Poisons Regulations 2002
I, the Governor in and over the State of Tasmania and its Dependencies in the Commonwealth of Australia, acting with the advice of the Executive Council, make the following regulations under the Poisons Act 1971 .16 December 2002
G. S. M. GREEN
Governor
By His Excellency’s Command,
D. E. LLEWELLYN
Minister for Health and Human Services
PART 1Preliminary1Short titleThese regulations may be cited as the Poisons Regulations 2002 . 2CommencementThese regulations take effect on 1 January 2003. 3Interpretation (1) In these regulations, unless the contrary intention appears – Act means the Poisons Act 1971 ; ambulance officer means a person who is – (a) an officer of the ambulance service appointed or employed under section 14(2) of the Ambulance Service Act 1982 ; or (b) an honorary ambulance officer appointed under section 16 of the Ambulance Service Act 1982 ; Ambulance Service means the Tasmanian Ambulance Service established under the Ambulance Service Act 1982 ; approved firstaid kit means a firstaid kit kept in accordance with approval granted under regulation 95 ; approved name, in relation to a poison, restricted substance or narcotic substance means the name for that poison, restricted substance or narcotic substance determined in a manner approved by the Minister; approved recording system means a system or method approved by the Pharmacy Board of Tasmania for the keeping of records of prescriptions; authorised nurse means a nurse who holds a nurse’s authority granted under regulation 30 ; authorised officer, in relation to a medical institution, means – (a) a pharmaceutical chemist employed as such in that institution or, where more than one pharmaceutical chemist is employed, the chief pharmaceutical chemist; or (b) where no pharmaceutical chemist is employed in that institution, the medical practitioner in charge of that institution; or (c) where no pharmaceutical chemist is employed in that institution and there is no medical practitioner in charge thereof, the registered nurse in charge of that institution; authorised optometrist means a person who is authorised under Division 3A of Part 3 of the Optometrists Registration Act 1994 to prescribe a restricted substance; Board means the Pharmacy Board of Tasmania; chemist means – (a) a pharmaceutical chemist; or (b) a manufacturing chemist or wholesale chemist licensed under section 16 of the Act; Commonwealth Department means the Department of State of the Commonwealth responsible for the administration of the Therapeutic Goods Act 1989 of the Commonwealth or of such Act that from time to time has effect in substitution for that Act; day book means any continuous written record kept by a medical practitioner indicating the medicines or narcotic substances supplied to patients; declared restricted substance means a restricted substance that, in accordance with an order in force under section 36 of the Act, is a substance to which that section applies; dental therapist means a person who is registered as a dental therapist under the Dental Practitioners Registration Act 2001 ; dentist means a person who is registered as a dentist under the Dental Practitioners Registration Act 2001 ; detainee means a person who is being lawfully detained in a detention centre; detention centre means a detention centre established under section 123 of the Youth Justice Act 1997 ; Director of Ambulance Services means the Director of Ambulance Services holding office under the Ambulance Service Act 1982 ; dispensary means the room or area, within a pharmacy or other premises, that a pharmaceutical chemist uses for the dispensing or preparation of prescriptions, medicines or drugs; drug means a poison intended for human therapeutic use or animal therapeutic use; drug therapy chart means a document prepared by a medical practitioner or dentist authorising the administration of a scheduled substance to a person; enrolled nurse means a person enrolled under the Nursing Act 1995 ; health professional means – (a) a dentist; and (b) a medical practitioner; and (c) a pharmaceutical chemist; and (d) a registered nurse; and (e) a veterinary surgeon; immediate wrapper means – (a) any material used as the first wrapper for a single tablet, pastille, capsule or product unit; or (b) strip packaging when used in connection with some form of primary pack; internal use, in respect of a substance, means administration orally, parenterally or by way of a body orifice but does not include the administration of topical preparations for use in the nose, eyes, ears, mouth or throat or douches for rectal, vaginal or urethral use; medical institution means an institution the sole or main object, or one of the main objects, of which is, or is held out to be, the provision of accommodation (whether with or without medical or other treatment) for – (a) persons suffering from any illness, injury, infirmity or mental disorder; or (b) pregnant women or women immediately after childbirth; or (c) persons who are substantially and permanently handicapped by illness, injury or congenital deformity, or by any other disability; or (d) persons who are aged; narcotic substance includes an exempted narcotic substance; optometrist means a person who is registered as an optometrist under the Optometrists Registration Act 1994 ; patient means, when used in relation to a medical practitioner, dentist, podiatrist, dental therapist, registered nurse, optometrist or enrolled nurse, a person upon whom that medical practitioner, dentist, podiatrist, dental therapist, registered nurse, optometrist or enrolled nurse attends in the exercise of his or her practice, profession or calling as such; pharmacy means a shop or other place, or a part of a shop or other place, in which a person practises as a pharmacist; podiatrist means a person who is registered as a podiatrist under the Podiatrists Registration Act 1995 ; primary pack means the package, other than any wrapping, bag, carton or similar article, in which any poison or restricted substance is placed for the purposes of delivery to a person after sale; Registrar of Chemical Products means the Registrar of Chemical Products appointed under the Agricultural and Veterinary Chemicals (Control of Use) Act 1995 ; selected container means – (a) a single use syringe; or (b) any other container having a capacity not exceeding 10 millilitres; specified potent substance means a substance that, in accordance with regulation 49 , is a specified potent substance for the purposes of Division 3 of Part 4 ; specified psychotropic substance means a restricted substance that, in accordance with regulation 45 , is a specified psychotropic substance for the purposes of section 38(1)(b) of the Act; trainee pharmacist means a person who is undertaking an approved registration program for the purposes of Part 2 of the Pharmacists Registration Act 2001 ; Uniform Standard means the Standard for the Uniform Scheduling of Drugs and Poisons published by the Commonwealth under the Therapeutic Goods Act 1989 of the Commonwealth, as amended from time to time. (2) In these regulations, a reference to a form followed by a number is, unless otherwise indicated, a reference to the form of that number set out in Schedule 1 . (3) A reference in these regulations to a substance includes, unless specifically exempted – (a) the substance prepared from natural sources or artificially; and (b) if the substance is a plant, other than a plant included in Schedule 8 to the Poisons List or a prohibited plant, that plant or any part of it when packed or prepared for therapeutic use; and (c) any salt, active principle or derivative of the substance, including esters and ethers, and any salt of the active principle or derivative; and (d) any alkaloid of the substance and any salt of the alkaloid; and (e) any stereo-isomer of the substance and any salt of the stereo-isomer, except if the substance is levomethorphan or levorphanol; and (f) any preparation or admixture containing any proportion of the substance or of any other substance included in paragraph (a) , (b) , (c) , (d) or (e) . (4) If a poison is present in a substance or preparation as a salt, active principle or derivative, any concentration, strength or quantity in respect of that substance or preparation is to be calculated as the concentration, strength or quantity of the poison in the form in which it is named in the Poisons List. (5) A reference in these regulations to a substance by name followed, in parentheses, by a capital letter "S" and a number is a reference to that substance when included in the correspondingly numbered Schedule to the Poisons List. 4Preparations containing substances listed in two or more Schedules to Poisons List (1) Subject to subregulation (2) , where a preparation contains 2 or more scheduled substances, that preparation, unless the contrary intention appears, is to be taken to be included in each of the Schedules to the Poisons List in which those substances are included. (2) Where, in relation to a preparation referred to in subregulation (1) , it is not possible to comply both with a requirement of the Act applicable to that preparation by reason of its inclusion in one Schedule to the Poisons List and with such a requirement applicable to it by reason of its inclusion in another such Schedule, the preparation, unless the contrary intention appears, is to be taken for the purposes of the Act to be included in the more restrictive of those Schedules. (3) For the purposes of subregulation (2) , the comparative restrictiveness of the Schedules to the Poisons List, in descending order, is 8, 4, 7, 1, 3, 2, 6, 5. PART 2Administration5Manufacturing chemists and wholesale chemists (1) An application for a licence to carry on business as a – (a) manufacturing chemist or to make, refine or prepare a narcotic substance is to be made by a qualified person and accompanied by the relevant fee specified in item 1 of Schedule 9 ; and (b) wholesale chemist is to be and accompanied by the relevant fee specified in item 2 of Schedule 9 . (2) A licence – (a) to carry on business referred to in subregulation (1)(a) is to be in accordance with Form 1; and (b) to carry on business referred to in subregulation (1)(b) is to be in accordance with Form 2. (3) For the purposes of – (a) section 16(2)(a) of the Act, Form 1 is prescribed; and (b) section 16(3)(a) of the Act, Form 2 is prescribed. (4) In subregulation (1)(a) , qualified person means – (a) a medical practitioner, pharmaceutical chemist, dentist or veterinary surgeon; or (b) a person who holds a degree or diploma approved by the Minister; or (c) a person approved by the Secretary; or (d) a person who is, or is eligible to be – (i) a Fellow or Associate of the Royal Australian Chemical Institute; or (ii) a Fellow, Associate or Licentiate of the Royal Institute of Chemistry; or (e) where the carrying out of a process involving a prohibited plant is only preparatory to the use of that plant for the manufacture of a narcotic substance, a person approved by the Minister. 