Version No. 035
Drugs, Poisons and Controlled Substances Regulations 1995
S.R. No. 63/1995
Version incorporating amendments as at 20 September 2005
table of provisions
Regulation Page
v
Regulation Page
Part 1—Preliminary 1
1. Objectives 1
2. Authorising provisions 2
3. Revocation 2
4. Definitions 2
Part 1A—Prescribed Poisons for Categories of Nurse Practitioner 8
4A. Prescribed poisons related to certain categories of nurse practitioner 8
Part 2—Drugs of Dependence, Schedule 4 Poisons, Schedule 8 Poisons and Schedule 9 Poisons 9
Division 1—Possession 9
5. Possession and administration of drugs of dependence,
Schedule 4, Schedule 8 and Schedule 9 poisons 9
6. Permit required for Schedule 9 poisons 13
Division 2—Treatment 13
7. Patient identity and therapeutic need to be determined—
medical practitioners 13
7A. Patient identity and therapeutic need to be determined—
nurse practitioners 14
8. Patient identity and therapeutic need to be determined—
dentists 15
8A. Therapeutic need to be determined—authorised optometrists 16
9. Patient identity and therapeutic need to be determined for
drugs of dependence—pharmacists 16
10. Therapeutic need to be determined—veterinary practitioners 17
11. Notification of fraudulent obtaining of drugs or poisons 17
12. Pharmacist administration, sale or supply authorised from withinVictoria 18
13. Supply on copy of prescription permitted in certain circumstances 19
14. Pharmacist administration, sale or supply authorised from
outside Victoria 20
15. Form of notification under section 33(1) of the Act 20
16. Form of application and notification under sections33(2) and33(3) of the Act 20
17. Form of permit under section 34 of the Act 21
18. Permit required in particular circumstances for specialised
supply 21
19. Dentists not able to obtain permit for specialised supply 22
20. Veterinary practitioners to obtain approval for specialised
supply 22
21. Disclosure of drug use within previous 8 weeks required 23
Division 3—Supply 24
22. Persons authorised to write prescriptions 24
23. Style and required particulars for prescriptions 25
24. Emergency directions to pharmacists regarding supply 27
25. Particular prescription details to be verified prior to supply 28
26. Containers of drugs to be labelled with certain details 28
27. Duration of prescriptions 30
28. Circumstances where prescriptions are not to be filled 30
29. Duty of pharmacist to notify different prescribers of similar supply 31
30. Retention of original prescriptions or orders once supply completed 32
Division 4—Storage 33
31. Application of regulations in this Division 33
32. General security requirement—Schedule 4 poisons 33
33. Secure storage 34
34. Facility to be secured at all times 35
35. Storage requirements—authorised persons 35
36. Additional security provisions required in certain
circumstances 36
Division 5—Records 37
37. Definition of transaction 37
38. Persons required to keep records 37
39. Details to be contained in records 38
40. Methods by which records are to be retained and retrieved 39
41. Accurate records to be kept 40
42. Discrepancies in records to be investigated 40
43. Lost or stolen records to be reported 40
Division 6—Administration 41
44. Use of drugs and poisons restricted to person named in prescription 41
45. Persons who may administer drugs and poisons in health
services 41
46. Administration of drugs and poisons to be authorised 42
47. Self administration of drugs and poisons restricted 44
48. Administration or supply of drugs and poisons prohibited if to support drug dependency 44
Division 7—Destruction of Schedule 8 poisons and Schedule9
poisons 45
49. Wilful destruction prohibited 45
50. Exceptions 45
Division 8—Cultivation of narcotic plants 47
51. Authority to cultivate narcotic plants for non-therapeutic uses 47
Division 9—Warrants for ovulatory stimulants, prostaglandins, retinoids and thalidomide 47
52. Requirement for warrants 47
53. Warrant number to be included in any prescription 47
54. Prohibition on dentists 47
Part 3—Schedule 7 Poisons 48
55. Controls concerning listed regulated poisons 48
56. Storage requirements 48
57. Records 48
Part 4—Schedule 3 Poisons 50
58. Therapeutic need to be determined—medical practitioners 50
58A. Therapeutic need to be determined—nurse practitioners 50
59. Therapeutic need to be determined—veterinary practitioners 50
60. Therapeutic need to be determined—dentists 51
