Drugs of Dependence (General) Regulations 1985 (SA)

(Reprint No. 2)

South Australia

DRUGS OF DEPENDENCE (GENERAL) REGULATIONS 1985

These regulations are reprinted pursuant to the Subordinate Legislation Act 1978 and incorporate all amendments in force as at 6 July 2000.

REGULATIONS UNDER THE CONTROLLED

SUBSTANCES ACT 1984

DRUGS OF DEPENDENCE (GENERAL) REGULATIONS 1985

being

No. 75 of 1985: Gaz. 9 May 1985, p. 14981

as varied by

No. 60 of 1988: Gaz. 7 April 1988, p. 894

No. 82 of 1998: Gaz. 28 May 1998, p. 23482

No. 82 of 1999: Gaz. 27 May 1999, p. 28573

No. 89 of 2000: Gaz. 25 May 2000, p. 27714

No. 162 of 2000: Gaz. 6 July 2000, p. 335

1 Came into operation 9 May 1985: reg. 2.

2 Came into operation 1 July 1998: reg. 2.

3 Came into operation 1 July 1999: reg. 2.

4 Came into operation 1 July 2000: reg. 2.

5 Came into operation 6 July 2000: reg. 2.

SUMMARY OF PROVISIONS

1.                Title

2.                Commencement

3.                Interpretation

4.                Supply of a drug from a health service pharmacy to a health service

5.                Ordinary and emergency delivery of a drug to a ward from a health service pharmacy

6.                Registered nurse for the time being in charge of a ward to have control and supervision of drugs in ward

7.                Drug Register to be kept in relation to a health service pharmacy

8.                Entries in Drug Register of health service when imprest stocks established, added to or replenished or when drugs are supplied in case of emergency

9.                Drug from place other than health service pharmacy to be delivered into possession of registered nurse

10.                Receipt given in case of emergency

11.                Inspection of drugs, records and places of storage of drugs by a health service pharmacist for security purposes

12.                Examination, counting and checking of drugs stored in ward

13.                Drug Administration Record and Special Record Book to be kept in each ward where drugs usually administered to patients

14.                Form of Drug Administration Record

15.                Form of Special Record Book

16.                Control and supervision of Drug Administration Record and Special Record Book

17.                Entry to be made in Drug Administration Record in relation to the administration of a drug

18.                Signing and dating of an entry in Drug Administration Record

19.                Administration of drug to be witnessed

20.                Person witnessing administration of drug to sign Drug Administration Record

21.                Entries to be made in Drug Administration Record on receipt of a drug into a ward

22.                Untrue or misleading entry in Drug Administration Record or Special Record Book

23.                Erasure or obliteration of an entry in Drug Administration Record or Special Record Book

24.                Correction of an error in Drug Administration Record

25.                Correction of an error in Special Record Book

25A.	Special Restrictions on Supply of Butorphanol
26.	Supply of a drug by a supplier
27.	Order of a drug by telephone from a supplier
28.	Delivery of a drug by supplier to a servant or agent of a person who has ordered the drug
29.	Prescriber to write a prescription
30.	Requirements in relation to a prescription written by a prescriber who is a medical practitioner or a dentist
31.	Requirements in relation to a prescription written by a prescriber who is a veterinary surgeon
32.	Additional information in prescription
33.	Prescription for above average or potentially dangerous dose
34.	Instruction by telephone to dispense a drug in case of emergency
35.	Restriction on dispensing
36.	Prescription not to be dispensed by pharmacist in certain circumstances
37.	Pharmacist may make enquiries in relation to a prescription
38.	Additional requirements in relation to the dispensing of prescriptions for certain drugs
39.	Entry in Prescription Record by Pharmacist
40.	Place where Prescription Record to be kept
41.	Cancellation of prescription
42.	Cancelled prescription to be forwarded to Department
43.	Copies of certain prescriptions to be forwarded to the Department
44.	Prescription to be signed by person taking delivery of drug
45.	Duty of pharmacist to notify Department if no prescription dispensed, or no order supplied, for a period of one month
46.	Register of Drugs of Dependence
47.	Form of Register of Drugs of Dependence
48.	Entries in Register of Drugs of Dependence
49.	Separate Register of Drugs of Dependence for separate premises
50.	Register of Drugs of Dependence to be kept on premises
51.	Untrue or misleading entry in Register of Drugs of Dependence
52.	Entry in Register of Drugs of Dependence not to be erased or obliterated
53.	Correction of error in Register of Drugs of Dependence
54.	Balancing the Register of Drugs of Dependence
55.	Administration of drug to be carried out in accordance with instructions of medical practitioner
56.	Administration of drug to be carried out in accordance with instructions of dentist
57.	Written instructions of medical practitioner or dentist in the Medication Record of a patient in relation to the administration of a drug
58.	Administration of drug may be carried out on telephone instructions
59.	Mode of giving telephone instructions for administration of a drug to a patient in a health service
60.	Procedure to be followed on receipt of telephone instructions for administration of a drug to a patient in a health service
61.	Entries in Medication Record by medical practitioner or dentist following telephone instructions
62.	Calculation of two year retention period for records
63.	Storage of retained records
64.	Safe storage of drugs in a health service
65.	Drugs stored in a ward to be in a locked cabinet
66.	Safe storage of drugs in a pharmacy other than a health service pharmacy
67.	Access to a pharmacy safe
68.	Other places of storage of drugs
69.	Initiation of analysis pursuant to section 53(3) of the Act
70.	Form pursuant to section 53(4) of the Act
71.	Prescribed fee for the purposes of section 53(3) of the Act
72.	Application for a licence for the purposes of section 31(3)(d) of the Act
73.	Application for a licence for the purposes of section 32(2)(c) of the Act
74.	Application to renew licence granted pursuant to section 31(3)(d) of the Act
75.	Application to renew licence granted pursuant to section 32(2)(c) of the Act
76.	Fees
77.	Delivery of a drug by post
78.	Delivery of a drug by carrier
79.	Packing of drugs for delivery
80.	Regulation 79 not to apply in certain circumstances
81.	Certificate of identification
82.	Penalty

APPENDIX

LEGISLATIVE HISTORY

Title

1. These regulations may be cited as the Drugs of Dependence (General) Regulations 1985.

Commencement

2. These regulations shall take effect from 9 May 1985.

Interpretation

3. In these regulations:

"Act" means the Controlled Substances Act 1984;

"administration" in relation to a drug means the administration of a dose of such drug to a

person or to an animal; and

"administer" has a corresponding meaning;

"dispense" means the supply of a drug:

(a)	by a medical practitioner or a pharmacist to a person, or to the agent of such person, pursuant to a prescription written for such person by a prescriber who is a medical practitioner or a dentist; or
(b)	by a veterinary surgeon or a pharmacist to a person, or to the agent of such person, pursuant to a prescription written for such person by a prescriber who is a veterinary surgeon for the use of such drug in the course of veterinary treatment of an animal in the possession and under the control of that person; or
(c)	by a pharmacist to a person, or to the agent of such person, pursuant to telephone instructions given in respect of that person, in accordance with these regulations, by a prescriber who is a medical practitioner or a dentist; or
(d)	by a pharmacist to a person, or to the agent of such person, pursuant to telephone instructions given for that person in accordance with these regulations, by a prescriber who is a veterinary surgeon, in respect of the use of such drug in the course of veterinary treatment of an animal in the possession and under the control of that person,

and "dispensing" has a corresponding meaning;

