Poisons and Therapeutic Goods Act 1966 Poisons and Therapeutic Goods Amendment (Fees and Penalties) Regulation 1996 (1996-470) [GG No 109 of 25.9.1996] (NSW)

Case

1996 No 470

New South Wales

Poisons and Therapeutic Goods

Amendment (Fees and Penalties)

Regulation 1996

under the

Poisons and Therapeutic Goods Act 1966

His Excellency the Governor, with the advice of the Executive Council, has made the following Regulation under the Poisons and Therapeutic Goods Act 1966.

ANDREW REFSHAUGE

Deputy Premier and Minister for Health

Explanatory note

The object of this Regulation is to amend the Poisons and Therapeutic

Goods Regulation 1994 in the following unrelated ways:

to remove any doubt as to who is liable to prosecution for certain offences created by the Poisons and Therapeutic Goods Regulation 1994. It does this by repealing and remaking certain of the provisions

of that Regulation that create offences.

to increase the application fees for certain licences and the annual fees payable for those licences. The licences concerned are licences to supply by wholesale any poisons or restricted substances and licences to manufacture drugs of addiction at, or to supply drugs of addiction from, any premises.

This Regulation also makes an amendment by way of statute law revision. This Regulation is made under the Poisons and Therapeutic Goods Act 1966, including section 17 (Regulations under Part 3) and section 45C (the general regulation-making power).

Published in Gazette No 109 of 25 September 1996, page 6507 Page 1

1996 No 470

C l a u s e 1 Poisons and Therapeutic Goods Amendment (Fees and Penalties) Regulation 1996

Poisons and Therapeutic Goods Amendment

(Fees and Penalties) Regulation 1996

1 Name of Regulation

This Regulation is the Poisons and Therapeutic Goods

Amendment (Fees and Penalties) Regulation 1996.

2 Commencement

This Regulation commences on 30 September 1996.

  1. Amendment of Poisons and Therapeutic Goods Regulation 1994

    The Poisons and Therapeutic Goods Regulation I994 is amended as set out in Schedule 1.

4 Notes

The explanatory note does not form part of this Regulation.

1996 No 470

Poisons and Therapeutic Goods Amendment (Fees and Penalties) Regulation 1996

Amendments Schedule 1
Schedule 1 Amendments

(Clause 3)

[1]      Clause 4 Packaging and labelling generally

Omit clause 4 (3). Insert instead:

(3) A pharmacist who:
(a) supplies any quantity of a Schedule 3 drug on prescription, or
(b) supplies (whether on prescription or otherwise) any quantity of a substance to which clause 25 applies,
must ensure that the substance is labelled in accordance with the requirements of Appendix A instead of in accordance with the requirements of subclause (1).

[2]        Clause 13 Certain Schedule 3 substances

Omit clause 13 (2). Insert instead:

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

[3]        Clause 18 Supply of dihydrocodeine

Omit clause 18 (2). Insert instead:

(2)

A pharmacist who supplies dihydrocodeine must comply with the requirements of clause 15 as if dihydrocodeine were a Schedule 1 substance.

1996 No 470

Poisons and Therapeutic Goods Amendment (Fees and Penalties) Regulation 1996

Schedule 1 Amendments
  1. Clause 19

    Omit the clause. Insert instead:

19 Prescriptions for Schedule 3 substances to be endorsed

A pharmacist who supplies a Schedule 3 substance must endorse the prescription for the substance in accordance with clause 43 as if the substance were a restricted substance.

Maximum penalty: 10 penalty units.

  1. Clause 25 Supply of certain Schedule 3 substances to be recorded

    of the supply”.

Omit “Details of the supply on prescription of a substance to which substance to which this clause applies must record details
this clause applies must be recorded” from clause 25 (2).
  1. Clause 27 Packaging and labelling generally

    Omit clause 27 (4). Insert instead:

(4) A pharmacist who supplies any quantity of a restricted substance must ensure that the substance is labelled in accordance with the requirements of Appendix A instead of in accordance with the requirements of subclause (1).

[7]        Clause 37 Form of prescription

Insert after clause 37 (5):

(6)

A person who issues a prescription for a restricted substance must ensure that the prescription complies

with the requirements of this clause.

1996 No 470

Poisons and Therapeutic Goods Amendment (Fees and Penalties) Regulation 1996

Amendments Schedule 1

[8]       Clauses 38 Emergency prescriptions may be given by telephone or otherwise

endorsed" from clause 38 (3).

Omit “A prescription that is issued under this clause must be must ensure that the prescription is endorsed".

[9]      Clause 39 Authority required to prescribe certain restricted substances

which this clause applies" from clause 39 (4).

Omit “A prescription that authorises the supply of a substance to supply of a substance to which this clause applies must ensure".

[10]   Clause 39 (4)

Omit “must be endorsed" wherever occurring.
Insert instead “that the prescription is endorsed".

[11]     Clause 41 Prescriptions may be filled only if in proper form

Omit clause 41 (3). Insert instead:

(3) A pharmacist must not supply a restricted substance more than once on a prescription referred to in subclause (2), regardless of how many times the prescription purports to authorise the supply of the substance.

[12]   Clause 72 Packaging and labelling generally

Omit clause 72 (3). Insert instead:

(3)

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

1996 No 470

Poisons and Therapeutic Goods Amendment (Fees and Penalties) Regulation 1996

S c h e d u l e 1 A m e n d m e n t s

[13]   Clause 82 Form of prescription

following details” from clause 82 (1).

Omit “A prescription for a drug of addiction must include the addiction must ensure that the prescription includes the following details” .

  1. Clause 82 (3)

Omit “A prescription that is made out in a manner approved under a manner approved under subclause (2) (b) must ensure that the prescription is endorsed”.
subclause (2) (b) must be endorsed”.
  1. Clause 83 Emergency prescriptions may be given by telephone or otherwise

Omit ‘‘A prescription that is issued under this clause must be must ensure that the prescription is endorsed”.
endorsed” from clause 83 (3).
  1. Clause 88 Prescriptions may be filled only if in proper form

    Omit clause 88 (3). Insert instead:

(3) A pharmacist must not supply a drug of addiction more than once on a prescription referred to in subclause (2), regardless of how many times theprescription purports to authorise the supply of the drug.
  1. Clause 141A Applications for licences

    Renumber the last paragraph of subclause (2) as (c).

1996 No 470

Poisons and Therapeutic Goods Amendment (Fees and Penalties) Regulation 1996

Amendments Schedule 1

[18]     Clauses 141A (3) (a), 141E (a), 142 (3) (a) and (4) (b) and 146 (1) (a) and (2) (b)

Omit “$40” wherever occurring. Insert instead “$45”.

[19]     Clauses 141A (3) (b) and 141 E (b)

Omit “$285” wherever occurring. Insert instead “$300”.

[20]     Clauses 142 (3) (b) and 146 (1 ) (b)

Omit ‘‘$380’’ wherever occurring. Insert instead “$395”.

[21]     Clauses 142 (4) (a) and 146 (2) (a)

Omit “$5” wherever occurring. Insert instead “$l0”.

[22]     Clauses 142 (4) (c) and 146 (2) (c)

Omit “$190" wherever occurring. Insert instead “$200”.

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