61. Therapeutic need to be determined—pharmacists 51
62. Restrictions on storage and display 51
63. Personal supply and use requirements 52
64. Administration or supply prohibited if to support drug dependency 52
Part 5—Special Schedule 7 Substances 53
65. Licences, permits or warrants required for special substances 53
Part 6—General Requirements 54
66. Poisons to be sold by wholesale and retail in original unopened packs 54
67. Transfer of poisons to inappropriate containers prohibited 54
68. Lost or stolen poisons to be notified 55
69. Access to certain poisons restricted to a needs basis 55
70. Form of seizure notice under section 43(1) of the Act 56
71. Form of complaint notice against a seizure under section 43(2) ofthe Act 56
Part 7—Licences and Permits Issued Under
theAct 57
72. Licence to sell or supply Schedule 2 poisons by retail 57
73. Fees 57
Parts 8–10—Revoked 61
74–118. Revoked 61
Part 11—Transitionals 63
119. Continuity of exemptions, approvals and authorities 63
______
SCHEDULES 64
SCHEDULE 1—Revocation 64
SCHEDULE 2—Forms 69
Form DP1—Notification of Drug Dependent Person 69
Form DP2—Treatment with Schedule 8 Poisons or Schedule 9 Poisons by a Medical Practitioner or Schedule 8 Poisonsby a Nurse Practitioner 70
Form DP3—Permit to Administer, Prescribe or Supply a Schedule 8 Poison or Schedule 9 Poison by a Medical Practitioner ora Schedule 8 Poison by a Nurse Practitioner 73
Form DP4—Notice of Seizure 74
Form DP5—Notice of Complaint in Respect of a Seizure 75
SCHEDULE 3 76
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ENDNOTES 78
1. General Information 78
2. Table of Amendments 79
3. Explanatory Details 81
v
Version No. 035
Drugs, Poisons and Controlled Substances Regulations 1995
S.R. No. 63/1995
Version incorporating amendments as at 20 September 2005
3
Part 1—Preliminary
Drugs, Poisons and Controlled Substances Regulations 1995
S.R. No. 63/1995
Part 1—Preliminary
1. Objectives
The objectives of these Regulations are to—
(a) facilitate and enhance the orderly sale, supply, prescribing, administration, dispensing and use of drugs, poisons and controlled substances by health professionals, authorised persons, licensed or permitted persons and the general public; and
(b) implement national recommendations regarding the advertising, sale, supply, use, packaging and labelling of drugs, poisons and controlled substances; and
(c) prescribe fees relating to the provision of licences and permits issued under the Drugs, Poisons and Controlled Substances Act 1981; and
(d) prescribe forms and other matters necessary to be prescribed for the purposes of the Drugs, Poisons and Controlled Substances Act 1981.
2. Authorising provisions
r. 2
These Regulations are made under sections 19(2), 22(1)(b), 22A(1), 32, 33(1), 33(2), 33(3), 34(1), 43(1)(a), 43(2), 72, 129, 131, 132, 132A, 132B and 133A of the Drugs, Poisons and Controlled Substances Act 1981.
3. Revocation
The Regulations set out in Schedule 1 are revoked.
4. Definitions
In these Regulations—
"animal" includes any bird, fish or insect;
Reg.4 def. of "approved" amendedby S.R. No. 150/2004 reg.28(1)(a).
"approved" means approved in writing by the Secretary;
Reg. 4 def. of "authorised optometrist" inserted by S.R. No. 132/1998
reg. 4(a).
"authorised optometrist" means a registered optometrist whose registration is endorsed under section11 of the Optometrists Registration Act 1996;
Reg.4 def. of "child resistant closure" amendedby S.R. No. 150/2004 reg.28(1)(b).
"child resistant closure" means—
(a) in the case of a can fitted with a press-on lid, a lid of the design known as "double tight" or "triple tight"; or
(b) a closure which is resistant to opening by children and is of a design approved by the Secretary;
Reg. 4 def. of "chiropodist" revokedby S.R. No. 150/2004 reg.28(1)(c).
* * * * *
"dermal use" means application of a poison or controlled substance to the skin for the purpose of producing a localised effect on the surface of the skin;
"direction" means authoritative instruction or guidance provided personally but does not necessarily imply personal supervision;
"external use" means use on a body surface, other than the surface of the mouth, rectum, vagina, urethra, or other body orifice and includes topical use in the nose, eyes or ears;
Reg. 4 def. of "health service" amended by S.R. No. 43/2004 reg.3(a)(i)(ii).
