Part 4Prescriptions and dispensing

Part 4—Prescriptions and dispensing 33—How prescriptions are to be given (1) Subject to this regulation, a prescriber must give a prescription for a drug— (a) in writing; or (b) in an approved electronic form. (2) A prescriber may, if of the opinion that good reason exists for doing so, give a prescription for a drug to a pharmacist by— (a) telephone; or (b) fax; or (c) an approved electronic communication. (3) If a prescriber gives a prescription in writing, the prescriber must give the prescription to— (a) in the case of a prescription for a drug for human use— (i) the person for whom the drug is to be supplied; or (ii) a person acting on behalf of the person for whom the drug is to be supplied; or (b) in the case of a prescription for a drug for animal use— (i) the owner of the animal; or (ii) a person acting on behalf of the owner of the animal. (4) If a prescription is given in an approved electronic form, the prescriber must— (a) in the case of a prescription in a form approved by the Secretary under the Commonwealth Regulations—prepare and submit the prescription in accordance with any approved information technology requirements (as defined in the Commonwealth Regulations) by means of an eligible electronic communication (as defined in the Commonwealth Regulations); or (b) in the case of a prescription in a form approved by the Minister—prepare and submit the prescription in accordance with approved information technology requirements (if any) by means of an approved electronic communication. (5) If a prescription is prepared in an approved electronic form, the prescriber must include in the prescription— (a) the date on which the prescription is given; and (b) the prescriber's professional name, address and telephone number; and (c) the full name and address of the person for whom the prescription is intended; and (d) the name, dose form and (if relevant) the route of administration of the drug being prescribed; and (e) if applicable—the strength of the drug being prescribed; and (f) the dose of the drug to be administered to the person for whom the drug is being prescribed; and (g) the frequency at which the drug is to be administered; and (h) the total amount of the drug to be supplied each time the prescription is dispensed; and (i) the total number of times the drug may be dispensed; and (j) if the prescription is for a drug of dependence for human use—the date of birth of the person for whom the prescription is intended; and (k) the words— (i) "For dental treatment only" if the prescriber is a dentist; or (ii) "For podiatric treatment only" if the prescriber is a podiatrist; or (iii) "For animal treatment only" if the prescriber is a veterinary surgeon. (6) If a prescription for a monitored drug for human use is prepared in an approved electronic form, the prescriber must— (a) keep a record of— (i) the details required by subregulation (5) to be included in the prescription; and (ii) the date of birth of the person for whom the prescription has been prepared; and (b) transmit that record electronically to a data source entity at, or immediately following, the time the record is created (unless subregulation (6a) applies). (6a) If a prescriber is unable to transmit a record relating to a prescription in accordance with subregulation (6)(b) because the electronic system used to keep the record is not compatible with the electronic system of a data source entity, the prescriber must transmit the record electronically to the Chief Executive so that it is received no later than— (a) if the prescription is prepared on a day falling within the first 14 days of a month—the 21st day of that month; or (b) if the prescription is prepared on any other day—the 7th day of the month following the month in which the prescription was prepared; or (6b) The Minister may exempt a prescriber or class of prescribers from the operation of subregulation (6)(b) or (6a) (or both) if satisfied that proper cause exists for the exemption. (7) If a prescription is given to a pharmacist by telephone, the prescriber must give the pharmacist— (a) the prescriber's professional name, address and telephone number; and (b) the full name and address of the person for whom the prescription is intended (or, if the prescription is intended for an animal, the species of animal for which it is intended, the name and address of the owner of the animal and the name (if any) of the animal); and (c) the name, dose form and (if relevant) the route of administration of the drug being prescribed; and (d) if applicable—the strength of the drug being prescribed; and (e) the dose of the drug to be administered to— (i) the person for whom the drug is being prescribed; or (ii) the animal in relation to which the drug is being prescribed, (as the case may be); (f) the total amount of the drug to be supplied; and (g) the frequency at which the drug is to be administered; and (h) if the prescription is for a drug of dependence for human use—the date of birth of the person for whom the prescription is intended. (8) If a prescription is given to a pharmacist by telephone— (a) the prescriber must, immediately after so giving the prescription, complete a prescription in writing that— (i) clearly states that it is given in confirmation of the prescription given by telephone on the particular date on which it is so given; and (ii) otherwise complies with these regulations; and (b) the prescriber must forward the written prescription to the pharmacist— (i) if the prescription is for a drug of dependence—within 24 hours of giving the prescription by telephone; or (ii) in