances

Division 3—Prescriptions

12. Unauthorised persons not to prescribe Schedule 3 substances
13. Certain Schedule 3 substances

14. Quantity and purpose of prescriptions to be appropriate

Division 4—Supply

15. Schedule 1 substances to be supplied only to adults known to dealers
16. Schedule 2 and 3 substances may be supplied by authorised persons
17. Schedule 3 substances to be supplied personally by pharmacists

1994—No. 436

18. Supply of dihydrocodeine
19. Prescriptions for Schedule 3 substances to be endorsed
20. Schedule 7 substances to be supplied and used only under an authority
21. “Particular use” poisons may only be supplied in original containers
22. Supply of art materials. toys, furniture etc. containing poisons

23. Quantity and purpose of supply to be appropriate

Division 5—Records of supply

24. Registers of Schedule 1 substances

25. Supply of certain Schedule 3 substances to be recorded

Division 6—Miscellaneous

26. Poisons to be used or disposed of safely

PART 3—RESTRICTED SUBSTANCES (S4)

Division 1—Packaging and labelling

27. Packaging and labelling generally
28. Misleading labelling of restricted substances and other substances

29. Exemptions

Division 2—Storage

30. Storage generally
31. Storage of pentazocine elsewhere than in hospital wards

32.  Storage of prescribed restricted substances (including pentazocine) in hospital wards

33. Responsibility for storage in hospitals

Division 3—Prescriptions

34. Unauthorised persons not to prescribe restricted substances
35. Prescriptions may only be issued for certain purposes

36. Quantity and purpose of prescriptions to be appropriate
37. Form of prescriptions
38. Emergency prescriptions may be given verbally or by telephone
39. Authority required to prescribe certain restricted substances

40. Records to be kept of certain prescriptions

Division 4—Supply

Subdivision 1—Supply on prescription

41. Prescriptions may only be filled if in proper form
42. Certain prescriptions not to be filled
43. Prescriptions to be endorsed
44. Prescriptions for certain substances to be kept

1994—No. 436

Subdivision 2—Supply without prescription

45. Supply by medical practitioners, dentists and veterinary surgeons
46. Emergency supply by pharmacists on direction of medical practitioners

47.   Emergency supply by pharmacists otherwise than on direction of medical practitioners

48. Supply by pharmacists in accordance with Commonwealth entitlements

Subdivision 3—Supply in hospitals

49. Supply by pharmacists

50. Supply in original containers: sec. 19

Subdivision 4—Administration

51. Administration by persons employed at a hospital 52. Administration of prescribed restricted substances 53. Authority required to administer certain restricted substances

Subdivision 5—General

54. Research drugs
55. Authority required to supply certain restricted substances
56. Restricted substances may be supplied by authorised persons

57. Quantity and purpose of supply to be appropriate

Division 5—Records of supply

58. Supply on prescription to be recorded

59.  Records to be kept of supply of restricted substances by medical practitioners, dentists and veterinary surgeons

60. Emergency supplies of restricted substances to be separately recorded

61. Drug registers to be kept for pentazocine

Division 6—Miscellaneous

62. Prescribed restricted substances: secs. 16, 18A
63. Authorised persons: sec. 16 (1) (e)
64. Disclosure of other prescribed restricted substances obtained or prescribed
65. Delivery by carrier
66. Pentobarbitone sodium
67. Benzylpenicillin
68. Restricted substances to be used or disposed of safely
69. Destruction of pentazocine
70. Loss or theft of prescribed restricted substances
71. Forfeiture of prescribed restricted substances

1994—No. 436

PART 4—DRUGS OF ADDICTION (S8)

Division 1—Packaging and labelling

72. Packaging and labelling generally
73. Misleading labelling of drugs of addiction and other substances
74. Packages to be sealed so that broken seal is readily distinguishable

75. Exemptions

Division 2—Storage

76. Storage generally
77. Storage in hospitals

78. Storage in pharmacies

Division 3—Prescriptions

79. Unauthorised persons not to prescribe drugs of addiction
80. Prescriptions may only be issued for certain purposes
81. Quantity and purpose of prescriptions to be appropriate
82. Form of prescriptions
83. Emergency prescriptions may be given verbally or by telephone
84. Records of prescriptions
85. Prescriptions for amphetamines

86. Exceptions to sec. 28 (a) and (b)

Division 4—Supply

Subdivision 1—Supply on prescription 87. Pharmacists may supply drugs of addiction on prescription 88. Prescriptions may only be filled if in proper form

89. Certain prescriptions not to be filled
90. Prescriptions for certain drugs require verification
91. Prescriptions to be endorsed
92. Prescriptions to be kept
93. Supply by pharmacists of amphetamines

94. Exceptions to sec. 28 (a) and (b)

Subdivision 2—Supply without prescription

95. Supply to be on the basis of a written order
96. Emergency supply by pharmacists
97. Supply by pharmacists in accordance with Commonwealth entitlements
98. Supply of amphetamines

