Div 3Registration of pharmacies and depots

Division 3—Registration of pharmacies and depots 40—Registers (1) The General Manager must keep the following registers on behalf of the Authority: (a) a register of pharmacies; (b) a register of pharmacy depots. (2) The register of pharmacies must include, in relation to each premises on the register— (a) the address of the premises; and (b) the full name and nominated contact address of the person who carries on a pharmacy business at the premises; and (c) information prescribed by the regulations, (3) The register of pharmacy depots must include, in relation to each premises on the register— (a) the address of the premises; and (b) information prescribed by the regulations, (4) A person must, within 1 month after ceasing to carry on a pharmacy business at a pharmacy, inform the General Manager in writing of that fact. (5) The General Manager is responsible to the Authority for the form and maintenance of the registers. (6) The General Manager must correct an entry in a register that is not, or has ceased to be, correct. (7) The registers must be kept available for inspection by any person during ordinary office hours at the principal office of the Authority and the registers or extracts from the registers may be made available to the public by electronic means. (8) A person may, on payment of the prescribed fee, obtain a copy of any part of a register under this section. 41—Registration of premises as pharmacy (1) A person must not provide restricted pharmacy services except at premises registered as a pharmacy under this section. (1a) A person must not own, or hold a proprietary interest in, a pharmacy business unless the business is carried on at premises registered as a pharmacy under this section. (2) The registered premises must incorporate areas used for any business carried on in association with the provision of pharmacy services. (3) If, on application made to the Authority for the registration of premises as a pharmacy, the Authority is satisfied that the premises and its location comply with— (a) the requirements of the regulations; and (b) the requirements determined by the Authority to be necessary for the registration of the premises as a pharmacy, the Authority must, subject to subsection (5), register the premises. (4) Registration under this section remains in force until 30 September next ensuing after the grant of registration and may from time to time be renewed for successive periods of 1 year expiring on 30 September. (5) The Authority must not register, or renew the registration of, premises as a pharmacy unless satisfied that members of the public cannot directly access the premises from within the premises of a supermarket. (6) The Authority may refuse to renew the registration of premises as a pharmacy if not satisfied that the premises and its location comply with the requirements of the regulations or the requirements determined by the Authority to be necessary for the registration of the premises as a pharmacy. (7) An application for registration or renewal of registration under this section must— (8) An applicant for registration or renewal of registration must, if the Authority so requires, provide the Authority with specified information to enable the Authority to determine the application. (9) This section does not apply in relation to the dispensing of drugs or medicines by a medical practitioner in the ordinary course of his or her profession. (10) In this section— supermarket has the meaning assigned by the regulations. 42—Restriction on number of pharmacies (1) Friendly Society Medical Association Limited must not provide pharmacy services at more than 40 pharmacies in this State. (2) A person other than a friendly society must not provide pharmacy services at more than 6 pharmacies in this State. (3) A friendly society other than Friendly Society Medical Association Limited must not commence to provide pharmacy services at a pharmacy if friendly societies other than Friendly Society Medical Association Limited already provide pharmacy services at 9 pharmacies in this State or, if another number of pharmacies is prescribed, that number (as recorded on the register of pharmacies). (4) In determining the number of pharmacies at which a natural person provides pharmacy services, pharmacies at which the person provides pharmacy services as a natural person and pharmacies at which any body corporate or trust in which the person occupies a position of authority provides pharmacy services must be taken into account. 