"drug" means a drug of dependence;

"Drug Administration Record" means a Drug Administration Record kept in relation to a ward

pursuant to these regulations;

"health service" means a health service provided in any place for the public, or any section of the public, for the purpose of curing, alleviating, diagnosing or preventing the spread of any mental or physical disease, abnormality or disability, occurring or likely to occur among the public or any section of the public, and includes a hospital and a nursing home;

"health service pharmacist" means the pharmacist in charge of a health service pharmacy;

"health service pharmacy" means portion of any premises contained within a health service, and used solely to provide all or part of the pharmacy services required by such health service, whether or not such premises are registered pursuant to section 17 of the Pharmacy Act 1935, but does not include portion of any premises contained within a health service, and used solely to provide all or part of the pharmacy services required by that health service where such pharmacy services are of a minor nature;

"imprest stocks" means stocks of drugs for use in a ward which are supplied to, and held in,

such ward in predetermined amounts in relation to each type of drug in such stocks;

"licence" means a licence granted pursuant to the Act;

"order" means an oral or written request to a supplier to supply a drug to the person who has

given or written such order, but does not include a prescription;

"pharmacy" in relation to a pharmacy other than a health service pharmacy, means premises

registered pursuant to section 17 of the Pharmacy Act 1935;

"predetermined amount" in relation to a drug, means the maximum quantity of such drug which may be held in the imprest stocks of a ward for the proper treatment of patients in that ward at any time, as determined from time to time by the persons having the medical superintendence of the health service in which such ward is situated;

"preparation" means a substance or combination of substances containing a drug by way of

admixture;

"prescriber" means a medical practitioner, dentist or veterinary surgeon lawfully entitled to write a prescription, or to give oral (including telephone) instructions to a pharmacist for the dispensing of a drug;

"prescription" means a prescription written by:

(a)	a prescriber who is a medical practitioner or a dentist, for the supply of a drug to a patient of such medical practitioner or dentist; or
(b)	a prescriber who is a veterinary surgeon, for the supply of a drug to a person who is a client of such veterinary surgeon for administration to an animal in the possession and under the control of such person, in the course of the veterinary treatment of that animal,

and the word "prescribe" has a corresponding meaning;

"Prescription Record" means a Prescription Record kept pursuant to the Pharmacy Act 1935;

"quantity":

(a)

in relation to a drug in the form of a solid preparation, means the total number of dosage units of a specified strength of that drug;

(b)

in relation to a drug in the form of a liquid preparation, means the total number of containers of that preparation each containing a specified strength of that drug;

(c)

in relation to a drug in pure form, means:

(i)	the total mass of that drug, if a solid; or
(ii)	the total volume of that drug if a liquid;

"Register" means a Register of Drugs of Dependence kept pursuant to these regulations;

"registered nurse" means a nurse registered pursuant to the Nurses Registration Act 1920;

"register holder" means a person required to keep a Register of Drugs of Dependence pursuant

to these regulations;

"repeat prescription" means a prescription which may be dispensed more than once;

"signature" in relation to a person who is a body corporate, means the usual signature of a natural person duly authorised to act on behalf of that body corporate for the purposes of the doing, suffering or omission of anything to be done, suffered or omitted pursuant to these regulations,

and the words "sign" and "signing" have a corresponding meaning;

"Special Record Book" means a Special Record Book kept in relation to a ward pursuant to

these regulations;

"supplier" means a person who supplies a drug pursuant to an order;

"ward" means a ward, operating theatre, clinic, unit, section or department of a health service in

which patients of such health service are treated.

Supply of a drug from a health service pharmacy to a health service

4. (1) A drug shall only be supplied to a health service from a health service pharmacy:

(a)	for a patient in a health service pursuant to a prescription written by a prescriber who is a medical practitioner or a dentist; or
(b)	pursuant to an order of a registered nurse in charge of a ward for the establishment or replenishment of imprest stocks of that drug in that ward.

(2) When a drug is supplied from a health service pharmacy to a health service on an order referred to in paragraph (b) of subregulation (1), a health service pharmacist supplying such drug shall ensure that the quantity of the drug supplied does not exceed the maximum permissible quantity of the drug which may be included in the imprest stocks without exceeding the predetermined amount for such imprest stocks.

Ordinary and emergency delivery of a drug to a ward from a health service pharmacy

5. (1) Subject to subregulations (2) and (3), the delivery of a drug to a ward shall be made personally to the registered nurse having the control and supervision of all drugs in that ward pursuant to regulation 6 of these regulations, by the health service pharmacist, or some person who is under the direct and constant personal supervision of the health service pharmacist.

(2) If, in the opinion of a medical practitioner having the immediate supervision of a patient in a health service, an emergency exists in respect of that patient, the medical practitioner may obtain delivery of a drug from a health service pharmacy to a ward in such manner as he thinks fit.

(3) If in the opinion of a dentist having the immediate supervision of a patient in a health service, an emergency exists in respect of that patient, the dentist may obtain delivery of a drug from a health service pharmacy to a ward in such manner as he thinks fit.

Registered nurse for the time being in charge of a ward to have control and supervision of drugs in ward

6. Subject to regulation 10 of these regulations all drugs in a ward, including imprest stocks, shall be under the control and supervision of a registered nurse for the time being in charge of that ward.

Drug Register to be kept in relation to a health service pharmacy

7. (1) A Drug Register shall be kept in relation to a health service pharmacy.

(2) The health service pharmacist shall have the control and supervision of the Drug Register.

(3) The Drug Register shall be kept within a health service pharmacy.

Entries in Drug Register of health service when imprest stocks established, added to or replenished or when drugs are supplied in case of emergency

8. (1) When imprest stocks are established, added to or replenished the health service pharmacist shall cause the following entries to be made in the Drug Register:

(a)	the quantity and type of each drug used to establish, add to or replenish such imprest stocks; and
(b)	the date on which such imprest stocks are established, added to or replenished.

(2) When a medical practitioner or a dentist obtains delivery of a drug to a ward from a health service pharmacy in a case of an emergency within the meaning of regulation 5(2) or 5(3) of these regulations, the health service pharmacist shall cause the following entries to be made in the Drug Register of the health service pharmacy:

(a)	the quantity and type of each drug delivered; and
(b)	the date on which each drug is delivered.

Drug from place other than health service pharmacy to be delivered into possession of registered nurse

9. Subject to regulation 10 of these regulations, when a drug is delivered into a ward from a place other than a health service pharmacy such drug shall be delivered into the possession of the registered nurse in the ward responsible for the control and supervision of drugs in that ward pursuant to regulation 6 of these regulations.

Receipt given in case of emergency

10. When a drug is delivered into a ward in a case of emergency within the meaning of regulation 5(2) or 5(3) of these regulations:

(a)	the drug shall be delivered to a registered nurse in the ward if it is practicable to do so, and if not, to some other responsible person in the ward; and
(b)	a registered nurse or other person to whom a drug is delivered pursuant to paragraph (a) of this regulation shall immediately give to the person delivering such drug a signed and dated receipt for such drug.

