Pharmacy Act 1964 Pharmacy (General) Regulation 1993 (1993-453) [GG No 97 of 1.9.1993] (NSW)
1993—No. 453
PHARMACY ACT 1964—REGULATION
(Pharmacy (General) Regulation 1993)
NEW SOUTH WALES
[Published in Gazette No. 97 of 1 September 1993]
HIS Excellency the Governor, with the advice of the Executive Council, and in pursuance of the Pharmacy Act 1964, has been pleased to make the Regulation set forth hereunder.
RON PHILLIPS
Minister for Health.
PART 1—PRELIMINARY
Citation
1. This Regulation may be cited as the Pharmacy (General) Regulation
1993.
Commencement
2. This Regulation commences on 1 September 1993.
Definitions
3. (1) In this Regulation:
“pecuniary interest” includes a direct or indirect pecuniary interest;“pharmacy business” means the business of a pharmacist carried on
in a pharmacy;
“the Act” means the Pharmacy Act 1964.
(2) In this Regulation, a reference to a Form is a reference to a Form
set out in Schedule 1.
1993—No. 453
PART 2—REGISTRATION OF PHARMACISTS
Applications for registration
4. An application for registration as a pharmacist is to be made in a form approved by the Board.
Qualifications for registration: prescribed period of work as assistant
(sec. 13)
5. (1) For the purposes of section 13 (1) (b) of the Act, the prescribed period as an assistant is:
(a) 2,300 hours, in the case of a person who has been awarded a pass degree in pharmacy; or (b) 2,000 hours, in the case of a person who has been awarded an honours degree in pharmacy or who (in addition to having been awarded a pass degree in pharmacy) has been awarded a higher degree in pharmacy or a postgraduate diploma in pharmacy.
(2) In calculating the number of hours for which a person has served as an assistant, the following periods are to be excluded:
(a)
any period served before the person’s successful completion of the first academic year of a course leading to a first degree in pharmacy;
(b)
any hours above 300 served during the period between the person’s successful completion of that year and the person’s successful completion of the remainder of the course;
(c) any period of less than 30 hours served in any one week;
(d) any hours above 45 served in any one week;
(e) any period of less than 150 hours served in any one location.
(3) Subclauses (1) and (2) do not apply to persons who commenced a
course for a degree in pharmacy before the commencement of this
Regulation.
(4) Regulation 30A of the Pharmacy Regulations (as in force immediately before the commencement of this Regulation) continues to apply to persons who commenced a course for a degree in pharmacy after 22 February 1991 and before the commencement of this Regulation.
Qualifications for registration: interstate and overseas applicants
(sec. 14)
6. For the purposes of section 14 of the Act, the qualifications listed in Schedule 2 are prescribed qualifications.
1993—No. 453
Certificates of registration (secs. 17, 17A)
7. (1) For the purposes of section 17 (2) of the Act, Form 1 is the prescribed form for a certificate of registration.
(2) For the purposes of section 17A (1) and (2) of the Act, Form 2 is the prescribed form for a certificate of provisional registration.
(3) The Board may issue a duplicate certificate of registration or certificate of provisional registration, on payment of the fee fixed by the Board, if it is satisfied that the original certificate has been lost, destroyed or mutilated.
Certificates of identity
8. The Registrar may, at the request of a pharmacist, issue a certificate of identity, in a form approved by the Board, on payment of the fee fixed by the Board.
Applications for restoration of name to register (sec. 19)
9. (1) An application for restoration of the name of a pharmacist to the register must be in a form approved by the Board.
(2) The Board may waive such part of the fee payable under section 19 (4) of the Act as it may, in any particular case, consider proper.
PART 3—PHARMACIES
Approval of pharmacy premises: standards to be complied with (sec.
24A)
10. (1) For the purposes of section 24A (4) of the Act, the following standards for premises are prescribed:
at least one doorway allowing direct public access to the premises
is to be provided;
secure doors, windows and roof are to be provided;
the premises are to be equipped with a dispensing area of at least
8 square metres or such lesser area as the Board may approve in aparticular case;
pharmaceutical products at appropriate temperatures is to be a refrigerator suitable for the storage of biological and provided.