1994—No. 436

Subdivision 3—Supply in hospitals

99. Supply by pharmacists

Subdivision 4—Administration

100. Administration by persons employed at a hospital

101. Self-administration by medical practitioners and dentists

Subdivision 5—General

102. Unauthorised manufacture and supply of drugs of addiction prohibited

103.  Possession of drugs of addiction by medical practitioners, dentists, veterinary surgeons, hospital pharmacists

104. Possession of drugs of addiction by retail pharmacists

105. Possession of drugs of addiction by chief nurses of private hospitals
106. Possession of drugs of addiction by masters of ships
107. Possession of hallucinogens
108. Authorities to possess and administer drugs of addiction

109. Mode of delivery

110. Delivery by carrier

111. Quantity and purpose of supply to be appropriate

Division 5—Records of supply

Subdivision 1—Drug registers otherwise than for hospital wards

112. Application of Subdivision 113. Drug registers to be kept 114. Entries in drug registers

115. Supply on prescription to be recorded

Subdivision 2—Drug registers for hospital wards

116. Application of Subdivision
117. Drug registers to be kept

118. Entries in drug registers

Subdivision 3—General

119. Periodical inventory of drugs of addiction stock

120. Loss or destruction of registers

Division 6—Miscellaneous

121. Prescribed drugs of addiction: sec. 28
122. Loss or theft of drugs of addiction
123. Drugs of addiction not to be destroyed
124. Destruction of unusable drugs of addiction in hospital wards

1994—No. 436

PART 5—WHOLESALE DEALING

125. Authorised possession for the purposes of wholesale dealing: sec. 4
126. Restrictions on wholesale dealing
127. Records of wholesale dealing

128. Supply of clinical samples

PART 6—DRUG PRECURSORS

129. Definitions
130. Supply of drug precursors
131. Invoices to be kept separately
132. Returns to Commissioner of Police
133. Supply for drug production
134. Loss or theft of drug precursors
135. Obtaining drug precursors by false representation

136. Exemptions

PART 7—LICENCES AND AUTHORITIES

Division 1—Licences to supply Schedule 2 substances

137. Applications for licences

138. Consideration of applications

139. Licences
140. Conditions of licences

141. Annual licence fees

Division 2—Licences to manufacture or supply drugs of addiction

142. Applications for licences
143. Consideration of applications
144. Licences
145. Conditions of licences

146. Annual licence fees

Division 3—Authorities

147. Authorities

148. Conditions of authorities

Division 4—Suspension and cancellation of licences and authorities

149. Grounds for suspension or cancellation
150. Suspension or cancellation

1994—No. 436

PART 8—MISCELLANEOUS

151.   Director-General may restrict authorisations conferred by this Regulation

152.    Appeals to the District Court

153.    Records generally

154.    False or misleading entries in records and registers

155.    False or misleading applications

156.  Service of notices

157.    Applications for authorities under sec. 29

158.   Quorum for Poisons Advisory Committee

159.   Repeal

160.  Transitional

APPENDIX A—LABELLING OF THERAPEUTIC SUBSTANCES
APPENDIX B—SPECIAL RESTRICTED SUBSTANCES
APPENDIX C—DRUG PRECURSORS
APPENDIX D—PRESCRIBED RESTRICTED SUBSTANCES
APPENDIX E-WHOLESALE DEALING
APPENDIX F—RESIDENTIAL CENTRES FOR DISABLED PERSONS
APPENDIX G—FORMS

DICTIONARY

EXPLANATORY NOTE

The object of this Regulation is to repeal and remake, without any major changes in substance, the Poisons Regulations under the Poisons Act 1966. The new Regulation makes provision with respect to the following matters:

(a)

the packaging, labelling, storage, prescription and supply of poisons (that is, substances included in Schedule 1, 2, 3 , 5 , 6 or 7 of the Poisons List kept under the Act) and the making of records in relation to the supply of poisons (Part 2);

(b)

the packaging, labelling, storage, prescription and supply of restricted substances (that is, substances included in Schedule 4 of the Poisons List) and the making of records in relation to the supply of restricted substances (Part 3);

(c)

the packaging, labelling, storage, prescription and supply of drugs of addiction (that is, substances included in Schedule 8 of the Poisons List) and the making of records in relation to the supply of drugs of addiction (Part 4);

(d)

the prescription of certain activities for the purpose of enabling persons engaged in those activities to supply substances by wholesale, and the regulation of wholesale dealing in those substances (Part 5);

(e)

the regulation of the supply of drug precursors (that is, substances from which other drugs can be derived) (Part 6);

(f)

the issue. suspension and cancellation of licences and authorities for the purposes of the Act (Part 7);

(g) other matters of a formal or machinery nature (Parts 1 and 8).

1994—No. 436

A feature of the new Regulation is its adoption, by reference, of the provisions of the Standard for the Uniform Scheduling of Drugs and Poisons (a publication of the Australian Health Ministers' Advisory Council) with respect to the packaging and labelling of substances.

This Regulation is made under the Poisons Act 1966, including section 45C (the
general regulation making power) and sections 4, 9, 16, 17, 18A, 19, 24, 28 and 29.

This Regulation is made in connection with the staged repeal of subordinate legislation under the Subordinate Legislation Act 1989.

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