Inspection of drugs, records and places of storage of drugs by a health service pharmacist for security purposes

11. (1) A health service pharmacist shall ensure that all drugs supplied, stored or in use in a

health service are adequately protected at all times against unauthorised removal, interference or use.

(2) For the purposes of subregulation (1) a health service pharmacist may inspect:

(a) any drug;

(b) any imprest stocks;

(c)	any record in relation to the supply, storage or use of a drug;
(d)	any place of storage of a drug.

Examination, counting and checking of drugs stored in ward

12. (1) The registered nurse for the time being in charge of a ward shall, at the end of his shift, count all of the drugs stored in the ward, including but without limiting the generality of the foregoing, all drugs in the imprest stocks.

(2) Subject to subregulation (3), if, after counting drugs pursuant to subregulation (1), a registered nurse:

(a)

ascertains that the correct amount of drugs is stored in the ward, he shall:

(i)	enter the word "correct" in the Drug Administration Record; and
(ii)	insert the time and date of such entry; and
(iii)	place his signature alongside such entry;

(b)

ascertains that an incorrect amount of drugs is stored in the ward he shall:

(i)	enter the word "incorrect" in the Drug Administration Record; and
(ii)	legibly enter a short hand-written statement explaining why an incorrect amount of drugs is stored in the ward; and
(iii)	enter the quantity of drugs in storage in the ward at the end of his shift; and
(iv)	enter the time and date of the entries and statement referred to in subparagraphs (i), (ii) and (iii) of this paragraph;and
(v)	place his signature alongside such entries; and
(vi)	promptly report to the health service pharmacist that an incorrect amount of drugs is stored in the ward.

(3) The requirements of subregulation (2) may be satisfied by recording the relevant entries referred to in paragraph (a) or (b) of that subregulation in a Special Record Book instead of the Drug Administration Record.

(4) A Special Record Book shall be used only for the purposes of recording information pursuant to subregulation (3).

(5) Subject to subregulation (6) an entry made by a registered nurse in a Drug Administration Record pursuant to subregulation (2) or a Special Record Book pursuant to subregulation (3) shall be witnessed by the registered nurse commencing the shift next following the shift of the registered nurse who makes such entry.

(6) If a new shift is not commenced on the conclusion of the shift immediately preceding it, an entry made in the Drug Administration Record or the Special Record Book pursuant to subregulation (2) or subregulation (3) may be witnessed by another nurse working on the same shift as the nurse who makes the entry.

(7) Where an entry in the Drug Administration Record or the Special Record Book is witnessed by a nurse pursuant to subregulation (6), that entry shall be checked by a registered nurse at the commencement of the next shift.

Drug Administration Record and Special Record Book to be kept in each ward where drugs usually administered to patients

13. (1) A Drug Administration Record shall be kept in each ward of a health service where drugs are usually administered to patients.

(2) If a Special Record Book is used pursuant to regulation 12(3) of these regulations, such Special Record Book shall be kept in the ward in relation to which it is used.

Form of Drug Administration Record

14. (1) A Drug Administration Record shall consist of separate folios.

(2) Each folio of a Drug Administration Record shall be in the following form:

DRUG ADMINISTRATION RECORD

Folio No:

WARD. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. . .

TYPE STRENGTH AND FORM OF DRUG .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. . .

DATE	TIME	NAME OF	DOSE	SIGNATURE OF	WITNESSED	STOCK	STOCK
PATIENT	PERSON	BY	RECEIVED	IN
ADMINISTERING	WARD
OR TAKING DELIVERY

(3) Only drugs of the same type, strength and form shall be entered on the same folio of a Drug Administration Record.

Form of Special Record Book

15. (1) A Special Record Book shall consist of separate folios.

(2) Where a Special Record Book is used instead of a Drug Administration Record pursuant to regulation 12(3) of these regulations only drugs of the same type, strength and form shall be entered on the same folio of the Special Record Book.

Control and supervision of Drug Administration Record and Special Record Book

16. A registered nurse for the time being in charge of a ward shall have the control and supervision of the Drug Administration Record or Special Record Book for that ward.

Entry to be made in Drug Administration Record in relation to the administration of a drug

17. (1) As soon as practicable after the administration of a drug to a patient in a ward, an appropriate entry in relation to the administration of that drug shall be made in the Drug Administration Record in accordance with these regulations.

(2) An entry in a Drug Administration Record referred to in subregulation (1) shall be made by the person administering the drug.

Signing and dating of an entry in Drug Administration Record

18. Subject to these regulations each entry in the Drug Administration Record shall be signed and dated by the person making such entry.

Administration of drug to be witnessed

19. The administration of a drug to a patient in a ward shall be witnessed by a nurse, or in the absence of a nurse, by some other responsible person.

Person witnessing administration of drug to sign Drug Administration Record

20. A person who witnesses the administration of a drug pursuant to regulation 19 of these regulations shall sign the Drug Administration Record as soon as practicable after the administration of such drug.

Entries to be made in Drug Administration Record on receipt of a drug into a ward

21. When a drug is supplied to a ward pursuant to regulation 5(1) or 9 of these regulations the registered nurse taking delivery of such drug shall:

(a)

take delivery of the drug in the presence of a witness, who shall be an employee of the health service; and

(b)

cause the following information to be entered in the Drug Administration Record:

(i)	the quantity of the drug received;
(ii)	the date of the receipt of the drug;
(iii)	the time of the receipt of the drug;
(iv)	the name of the registered nurse taking delivery of the drug;
(v)	the name of the person witnessing the receipt of the drug;
(vi)	the total stock of the drug in the ward immediately after delivery.

Untrue or misleading entry in Drug Administration Record or Special Record Book

22. No entry which is untrue or misleading in any respect shall be made in a Drug Administration Record or a Special Record Book.

Erasure or obliteration of an entry in Drug Administration Record or Special Record Book

23. No entry in a Drug Administration Record or a Special Record Book shall be wholly or partially erased or wholly or partially obliterated.

Correction of an error in Drug Administration Record

24. (1) An error in a Drug Administration Record shall be corrected in the following manner:

(a)

the erroneous entry shall be ruled out in indelible ink so as to be clearly legible after it has been ruled out;

(b)

the erroneous entry shall be marked with an appropriate symbol for reference to a marginal note or a footnote;

(c)

a marginal note or a footnote shall be made on the same folio as the folio containing the erroneous entry;

(d)

a marginal note or footnote referred to in paragraph (c) of this regulation shall contain:

(i)	the correct information;
(ii)	the date of the correction;
(iii)	the initials of the person making such correction;

(e)

the corrected entry together with the marginal note or footnote shall be dated and initialled by the person making such correction.

(2) A correction in a Drug Administration Record pursuant to subregulation (1) shall be made only by a person entitled to make an entry in such Drug Administration Record pursuant to these regulations.

