Pharmacy Act 1964 PHARMACY (GENERAL) REGULATION 1998 - Made under the Pharmacy Act 1964 - As at 25 February 2008 - Reg 476 of 1998 TABLE OF PROVISIONS TABLE OF PROVISIONS PART 1 - PRELIMINARY 1. Name of Regulation 2. Commencement 3. Notes 4. Definitions PART 2 - REGISTRATION OF PHARMACISTS 5. Applications for registration 6. Qualifications for registration: prescribed universities (section 13) 6A. Qualifications for registration: prescribed period for Master of Pharmacy (section 13) 7. Qualifications for registration: prescribed period of work as assistant (section 13) 8. Qualifications for registration: interstate and overseas applicants (section 14) 9. Certificates of registration (sections 17, 17A) 10. Certificates of identity 11. Applications for restoration of name to register (section 19) PART 3 - PHARMACIES 12. Approval of pharmacy premises: standards to be complied with (section 24A) 13. Branch pharmacies (section 26) 14. After-hours pharmacies: changes in partnership agreements etc 15. Notice of acquisition or disposal of interest in pharmacy 16. Advertising 17. Equipment etc to be kept in pharmacy PART 4 - MISCELLANEOUS 18. Registrar to be Secretary to the Board etc 19. Dispensing by medical practitioners: when permitted (section 28) 20. Death of pharmacist to be notified (section 29) 21. Savings for pecuniary interests before 5 October 1990 (section 25) 22. Repeal SCHEDULE 1 SCHEDULE 2 SCHEDULE 3 PHARMACY (GENERAL) REGULATION 1998 - REG 1 Name of Regulation 1 Name of Regulation This Regulation is the Pharmacy (General) Regulation 1998. PHARMACY (GENERAL) REGULATION 1998 - REG 2 Commencement 2 Commencement This Regulation commences on 1 September 1998. PHARMACY (GENERAL) REGULATION 1998 - REG 3 Notes 3 Notes The explanatory note and table of contents do not form part of this Regulation. PHARMACY (GENERAL) REGULATION 1998 - REG 4 Definitions 4 Definitions 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. PHARMACY (GENERAL) REGULATION 1998 - REG 5 Applications for registration 5 Applications for registration An application for registration as a pharmacist is to be made in a form approved by the Board. PHARMACY (GENERAL) REGULATION 1998 - REG 6 Qualifications for registration: prescribed universities (section 13) 6 Qualifications for registration: prescribed universities (section 13) For the purposes of section 13 (1) (a) of the Act, the following universities are prescribed universities: (a) Charles Sturt University, (b) University of Newcastle. PHARMACY (GENERAL) REGULATION 1998 - REG 6A Qualifications for registration: prescribed period for Master of Pharmacy (section 13) 6A Qualifications for registration: prescribed period for Master of Pharmacy (section 13) For the purposes of section 13 (1A) (a) of the Act, the prescribed period in respect of the course for: (a) a Master of Pharmacy at the University of Newcastle, or (b) a Master of Pharmacy at the University of Sydney, is 2 years. PHARMACY (GENERAL) REGULATION 1998 - REG 7 Qualifications for registration: prescribed period of work as assistant (section 13) 7 Qualifications for registration: prescribed period of work as assistant (section 13) (1) For the purposes of section 13 (1) (b) of the Act, the prescribed period as an assistant is 2,000 hours. (2) In calculating the number of hours that a person has served as an assistant, the following periods are not to be included: (a) in the case of a person who has commenced a course leading to a first degree in pharmacy between 1 September 1993 and 1 October 1995: (i) any period served before the person’s successful completion of the first academic year of the course, and (ii) 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 course, (b) in the case of a person who commences a course leading to a first degree in pharmacy after 1 October 1995, any period served before the person’s successful completion of the course, (c) in all cases: (i) any period of less than 30 hours served in any one week, and (ii) any hours above 45 served in any one week, and (iii) 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 1 September 1993. (4) Regulation 30A of the Pharmacy Regulations (as in force immediately before 1 September 1993) continues to apply to persons who commenced a course for a degree in pharmacy after 22 February 1991 and before 1 September 1993. PHARMACY (GENERAL) REGULATION 1998 - REG 8 Qualifications for registration: interstate and overseas applicants (section 14) 8 Qualifications for registration: interstate and overseas applicants (section 14) For the purposes of section 14 of the Act, the qualifications listed in Schedule 1 are prescribed qualifications. PHARMACY (GENERAL) REGULATION 1998 - REG 9 Certificates of registration (sections 17, 17A) 9 Certificates of registration (sections 17, 17A) (1) For the purposes of section 17 (2) of the Act, the prescribed form for a certificate of registration is the form set out as Form 1 in Schedule 2. (2) For the purposes of section 17A (1) and (2) of the Act, the