Poisons and Therapeutic Goods Amendment (Miscellaneous) Regulation 2005 (NSW)
2005 No 604
New South Wales
Poisons and Therapeutic Goods
Amendment (Miscellaneous)
Regulation 2005
under the
Poisons and Therapeutic Goods Act 1966
Her Excellency the Governor, with the advice of the Executive Council, has made the following Regulation under the Poisons and Therapeutic Goods Act 1966.
JOHN HATZISTERGOS, M.L.C.,
Minister for Health
Explanatory note
The object of this Regulation is to amend the Poisons and Therapeutic Goods Regulation
2002:
| (a) | to provide that pharmacists may personally supply certain quantities of adrenaline so that it may be used for the first aid management of anaphylaxis, and |
| (b) | to remove the prohibition on the supply of certain agents used for the diagnosis of human immunodeficiency virus infection, and |
| (c) | to provide that pharmacists are to keep records of emergency supplies of medicines to nursing homes, and |
| (d) | to clarify the requirements for the storage of drugs of addiction by ambulance officers and air ambulance flight nurses, and |
| (e) | to update a description of methadone syrup to methadone in oral liquid form, and |
| (f) | to provide that the Director-General of the Department of Health may approve additional entries required to be made in drug registers and ward registers, and may exempt certain persons and drugs of addiction from certain requirements in relation to those registers, and |
| (g) | to insert a reference to buprenorphine in relation to the grounds for suspension or cancellation of licences and authorities, and |
| (h) | to provide that optometrists may possess and be supplied by wholesale with certain substances described in the Optometrists Act 2002. |
This Regulation is made under the Poisons and Therapeutic Goods Act 1966, including sections 4, 17, 24 and 45C (the general regulation-making power).
| Published in Gazette No 120 of 30 September 2005, page 7725 | Page 1 |
| 2005 No 604 | Poisons and Therapeutic Goods Amendment (Miscellaneous) Regulation |
| Clause 1 | 2005 |
Poisons and Therapeutic Goods Amendment
(Miscellaneous) Regulation 2005
under the
Poisons and Therapeutic Goods Act 1966
1 Name of Regulation
This Regulation is the Poisons and Therapeutic Goods Amendment
(Miscellaneous) Regulation 2005.
2 Amendment of Poisons and Therapeutic Goods Regulation 2002
The Poisons and Therapeutic Goods Regulation 2002 is amended as set out in Schedule 1.
| Poisons and Therapeutic Goods Amendment (Miscellaneous) Regulation | 2005 No 604 |
| 2005 | |
| Amendments | Schedule 1 |
| Schedule 1 | Amendments |
(Clause 2)
[1] Clause 17 Schedule 3 substances to be supplied personally by pharmacists
Insert after clause 17 (4):
(5) This clause does not apply to the supply of adrenaline for
anaphylaxis first aid purposes if:
(a) the adrenaline is contained in single use automatic injectors that have been filled by the manufacturer with no more than 0.3 milligrams of adrenaline each, and (b) the supply is to a person who holds a current first aid certificate issued after completion of a first aid course approved by the WorkCover Authority as referred to in regulations made under the Occupational Health and Safety Act 2000, and the person has received training on the symptoms and first aid management of anaphylaxis from: (i) a first aid training organisation approved by the WorkCover Authority, or
(ii) any other organisation approved by the Director-General for the purposes of this paragraph.
[2] Clause 19 Certain Schedule 7 substances to be supplied and used only under an authority
Insert “any or all of” after “from” in clause 19 (6).
[3] Clause 50 Research drugs
Omit clause 50 (1). Insert instead:
(1) This clause applies to thalidomide other than as registered goods.
[4] Clause 50 (2) and (3) (a) and (b)
Omit “a substance to which this clause applies” wherever occurring.
Insert instead “thalidomide”.[5] Clause 50 (2) and (3) (a) and (b)
Omit “the substance” wherever occurring. Insert instead “thalidomide”.
| 2005 No 604 | Poisons and Therapeutic Goods Amendment (Miscellaneous) Regulation 2005 |
| Schedule 1 | Amendments |
[6] Clause 56 Certain supplies of restricted substances to be separately recorded
Insert “, or a relevant prescribed substance as referred to in clause 46,” after
“clause 45” in clause 56 (2).[7] Clause 72 Storage generally
Omit the clause. Insert instead:
72 Storage generally
(1) A person who is in possession of any drug of addiction must keep
the drug:
(a) in his or her possession stored apart from all other goods (other than cash or documents) in a separate room, safe, cupboard or other receptacle securely attached to a part of the premises and kept securely locked when not in immediate use, or (b) stored in any other manner approved by the Director-General for the particular person or class of persons to which the person belongs. (2) A person who is a medical practitioner, dentist, veterinary surgeon or a person referred to in clause 101 (1) (g) is taken to comply with subclause (1) (a) 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 person. Maximum penalty: 20 penalty units.
[8] Clause 91 Records to be kept by pharmacists of methadone or buprenorphine prescriptions
Omit “methadone syrup” wherever occurring in clause 91 (1) and (2) (d) and
(f).Instead instead “methadone in oral liquid form”.
[9] Clause 92 Supply by pharmacists of methadone or buprenorphine tablets
Omit “methadone syrup” wherever occurring.
Instead instead “methadone in oral liquid form”.[10] Clause 112 Entries in drug registers
Insert after clause 112 (1) (i):
(j) any other details approved by the Director-General.
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| Amendments | Schedule 1 |
[11] Clause 112 (3) and (4)
Insert after clause 112 (2):
(3) The Director-General may, by order in writing, exempt any person or drug of addiction, or any class of persons or drugs of addiction, from any or all of the requirements of this clause. (4) Such an exemption may be given unconditionally or subject to
conditions.
[12] Clause 116 Entries in ward registers
Insert after clause 116 (1) (d):
(e) any other details approved by the Director-General.
[13] Clause 116 (3) and (4)
Insert after clause 116 (2):
(3) The Director-General may, by order in writing, exempt any person or drug of addiction, or any class of persons or drugs of addiction, from any or all of the requirements of this clause. (4) Such an exemption may be given unconditionally or subject to
conditions.
[14] Clause 168 Grounds for suspension or cancellation
Insert “or buprenorphine” after “supply of methadone” in clause 168 (1) (d).
[15] Appendix C Supply by wholesale
Omit clause 6 (including the Table to the clause). Insert instead:
6 Optometrists
An optometrist is authorised to be in possession of any Schedule 2, 3 or 4 substance prescribed under the Optometrists Act 2002 for the purposes of section 21 (5) of that Act.
[16] Appendix C, clause 8
Omit clause 8 (2). Insert instead:
(2) In this clause, dental therapist means a registered dental therapist
under the Dental Practice Act 2001.
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| Schedule 1 | Amendments |
[17] Appendix C, clause 19
Insert after clause 18:
19 Anaphylaxis first aid A person is authorised to be in possession of adrenaline in connection with the carrying out of anaphylaxis first aid if:
(a)
the adrenaline is contained in single use automatic injectors that have been filled by the manufacturer with no more than 0.3 milligrams of adrenaline each, and
(b)
the person holds a current first aid certificate issued after completion of a first aid course approved by the WorkCover Authority as referred to in regulations made under the Occupational Health and Safety Act 2000, and the person has received training on the symptoms and first aid management of anaphylaxis from:
(i)
a first aid training organisation approved by the WorkCover Authority, or
(ii) any other organisation approved by the
Director-General for the purposes of clause 17
(5) (b).
BY AUTHORITY
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