Correction of an error in Special Record Book

25. (1) An error in a Special Record Book shall be corrected in the following manner:

(a)

the erroneous entry shall be ruled out in indelible ink so as to be clearly legible after it has been ruled out;

(b)

the erroneous entry shall be marked with an appropriate symbol for reference to a marginal note or a footnote;

(c)

a marginal note or a footnote shall be made on the same folio as the folio containing the erroneous entry;

(d)

a marginal note or footnote referred to in paragraph (c) of this regulation shall contain:

(i)	the correct information;
(ii)	the date of the correction;
(iii)	the initials of the person making the correction;

(e)

the corrected entry together with the marginal note or footnote shall be dated and initialled by the person making such correction.

(2) A correction in a Special Record Book, pursuant to subregulation (1), shall be made only by a person entitled to make an entry in such Special Record Book pursuant to these regulations.

Special Restrictions on Supply of Butorphanol

25A. (1) A medical practitioner or a dentist must not prescribe for, or administer or supply to,

any person the drug "Butorphanol" except in accordance with an authority granted by the Minister.

Penalty: $1 000.

(2) An authority under this regulation may be granted on such conditions as the Minister considers appropriate.

(3) A pharmacist must not sell or supply to any person the drug "Butorphanol" except pursuant

to—

(a)	an authority granted by the Minister to a medical practitioner or a dentist; or
(b)	the prescription of a veterinary surgeon.

Penalty: $1 000.

Supply of a drug by a supplier

26. (1) A drug, other than a drug comprising all or part of a doctor’s bag order within the meaning of the National Health Act 1953 (Commonwealth), shall be supplied by a supplier pursuant to these regulations.

(2) Subject to regulation 27 of these regulations a supplier shall not supply a drug unless the person requesting the supply of the drug gives to the supplier an order in writing addressed to the supplier which:

(a)	contains the information in subregulation (3); and
(b)	is addressed to the supplier, at his business address.

(3) An order given to a supplier pursuant to subregulation (2) shall:

(a)	state the name and full address of the person ordering the drug;
(b)	state the type of the drug ordered;
(c)	state the quantity of the drug ordered;
(d)	state the date of the making of the order;
(e)	be signed by the person ordering the drug.

(4) A supplier who supplies a drug pursuant to an order shall:

(a)	as soon as practicable after supplying such drug, cancel the order pursuant to which it is supplied, by writing the word "CANCELLED" on the order; and
(b)	retain the cancelled order in good order and condition; and
(c)	forward the cancelled order to the Department by ordinary post on or before the 15th day of the month next following the month during which the drug was supplied by the supplier.

Order of a drug by telephone from a supplier

27. (1) Subject to subregulations (2) and (3), a person may order a drug from a supplier by

telephone.

(2) If a person orders a drug by telephone pursuant to subregulation (1) he shall, within 48 hours of making such telephone order, personally deliver or send by post to the supplier an order in writing for such drug.

(3) An order in writing delivered or sent to a supplier pursuant to subregulation (2) shall:

(a)	state the name and full address of the supplier;
(b)	state the name and full address of the person ordering the drug;
(c)	state the type of the drug ordered;
(d)	state the quantity of the drug ordered;
(e)	state the date on which the telephone order is given;
(f)	be signed by the person ordering the drug;
(g)	state that the order is in confirmation of the telephone order to the supplier for the supply of the drug.

(4) If a supplier supplies a drug pursuant to subregulation (1) and does not receive an order in writing within 7 days of the receipt by him of the telephone order for the supply of such drug, he shall inform the Minister in writing as soon as practicable that he has not received such order within such seven day period.

Delivery of a drug by supplier to a servant or agent of a person who has ordered the drug

28. A supplier shall not deliver a drug to a servant or agent of a person who has ordered a drug from such supplier unless such servant or agent provides the supplier with sufficient written evidence of his identity.

Prescriber to write a prescription

29. No person other than a prescriber shall write a prescription.

Requirements in relation to a prescription written by a prescriber who is a medical practitioner or a dentist

30. Subject to regulation 34 of these regulations a prescription written by a prescriber who is a medical practitioner or a dentist shall:

(a) be written legibly;

(b)

be written in indelible ink;

(c)

be signed by the prescriber;

(d)

be dated by the prescriber;

(e)

state:

(i)	the professional name of the prescriber; and
(ii)	the professional address of the prescriber; and
(iii)	the professional telephone number of the prescriber; and
(iv)	the name of the person for whom the prescription is written; and
(v)	the full address of the person for whom the prescription is written.

Requirements in relation to a prescription written by a prescriber who is a veterinary surgeon

31. Subject to regulation 34 of these regulations a prescription written by a prescriber who is a

veterinary surgeon shall:

(a) be written legibly;

(b)

be written in indelible ink;

(c)

be signed by the prescriber;

(d)

be dated by the prescriber;

(e)

state:

(i)	the professional name of the prescriber;
(ii)	the professional address of the prescriber;
(iii)	the professional telephone number of the prescriber;
(iv)	the name of the person for whom the prescription is written;
(v)	the name (if any) of the animal in respect of which the prescription is written;
(vi)	the full address of the person for whom the prescription is written;

(e)

have written on it the words "FOR ANIMAL TREATMENT ONLY".

Additional information in prescription

32. Every prescriber shall insert the following additional information in each prescription written

by him:

(a)	the name of the drug prescribed;
(b)	the strength of the drug prescribed, where applicable;
(c)	the total amount of the drug prescribed, or the total amount of the preparation containing the drug, to be supplied each time the prescription is dispensed;
(d)	the dose of the drug prescribed, or the dose of the preparation containing the drug, to be administered to the person for whom the drug is prescribed or to be administered to the animal in relation to which the drug is prescribed;
(e)	if the prescription is a repeat prescription, the number of times the prescription is to be repeated.

Prescription for above average or potentially dangerous dose

33. If a prescription is written by a prescriber for an above average or potentially dangerous dose of a drug, the prescriber shall clearly show in writing on the face of the prescription that such above average or potentially dangerous dose of such drug is intended to be prescribed by him, and in particular but without limiting the generality of the foregoing, the prescriber shall:

(a)	underline the statement of the dose of the drug in the prescription; and
(b)	insert the prescriber’s initials alongside the underlined portion of the prescription referred to in paragraph (a) of this regulation.

Instruction by telephone to dispense a drug in case of emergency

34. (1) Subject to subregulation (4), if a prescriber is of the opinion that an emergency exists, he may instruct a pharmacist by telephone to dispense a drug in accordance with this regulation.

(2) When instructing a pharmacist by telephone to dispense a drug pursuant to subregulation (1), a prescriber shall state to such pharmacist:

(a)	his name and his full address;
(b)	the name of the drug to be dispensed;
(c)	the strength of the drug to be dispensed, where applicable;
(d)	the total amount of the drug or the total amount of the preparation containing the drug to be dispensed;
(e)	thedoseofsuchdrugorthedoseofthepreparationcontainingsuchdrugtobe administered to the person for whom the drug is prescribed or to be administered to the animal in relation to which the drug is prescribed.

(3) Within 24 hours of giving instructions by telephone to a pharmacist pursuant to subregulations (1) and (2) a prescriber shall write a prescription, in accordance with regulations 30, 31, 32 and 33 of these regulations (to the extent to which such regulations apply to the prescriber), and shall personally deliver or send such prescription by post to that pharmacist.

(4) No more than 4 days’ supply of a drug shall be dispensed by a pharmacist for a patient or in respect of an animal pursuant to this regulation.