"health service" means ambulance, dental, medical, nursing, pharmaceutical or surgical services but does not include a health service which is an aged care service within the meaning of the Aged Care Act 1997 of the Commonwealth unless that aged care service is a nursing home;
r. 4
"height" in relation to letters used for words, expressions or statements on labels means the height of capital letters or lower case letters having an ascender or descender;
"immediate container" includes all forms of containers in which a poison is directly packed but does not include a container intended for consumption or an immediate wrapper;
"immediate wrapper" means metal foil, plastic foil, waxed paper or other material not intended for consumption when used as the first wrapper for a dosage unit or dressing;
"internal use" means administration—
(a) orally; or
(b) for absorption and the production of a systemic effect—
(i) by way of a body orifice other than the mouth; or
(ii) parenterally, other than by application to unbroken skin—
but does not include topical use in the nose, eyes, ears, mouth, throat, rectum, vagina or urethra;
"listed regulated poison" means a Schedule 7 poison that is included in Part 2 of Chapter 1 of the Poisons Code in the list of substances that are not for general sale by retail;
"main label" means that portion of a label on which the name of the product is most prominently shown, and when the name of the product is equally prominent on 2 or more portions, each is considered to be a main label;
r. 4
"measure pack" means one of 2 or more sealed containers each of which contains a measured quantity of a poison or controlled substance for use on one occasion as a pesticide or domestic product and which forms part of a single primary pack;
"name and address" means the name and address of the manufacturer or distributor in Australia, but does not include a post office, cable, telegraphic or code address;
Reg. 4 def. of "nurse" substituted by S.R. No. 44/2004
reg. 3.
"nurse" means—
(a) a person registered in division 1, division 3 or division 4 of the register of nurses established under the Nurses Act 1993;
(b) a person registered in division 2 of that register whose registration is endorsed under section 8C of that Act;
Reg. 4 def. of "nursing home" inserted by S.R. No. 43/2004 reg.3(b).
"nursing home" means—
r. 4
(a) an aged care service within the meaning of the Aged Care Act 1997 of the Commonwealth which was a nursing home within the meaning of the National Health Act 1953 of the Commonwealth where an approval within the meaning of that Act was in force, or had been deemed to be in force, under Part V of that Act immediately before 1 October 1997; or
(b) an aged care service within the meaning of the Aged Care Act 1997 of the Commonwealth where all places within the meaning of that Act are allocated to the provision of a high level of residential care within the meaning of that Act;
Reg. 4 def. of "optometrist" revoked by S.R. No. 132/1998
reg. 4(b).
* * * * *
"ovulatory stimulant" means a substance listed as an ovulatory stimulant in Part 2 of Chapter1 of the Poisons Code;
"palliative care service" means a service which provides medical and nursing care to persons who are terminally ill;
"personally supervise" means to closely and continuously personally supervise and control, and requires the actual presence of the person exercising the supervision;
"pharmacy" has the same meaning as in section3 of the Pharmacists Act 1974;
"pharmacy department" has the same meaning as in section 3 of the Pharmacists Act 1974;
Reg. 4 def. of "podiatrist" inserted by S.R. No. 150/2004 reg.28(1)(d).
"podiatrist" means a person registered as a podiatrist under the Podiatrists Registration Act 1997;
r. 4
"primary pack" means the pack in which a poison or controlled substance and its immediate container or immediate wrapper or measure pack are presented for sale or supply, but does not include any wrapping, bag, carton or similar article in which any primary pack is placed at the time of sale or supply;
"prostaglandin" means a substance listed as a prostaglandin in Part 2 of Chapter 1 of the Poisons Code;
"retinoid" means a substance listed as a retinoid in Part 2 of Chapter 1 of the Poisons Code;
"selected container" means—
(a) an injection vial having a nominal capacity of 10 millilitres or less; or
(b) a single use syringe; or
(c) any other container for substances for therapeutic use having a nominal capacity of 10 millilitres or less;
Reg. 4 def. of "special Schedule 4 substance" revoked by S.R. No. 75/1997 reg.5.
* * * * *
"special Schedule 7 substance" means a substance listed as a special Schedule 7 substance in Part 2 of Chapter 1 of the Poisons Code;
Reg. 4 def. of "special Schedule 8 or Schedule 9 substance" revoked by S.R. No. 75/1997 reg.5.
* * * * *
"storage facility" includes a cabinet, receptacle, cupboard, refrigerator or room;
"the Act" means the Drugs, Poisons and Controlled Substances Act 1981;
"topical use" means application of a poison or controlled substance for the purpose of producing a localised effect on the surface of the organ or within the tissue to which it is applied.
r. 4
______
Pt. 1A (Heading and reg.4A) insertedby S.R. No. 150/2004 reg.4.
Part 1A—Prescribed Poisons for Categories of Nurse Practitioner
Reg. 4A insertedby S.R. No. 150/2004 reg.4.
4A. Prescribed poisons related to certain categories of nurse practitioner
r. 4A
(1) The prescribed Schedule 2, 3, 4 and 8 poisons that a nurse practitioner whose registration is endorsed with the category of nurse practitioner–wound management is authorised to obtain and have in his or her possession and to use, sell or supply are the poisons set out in Part 1 of Schedule 3.