43—Supervision of pharmacies by pharmacists (1) A person who carries on a pharmacy business must ensure that a pharmacist is in attendance and available for consultation by members of the public at each pharmacy at which the business is carried on while the pharmacy is open to the public. (1a) Subsection (1) does not to apply to a person who carries on a pharmacy business in circumstances where— (a) the person is authorised by the Authority to operate the pharmacy business without a pharmacist being physically in attendance at the pharmacy; and (b) a pharmacist is, by means of Internet or other electronic communication (other than communication of a kind specified by the Authority), in attendance during any period the pharmacy business is operating and is available for consultation by members of the public. (1b) The Authority may only grant an authorisation under subsection (1a)(a) in respect of a pharmacy if— (a) the pharmacy is located within a prescribed area; and (b) the authorisation is reasonably necessary to ensure that pharmacy services are available to persons who would not otherwise have direct and timely access to such services; and (c) the Authority is satisfied that a pharmacy services provider, who is proposed to provide pharmacy services as part of the operation of the pharmacy business without a pharmacist being physically in attendance at the pharmacy, has taken all reasonable steps to ensure that the provider will comply with a code of conduct applying to the provider under this Act in respect of such operation. (1c) An authorisation granted under subsection (1a)(a) will be subject to the following conditions: (a) any conditions prescribed by the regulations; (b) any conditions imposed by the Authority. (1d) A condition of an authorisation under subsection (1c) may, without limitation— (a) specify a pharmacy service, or pharmacy services of a class, which may not be provided while a pharmacist is not physically in attendance at the pharmacy pursuant to the authorisation; or (b) require the physical attendance of a pharmacist at the pharmacy at specified intervals; or (c) specify staffing requirements (including staff qualifications) for a pharmacy while a pharmacist is not physically in attendance at the pharmacy pursuant to the authorisation; or (d) otherwise limit or restrict the circumstances or manner in which pharmacy services may be provided while a pharmacist is not physically in attendance at the pharmacy pursuant to the authorisation. (1e) The Authority may, by notice in writing to a person holding an authorisation under subsection (1a)(a)— (a) vary or revoke a condition imposed under subsection (1c)(b); or (b) impose a new condition in relation to the authorisation; or (c) revoke the authorisation. (1f) A person must not contravene or fail to comply with a condition applying in relation to an authorisation granted under subsection (1a)(a). (1g) Subsection (1b)(a) does not apply in circumstances determined by the Authority to be circumstances of an emergency. (2) A person is not in breach of subsection (1) on account of a failure to have a pharmacist in attendance in the manner required by that subsection if— (a) restricted pharmacy services or prescribed pharmacy services are not, while a pharmacist is not in attendance, offered to members of the public; and (b) access to those areas of the pharmacy used for the provision of restricted pharmacy services or prescribed pharmacy services is physically prevented; and (c) the person who carries on the pharmacy business at the premises can prove— (i) that the person has taken reasonable steps to consider the interests of members of the public who might be interested in accessing the pharmacy business; and (ii) that any period when a pharmacist would not be in attendance was published in advance in accordance with any requirements prescribed by the regulations; and (iii) that during the period referred to in subparagraph (ii) the staff at the pharmacy had reasonable on‑call access to a pharmacist or a medical practitioner. (3) In addition, it is a defence to an alleged breach of subsection (1) to prove that the pharmacist who would usually be available for the purposes of that subsection was absent due to an exceptional and unforeseen circumstance. emergency includes an event (whether occurring in the State, outside the State or in and outside the State) that causes, or threatens to cause— (a) the death of, or injury or other damage to the health of, any person; or (b) the destruction of, or damage to, any property; or (c) a disruption to essential services or to services usually enjoyed by the community; or (d) harm to the environment, or to flora or fauna; This is not limited to naturally occurring events (such as earthquakes, floods or storms) but would, for example, include fires, explosions, accidents, epidemics, pandemics, emissions of poisons, radiation or other hazardous agents, hijacks, sieges, riots, acts of terrorism and hostilities directed by an enemy against Australia. pharmacist means a person who holds a general registration under the Health Practitioner Regulation National Law to practise in the pharmacy profession. 44—Certain other businesses not to be carried on at pharmacy A person must not, at a pharmacy, carry on a business consisting of or involving— (a) the sale of alcohol or tobacco products; or (b) the sale of animals; or (c) the preparation of food or beverages for sale or consumption; or (d) a prescribed activity. 