Restriction on dispensing

35. No person other than:

(a) a medical practitioner; or

(b) a pharmacist; or

(c) a veterinary surgeon,

shall dispense a prescription.

Prescription not to be dispensed by pharmacist in certain circumstances

36. No pharmacist shall dispense a prescription which:

(a)	is presented to him for dispensing more than six months after the date of the prescription; or
(b)	is marked "CANCELLED"; or
(c)	is wholly or partially illegible; or
(d)	in the case of a prescription which is written in duplicate, if the duplicate copy only of the prescription is presented to him for dispensing; or
(e)	in the case of a repeat prescription, if the prescription is presented to him for dispensing within three days of the date on which it was last dispensed.

Pharmacist may make enquiries in relation to a prescription

37. (1) When dispensing a prescription, a pharmacist may make such enquiries as he considers desirable from the prescriber who wrote the prescription.

(2) A pharmacist may make enquiries pursuant to subregulation (1) at any time before or after dispensing the prescription to which such enquiries relate.

Additional requirements in relation to the dispensing of prescriptions for certain drugs

38. (1) Subject to subregulation (2) no pharmacist shall dispense a prescription for any of the following drugs:

"dextromoramide" "hydromorphone" "methadone"

"oxycodone"

unless:

(a)	heispersonallyfamiliarwiththehandwritingoftheprescriberwhowrotethe prescription; or
(b)	the person for whom the drug is prescribed is known to the pharmacist who dispenses the drug; or
(c)	the pharmacist who dispenses the drug has personally verified from the prescriber that the prescription has been written by the prescriber whose name appears on the prescription.

(2) If paragraph (c) of subregulation (1) cannot be complied with by the pharmacist dispensing a prescription, he may dispense 2 days’ supply of the drug prescribed in the prescription at the dose set out in such prescription.

(3) Where a pharmacist dispenses a prescription in accordance with subregulation (2), and he subsequently verifies pursuant to paragraph (c) of subregulation (1) that the prescriber duly wrote the prescription, he may dispense the balance of the prescription.

Entry in Prescription Record by Pharmacist

39. (1) Subject to subregulation (2), on the day on which a pharmacist dispenses a prescription, he shall enter the following information in the Prescription Record:

(a)	the name and full address of the person to whom the drug is dispensed;
(b)	the name and professional address of the prescriber of the drug;
(c)	the date upon which the drug is dispensed;
(d)	the name of the drug;
(e)	the strength of the drug, where applicable;
(f)	if the prescription is a repeat prescription, the total amount of the drug, or the total amount of the preparation containing the drug to be supplied each time the prescription is dispensed;
(g)	thedoseofthedrug,orthedoseofthepreparationcontainingsuchdrug,tobe administered to the person for whom the drug is prescribed, or to be administered to the animal in respect of which such drug is prescribed;
(h)	if the prescription is a repeat prescription the number of times the prescription is to be dispensed;

(i) the intervals of time at which the prescription is to be dispensed;

(j)	the date of the prescription;
(k)	a separate identifying number or letter, or a combination of numbers and letters, or other means to fully identify in the Prescription Record the prescription pursuant to which the drug is dispensed.

(2) When a repeat prescription is presented on a second or subsequent occasion for dispensing, the pharmacist dispensing the prescription shall:

(a)	if he has previously dispensed that prescription, make an entry in the Prescription Record which is a clear reference back to the earlier entry when he first dispensed such prescription; or
(b)	if he has not previously dispensed the prescription, make an entry in the Prescription Record in accordance with subregulation (1).

Place where Prescription Record to be kept

40. A Prescription Record referred to in regulation 39 of these regulations shall be kept at all times at the place in which the drugs to which it relates are dispensed.

Cancellation of prescription

41. (1) Where a prescription may be dispensed only once the person dispensing the prescription shall clearly write the word "CANCELLED" on the face of the prescription (and also on the face of a duplicate copy of the prescription if it has been issued in duplicate) after the prescription is dispensed.

(2) Where a person is dispensing a repeat prescription for the last time he shall clearly write the word "CANCELLED" on the face of the prescription (and also on the face of a duplicate copy of the prescription, if it is issued in duplicate) after such repeat prescription is dispensed.

Cancelled prescription to be forwarded to Department

42. (1) A person who dispenses and cancels a prescription (other than a prescription written pursuant to the National Health Act 1953 (Commonwealth)) shall, upon the cancellation of such prescription, retain the cancelled prescription and forward it (together with the duplicate copy of such prescription, if any) to the Department:

(a)	no later than the 15th day of the month next following the month during which the prescription was cancelled; or
(b)	at such time as may be orally or in writing notified to such person by an authorised officer.

(2) Where a prescription is issued pursuant to the National Health Act 1953 (Commonwealth) and is cancelled the duplicate copy only of that prescription shall be forwarded to the Department in the same manner as a prescription to which subregulation (1) applies.

Copies of certain prescriptions to be forwarded to the Department

43. A person who dispenses a repeat prescription prior to the last occasion on which it is dispensed, shall make a true copy of that prescription and shall send such copy by post to the Department:

(a)	no later than the 15th day of the month next following the month during which such prescription is dispensed and copied; or
(b)	at such time as may be orally or in writing notified to such person by an authorised officer.

Prescription to be signed by person taking delivery of drug

44. Where a drug is dispensed pursuant to a prescription, the person who takes delivery of the drug shall sign and date the prescription at the time of taking delivery, and where the prescription is in duplicate, such person shall ensure that his signature and the date are written on both the original and the duplicate copies of the prescription.

Duty of pharmacist to notify Department if no prescription dispensed, or no order supplied, for a period of one month

45. (1) If a pharmacist has not dispensed a drug pursuant to a prescription, or supplied a drug pursuant to an order, for a period of one month, he shall, no later than the 15th day of the month next following the said monthly period, send by post to the Department a notice in writing under his professional name and professional address containing the following statement:

"During the period of one month expiring on 19, I did not dispense any prescriptions for drugs of dependence, or supply any orders for drugs of dependence.".

(2) A statement in a notice sent to the Department pursuant to subregulation (1) shall be:

(a)	completed with reference to the monthly period to which it applies; and
(b)	signed and dated by the pharmacist who prepares it.

Register of Drugs of Dependence

46. Every manufacturer of a drug, producer of a drug, seller of a drug and every supplier shall be a register holder.

Form of Register of Drugs of Dependence

47. A register holder shall keep a Register in the following form:

REGISTER OF DRUGS OF DEPENDENCE

DATE	NAME AND	AMOUNT	AMOUNT	BALANCE	PRESCRIPTION	INITIALS
ADDRESS OF	RECEIVED	SUPPLIED	OF STOCK	OR ORDER	OF
PERSON FROM	NUMBER	PERSON
WHOM DRUG	MAKING
OBTAINED OR	ENTRY
TO WHOM DRUG SUPPLIED

Entries in Register of Drugs of Dependence

48. (1) A Register shall only be used by a register holder for the purposes of recording information pursuant to these regulations.

(2) Only drugs of the same type, strength and form shall be entered on the same folio of a

Register.

(3) All entries in a Register shall be written legibly in indelible ink.