6Granting of permits by Minister (1) The Minister may, on the application of a person and on payment of the fee (if any) specified in Schedule 9 , grant a permit under this regulation. (2) A permit under subregulation (1) authorises the person to whom it is issued to purchase from a licensed manufacturing chemist or a licensed wholesale chemist any of the substances specified in Schedule 1 , 2 , 3 or 4 to the Poisons List in such quantities and on such conditions, limitations and restrictions as the Minister may determine and as may be specified in the permit for use by the person for industrial, educational, advisory or research purposes. (3) A permit issued under subregulation (1) remains in force until it is cancelled, suspended or revoked by the Minister. PART 3Narcotic substances and prohibited plantsDivision 1Licences in respect of narcotic substances and prohibited plants7Licences to manufacture, &c., narcotic substances for scientific purposes (1) The Minister may, on the application of a person – (a) who is in charge of a laboratory for the purpose of research or instruction; or (b) who is an analyst appointed under section 19 of the Act –grant a licence authorising that person – (c) to manufacture, use or possess any narcotic substance specified in the licence for such purpose as is specified in the licence; or (d) to purchase that narcotic substance by an order written in ink from a pharmaceutical chemist, a licensed manufacturing chemist, a licensed wholesale chemist or such other person as may be specified in the licence. (2) The holder of a licence issued under subregulation (1) is to keep a record written in ink in the form and manner approved by the Secretary showing – (a) the amount of narcotic substance acquired for use under the licence; and (b) the date on which, and the source from which, the narcotic substance was acquired; and (c) the purpose for which, the amount of, and the date on which, the narcotic substance was used. 8FeesThe annual fees specified in Schedule 9 are prescribed as the annual fees that are payable in respect of the several matters to which they respectively relate. Division 2Possession of narcotic substances9Possession of narcotic substances for purposes of profession, &c.In addition to the persons authorised by section 48 of the Act to possess narcotic substances, a person who is – (a) an authorised officer of a medical institution; or (b) a registered nurse in charge of a ward in a medical institution; or (c) an authorised nurse; or (d) an ambulance officer – may possess and use any narcotic substances for the purposes of his or her profession or employment. Division 3Supply of narcotic substances10Inquiries, &c., before supplying narcotic substance to patient (1) A medical practitioner, dentist or an authorised nurse must not supply, or write or issue a prescription for the supply of, a narcotic substance to a person unless the medical practitioner, dentist or authorised nurse has taken such steps as are reasonably open to him or her to ascertain – (a) the nature and amount of any narcotic substances supplied to that person within the previous 2 months; and (b) the circumstances in which those narcotic substances were so supplied. Penalty: Fine not exceeding 10 penalty units.
(2) A person who obtains from, or as a result of a prescription written or issued by, a medical practitioner or dentist a narcotic substance by failing, before or at the material time, to notify the medical practitioner or dentist the name and the place of practice of a medical practitioner or dentist by whom within a period of 2 months before the material time a narcotic substance was supplied to the person or a prescription for a narcotic substance was written or issued in respect of the person is guilty of an offence.Penalty: Fine not exceeding 10 penalty units.
(3) Subregulations (1) and (2) do not apply to the supply of a narcotic substance to a medical practitioner, dentist, licensed wholesale chemist, licensed manufacturing chemist or pharmaceutical chemist, otherwise than for the purpose of its administration to the person to whom it is supplied. (4) In this regulation, material time, when used in relation to the obtaining of – (a) a narcotic substance from a medical practitioner, veterinary surgeon, dentist or authorised nurse, means the time at which that substance was obtained; or (b) a narcotic substance as a result of a prescription written or issued by a medical practitioner or dentist, means the time at which that prescription was written or issued; or (c) a prescription for a narcotic substance from a medical practitioner, veterinary surgeon or dentist, means the time at which the prescription was obtained. 11Supply of narcotic substances (1) A person must not supply a narcotic substance to a person who is not authorised by the Act or these regulations to have possession of that narcotic substance.Penalty: Fine not exceeding 10 penalty units.
(2) Except as otherwise provided in these regulations, a pharmaceutical chemist must not supply a narcotic substance to a person who is not a medical practitioner, veterinary surgeon, dentist, licensed manufacturing chemist, licensed wholesale chemist or pharmaceutical chemist, except on a prescription issued by a medical practitioner, veterinary surgeon or dentist.Penalty: Fine not exceeding 10 penalty units.
(3) Except as otherwise provided in these regulations, a licensed manufacturing chemist or licensed wholesale chemist must not supply, or cause or permit to be supplied, a narcotic substance to a person who is not a medical practitioner, veterinary surgeon, dentist or pharmaceutical chemist.Penalty: Fine not exceeding 10 penalty units.
(4) A medical practitioner, dentist or authorised nurse must not supply a narcotic substance to a person except for the purpose of its administration to a patient.Penalty: Fine not exceeding 10 penalty units.
(5) A veterinary surgeon must not supply a narcotic substance to a person except for the purpose of its administration to an animal.Penalty: Fine not exceeding 10 penalty units.
(6) Nothing in subregulation (4) or (5) prohibits a medical practitioner, veterinary surgeon, dentist or authorised nurse from supplying a narcotic substance to a medical practitioner, veterinary surgeon, dentist, licensed wholesale chemist, licensed manufacturing chemist or pharmaceutical chemist. (7) Where a person supplies a narcotic substance on a written order, the person must – (a) write clearly in ink on the order the word "Cancelled"; and (b) retain that order in a file kept for the purpose for a period of 2 years from the date on which the narcotic substance was supplied. Penalty: Fine not exceeding 10 penalty units.
(8) This regulation does not apply to a narcotic substance that is kept or used in a prescribed institution within the meaning of section 48 of the Act for the purposes of that institution or to a narcotic substance which is kept or used under a licence granted under regulation 7 . (9) Nothing in this regulation prohibits the administration to a person, in the case of an emergency, of a narcotic substance kept in any aircraft, ambulance or vessel where – (a) the services of a medical practitioner are not readily available; or (b) it is not practicable to obtain the narcotic substance from any other source. (10) Nothing in this regulation prohibits a pharmaceutical chemist, licensed wholesale chemist or licensed manufacturing chemist from supplying any narcotic substance to – (a) an authorised officer in a medical institution for the use of the narcotic substance for the purpose of that institution; or (b) a person holding a licence under regulation 7 ; or (c) an authorised nurse; or (d) a person holding the Secretary’s written authority for use in respect of an ambulance service; or (e) a person controlling an approved firstaid kit; or (f) the master of a vessel for the purpose of providing medical treatment to passengers or crew of that vessel. 12Conveyance of narcotic substancesA person may possess a narcotic substance for the purpose of conveying it to any person or place if – (a) the narcotic substance is contained in a sealed package or container; and (b) the person is acting – (i) in the course of the person’s business or employment to carry, convey or deliver articles or containers of a similar nature; or (ii) under the directions of a person authorised by the Act to have possession of that narcotic substance. Division 4Records and returns as to narcotic substances13Narcotic substances register to be kept by certain persons (1) The following people must keep a narcotic substances register in accordance with this regulation: (a) a medical practitioner; (b) a veterinary surgeon; (c) a dentist; (d) a pharmaceutical chemist; (e) a licensed manufacturing chemist; (f) a licensed wholesale chemist; (g) an authorised officer; (h) an authorised nurse. Penalty: Fine not exceeding 10 penalty units.