prescribed form for a certificate of provisional registration is the form set out as Form 2 in Schedule 2. (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. PHARMACY (GENERAL) REGULATION 1998 - REG 10 Certificates of identity 10 Certificates of identity 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. PHARMACY (GENERAL) REGULATION 1998 - REG 11 Applications for restoration of name to register (section 19) 11 Applications for restoration of name to register (section 19) (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. PHARMACY (GENERAL) REGULATION 1998 - REG 12 Approval of pharmacy premises: standards to be complied with (section 24A) 12 Approval of pharmacy premises: standards to be complied with (section 24A) (1) For the purposes of section 24A (4) of the Act, the following standards for premises are prescribed: (a) at least one doorway allowing direct public access to the premises is to be provided, (b) secure doors, windows and roof are to be provided, (c) 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 a particular case, (d) a refrigerator suitable for the storage of biological and pharmaceutical products at appropriate temperatures is to be provided. (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. PHARMACY (GENERAL) REGULATION 1998 - REG 13 Branch pharmacies (section 26) 13 Branch pharmacies (section 26) (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 12, 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). PHARMACY (GENERAL) REGULATION 1998 - REG 14 After-hours pharmacies: changes in partnership agreements etc 14 After-hours pharmacies: changes in partnership agreements etc (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. (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 (subclause (4)): 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. PHARMACY (GENERAL) REGULATION 1998 - REG 15 Notice of acquisition or disposal of interest in pharmacy 15 Notice of acquisition or disposal of interest in pharmacy (1) A person who intends to acquire any pecuniary interest in a pharmacy business (whether by purchase or otherwise) must cause written notice of the intended acquisition to be given to the Board at least 14 days before acquiring the interest. Maximum penalty: 2 penalty units. (2) A person 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. Maximum penalty: 2 penalty units. (3) The notices referred to in subclauses (1) and (2) 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. (4) Subclause (2) 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. (5) 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. Maximum penalty: 2 penalty units. (6) The notice must be in a form approved by the Board. (7) A person must not, in any 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. PHARMACY (GENERAL) REGULATION 1998 - REG 16 Advertising 16 Advertising (1) The owner of a pharmacy must cause to be displayed: (a) at or near the main entrance of the pharmacy, the name of the owner of the pharmacy business, and (b) 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”. Maximum penalty: 2 penalty units. (2) An advertisement that relates to a pharmacy or pharmacy services must not: (a) be false, misleading or deceptive, or (b) create an unjustified expectation of beneficial treatment or give any warranty of satisfaction, or (c) promote the unnecessary or inappropriate use of pharmacy services, or (d) claim or imply superiority for a pharmacist in the practice of pharmacy. (3) A person who publishes, or causes to be published, an advertisement in contravention of subclause (2) is guilty of an offence. Maximum penalty: 2 penalty units. PHARMACY (GENERAL) REGULATION 1998 - REG 17 Equipment etc to be kept in pharmacy 17 Equipment etc to be kept in pharmacy 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. PHARMACY (GENERAL) REGULATION 1998 - REG 18 Registrar to be Secretary to the Board etc 18 Registrar to be Secretary to the Board etc The Registrar is also the Secretary to the Board and any committee (other than a professional standards committee) established by the Board. PHARMACY (GENERAL) REGULATION 1998 - REG 19 Dispensing by medical practitioners: when permitted (section 28) 19 Dispensing by medical practitioners: when permitted (section 28) 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. PHARMACY (GENERAL) REGULATION 1998 - REG 20 Death of pharmacist to be notified (section 29) 20 Death of pharmacist to be notified (section 29) (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. PHARMACY (GENERAL) REGULATION 1998 - REG 21 Savings for pecuniary interests before 5 October 1990 (section 25) 21 Savings for pecuniary interests before 5 October 1990 (section 25) (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: (a) the interest is an interest that the individual, body corporate or unincorporated body had immediately before 5 October 1990 and that was lawful pursuant to section 25 (2) (b), (b1), (c), (d), (e) or (f) of the Act (as in force immediately before