(4) On the day a drug is obtained or supplied by a register holder an appropriate entry in relation to such drug shall be made in the Register.

Separate Register of Drugs of Dependence for separate premises

49. Where the manufacture, production, sale or supply of drugs or any of those activities is carried out on separate premises a separate Register shall be kept in relation to each of those premises where such activities are carried out.

Register of Drugs of Dependence to be kept on premises

50. A Register shall be kept at all times on the premises to which it relates.

Untrue or misleading entry in Register of Drugs of Dependence

51. No entry which is untrue or misleading shall be made in a Register.

Entry in Register of Drugs of Dependence not to be erased or obliterated

52. No entry in a Register shall be wholly or partially erased or wholly or partially obliterated.

Correction of error in Register of Drugs of Dependence

53. (1) An erroneous entry in a Register shall be corrected in the following manner:

(a)

the erroneous entry shall be ruled out in indelible ink so as to be clearly legible after it has been ruled out;

(b)

the erroneous entry shall be marked with an appropriate symbol for reference to a marginal note or a footnote;

(c)

a marginal note or a footnote shall be made on the same folio as the folio containing the erroneous entry;

(d)

a marginal note or a footnote referred to in paragraph (b) of this subregulation shall contain:

(i)	the correct information;
(ii)	the date of the correction;
(iii)	the initials of the person making such correction.

(2) The corrected entry together with the marginal note or footnote shall be dated and initialled by the person making such correction.

Balancing the Register of Drugs of Dependence

54. On the last day of each month (hereinafter called "the balance day" in this regulation) a register holder shall balance off the Register to show, for the period ending on the balance day:

(a)	the total quantity of each strength of each type of drug supplied by the register holder;
(b)	the total quantity of each strength of each type of drug obtained by the register holder;
(c)	the balance quantity of each strength of each type of drug on hand in the stocks of the register holder at the balance date.

Administration of drug to be carried out in accordance with instructions of medical practitioner

55. Subject to these regulations the administration of a drug to a patient in a health service shall only be carried out in accordance with written or oral instructions of the medical practitioner immediately responsible for the treatment of that patient.

Administration of drug to be carried out in accordance with instructions of dentist

56. Subject to these regulations the administration of a drug to a dental patient in a health service shall only be carried out in accordance with written or oral instructions of the dentist immediately responsible for the treatment of that patient.

Written instructions of medical practitioner or dentist in the Medication Record of a patient in relation to the administration of a drug

57. (1) A drug shall only be administered to a patient in a health service pursuant to the written instructions of a medical practitioner or a dentist, if those instructions:

(a)

are written in the Medication Record of the patient; and

(b)

include the following information:

(i)	the name of the drug;
(ii)	the form of the drug;
(iii)	the strength of the drug;
(iv)	the route of administration of the drug;
(v)	the frequency of administration of the drug;
(vi)	the duration of the administration of the drug.

(2) When acting pursuant to instructions given in accordance with subregulation (1), a registered nurse shall not administer a drug to a patient for a period exceeding 10 days, calculated from the date of such instructions, unless such instructions are renewed at the end of the initial ten day period for a further period of 10 days, in accordance with subregulation (1).

(3) A registered nurse may continue to administer a drug to a patient for 10 day periods after the expiration of the further period of 10 days referred to in subregulation (2), provided that instructions for the administration of such drug are renewed at the end of each 10 day period in accordance with subregulation (1).

(4) Written instructions, in relation to the administration of a drug to a patient in a health service, given by a medical practitioner or a dentist pursuant to this regulation, may be renewed by telephone in accordance with regulations 58 and 59 of these regulations.

Administration of drug may be carried out on telephone instructions

58. (1) The administration of a drug to a patient in a health service may be carried out by a registered nurse upon the receipt of telephone instructions from a medical practitioner or a dentist, given in accordance with regulation 59 of these regulations.

(2) When acting pursuant to telephone instructions in relation to the administration of a drug to a patient in a health service, a registered nurse shall net administer such drug to the patient for a period exceeding 10 days, calculated from the date of the telephone instructions, unless such instructions are renewed at the end of the initial ten day period for a further period of 10 days, in accordance with regulation 59 of these regulations.

(3) A registered nurse may continue to administer a drug to a patient in a health service, on telephone instructions, for ten day periods after the expiration of the further period of 10 days referred to in subregulation (2), provided that such telephone instructions are given in accordance with regulation 59 of these regulations.

(4) Telephone instructions for the administration of a drug to a patient in a health service, given by a medical practitioner or a dentist pursuant to this regulation, may be renewed in writing in accordance with regulation 57 of these regulations.

Mode of giving telephone instructions for administration of a drug to a patient in a health service

59. When a drug is to be administered to a patient in a health service on telephone instructions given pursuant to regulation 58 of these regulations, the medical practitioner or dentist giving such instructions shall separately state such instructions over the telephone to two persons employed in the health service, one of whom shall be a registered nurse.

Procedure to be followed on receipt of telephone instructions for administration of a drug to a patient in a health service

60. (1) Where instructions are given by telephone for the administration of a drug to a patient in a health service pursuant to regulations 58 and 59 of these regulations, only the person who is a registered nurse who has received such telephone instructions shall administer such drug to the patient.

(2) As soon as practicable after administering a drug to a patient pursuant to subregulation (1), the registered nurse shall make the following entries in the Medication Record of the patient to whom the drug has been administered:

(a)	the information in regulation 57(1)(b) of these regulations; and
(b)	the statement "by telephone instructions"; and
(c)	the date upon which the telephone instructions were given; and
(d)	the name of the medical practitioner or dentist who gave the telephone instructions; and
(e)	the name of the registered nurse who administered the drug to the patient pursuant to the telephone instructions, and
(f)	the name of the person, other than the registered nurse referred to in paragraph (e) of this subregulation, who also received the telephone instructions.

(3) The person referred to in paragraph (f) of subregulation (2) shall sign and date the Medication Record of the patient when entries are made in such medication record pursuant to that subregulation by the person who is a registered nurse.

Entries in Medication Record by medical practitioner or dentist following telephone instructions

61. Within 24 hours of giving instructions by telephone, pursuant to regulation 57(4) or 58 of these regulations, the medical practitioner or dentist who gives such instructions shall sign and date the relevant entries in the Medication Record of the patient in relation to whom such instructions are given.

Calculation of two year retention period for records

62. Where a written record is required to be kept for a period of two years pursuant to these regulations, and:

(a)	no more than one transaction is recorded per sheet of paper of that record, each sheet of paper shall be kept for a period of two years from the date of the recording of the relevant transaction; or
(b)	more than one transaction is recorded per sheet of paper of that record, each sheet of paper shall be kept for a period of two years from the date of the last transaction recorded on the relevant sheet of paper.

Storage of retained records

63. All records required to be retained for any period of time pursuant to these regulations shall be stored in a safe place so as to prevent them from being tampered with by unauthorised persons, or deteriorating during storage.

Safe storage of drugs in a health service

64. (1) A health service pharmacy shall contain a cabinet for the safekeeping of drugs (hereinafter called a "health service safe" in these regulations).