45—Registration of premises as pharmacy depot (1) A person must not use premises outside Metropolitan Adelaide as a pharmacy depot unless the premises are registered as a pharmacy depot under this section. (2) If, on application made to the Authority for the registration of premises as a pharmacy depot, the Authority is satisfied that— (a) the premises comply with the regulations; and (b) the premises comply with the requirements determined by the Minister to be necessary for the registration of premises as a pharmacy depot, the Authority must register the premises. (3) Registration under this section remains in force until 30 September next ensuing after the grant of registration and may from time to time be renewed for successive periods of 1 year expiring on 30 September. (4) The Authority may refuse to renew the registration of premises as a pharmacy depot if not satisfied that the premises comply with the regulations or the requirements determined by the Authority to be necessary for the registration of the premises as a pharmacy depot. (5) An application for registration or renewal of registration under this section must— (6) An applicant for registration or renewal of registration must, if the Authority so requires, provide the Authority with specified information to enable the Authority to determine the application. 46—Conditions (1) The registration of a pharmacy or pharmacy depot under this Division will be subject to any condition— (a) imposed by the Authority in relation to the registration; or (b) prescribed by the regulations. (2) The Authority may, if the Authority considers it appropriate to do so, by notice in writing to the person holding the registration, vary a condition to which a registration is subject. (3) A person who holds a registration may, on application to the Authority in writing, request the variation of a condition to which the registration is subject and the Authority may, as the Authority thinks fit— (a) grant the variation; or (b) refuse to grant the variation. (4) The condition of a registration may be varied by the addition, substitution or deletion of 1 or more conditions. (5) A person must not contravene or fail to comply with a condition of a registration. (6) A condition of the registration of a pharmacy that is inconsistent with section 43(1a) will, to the extent of the inconsistency, be taken to be modified to give effect to that section. 47—Notices (1) An authorised officer may issue a notice under this section for the purpose of securing compliance with— (a) a condition of a registration under this Division; or (b) a requirement imposed in relation to registration under this Division. (2) A notice under this section— (a) must be in the form of a written notice served on the person to whom it is issued; and (b) must specify the person to whom it is issued (whether by name or by a description sufficient to identify the person); and (c) must state the purpose for which the notice is issued and give notice of the condition or requirement to which it relates; and (d) may impose any requirement reasonably required for the purpose for which the notice is issued including 1 or more of the following: (i) a requirement that the person discontinue a specified activity until further notice from an authorised officer or the General Manager; (ii) a requirement that the person not carry on a specified activity except subject to specified conditions; (iii) a requirement that the person comply with a specified requirement under this Act; (iv) a requirement that the person furnish to the General Manager specified reports; and (e) must state that the person may, within 28 days, seek a review by the Tribunal under section 34 of the South Australian Civil and Administrative Tribunal Act 2013 of the decision to issue the notice. (3) An authorised officer may, by written notice served on a person to whom a notice under this section has been issued, vary or revoke the notice. (4) A person to whom a notice is issued under this section must not, without reasonable excuse, fail to comply with the notice. Maximum penalty: $10 000. (5) A person must not hinder or obstruct a person complying with a notice under this section. Maximum penalty: $10 000. (6) Without limiting subsection (4), if a person to whom a notice is issued under this section fails to comply with the notice, the General Manager may, after due inquiry, suspend or cancel the registration of premises as a pharmacy or pharmacy depot (as the case may be) under this Division. 48—Reviewable decisions (1) The following are reviewable decisions for the purposes of this Division: (a) a refusal by the Authority to register, or renew the registration of, premises as a pharmacy or pharmacy depot under this Division; (b) a decision by an authorised officer to issue a notice under section 47; (c) a decision by the Authority to suspend or cancel the registration of premises as a pharmacy or pharmacy depot under this Division. (2) A person may apply to the Tribunal under section 34 of the South Australian Civil and Administrative Tribunal Act 2013 for a review of a reviewable decision. (3) An application for review must be made to the Tribunal within 28 days after the making of the relevant decision (or such longer period as the Tribunal may allow).