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(2) The dispensing area referred to in subclause (1) (c):
(a) must have adequate lighting and ventilation; and
(b)
must have adequate heating facilities for dispensing and compounding drugs and medicines; and
(c)
must be equipped with a stainless steel or similarly impervious sink, being a sink that has an impervious surround and is supplied with hot and cold running water; and
(d)
must have a dispensing bench that is at least 40 centimetres wide, and of sufficient length to provide not less than 1 square metre of free working space, and that has an impervious covering.
Branch pharmacies (sec. 26)
11. (1) An application for an approval of premises as suitable for a branch pharmacy is to be made to the Registrar in a form approved by the Board and is to be accompanied by the fee fixed by the Board.
(2) The Board may reject the application or may approve the premises concerned as being suitable for carrying on a pharmacy business.
(3) Premises are not to be approved:
(a) if they fail to comply with the standards set out in clause 10; or
(b) if they are to operate as a branch pharmacy for more than 25 hours a week; or (c) if they are on or near premises approved by the Board under section 24A of the Act; or (d) if they fail to comply with such other conditions or requirements as the Board determines.
(4) An approval remains in force for the period of 12 months from the date on which it was given.
(5) The Board may, by written notice served on the pharmacist in charge of a branch pharmacy, revoke an approval at any time if the premises concerned are found not to comply with any condition referred to in subclause (3).
After-hours pharmacies: changes in partnership agreements etc.
12. (1) If the members of a partnership conducting an after-hours pharmacy execute an agreement relating to the conduct of the pharmacy, a copy of the agreement must be lodged with the Registrar within 14 days after execution.
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(2) If there is an alteration in the name, place of business or residential address of a member of a partnership conducting an after-hours pharmacy, particulars of the alteration must be lodged with the Registrar within 14 days after it occurs.
(3) Before being lodged, a copy of an agreement or particulars of an
alteration must be certified as correct by each member of the partnership.(4) Each member of the partnership must ensure that the requirements of this clause are complied with.
Maximum penalty: 2 penalty units.
(5) Compliance with the requirements of subclauses (1) and (2) by any
one of the members of the partnership is taken to be compliance by them
all.
Notice of acquisition or disposal of interest in pharmacy
13. (1) A person:
(a) who acquires a pecuniary interest in a pharmacy business, whether by purchase or otherwise; or (b) who ceases to have a pecuniary interest in a pharmacy business, must, within 14 days after doing so, cause written notice of that fact to be given to the Board.
(2) The notice must be in a form approved by the Board and must be accompanied by copies of the following:
(a) any bill of sale referred to in the notice;
(b) any sale agreement for the business;
(c) any partnership agreement for the business;(d) any lease for the pharmacy;
(e) any agreement under which any other person has a pecuniary interest in the business.
(3) Subclause (1) (b) does not apply to a person who has ceased to have an interest in a pharmacy business because the person’s name has been removed from the Register or because the person is suspended from practising as a pharmacist.
(4) A company carrying on a pharmacy business must, within 14 days after any change in composition of the board of directors of the company, cause written notice of that fact to be given to the Board.
) The notice must be in a form approved by the Board.
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(6) A person must not, in a notice under this clause, make any statement that the person knows to be false or misleading in a material particular.
Maximum penalty: 2 penalty units.
Advertising
14. (1) The owner of a pharmacy must cause to be displayed at or near the main entrance of the pharmacy, and adjacent to the area where dispensing is carried on, the name of the pharmacist in charge of the pharmacy followed by the words “PHARMACIST IN CHARGE”.
(2) A person carrying on a pharmacy business:
(a)
must not, in any advertisement, claim or imply professional superiority or give any warranty of satisfaction, purity of drugs or accuracy in dispensing; and
(b)
must not, in any advertisement or otherwise, hold himself or herself out to be willing, capable or entitled to give advice in the treatment of a medical condition, otherwise than to the extent to which the advice is part of the practice of pharmacy.
Maximum penalty: 2 penalty. units.
Equipment etc. to be kept in pharmacy
15. A person carrying on a pharmacy business must install and maintain in the pharmacy the equipment, appliances and publications listed in Schedule 3.
Maximum penalty: 2 penalty units.
PART 4—MISCELLANEOUS
Registrar to be Secretary to the Board etc.
16 The Registrar is also the Secretary to the Board and any committee
(other than a professional standards committee) established by the Board.