(2) A health service safe shall conform to the following specifications, as minimum requirements, in that it shall:

(a)	be constructed of black mild steel plate built not less than 9.5 mm thick;
(b)	be constructed with continuous welding of all edges;
(c)	be fitted with a door constructed of mild steel plate not less than 9.5 mm thick, the door being flush fitting with a clearance around the door of not more than 1.6 mm;
(d)	have a fixed locking bar welded to the inside face of the door near the hinged edge which engages in a rebate in the safe body when the door is closed;
(e)	be fitted with a five lever keylock or locking mechanism providing at least equivalent security either of which shall be securely affixed to the rear face of the door;
(f)	be attached to the wall or floor of the premises in accordance with subparagraph (g) or (h) of this subregulation;
(g)	where mounted on a brick or concrete wall or floor be attached to such wall or floor by means of suitably sized expanding bolts through holes 9.5 mm diameter drilled in the rear or bottom of the safe;
(h)	where mounted on a timber frame wall or floor be attached to such wall or floor frame by means of suitably sized coach screws through holes 9.5 mm diameter drilled in the rear or bottom of the safe;

(i) where the wall or floor is constructed of material other than brick or concrete or with other than a timber frame, be attached to such wall, floor or frame in such manner as provides equivalent security to a mounting pursuant to paragraph(f) of this subregulation.

Drugs stored in a ward to be in a locked cabinet

65. (1) Drugs stored in a ward shall be placed in a securely locked cabinet (hereinafter called a "cabinet" in these regulations).

(2) At all times while on duty the registered nurse for the time being in charge of a ward shall keep the key to the cabinet of the ward in his control and possession.

(3) The registered nurse for the time being in charge of a ward, shall, at the termination of his shift, deliver the key referred to in subregulation (2) to the registered nurse in charge of that ward who comes on duty for the next shift.

(4) Subject to subregulation (6) a cabinet shall only be unlocked by a registered nurse for the

purposes of:

(i)      the removal of drugs for administration to patients in the ward pursuant to these regulations;

(ii)     the storage of drugs;

(iii)    the examination and counting of drugs pursuant to regulation 10 of these regulations.

(5) Subject to subregulation (6), when a cabinet is unlocked pursuant to subregulation (4), it shall be immediately re-locked after use.

(6) No person other than a registered nurse referred to in subregulation (2) or a health service pharmacist acting pursuant to regulation 9 of these regulations shall:

(a)	lock or unlock a cabinet;
(b)	remove, add to or in any way interfere with any drugs in a cabinet.

Safe storage of drugs in a pharmacy other than a health service pharmacy

66. (1) All drugs in a pharmacy other than a health service pharmacy shall be stored in a pharmacy safe within the meaning of this regulation, when such drugs are not being dispensed pursuant to prescriptions, or supplied pursuant to orders.

(2) The owner of a pharmacy other than a health service pharmacy shall cause to be installed in such pharmacy a cabinet for the safekeeping of drugs (hereinafter called a "pharmacy safe" in these regulations).

(3) A pharmacy safe shall conform to the following specifications, as minimum requirements, in

that it shall:

(a)	be constructed of black mild steel plate not less than 9.5 mm thick;
(b)	be constructed with continuous welding of all edges;
(c)	be fitted with a door constructed of mild steel plate not less than 9.5 mm thick, the door being flush fitting with a clearance around the door of not more than 1.6 mm;
(d)	have a fixed locking bar welded to the inside face of the door near the hinged edge which engages in a rebate in the safe body when the door is closed;
(e)	be fitted with a five lever keylock or locking mechanism providing at least equivalent security either of which shall be securely affixed to the rear face of the door;
(f)	be attached to the wall or floor of the premises in accordance with paragraph (g) or (h) of this subregulation;
(g)	where mounted on a brick or concrete wall or floor be attached to such wall or floor by means of suitably sized expanding bolts through holes 9.5 mm diameter drilled in the rear or bottom of the safe;
(h)	where mounted on a timber frame wall or floor be attached to such wall or floor frame by means of suitably sized coach screws through holes 9.5 mm diameter drilled in the rear or bottom of the safe;

(i) where the wall or floor is constructed of material other than brick or concrete or with other than a timber frame be attached to such wall, floor or frame in such manner as provides equivalent security to a mounting pursuant to paragraph(f) of this subregulation.

Access to a pharmacy safe

67. (1) A pharmacist shall retain the keys to a pharmacy safe in his personal possession at all times when such keys are not in use.

(2) Only a pharmacist may lock or unlock a pharmacy safe.

(3) A pharmacy safe may only be unlocked for the following purposes:

(a)	the removal of drugs for dispensing pursuant to prescriptions or supply pursuant to orders; or
(b)	the storage of drugs; or
(c)	the examination and counting of drugs.

(4) No person other than a pharmacist shall remove, add to or in any way interfere with any drugs in a pharmacy safe.

(5) When a pharmacy safe is unlocked pursuant to this regulation the pharmacist who unlocks it shall immediately re-lock such safe after use.

Other places of storage of drugs

68. Subject to regulations 64, 65 and 66 of these regulations, where drugs are temporarily or permanently stored in any place of storage, including but without limiting the generality of the foregoing, a place of storage for drugs in a vehicle, any such place of storage shall be so constructed, secured and used as to prevent the unauthorised removal of, or interference with, such drugs.

Initiation of analysis pursuant to section 53(3) of the Act

69. (1) Pursuant to section 53(3) of the Act a person (hereinafter called an "instructing party" in

this regulation) shall initiate an analysis by notice in writing (hereinafter called a "notice" in this

regulation) addressed to an analyst or botanist at the professional address of such analyst or botanist.

(2) The instructing party shall:

(a)	insert in the notice a full description of the substance to be analysed pursuant to section 53 of the Act;
(b)	sign and date the notice.

Form pursuant to section 53(4) of the Act

70. Pursuant to section 53(4) of the Act the prescribed form is as follows:

CONTROLLED SUBSTANCES ACT 1984

CERTIFICATE OF ANALYSIS

PURSUANT to section 53 of the Controlled Substances Act 1984, I1 , .. .. .. .. .. .. .. .. .. .. .. .. .. . .

an analyst/botanist2 appointed under the Act, hereby certify that3 .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. . .

Dated4 .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .

Signed5 .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .	analyst/botanist2
appointed under the Act.

Instructions For Filling Out This Form

1.        Full name of the analyst/botanist to be inserted here.

2.        Delete whichever is inapplicable.

3.        Results of the analysis to be inserted here.

4.        Date of certificate of analysis to be inserted here.

5.        Usual signature of analyst/botanist to be inserted here.

Prescribed fee for the purposes of section 53(3) of the Act

71. The fee for the purposes of section 53(3) of the Act shall be $150.00 per substance analysed.

Application for a licence for the purposes of section 31(3)(d) of the Act

72. An application for a licence for the purposes of section 31(3)(d) of the Act shall be made in writing to the Minister.

Application for a licence for the purposes of section 32(2)(c) of the Act

73. An application for a licence for the purposes of section 32(2)(c) of the Act shall be made in writing to the Minister.

Application to renew licence granted pursuant to section 31(3)(d) of the Act

74. An application to renew a licence granted pursuant to section 31(3)(d) of the Act shall be made in writing to the Minister.