(2) A separate narcotic substances register is to be kept in respect of each type or kind of narcotic substance or any preparation of a narcotic substance. (3) A pharmaceutical chemist must keep a separate narcotic substances register in respect of each of the premises in which he or she carries on business as a pharmaceutical chemist. (4) Where a medical practitioner, veterinary surgeon or dentist carries on practice at 2 or more premises, he or she must keep a separate narcotic substances register in respect of each of those premises. (5) A narcotic substances register must be in the form set out in Part 1 of Schedule 2 and must be kept in accordance with the rules contained in Part 2 of that Schedule. (6) Notwithstanding subregulation (5) , a person referred to in subregulation (1) may use a narcotic substances register other than the register referred to in subregulation (5) if the other narcotic substances register – (a) is in a form approved by the Secretary; and (b) is kept in such manner as the Secretary may direct. (7) Each entry, marking, number or note made in a narcotic substances register is to be made in ink. (8) No alteration, obliteration or cancellation may be made in any narcotic substances register, but any mistake in any entry in the register may be corrected by a marginal note or footnote and the correction initialled and dated. (9) A person must not make any entry in a narcotic substances register if the person knows the entry to be false or misleading.Penalty: Fine not exceeding 10 penalty units.
(10) Each entry in a narcotic substances register is to be made as soon as practicable after the occurrence of the event to which it relates and, in any event, not later than 48 hours after the occurrence of that event. (11) Notwithstanding anything in this regulation, where a medical practitioner, other than a dispensing medical practitioner, who supplies a narcotic substance to a patient, keeps a day book, it is sufficient compliance with the provisions of this regulation if an entry containing all particulars with respect to the supply of that narcotic substance to the patient, which apart from this subregulation would be required to be made in the narcotic substances register, were made in the day book. (12) Where the Secretary requests by a notice in writing any person required by these regulations to keep a narcotic substances register to furnish to the Secretary any information relating to the keeping of the register, that person must as soon as practicable comply with the request. (13) Nothing in these regulations requires a person who is required to keep a narcotic substances register to make any entry with respect to a narcotic substance supplied to the person by a medical practitioner, veterinary surgeon, dentist or authorised nurse if the narcotic substance is for the person’s personal use. 14Retaining of records (1) A person licensed or authorised under these regulations to manufacture, sell or supply any narcotic substance must keep every record, prescription, invoice and other document relating to any transaction involving any narcotic substance for not less than 2 years from the latest date on which such record, prescription, invoice, order or document was made or acted upon.Penalty: Fine not exceeding 10 penalty units.
(2) On demand by an inspector – (a) the holder of any licence to manufacture, sell or supply any narcotic substance; or (b) any person authorised by regulation 9 to possess and use a narcotic substance – must furnish particulars of the quantity of any narcotic substance obtained and the amount disposed of or on hand.Penalty: Fine not exceeding 10 penalty units.
Division 5Prescriptions for narcotic substances15Prescribing and supply of narcotic substances (1) A person, other than a medical practitioner, veterinary surgeon or dentist, must not write or issue a prescription for a narcotic substance.Penalty: Fine not exceeding 10 penalty units.
(2) A medical practitioner, veterinary surgeon or dentist, subject to this regulation, is authorised to write or issue a prescription for a narcotic substance. (3) A person must not write or issue a prescription for the purpose of procuring a narcotic substance for administration to himself or herself.Penalty: Fine not exceeding 10 penalty units.
(4) A person must not write or issue a prescription for a narcotic substance unless the prescription bears (otherwise than in handwriting) the name of the person writing or issuing the prescription and the address of the person’s place of residence or of the place at which the person carries on practice.Penalty: Fine not exceeding 10 penalty units.
(5) Subregulation (4) does not apply in the case of an emergency when the means of complying with that subregulation are not readily available to the person writing or issuing the prescription. (6) Where a medical practitioner, veterinary surgeon or dentist writes or issues a prescription for a narcotic substance he or she must comply with the following conditions: (a) he or she is to legibly write the prescription in ink and, in his or her own handwriting, is to record on the prescription – (i) the date on which it is written; and (ii) the name, including initials and address, of the patient or, in the case of an animal, the name and address of the owner; and (iii) the name of the narcotic substance and quantity to be dispensed; and (iv) subject to subregulation (8) , the number of times that the dispensing of the prescription may be repeated and the interval between each dispensing of the prescription; and (v) adequate directions for use – and sign the prescription with his or her usual signature; (b) he or she is not to include on that prescription a preparation other than the preparation which is or includes the narcotic substance; (c) if a medical practitioner, he or she is not to write or issue a prescription for the supply of a narcotic substance for any purpose other than in the course of medical treatment; (d) if a veterinary surgeon, he or she is not to write or issue a prescription for the supply of a narcotic substance for any purpose other than in the course of animal treatment and is to endorse on a prescription which he or she issues the words "For animal treatment only"; (e) if a dentist, he or she is not to write or issue a prescription for the supply of a narcotic substance for any purpose other than in the course of dental treatment; (f) where the prescription contains an unusual dose, the medical practitioner, veterinary surgeon or dentist by whom it is written or issued is to underline the relevant part of the prescription and place his or her usual signature or initials in ink alongside the underlining. Penalty: Fine not exceeding 10 penalty units.
(7) Notwithstanding subregulation (6)(a)(ii) , a medical practitioner, veterinary surgeon or dentist may use a printed label in a prescription to identify the patient or owner of the animal, if that label is initialled by the medical practitioner, veterinary surgeon or dentist. (8) A dentist must not write or issue a prescription for a narcotic substance that may be dispensed on more than one occasion.Penalty: Fine not exceeding 10 penalty units.
(9) A person must not write or issue a prescription for a narcotic substance which, or any part of which, is in a code or cipher.Penalty: Fine not exceeding 10 penalty units.
(10) A veterinary surgeon must not prescribe or supply any of the narcotic substances specified in regulation 18(1) otherwise than in accordance with an authorisation under subregulation (11) .Penalty: Fine not exceeding 10 penalty units.
(11) The Secretary may, either generally or in a particular case, authorise a veterinary surgeon to prescribe or supply methylphenidate for veterinary purposes. (12) An authorisation under subregulation (11) – (a) is to be in writing signed by the Secretary; and (b) in the case of a general authorisation, is to require that, within 24 hours of each occasion on which the veterinary surgeon prescribes or supplies methylphenidate, the veterinary surgeon send to the Secretary notice in writing specifying – (i) the name and address of the owner of the animal for the treatment of which the prescription was given or the methylphenidate was supplied; and (ii) the amount of methylphenidate prescribed or supplied; and (iii) the date of the prescription or supply; and (c) may specify such other conditions to which it is subject as the Secretary thinks fit; and (d) may, at any time, be revoked or amended by the Secretary by notice in writing given to the veterinary surgeon. (13) A dentist must not prescribe for, or supply to, a person any of the narcotic substances specified in regulation 18(1) .Penalty: Fine not exceeding 10 penalty units.