that day), and (b) the interest is the same interest in the same pharmacy business as the individual, body corporate or unincorporated body had immediately before 5 October 1990, and (c) the pharmacy business is carried on in either the shop in which that business was carried on immediately before 5 October 1990 (referred to in this clause as the "original shop") or a shop in the prescribed area for the original shop, and (d) in the case of a body corporate that is a listed corporation within the meaning of the Corporations Act 2001 of the Commonwealth—the body corporate was a listed corporation immediately before 7 September 2006. (2) The "prescribed area" for the original shop means, for the purposes of subclause (1) (c): (a) if the original shop was situated in the area that consists of the County of Cumberland, the County of Northumberland and the City of Wollongong—that area, or (b) in any other case—the area within 16 kilometres of the original shop. (3) For the purposes of removal of doubt, it is declared that a change in the trading name under which a pharmacy business is carried on (whether or not the change occurred before, or occurs after, the commencement of the Pharmacy (General) Amendment (Exceptions) Regulation 2002) does not constitute a change in the identity of a pharmacy business and is not relevant in determining whether a pharmacy business is the same pharmacy business as existed immediately before 5 October 1990. (4) For the purposes of removal of doubt, it is declared that it does not matter for the purposes of this clause that any relocation of a pharmacy business after 5 October 1990 occurred with or without the approval of the Minister. (5) 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. PHARMACY (GENERAL) REGULATION 1998 - REG 22 Repeal 22 Repeal (1) The Pharmacy (General) Regulation 1993 is repealed. (2) Any act, matter or thing that, immediately before the commencement of this Regulation, had effect under the Pharmacy (General) Regulation 1993 is taken to have effect under this Regulation. PHARMACY (GENERAL) REGULATION 1998 - SCHEDULE 1 SCHEDULE 1 – Interstate and overseas qualifications (Clause 8) _____________________________________________________________________________ |_____________________________________________________________________________| |_____________________________________________________________________________| |_____________________________________________________________________________| |_____________________________________________________________________________| |Bachelor of Pharmacy |Victorian College of Pharmacy, Monash | |_____________________________________________________________________________| |_____________________________________________________________________________| |Prescribed Certificate of Fitness |Pharmacy Board of Queensland | |_____________________________________________________________________________| |_____________________________________________________________________________| |_____________________________________________________________________________| |Bachelor of Pharmaceutical Science | | |(pre-pharmacy major) with Master of |Griffith University | |_____________________________________________________________________________| |_____________________________________________________________________________| |Standard Certificate issued prior to 9|Pharmacy Board of South Australia | |_____________________________________________________________________________| |_____________________________________________________________________________| |_____________________________________________________________________________| |Diploma in Pharmacy |South Australian Institute of | |_____________________________________________________________________________| |Degree in Pharmacy |South Australian Institute of | |_____________________________________________________________________________| |_____________________________________________________________________________| |Degree in Pharmacy of Joint Faculty of|South Australian Institute of | |_____________________________________________________________________________| |_____________________________________________________________________________| |_____________________________________________________________________________| |Diploma in Pharmacy |Perth Technical College, Western | |_____________________________________________________________________________| |Associateship in Pharmacy |Western Australian Institute of | |_____________________________________________________________________________| |Bachelor of Science in Pharmacy |Western Australian Institute of | |_____________________________________________________________________________| |_____________________________________________________________________________| |_____________________________________________________________________________| |_____________________________________________________________________________| |Diploma in