Application to renew licence granted pursuant to section 32(2)(c) of the Act

75. An application to renew a licence granted pursuant to section 32(2)(c) of the Act shall be made in writing to the Minister.

Fees

76. The fees set out in the second column below are prescribed in respect to the things to be done under the Act and set out alongside such fees in the first column below:

ITEM FEE

$

1. For an application for a licence to manufacture, produce or sell a drug, where

such application is made pursuant to section 32(2)(c) of the Act in relation to:

(a) premises being the principal premises to be used for the manufacture,

production or sale of a drug .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. . 221.00

(b)	the first 10 branch premises, in addition to the principal premises, to be used
for the manufacture, production or sale of a drug—per branch premises .. 21.00

2. For an application for the renewal of a licence pursuant to section 55(3) of the Act where the licence was originally granted for the manufacture, production or sale of a drug pursuant to section 32(2)(c) of the Act in relation to:

(a)	premises being the principal premises used for the manufacture, production or
sale of a drug .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. . 221.00
(b)	the first 10 branch premises, in addition to the principal premises, used for
the manufacture,production or sale of a drug—per branch premises .. .. . 21.00

Delivery of a drug by post

77. Subject to the Postal Services Act 1975 (Commonwealth) and the regulations and by-laws made pursuant to that Act, a supplier may supply a drug to a person by sending it to that person by registered post, provided that:

(a)	the drug is packed in accordance with regulation 79 or 80 of these regulations;
(b)	the supplier delivers such drug to the post office;
(c)	the supplier arranges for the delivery of such drug by registered post at the post office;
(d)	thesupplierpromptlyobtainspossessionofalldocumentsissuedbythepostofficein relation to the lodging of the drug for delivery by registered post;
(e)	the supplier personally retains the documents referred to in paragraph (d) of this regulation for a period of 2 years after the date of the postage of the drug;
(f)	the supplier keeps the documents referred to in paragraph (d) of this regulation in a safe place, and in good order and condition during the 2 year period referred to in paragraph (e) of this regulation.

Delivery of a drug by carrier

78. A supplier may supply a drug to a person by means of a carrier of goods for hire (hereinafter called a "carrier" in this regulation), provided that:

(a)	the drug is packed in accordance with regulation 79 or 80 of these regulations;
(b)	the supplier delivers the drug to the carrier or his servant or agent for delivery by the carrier to the person to be supplied with the drug;
(c)	the supplier arranges for the delivery of the drug by the carrier;
(d)	the supplier obtains from the carrier a proper receipt for the package containing the drug which has been signed and dated by the carrier or his servant or agent;
(e)	the supplier personally retains the receipt referred to in paragraph (d) of this regulation for a period of 2 years from the date of the delivery of the drug to the carrier pursuant to paragraph (b) of this regulation;
(f)	the supplier keeps the receipt referred to in paragraph (e) of this regulation in a safe place, and in good order and condition during the 2 year period referred to in that paragraph;
(g)	the supplier engages a carrier who obtains a written acknowledgement of the receipt of the package containing the drug from the person to whom it has been supplied and delivered.

Packing of drugs for delivery

79. Subject to regulation 80 of these regulations, where a supplier delivers a drug by registered post or by a carrier of goods for hire pursuant to regulation 77 or 78 of these regulations he shall pack such drug in the following manner:

(a)	the drug shall be enclosed in a package which has an outer wrapping which is opaque;
(b)	thedrugshallbeenclosedinapackagewhichdoesnotcontainanygoodsotherthan suitable packing material to protect the drug in transit;
(c)	the outer wrapping of such package shall not have marked on it any writing or other matter indicating or likely to indicate that the package contains or may contain a drug;
(d)	the name and full address of the person to whom the drug is to be delivered shall be written on the outer wrapping of the package;
(e)	thereshallbeplacedbeneaththeouterwrappingofthepackageaclearlylegibleand accurate description in writing of the contents of the package, together with a document containing the following statement, printed in bold face sans serif capital letters, not less than 12.5 mm in height:

"DRUGS OF DEPENDENCE—CHECK CAREFULLY".

Regulation 79 not to apply in certain circumstances

80. Regulation 79 of these regulations shall not apply to a supplier who encloses a drug in a package containing other goods together with the drug (hereinafter called an "outer package" in this regulation), provided that:

(a)	the drug is first placed in a separate package (hereinafter called a "separate package") in this regulation;
(b)	the separate package has an outer wrapping which has the following statement printed on it in bold face sans serif capital letters, not less than 12.5 mm in height:

"DRUGS OF DEPENDENCE—CHECK CAREFULLY";

(c)

the separate package contains a clearly legible and accurate description in writing of the drug in that package;

(d)

the separate package does not contain any goods other than suitable packing material to protect the drug in transit;

(e)

the outer package containing the separate package has an outer wrapping which:

(i)	is opaque;
(ii)	does not have marked on it any writing or other matter indicating or likely to indicate that the outer package contains or may contain a drug;
(iii)	is clearly marked with the name and full address of the person to whom the drug is to be delivered.

Certificate of identification

81. For the purposes of section 50(2) of the Act a certificate of identification of an authorised officer shall be in the following form:

"CERTIFICATE OF IDENTIFICATION OF AN AUTHORISED OFFICER

Name1 .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .

Title2 .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. . .

Specimen signature3 .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .

Certificate4 .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. . .

Pursuant to section 50(2) of the Controlled Substances Act 1984, I certify that the person whose name, title, signature and photograph appear in this certificate is an authorised officer under the Act.

DATE5 .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. . (6 Space for photograph of certificate holder)

7.. .. .. .. .. .. .. .

Minister of Health

Instructions For Filling Out This Form

1. Full name of certificate holder to be inserted here.

2. Title of office of certificate holder to be inserted here.

3. Usual signature of certificate holder to be inserted here.

4. Number of certificate to be inserted here.

5. Date of certificate to be inserted here.

6. A recent head and shoulders photograph of the certificate holder to be affixed here.

7. Signature of Minister of Health to be inserted here.".

Penalty

82. Any person who commits a breach of or fails to comply with any of these regulations shall be guilty of an offence and liable to a penalty not exceeding $1 000.

APPENDIX

LEGISLATIVE HISTORY

(entries in bold type indicate amendments incorporated since the last reprint)

Regulation 25A:	inserted by 60, 1988, reg. 2
Regulation 25A(1) - (3):	varied by 162, 2000, reg. 3
Regulation 26(4):	varied by 162, 2000, reg. 4
Regulation 27(4):	varied by 162, 2000, reg. 5
Regulation 42(1):	varied by 162, 2000, reg. 6(a)
Regulation 42(2):	varied by 162, 2000, reg. 6(b)
Regulation 43:	varied by 162, 2000, reg. 7
Regulation 45(1):	varied by 162, 2000, reg. 8(a)
Regulation 45(2):	varied by 162, 2000, reg. 8(b)
Regulation 72:	varied by 162, 2000, reg. 9
Regulation 73:	varied by 162, 2000, reg. 10
Regulation 74:	varied by 162, 2000, reg. 11
Regulation 75:	varied by 162, 2000, reg. 12
Regulation 76:	varied by 82, 1998, reg. 3; 82, 1999, reg. 3; 89, 2000, reg. 3