16Record of prescribing and supply of narcotic substances (1) As soon as practicable after a medical practitioner, dentist or veterinary surgeon issues a prescription for, or supplies, a narcotic substance, he or she must make a record, in a form approved by the Secretary, setting out – (a) the name and address of the person for the treatment of whom, or of the owner of the animal for the treatment of which, the narcotic substance was prescribed or supplied; and (b) the date on which the prescription was issued or the narcotic substance was supplied, as the case requires; and (c) particulars of the narcotic substance sufficient to identify it and to indicate in what quantity and strength it was prescribed or supplied; and (d) particulars of the directions set out in the prescription, or provided with the narcotic substance, for the use of the narcotic substance; and (e) where the record relates to the issue of a prescription, particulars of any provision made in the prescription with respect to the number of occasions on which, and the minimum intervals at which, the dispensing of the prescription was authorised to be repeated. Penalty: Fine not exceeding 10 penalty units.
(2) A medical practitioner, dentist or veterinary surgeon must retain a record made under subregulation (1) for not less than 2 years.Penalty: Fine not exceeding 10 penalty units.
17Emergency prescribing and dispensing of narcotic substances (1) Notwithstanding regulation 11(2) , a pharmaceutical chemist may supply a narcotic substance on the instruction of a medical practitioner, veterinary surgeon or dentist if, because of the urgent circumstances in which the substance is required, it is impracticable, before the substance is required to be supplied, to – (a) issue a prescription for the substance; and (b) cause the prescription to be delivered to the chemist. (2) A medical practitioner, veterinary surgeon or dentist who issues an instruction under subregulation (1) to a pharmaceutical chemist must send to that chemist, within 24 hours of issuing the instruction, a prescription that – (a) complies with regulation 15(6) ; and (b) clearly states that it is in confirmation of the instruction to that chemist to supply the narcotic substance without a prescription. 18Prescription for certain narcotic substances to be issued only on authority of Secretary (1) A medical practitioner must not, without the authority of the Secretary, issue a prescription for, or supply to a patient, the following narcotic substances, namely: (a) amphetamine; (b) dexamphetamine; (c) dextromoramide; (d) fentanyl in patches for transdermal delivery, except in the case of a patient with cancer; (e) methylamphetamine; (f) methylphenidate; (g) phenmetrazine. Penalty: Fine not exceeding 10 penalty units.
(2) An application for an authority to issue a prescription for a narcotic substance referred to in subregulation (1) , or to supply to a patient a narcotic substance referred to in that subregulation – (a) is to be in a form determined by the Secretary; and (b) is to be signed by the medical practitioner by whom it is made; and (c) is to – (i) specify the patient in respect of whom it is made; and (ii) state whether, in the opinion of the medical practitioner, the patient is suffering from drug dependency; and (d) where in the opinion of the medical practitioner the patient in respect of whom the application is made is suffering from drug dependency, is to be accompanied by a notification under section 18 of the Alcohol and Drug Dependency Act 1968 ; and (e) is to be enclosed in a sealed envelope marked "Confidential" and lodged with, or forwarded by certified mail to, the Secretary. (3) An authority under this regulation is to be in writing and signed by the Secretary unless, in the case of emergency, it is given orally. (4) An authority that is given orally is to be confirmed in writing by the Secretary as soon as practicable after it is given. (5) An authority under this regulation is to specify the type and quantity of the narcotic substance that may – (a) be included in a prescription issued; or (b) be supplied to a patient – in accordance with the terms of the authority by the medical practitioner to whom the authority relates. (6) An authority under this regulation authorises the medical practitioner to whom the authority is given or some other medical practitioner authorised by him or her in writing – (a) to issue a prescription for a narcotic substance referred to in subregulation (1) for the use of the patient to whom the prescription relates; or (b) to supply to a patient a narcotic substance referred to in that subregulation for the use of that patient – in accordance with the terms of the authority. (7) In this regulation, drug dependency has the meaning assigned to that expression by section 4 of the Alcohol and Drug Dependency Act 1968 . 19Supply of certain narcotic substances without prior authority of Secretary (1) Notwithstanding the provisions of regulation 18 , the Secretary may issue a general authorisation to a medical practitioner to supply to a patient a narcotic substance referred to in regulation 18(1) without seeking the prior approval of the Secretary. (2) A general authorisation under this regulation is to – (a) be in writing and be signed by the Secretary; and (b) state the purposes for which the narcotic substance may be used; and (c) require that, within 7 days of a narcotic substance referred to in regulation 18(1) being supplied to a patient, the medical practitioner advise the Secretary in writing of – (i) the name and address of the patient supplied; and (ii) the name and amount of the narcotic substance supplied; and (iii) the date of the supply. (3) The Secretary may at any time in writing revoke or amend a general authorisation issued under this regulation. 20Registered nurse may possess and administer narcotic substanceA registered nurse may possess and administer to a person a narcotic substance without instructions from a doctor if – (a) the nurse is attending an emergency in a remote area and the person requires urgent treatment with medication; and (b) it is not practicable to obtain instructions from a doctor; and (c) the nurse has – (i) undergone an educational program approved by the Nursing Board of Tasmania; and (ii) has been authorised by that Board; and (d) the nurse follows appropriate procedures approved by the Secretary. 21Minister’s authorisation for possession and supply of narcotic substanceThe Minister may make an authorisation under section 25A of the Act in respect of a narcotic substance, or a class of narcotic substances, in the following circumstances: (a) where the registered nurse in respect of whom the authorisation is made is employed in a palliative care service approved by the Secretary; (b) where the registered nurse is employed in a community health centre approved by the Secretary at which it is impractical for a medical practitioner to attend and the nurse is acting in accordance with the instructions of a medical practitioner. Division 6Dispensing of narcotic substances22Dispensing of narcotic substances (S8) (1) A person must not dispense a narcotic substance except under regulation 17 or in accordance with a prescription written and issued in accordance with regulation 15 .Penalty: Fine not exceeding 10 penalty units.
(2) If a prescription for a narcotic substance directs that the substance be dispensed more than once – (a) the person responsible for dispensing the substance is to retain the prescription at the place at which the substance is dispensed; and (b) any subsequent dispensing of the substance is to be from the same place as the original dispensing. (3) Subregulation (2) does not apply if a person approved by the Secretary authorises the prescription to be transferred to another pharmacy. (4) An authorisation may be – (a) oral or written; and (b) subject to conditions. (5) Where a prescription for a narcotic substance directs that substance to be dispensed more than once, but does not specify the minimum intervals at which that prescription may be dispensed – (a) a person may dispense that prescription if – (i) the prescription conforms in all other respects with regulation 15(6) ; and (ii) that person ascertains, in accordance with subregulation (6) , the earliest date on which the dispensing of the prescription may be repeated; and (iii) on dispensing the prescription that person clearly and indelibly marks on it, over his or her signature and the date, a note specifying both the date so ascertained and how it was ascertained; and (b) a person who is unable to ascertain, in accordance with subregulation (6) , the earliest date on which the dispensing of the prescription may be repeated may dispense that prescription not more than once if – (i) the prescription conforms in all other respects with regulation 15(6) ; and (ii) on dispensing the prescription that person clearly and indelibly marks the word "cancelled" on the prescription. (6) The date referred to in subregulation (5)(a)(ii) is to be ascertained by reference to either, or both, of the following: (a) any specific directions incorporating a dosage rate that are included in the prescription for the use of that narcotic substance by the patient; (b) information obtained directly from the prescriber as to the minimum intervals at which that narcotic substance should be dispensed to the patient. (7) If the date referred to in subregulation (5)(a)(ii) is ascertained by reference only to the information referred to in paragraph (a) of subregulation (6) , that date is to be a date not earlier than 4 days before the day on which the quantity of the narcotic substance being dispensed would be exhausted if it is used strictly in accordance with the directions referred to in that paragraph. (8) A person must not dispense a prescription for a narcotic substance unless – (a) the person is a medical practitioner or registered pharmaceutical chemist; or (b) the person dispenses the prescription under the supervision of a medical practitioner or registered pharmaceutical chemist. Penalty: Fine not exceeding 10 penalty units.