Dispensing by medical practitioners: when permitted (sec. 28)
17. FOr the purposes of section 28 (2) (c) of the Act, each of the following are prescribed circumstances in which a medical practitioner may dispense medicine in the ordinary course of medical practice:
(a)
that the practitioner is issued with an approval number for dispensing by the Commonwealth Health Insurance Commission;
(b)
that the practitioner is employed by the Family Planning Association of New South Wales, practises in a clinic or premises operated by that Association and dispenses medicine (for use in connection with family planning) to persons attending the clinic or premises.
Death of pharmacist to be notified (sec. 29)
18. (1) This clause applies to the executor of the will, or the administrator or trustee of the estate, of a deceased person who was carrying on a pharmacy business at the date of his or her death, being an executor, administrator or trustee who carries on the business, or proposes to carry on the business, pursuant to section 29 of the Act.
(2) An executor, administrator or trustee to whom this clause applies must, within 90 days after the death of the pharmacist, cause written notice to be sent to the Registrar of
(a) the fact that the pharmacist has died; and
(b) the date of the pharmacist’s death; and
(c)
the fact that the executor, administrator or trustee carries on the business, or proposes to carry on the business, pursuant to section 29 of the Act.
Maximum penalty: 2 penalty units.
Repeal
19. (1) The Pharmacy Regulations and the Pharmacy (After-hours Pharmacies) Regulations 1967 are repealed.
(2) Any act, matter or thing that, immediately before the commencement of this Regulation, had effect under a regulation referred to in subclause (1) is taken to have effect under this Regulation.
Savings provision: pecuniary interests before 5.10.1990 (sec. 25)
20. (1) For the purposes of section 25 (2) (c) of the Act, an individual, a body corporate or an unincorporated body is not prevented from having a pecuniary interest in a pharmacy business:
if the interest in the business is of a kind referred to in section 25 (2) (b)–(f) of the Act as in force immediately before 5 October 1990 (the day on which those provisions were repealed); and
| as the individual, body corporate or unincorporated body had if the pecuniary interest is the same interest in the same business |
| immediately before 5 October 1990. |
1993—No. 453
(2) This clause does not apply to a person whose name has been removed from the Register or who is suspended from practising as a pharmacist.
SCHEDULE 1—FORMS
Form 1
(Cl. 7)
CERTIFICATE OF REGISTRATION
(PHARMACY ACT 1964)
(section 17 (2))
PHARMACY BOARD OF NEW SOUTH WALES
This is to certify that the name of .................................................................
was entered in the Register of Pharmacists for New South Wales under the Pharmacy
Act 1964 on the ...............................................................................................
day of ............................................................................................... 19 ..........
...................................
Registrar
Form 2
(Cl. 7)
CERTIFICATE OF PROVISIONAL REGISTRATION
(PHARMACY ACT 1964)
(section 17A)
PHARMACY BOARD OF NEW SOUTH WALES
No. .............
This is to certify that ......................................................................................
is provisionally registered as a Pharmacist until the ........................................................
day of ............................................................................................................19 .........
..............................................
(President/Board Member)
Date .......................................................