Pharmacy |Tasmanian College of Advanced | |_____________________________________________________________________________| |Bachelor of Applied Science in |Tasmanian College of Advanced | |_____________________________________________________________________________| |_____________________________________________________________________________| |_____________________________________________________________________________| |_____________________________________________________________________________| |Qualifying Examination Pass prior to |Pharmacy Board of New Zealand | |_____________________________________________________________________________| | |A board of Examiners constituted under| |Pharmacy Professional Examination Pass|the Pharmacy Act 1939 of the General | |_____________________________________________________________________________| |_____________________________________________________________________________| |Diploma in Pharmacy |Central Institute of Technology, New | |_____________________________________________________________________________| |_____________________________________________________________________________| PHARMACY (GENERAL) REGULATION 1998 - SCHEDULE 2 SCHEDULE 2 – Forms (Clause 9) Form 1 - Certificate of Registration Certificate of Registration (Pharmacy Act 1964) Certificate of Registration (section 17 (2)) Certificate of Registration Pharmacy Board of New South Wales This is to certify that the name ofwas entered in the Register of Pharmacists for New South Wales under the Pharmacy Act 1964 on theday of19 Registrar Form 2 - Certificate of Provisional Registration Certificate of Provisional Registration (Pharmacy Act 1964) Certificate of Provisional Registration (section 17A) Certificate of Provisional Registration Pharmacy Board of New South Wales No This is to certify thatis provisionally registered as a Pharmacist until theday of19 (President/Board Member) Date PHARMACY (GENERAL) REGULATION 1998 - SCHEDULE 3 SCHEDULE 3 – Equipment, appliances and publications to be installed and maintained in a pharmacy (Clause 17) 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 slab 1 Tablet counting tray Publications Poisons and Therapeutic Goods Act 1966, and the 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 1998 The latest editions of, and all published amendments and supplements to, the following publications, or other equivalents approved by the Board: Martindale -The Extra Pharmacopoeia Australian Pharmaceutical Formulary Australian Prescription Products Guide or MIMS Annual or Drugs on Disk Handbook for Patient Medication Counselling PHARMACY (GENERAL) REGULATION 1998 - NOTES Note: The Regulation was repealed by sec 157 (1) (c) of the Pharmacy Practice Act 2006 No 59 with effect from 25.2.2008. PHARMACY (GENERAL) REGULATION 1998 - NOTES Historical notes The following abbreviations are used in the Historical notes: ______________________________________________________________ |______________________________________________________________| |______________________________________________________________| |______________________________________________________________| |______________________________________________________________| |______________________________________________________________| |______________________________________________________________| |______________________________________________________________| Table of amending instrumentsPharmacy (General) Regulation 1998 published in Gazette No 123 of 21.8.1998, p 6237 and amended as follows: Pharmacy (General) Amendment (Exceptions) Regulation 2002 (GG No 253 of 11.12.2002, p 10543) Pharmacy (General) Amendment (Qualifications) Regulation 2004 (GG No 174 of 5.11.2004, p 8354) ______________________________________________________________________ | | |Pharmacy (General) Amendment (Exceptions) Regulation | |2005|(239)|2005. GG No 73 of 17.6.2005, p 2408. | | | | | |______________________________________________________________________| | | |Pharmacy (General) Amendment (Qualifications) Regulation | | |(539)|2005. GG No 111 of 2.9.2005, p 7217. | | | | | |______________________________________________________________________| | | |Pharmacy (General) Amendment (Interstate Qualifications) | |2006|(416)|Regulation 2006. GG No 95 of 28.7.2006, p 5929. | | | | | |______________________________________________________________________| | | |Pharmacy (General) Amendment (Listed Corporation Pecuniary | |2007|(231)|Interests) Regulation 2007. GG No 72 of 1.6.2007, p 3080. | | | | | |______________________________________________________________________| Table of amendments _______________________________________________________________________ |_______________________________________________________________________| |_______________________________________________________________________| |_______________________________________________________________________| |_______________________________________________________________________|