(9) A person must not cause or permit a person to dispense a prescription contrary to subregulation (1) or (8) .Penalty: Fine not exceeding 10 penalty units.
(10) In a proceeding for an offence committed or alleged to have been committed under subregulation (1) , it is a defence to show that the defendant believed, on reasonable grounds, that the prescription was written and issued in accordance with regulation 15 . (11) Nothing in subregulation (8) prevents the dispensing of a prescription for a narcotic substance by or under the supervision of a veterinary surgeon, if the narcotic substance is intended for administration to an animal. (12) A person must not dispense, or cause or allow to be dispensed, a prescription for a narcotic substance if the person knows, or has reason to believe, or if it appears from the markings made on the prescription, that the prescription has already been dispensed, unless the prescription has been issued by a medical practitioner who has indicated on the prescription in accordance with regulation 15 that the prescription may be dispensed more times than once.Penalty: Fine not exceeding 10 penalty units.
(13) Without prejudice to the foregoing provisions of this regulation, a person must not dispense, or cause or allow to be dispensed, a prescription for a narcotic substance on which it is indicated that that prescription may be dispensed more times than once, if the person knows, or has reason to believe, or if it appears from the markings on the prescription, that the prescription has already been dispensed the number of times indicated on the prescription.Penalty: Fine not exceeding 10 penalty units.
(14) The person by whom a narcotic substance is dispensed on a prescription and, if in so dispensing that narcotic substance that person is acting in the employment of some other person, that other person must ensure that, before the narcotic substance so dispensed is supplied to any person, there is clearly marked in ink on the prescription – (a) the date on which it is dispensed; and (b) the signature of the medical practitioner, veterinary surgeon, dental practitioner or pharmaceutical chemist by whom it is dispensed; and (c) the address of that person’s residence or place of business, or the name and address of the residence or place of business of the person in whose employment that person was acting when that person dispensed the prescription; and (d) the word "cancelled", unless – (i) the medical practitioner or veterinary surgeon by whom the prescription was issued has indicated on the prescription in accordance with regulation 15(6)(a)(iv) that the prescription may be dispensed on more than one occasion; and (ii) it appears from the prescription and the markings made on it that the prescription may be dispensed on a further occasion. Penalty: Fine not exceeding 10 penalty units.
(15) A person must not dispense a narcotic substance under a prescription which – (a) is illegible or defaced; or (b) is marked "cancelled"; or (c) appears to have been altered; or (d) appears to be fraudulent in any respect or forged. Penalty: Fine not exceeding 10 penalty units.
(16) A person to whom a prescription referred to in subregulation (15) is presented must – (a) retain the prescription notwithstanding that the prescription is not dispensed; and (b) as soon as practicable, inform the Secretary or a police officer of the relevant circumstances and the person’s reasons for not dispensing the prescription. Penalty: Fine not exceeding 10 penalty units.
(17) A person must not dispense a narcotic substance under a prescription which is presented more than 6 months after the date on which the prescription was issued.Penalty: Fine not exceeding 10 penalty units.
(18) A medical practitioner, veterinary surgeon, dentist or registered pharmaceutical chemist who, in the course of the practice or business carried on by him or her as such, dispenses, or causes or permits to be dispensed, a prescription that is required by this regulation to be marked with the word "cancelled", must keep that prescription in a file kept for that purpose for 2 years from the date on which it is dispensed.Penalty: Fine not exceeding 10 penalty units.
(19) Where a prescription is dispensed by or under the supervision of a medical practitioner, veterinary surgeon or dentist, he or she must mark, or cause to be marked, in ink on the package or container in which the narcotic substance is supplied – (a) a reference to the entry in the narcotic substances register, if an entry is made in the narcotic substances register; or (b) a reference to the entry in the day book, if an entry is made in the day book – in respect of the supply of that narcotic substance on that prescription.Penalty: Fine not exceeding 10 penalty units.
(20) A registered pharmaceutical chemist who, in the course of the business of a pharmaceutical chemist carried on by the pharmaceutical chemist, dispenses, or causes or permits to be dispensed, a prescription for a narcotic substance must mark, or cause to be marked, in ink on the package or container in which the narcotic substance is supplied a reference to the entry in the prescription book of the dispensing of that prescription.Penalty: Fine not exceeding 10 penalty units.
(21) Where, under the requirements of any law of the Commonwealth or of any Department of the Commonwealth, a prescription for a narcotic substance is required to be issued in duplicate and one of the copies is delivered or sent to any authority or person in accordance with those requirements, this regulation applies only to the other of those copies, and that copy is taken to be a prescription for a narcotic substance for the purposes of this regulation. (22) A person must not dispense, or cause or permit to be dispensed, a repeat of a prescription for a narcotic substance at an interval of time less than that indicated on the prescription.Penalty: Fine not exceeding 10 penalty units.
(23) For the purposes of subregulation (19) , narcotic substances register means the narcotic substances register referred to in regulation 13 . 23Restriction on dispensing certain narcotic substances (1) This regulation applies to the following narcotic substances: (a) dextromoramide; (b) hydromorphone; (c) methadone; (d) morphine; (e) pethidine. (2) A person who is unable to verify that a prescription for a narcotic substance to which this regulation applies is authentic must dispense no more of that substance than is sufficient for 2 days’ treatment if it is used in accordance with the instructions on the prescription.Penalty: Fine not exceeding 10 penalty units.
(3) For the purposes of subregulation (2) , a person is to be taken to have authenticated a prescription if that person – (a) is familiar with the handwriting of the purported prescriber and is satisfied that the prescription is in that handwriting; or (b) verifies with the purported prescriber that he or she wrote the prescription. Division 7Storage of narcotic substances24Storage of narcotic substances (1) A person who is authorised by the Act or these regulations to possess narcotic substances for the purposes of the person’s profession or employment – (a) must keep them stored apart from other goods in an enclosure that is constructed and secured in a manner approved by the Secretary; and (b) when the narcotic substance is not being used, must keep the enclosure securely locked and retain the key either on his or her person or in a place not readily accessible to other persons. (2) For the purposes of subregulation (1) , goods does not include – (a) money or negotiable instruments; or (b) declared restricted substances stored in accordance with regulation 57 . (3) Subregulation (1) does not apply to or in respect of an ambulance officer. (4) Notwithstanding subregulation (1) , a medical practitioner, veterinary surgeon or dentist may, for emergency purposes, keep narcotic substances in a bag in a vehicle or room which is kept securely locked when the vehicle or room is not occupied by that medical practitioner, veterinary surgeon or dentist. Division 8Storage and supply of narcotic substances in medical institutions25Authorised officer to store, supply, &c., narcotic substances in medical institutionThe authorised officer in a medical institution must – (a) receive all narcotic substances supplied to that institution for the purposes of that institution; and (b) store those narcotic substances in accordance with regulation 24 ; and (c) supply those narcotic substances in accordance with these regulations; and (d) keep a narcotic substances register in respect of those narcotic substances in accordance with regulation 13 . Penalty: Fine not exceeding 10 penalty units.
26Supply of narcotic substances in medical institution (1) If the authorised officer in a medical institution is a pharmaceutical chemist, he or she must not supply a narcotic substance otherwise than for its administration – (a) on a prescription written in accordance with the provisions of regulation 15 or the written request of – (i) the registered nurse in charge of the ward in which the narcotic substance is to be used or stored; or (ii) a medical practitioner; and (b) to a patient in that ward. Penalty: Fine not exceeding 10 penalty units.
(2) If the authorised officer in a medical institution is the medical officer in charge or registered nurse in charge of that institution, he or she must not supply a narcotic substance otherwise than for its administration – (a) on the written request of – (i) the registered nurse in charge of the ward in which the narcotic substance is to be used or stored; or (ii) a dentist; or (iii) a medical practitioner; and (b) to a patient in that ward Penalty: Fine not exceeding 10 penalty units.