1993—No. 453
SCHEDULE 2—INTERSTATE AND OVERSEAS QUALIFICATIONS
(Cl. 6)
Qualification: Granted by:
Victoria
Final Examination Certificate Pharmacy Board of Victoria Queensland
Prescribed Certificate of Fitness Pharmacy Board of Queensland issued after examination
Degree or Diploma in Pharmacy University of Queensland South Australia
Standard Certificate issued prior to Pharmacy Board of South Australia 9 December 1965
Bachelor of Pharmacy University of South Australia Degree in Pharmacy University of Adelaide Diploma in Pharmacy South Australian Institute of Technology
Degree in Pharmacy South Australian Institute of Technology
Diploma in Pharmacy University of Adelaide Degree in Pharmacy of Joint South Australian Institute of Faculty of University of Technology Adelaide Western Australia
Bachelor of Pharmacy Curtin University, Western Australia Diploma in Pharmacy Perth Technical College, Western Australia
Associateship in Pharmacy Western Australian Institute of Technology
Bachelor of Science in Pharmacy Western Australian Institute of Technology
Tasmania
Qualifying Examination Pass Pharmacy Board of Tasmania Bachelor of Pharmacy University of Tasmania Diploma in Pharmacy Tasmanian College of Advanced Education
Bachelor of Applied Science in Tasmanian College of Advanced Pharmacy Education
1993—No. 453
New Zealand
| Qualifying Examination Pass prior | Pharmacy Board of New Zealand |
to 1963
| Pharmacy Professional Examination | A board of Examiners constituted |
| Pass | under the Pharmacy Act 1939 of the General Assembly of New Zealand |
| Bachelor of Pharmacy | University of Otago, New Zealand |
| Diploma in Pharmacy | Central Institute of Technology, New |
Zealand
SCHEDULE 3—EQUIPMENT, APPLIANCES AND PUBLICATIONS TO BE
INSTALLED AND MAINTAINED IN A PHARMACY
(Cl. 15)
Equipment and appliances
Dispensing balance
Heavy duty scales, capable of weighing up to 1 kg
1 set of metric weights
Dispensing measures:
1 × 500 ml measure
1 × 200 ml measure 1 × 100 ml measure 1 × 20 ml measure 1 × 10 ml measure or graduated pipette
1 × 5 ml measure or graduated pipette
Adequate supplies of filter paper
2 Funnels
2 Mortars and pestles (one, at least, of glass)
2 Stirring rods
2 Spatulas
1 Ointment slab1 Tablet counting tray
Publications
Poisons Act 1966 and Regulations under that Act, together with the Poisons List proclaimed under section 8 of that Act or the Guide to the New South Wales Poisons Schedules published by the Pharmacy Guild of Australia (New South Wales Branch)
Pharmacy Act 1964 and Pharmacy (General) Regulation 1993
The latest edition of the “Extra Pharmacopeia—Martindale”
The latest edition of the “Australian Pharmaceutical Fomulary”
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The latest edition of the “Prescription Proprietary Guide” or other equivalent
approved by the Board
The latest edition of the “Pharmacy Handbook for Patient Counselling” published by
the Pharmaceutical Society of Australia
All published amendments and supplements to the above publications
TABLE OF PROVSIONS
PART 1—PRELIMINARY
1. Citation
2. Commencement3. Definitions
PART 2—REGISTRATION OF PHARMACISTS
4. Applications for registration
5. Qualifications for registration: prescribed period of work as assistant (sec. 13)
6. Qualifications for registration: interstate and overseas applicants (sec. 14)
7. Certificates of registration (secs. 17, 17A)
8. Certificates of identity9. Applications for restoration of name to register (sec. 19)
PART 3—PHARMACIES
10. Approval of pharmacy premises: standards to be complied with (sec. 24A)
11. Branch pharmacies (sec. 26)
12. After-hours pharmacies: changes in partnership agreements etc.
13. Notice of acquisition or disposal of interest in pharmacy
14. Advertising15. Equipment etc. to be kept in pharmacy
PART 4—MISCELLANEOUS
16. Registrar to be Secretary to the Board etc.
17. Dispensing by medical practitioners: when permitted (sec. 28)
18. Death of pharmacist to be notified (sec. 29)
19. Repeal
20. Savings provision: pecuniary interests before 5.10.1990 (sec. 25)
SCHEDULE 1—FORMS
SCHEDULE 2—INTERSTATE AND OVERSEAS QUALIFICATIONSSCHEDULE 3—EQUIPMENT, APPLIANCES, AND PUBLICATIONS TO BE
INSTALLED AND MAINTAINED IN A PHARMACY
1993—No. 453
EXPLANATORY NOTE
The object of this Regulation is to repeal the Pharmacy Regulations and the Pharmacy (After-hours Pharmacies) Regulations 1967 and to remake their provisions (other than the provisions relating to elections for the Pharmacy Board) as a new Regulation. The new Regulation makes provision with respect to the following matters:
(a) the registration of pharmacists (Part 2);
(b) the requirements to be observed in the conduct of pharmacies (Part 3);
(c) other matters of a minor, consequential or ancillary nature (Parts 1 and 4).
The provisions relating to elections for the Pharmacy Board are to be remade in a separate Regulation (the Pharmacy (Elections) Regulation 1993).
This Regulation is made under the Pharmacy Act 1964, including section 38 (the general regulation making power) and various other sections referred to in the Regulation.
This Regulation is made in connection with the staged repeal of subordinate legislation under the Subordinate Legislation Act 1989.
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