27Receipt for supply of narcotic substance in medical institutionWhere an authorised officer supplies a narcotic substance to any person in accordance with a written request under regulation 26(1)(a)(i) or (ii) or regulation 26(2) , the authorised officer must obtain from that person a receipt for the substance at the time of supply.Penalty: Fine not exceeding 10 penalty units.
28Storage and control of narcotic substances in wards of medical institutions (1) The registered nurse in charge of a ward of a medical institution must – (a) keep the narcotic substances supplied to that ward stored apart from all other goods, other than declared restricted substances, in a separate cupboard or receptacle that is securely fixed to the premises; and (b) keep that cupboard or receptacle securely locked at all times when the substances in it are not being used. Penalty: Fine not exceeding 10 penalty units.
(2) The registered nurse in charge of a ward must keep, in accordance with this regulation, a narcotic substances register to be known as a "ward narcotic substances register" with pages numbered consecutively for each type or kind of preparation of narcotic substance supplied to the ward.Penalty: Fine not exceeding 10 penalty units.
(3) A ward narcotic substances register is to be kept in accordance with the form contained in Part 1 of Schedule 3 and in accordance with the rules contained in Part 2 of that Schedule. (4) Notwithstanding subregulation (3) , the person in charge of a medical institution may authorise the registered nurse in charge of a ward in the medical institution to use a ward narcotic substances register other than the register referred to in that subregulation if the other ward narcotic substances register – (a) is in a form approved by the Secretary; and (b) is kept in such manner as the Secretary may direct. (5) Every entry, marking, number or note made in or on a ward narcotic substances register is to be made in ink as soon as practicable after the occurrence of the event to which it relates but not later than 24 hours from the occurrence of that event. 29Administration of narcotic substances (S8) in medical institutions (1) Subject to subregulation (2) and regulation 97 , a medical practitioner or dentist must not give instructions for a narcotic substance to be administered to a patient in a medical institution without completing and signing, in his or her own handwriting or in a manner approved by the Secretary, an authorisation to do so.Penalty: Fine not exceeding 10 penalty units.
(2) Nothing in subregulation (1) prohibits a medical practitioner or dentist from – (a) giving verbal instructions for a narcotic substance to be administered to a patient in a medical institution in an emergency if the medical practitioner or dentist subsequently complies with subregulation (3) ; or (b) including, in an authorisation under subregulation (1) , a printed label identifying the patient if that label is initialled by the medical practitioner or dentist. (3) A medical practitioner or dentist who verbally authorises the emergency administration of a narcotic substance to a patient under subregulation (2)(a) must, within 24 hours after giving those instructions, sign an entry in the patient’s medical history clearly indicating that the medical practitioner or dentist authorised the administration of that substance. (4) If of the opinion that it is necessary for a patient’s wellbeing, a registered nurse may continue to administer a narcotic substance to that patient in accordance with a verbal authorisation under subregulation (3) even though the medical practitioner or dentist has not signed an entry in accordance with that subregulation. (5) A person must not administer a narcotic substance to a patient in a medical institution except – (a) in a case to which subregulation (2)(a) or subregulation (4) applies; or (b) as otherwise provided in the Act or these regulations; or (c) on the written authorisation of a medical practitioner or dentist. Penalty: Fine not exceeding 10 penalty units.
Division 9Storage and use of narcotic substances in special cases30Minister may grant nurse's authority in certain circumstances (1) Where, on the application of a registered nurse, the Minister is satisfied that the nurse carries on his or her profession under such circumstances that the services of a medical practitioner are not readily available to give instructions for the administration of narcotic substances to the patients upon whom the nurse attends, the Minister may grant the nurse a nurse’s authority. (2) A nurse’s authority granted under subregulation (1) – (a) authorises its holder to have possession of such narcotic substances for the purpose for which the authority is issued and in such quantities as may be specified in the authority; and (b) ceases to have effect when the person by whom it is held ceases to hold the appointment or employment specified in the authority. (3) On an order in writing signed by the holder of a nurse’s authority granted under subregulation (1) and upon production by the holder of the authority, a pharmaceutical chemist may supply the holder of the authority with such narcotic substances and in such quantities as may be specified in the authority. (4) A person who has been granted a nurse’s authority under this regulation must keep a narcotic substances register in accordance with regulation 13 .Penalty: Fine not exceeding 10 penalty units.
31Narcotic substances on vessels (1) The master of a vessel may have possession of such narcotic substances as may be necessary for the purpose of ensuring that the requirements of the law of the Commonwealth or of the Marine and Safety Authority Act 1997 are complied with in respect of the vessel, if those substances have been supplied to the master on an order in writing signed by the master. (2) Without prejudice to the operation of subregulation (1) , a master of a vessel may keep on that vessel any narcotic substance that the Secretary may, in writing, allow to be kept on the vessel so long as – (a) the amount so kept does not exceed the amount of that substance that the Secretary has allowed to be so kept; and (b) any requirements made by the Secretary with respect to the place or manner in which the substance is kept on that vessel and with respect to the keeping of records of the acquisition, use or disposal of the substance are complied with. (3) A chemist may supply a narcotic substance to the master of a vessel on an order in writing signed by the master, if the chemist is satisfied that the substance is required for the purpose referred to in subregulation (1) or that the keeping of that substance on the vessel is allowed under subregulation (2) . (4) In this regulation, master includes the person (not being a pilot or harbourmaster) for the time being in charge or having control of any vessel. 32Narcotic substances for firstaid use (1) A person authorised under regulation 95 to possess a narcotic substance must enter or cause to be entered in a register kept solely for that purpose a record of – (a) all supplies of any narcotic substances procured or which otherwise come into the possession of that person; and (b) the quantity of the narcotic substance stored in approved firstaid kits by that person together with the information as to the place in which the narcotic substance is so stored; and (c) the date on which and the place in which the narcotic substance is used and the quantity of the narcotic substance that is used. Penalty: Fine not exceeding 10 penalty units.
(2) Each entry made in the register is to – (a) indicate the amount of each narcotic substance to which the entry relates that is stored in the approved firstaid kit immediately after completion of the event to which the entry relates; and (b) be signed by the person by whom the entry is made. (3) A person who keeps a narcotic substance in an approved firstaid kit must, as soon as possible after the narcotic substance has been used, notify the Secretary of that use.Penalty: Fine not exceeding 10 penalty units.
Division 10Destruction, disposal and loss, &c., of narcotic substances33Destruction of narcotic substances prohibited (1) A person who is licensed or authorised to be in possession of a narcotic substance must not wilfully – (a) destroy that narcotic substance; or (b) cause or permit that narcotic substance to be destroyed. Penalty: Fine not exceeding 10 penalty units.
(2) Subregulation (1) does not apply to the destruction of a narcotic substance – (a) by or under the personal supervision of an inspector under a direction of the Minister; or (b) in the possession of a person obtained pursuant to the prescription of a medical practitioner, veterinary surgeon or dentist; or (c) by the person for the time being holding, or performing the duties of, the office of Chief Pharmacist in the Department in the course of the duties of that office; or (d) by the holder of an office of analyst under section 19 of the Act in the course of the duties of that office; or (e) by a person authorised in writing to do so by the Secretary; or (f) by any 2 health professionals working jointly to destroy the narcotic substance. (3) An authorisation given under subregulation (2)(e) is subject to any conditions specified in it. (4) A health professional who destroys, or works jointly with another health professional to destroy, a narcotic substance must complete a narcotic substances register in accordance with regulation 13 in respect of that substance.Penalty: Fine not exceeding 10 penalty units.
34Procedures in case of loss, &c., of narcotic substances (1) In this regulation – (a) a reference to the unintentional destruction of a narcotic substance includes a reference to the unintentional disposal of that substance; and (b) a reference to a narcotic substance includes a reference to a narcotic substance in a parenteral solution. (2) If a narcotic substance is lost in a medical institution, clause 1 of Schedule 8 has effect. (3) If a narcotic substance is spilt, broken or unintentionally destroyed in a medical institution, clause 2 of Schedule 8 has effect. Division 11General35Miscellaneous duties of licence holder (1) The holder of a licence under this Part – (a) must not sell, keep or otherwise have possession of a narcotic substance except upon the premises specified in the licence; and (b) must not transact any dealing in a narcotic substance except by himself or herself or by a competent or responsible person acting on his or her behalf; and (c) must not sell or supply a narcotic substance to any person who is not authorised under these regulations to purchase or receive the substance; and (d) must keep and store a narcotic substance in his or her possession in accordance with these regulations; and (e) must keep and maintain a narcotic substances register in accordance with these regulations. Penalty: Fine not exceeding 10 penalty units.
(2) Notwithstanding subregulation (1)(a) , the Minister may authorise, in writing, a holder of a licence to have possession of a narcotic substance for such purpose and for such period as may be specified in the authority. 36Self-administration of narcotic substances prohibited (1) A person must not administer or cause to be administered to himself or herself by any means whatsoever a narcotic substance that is in the person’s possession, unless the narcotic substance has been supplied to the person for that purpose – (a) by, or on a prescription issued by, a medical practitioner; or (b) by an authorised nurse; or (c) by a dentist; or (d) by a person on the staff of a hospital in accordance with the instructions of a medical practitioner. Penalty: Fine not exceeding 10 penalty units.
(2) Nothing in this regulation prohibits the administration to a person of a narcotic substance required to be kept in any aircraft or vessel in the case of an emergency where the services of a medical practitioner are not readily available. 37Control of narcotic substances within Ambulance Service (1) Subject to subregulation (2) , the Director of Ambulance Services may issue directives to ambulance officers in respect of the following matters: (a) the procurement and distribution of narcotic substances for use by the Ambulance Service; (b) the keeping of records and the furnishing of reports and returns by ambulance officers in respect of narcotic substances; (c) the procedures to be followed, and the precautions to be taken, by ambulance officers in respect of – (i) the storage, handling and use of narcotic substances, whether in ambulance vehicles or elsewhere; and (ii) the loss, spillage, breakage or unintentional destruction of narcotic substances; and (iii) the disposal of unused or out-of-date narcotic substances. (2) A directive issued under subregulation (1) – (a) is not to contain a provision that is inconsistent with, or contrary to, a provision of the Act or these regulations; and (b) is of no effect until it has been approved by the Secretary. PART 4Poisons and restricted substancesDivision 1Storage of poisons, &c.38Storage of poisons, &c. (1) Where, at any premises, a person has possession, custody or control of, for sale or supply, a substance specified in Schedule 7 of the Poisons List, the person must keep the substance in a part of the premises that is partitioned off or otherwise separated from any part of the premises that is readily accessible to the public.Penalty: Fine not exceeding 10 penalty units.
(2) A chemist, medical practitioner, dentist, veterinary surgeon or optometrist who sells or supplies any substance specified in Schedule 3 or 4 to the Poisons List must keep it in either of the following so that the public does not have access to the substance: (a) a storeroom; or (b) the dispensary. Penalty: Fine not exceeding 10 penalty units.
(3) If a person has possession, custody or control of, for sale or supply, a substance specified in Schedule 2 of the Poisons List – (a) at premises which are not a pharmacy, the person must keep the substance behind a serving counter or in such other manner as to ensure that it is not readily accessible to the public; or (b) at a pharmacy, the person must keep the substance as specified in paragraph (a) or on a horizontal shelf that is – (i) affixed to, or placed immediately against, an internal wall or partition separating the dispensary from the remainder of the premises; or (ii) not more than 4 metres from, and in clear line of sight of, the dispensary; or (iii) susceptible, in such other manner as may be approved by the Secretary, of close supervision from the dispensary. Penalty: Fine not exceeding 10 penalty units.
(4) Where a person has possession, custody or control of, for sale or supply, a poison, the person must keep it separate and apart from other goods suitable for human or animal consumption in such a way that, if the container of the poison breaks or leaks, the poison will not intermix with or contaminate those goods.Penalty: Fine not exceeding 10 penalty units.
Division 2Advertising, prescribing, sale, supply and dispensing of restricted substances39Restriction on advertising of restricted substancesA person must not advertise a restricted substance except in publications that circulate generally only among persons lawfully engaged in medical, dental, veterinary, optometrical or pharmaceutical practice or in the manufacture or supply of restricted substances.Penalty: Fine not exceeding 10 penalty units.
40Prescriptions for restricted substances (1) A person, other than a medical practitioner, dentist, veterinary surgeon or authorised optometrist must not issue a prescription for a restricted substance.Penalty: Fine not exceeding 10 penalty units.
(2) A medical practitioner, dentist or veterinary surgeon, subject to this regulation, is authorised to issue a prescription for any restricted substance. (3) A medical practitioner, dentist, veterinary surgeon or authorised optometrist on issuing a prescription must comply with the following conditions: (a) except in a case where the Secretary otherwise approves, he or she is to write the prescription legibly in ink and, in his or her own handwriting, is to place upon the prescription – (i) the date on which it is written; and (ii) the name and address of the patient or, in the case of an animal, the name and address of its owner; and (iii) the name and the quantity of the restricted substance to be dispensed; and (iv) adequate directions for use; and (v) the number of times (if any) the dispensing of the prescription may be repeated; and (vi) where the prescription is for a declared restricted substance and the dispensing of the prescription is authorised, by its terms, to be repeated, the minimum intervals at which it may be dispensed; (b) he or she must sign the prescription; (c) the prescription must bear – (i) in print, the name and address of the medical practitioner, dentist, veterinary surgeon or authorised optometrist; or (ii) in print or block letters, the name and address of the person writing or issuing the prescription, where the patient is attending a public hospital; or (iii) in print or block letters, the name of the person writing or issuing the prescription where the patient is attending a public hospital and the address of that hospital appears on the prescription; (d) the prescription must be issued – (i) by a medical practitioner for use in the course of medical treatment only; or (ii) by a dentist for use in the course of dental treatment only and is endorsed in print with the words "For dental treatment only"; or (iii) by a veterinary surgeon for use in the course of animal treatment only and is endorsed in print with the words "For animal treatment only"; or (iv) by an authorised optometrist, for use in the course of optometrical treatment only; (e) where the prescription contains an unusual dose, the medical practitioner, dentist, veterinary surgeon or authorised optometrist by whom it is issued must underline that part of the prescription that refers to the unusual dose and initial that part in the margin. Penalty: Fine not exceeding 10 penalty units.
(4) Notwithstanding subregulation (3)(a)(ii) , a medical practitioner, dentist, veterinary surgeon or authorised optometrist may use a printed label in a prescription to identify the patient or owner of the animal, if that label is initialled by the medical practitioner, dentist, veterinary surgeon or authorised optometrist. (5) A prescription is to be taken, for the purposes of these regulations, to have been issued in accordance with subregulation (3) where – (a) the address of the patient, as shown on the prescription for a restricted substance issued by a medical practitioner or an authorised optometrist, is a medical institution; and (b) in place of adequate directions for use, the prescription includes a notation to the effect that the restricted substance is to be used as directed. (6) A medical practitioner or an authorised optometrist must not issue a prescription for a restricted substance in the form referred to in subregulation (5) unless, at the time of issue of the prescription – (a) the patient to whom the prescription relates is a patient in the medical institution referred to in the prescription; and (b) adequate directions, in writing, for the use of the restricted substance in relation to the patient have been, or are, given by the medical practitioner or authorised optometrist to a person having responsibility for the care of the patient in the medical institution. Penalty: Fine not exceeding 10 penalty units.
41Emergency prescribing and dispensing of restricted substances (1) Notwithstanding regulation 40(3) , a pharmaceutical chemist may supply a restricted substance on the instruction of a medical practitioner, veterinary surgeon, dentist or authorised optometrist if, because of the urgent circumstances in which the substance is required, it is impracticable, before the substance is required to be supplied, to – (a) issue a prescription for the substance; and (b) cause the prescription to be delivered to the chemist. (2) A medical practitioner, veterinary surgeon, dentist or authorised optometrist who issues an instruction under subregulation (1) must send to that chemist, within 24 hours of issuing the instruction, a prescription that – (a) complies with regulation 40(3) ; and (b) clearly states that it is in confirmation of the instruction to that chemist to supply the restricted substance without a prescription. Penalty: Fine not exceeding 10 penalty units.
42Records of prescribing of declared restricted substances (1) As soon as practicable after a medical practitioner, dentist or veterinary surgeon issues a prescription for a declared restricted substance, he or she must make a record of that prescription, in a form approved by the Secretary, showing – (a) the name and address of the person for the treatment of whom, or of the owner of the animal for the treatment of which, the substance was prescribed; and (b) the date of issue of the prescription; and (c) particulars of the substance sufficient to identify it and to indicate in what quantity and strength it was prescribed; and (d) particulars of the directions set out in the prescription for the use of the substance; and (e) particulars of any provision made in the prescription with respect to the number of times, and the minimum intervals at which, the dispensing of the prescription was authorised to be repeated. Penalty: Fine not exceeding 10 penalty units.
(2) A medical practitioner, dentist or veterinary surgeon must retain a record made under subregulation (1) for not less than 2 years.Penalty: Fine not exceeding 10 penalty units.
43Sale or supply of restricted substances (1) Where any medical practitioner, dentist, veterinary surgeon or authorised optometrist sells or supplies a restricted substance otherwise than by way of wholesale dealing, the substance must be sold or supplied – (a) by the medical practitioner only for use in the course of medical treatment; or (b) by the dentist only for use in the course of dental treatment; or (c) by the veterinary surgeon only for use in the course of animal treatment; or (d) by the authorised optometrist only for use in the course of optometrical treatment. (2) Where any medical practitioner, dentist, veterinary surgeon or optometrist sells or supplies a restricted substance other than by way of wholesale dealing in a quantity exceeding that required for 3 days’ treatment, he or she must comply with the following conditions: (a) before the restricted substance is sold or supplied a record of the sale or supply of that substance is to be made showing – (i) the date on which it was supplied; and (ii) the name and address of the person for whose treatment it was supplied or in the case of an animal the name and address of the owner; and (iii) the name and quantity of the restricted substance supplied; (b) the label on the container is to bear the particulars prescribed in regulation 87 ; (c) the record of the supply of the restricted substance is to be kept at the surgery or office of the person by whom that substance was supplied or sold, and is to be produced on demand to an inspector. Penalty: Fine not exceeding 10 penalty units.
44Dispensing prescriptions for restricted substances (S4) (1) Subject to subregulations (2) and (3) and to regulation 46 , a person must not supply a restricted substance otherwise than on, and in accordance with, a prescription issued, or a direction given, in accordance with regulation 40 .Penalty: Fine not exceeding 10 penalty units.
(2) A person may dispense not more than once a prescription for a restricted substance that conforms in all other respects with regulation 40(3) but does not specify a maximum number of times the dispensing of the prescription may be repeated if, upon dispensing the prescription, that person cancels it in accordance with subregulation (12) . (3) Where – (a) the dispensing of a prescription for a declared restricted substance is authorised, by the terms of the prescription, to be repeated but the prescription does not specify the minimum intervals at which the dispensing of the prescription may be repeated; and (b) the prescription conforms in all other respects with regulation 40(3) –a person may dispense that prescription if – (c) the person – (i) ascertains, in accordance with subregulation (4) , the earliest date on which the dispensing of the prescription may be repeated; and (ii) upon dispensing the prescription, marks on it, over the person’s signature and the date, a note that specifies both the date so ascertained and how it was ascertained; or (d) upon dispensing the prescription, the person cancels it in accordance with subregulation (12) . (4) The date referred to in subregulation (3)(c)(i) is to be ascertained by reference to either or both of the following: (a) specific directions for the use by the patient of the declared restricted substance, being directions incorporating a dosage rate, that are included in the prescription; (b) information obtained directly from the prescriber as to the minimum interval between occasions on which the declared restricted substance should be dispensed to the patient. (5) If the date referred to in subregulation (3)(c)(i) is ascertained by reference only to the information referred to in paragraph (a) of subregulation (4) , that date is to be a date not earlier than 4 days before the day on which the quantity of the declared restricted substance being dispensed would be exhausted if used strictly in accordance with the directions referred to in that paragraph. (6) A person, other than a pharmaceutical chemist or an assistant under the direct personal supervision of a pharmaceutical chemist, must not dispense a prescription for a restricted substance.Penalty: Fine not exceeding 10 penalty units.
(7) A pharmaceutical chemist or an assistant under the direct personal supervision of a pharmaceutical chemist, subject to this regulation, is authorised to dispense a prescription for a restricted substance. (8) A person must not dispense any prescription for a restricted substance or supply a restricted substance on or in accordance with any prescription unless the person complies with the following provisions: (a) the dispensing of the prescription must not be repeated more than the maximum number of times indicated on it and, if an interval of times is specified, at a shorter interval than that specified, and on each occasion upon which it is dispensed there is to be stamped or marked in writing or clearly shown on the prescription – (i) the date upon which it is dispensed; and (ii) the signature of the pharmaceutical chemist by whom it is dispensed or by whom its dispensing is supervised; and (iii) the address of the place at which it is dispensed; (b) where the occasion of the dispensing of the prescription is, in accordance with the terms of the prescription, the last occasion on which it may be dispensed, the person, upon dispensing it, must cancel it in accordance with subregulation (12) ; (c) before completion of the supply of the restricted substance, the person must make or cause to be made, in the approved recording system relating to the pharmacy at which that supply is effected, an entry that, subject to subregulation (9) , sets out – (i) the date on which the restricted substance is dispensed; and (ii) whether the authority for the dispensing by the person of the restricted substance is a prescription issued under regulation 40 or an instruction given under regulation 41 ; and (iii) the name of the person by whom that prescription was issued or that direction was given; and (iv) the name and address of the person for the treatment of whom, or of the owner of the animal for the treatment of which, the restricted substance was dispensed; and (v) the material part of the prescription or instruction, including particulars of any specification with respect to the repeated dispensing of the prescription; and (vi) the text of any note marked, under subregulation (3)(c)(ii) , on the prescription (if any) on the authority of which that person dispensed the restricted substance; (d) the label on the container of the restricted substance is to be marked with the identifying letter or number of the prescription appearing in the approved recording system and with such other particulars as are prescribed in regulation 87(2) ; (e) the approved recording system is to be kept at the place at which the restricted substance was dispensed and is produced on demand to an inspector. Penalty: Fine not exceeding 10 penalty units.
(9) Where the dispensing of a prescription is repeated at a pharmacy at which it was previously dispensed, the entry made under subregulation (8)(c) in relation to the repeat is to set out – (a) the date of the repeat; and (b) the name and address of the person for the treatment of whom, or of the owner of the animal for the treatment of which, the dispensing of the prescription was repeated; and (c) a note of the fact of the repeat by reference to the entry made under subregulation (8)(c) in relation to the first occasion of the dispensing of that prescription in that pharmacy. (10) As soon as possible after a prescription written under regulation 41 is received at the pharmacy at which the restricted substance to which it relates was dispensed, a pharmaceutical chemist engaged in the conduct of that pharmacy must – (a) clearly mark on the prescription a note setting out – (i) the date on which the restricted substance to which it relates was dispensed; and (ii) the name of the pharmaceutical chemist by whom, or under whose supervision, it was dispensed; and (iii) the name and address of the pharmacy at which it was dispensed; and (iv) the identifying mark relating to the approved recording system entry made in pursuance of subregulation (8)(c) in relation to the dispensing of that restricted substance; and (b) sign and date that note. Penalty: Fine not exceeding 10 penalty units.