any other case—as soon as practicable after giving the prescription by telephone. (9) If a prescription is given to a pharmacist by fax, the prescriber must forward the original prescription to the pharmacist— (a) in the case of a prescription for a drug of dependence—within 24 hours of giving the prescription by fax; or (b) in any other case—as soon as practicable after giving the prescription by fax, unless the prescriber has endorsed the prescription given by fax with the name and address of a single pharmacy at which the prescription may be dispensed. (10) If a prescription is given to a pharmacist by an approved electronic communication, the prescriber must comply with any requirements imposed by the Minister. (11) This regulation does not apply to a prescriber who gives a prescription for a drug if— (b) the provisions of the Commonwealth Regulations applying to the giving of a medication chart prescription for a pharmaceutical benefit are complied with in relation to the giving of the prescription of the drug (whether or not the drug is a pharmaceutical benefit). 34—Written prescriptions (1) A prescriber who writes a prescription for the supply of a drug must— (a) date the prescription with the date on which the prescription is written and sign the prescription; and (b) include on the prescription— (i) his or her professional name, address and telephone number; and (ii) the full name and address of the person for whom the prescription is intended or, if the prescription is intended for an animal, the species of animal for which it is intended, the name and address of the owner of the animal and the name (if any) of the animal; and (iii) the words— (A) "For dental treatment only" if the prescriber is a dentist; or (B) "For podiatric treatment only" if the prescriber is a podiatrist; or (C) "For animal treatment only" if the prescriber is a veterinary surgeon; and (c) specify on the prescription— (i) the name, dose form and (if relevant) the route of administration of the drug being prescribed; and (ii) if applicable—the strength of the drug; and (iii) the dose of the drug to be administered to the person for whom, or the animal for which, it is prescribed; and (iv) the frequency at which the drug is to be administered; and (v) the total amount of the drug to be supplied each time the prescription is dispensed; and (vi) the total number of times the drug may be dispensed; and (d) if the prescription is for a drug of dependence for human use, comply with the following additional requirements: (i) include on the prescription the date of birth of the person for whom the prescription is intended; (ii) express the total amount of the drug to be specified under subparagraph (c)(v) in both words and numerals. (1a) A prescriber who writes a prescription for the supply of a monitored drug for human use— (a) must keep a record of— (i) the details required to be included and specified under subregulation (1); and (ii) the date of birth of the person for whom the prescription has been written; and (b) if the record is kept in electronic form—must transmit that record electronically to a data source entity at, or immediately following, the time the record is created (unless subregulation (1b) applies). (1b) If a prescriber is unable to transmit a record relating to a prescription in accordance with subregulation (1a)(b) because the electronic system used to keep the record is not compatible with the electronic system of a data source entity, the prescriber must transmit the record electronically to the Chief Executive so that it is received no later than— (a) if the prescription is written on a day falling within the first 14 days of a month—the 21st day of that month; or (b) if the prescription is written on any other day—the 7th day of the month following the month in which the prescription was prepared; or (1c) The Minister may exempt a prescriber or class of prescribers from the operation of subregulation (1a)(b) or (1b) (or both) if satisfied that proper cause exists for the exemption. (2) If a prescriber writes a prescription for an above average strength or potentially dangerous dose of a drug, he or she must— (a) underline the statement of the dose of the drug on the prescription; and (b) sign his or her initials alongside the underlined portion of the prescription referred to in paragraph (a). (4) This regulation does not apply to a person who writes a prescription for a drug if— (b) the provisions of the Commonwealth Regulations applying to the giving of a medication chart prescription for a pharmaceutical benefit are complied with in relation to the giving of the prescription for the drug (whether or not the drug is a pharmaceutical benefit). 34A—Giving prescriptions for monitored drugs—special provisions (1) Before a prescriber gives a prescription for the supply of a monitored drug for human use (whether the prescription is given in writing, in an approved electronic form, by telephone, by fax or by an approved electronic communication), the prescriber must take all reasonable steps to check relevant information held in the monitored drugs database relating to the person for whom the drug is to be prescribed. (2) Subregulation (1) does not apply if— (b) the drug (not being dextromoramide or pethidine) is for use by a person whose life expectancy is reasonably believed by the registered health practitioner principally responsible for treatment of the person, to be less than 12 months and— (i) the prescriber has informed the Minister of the person's name and address, date of birth and the nature of the condition for which the drug is prescribed; and (ii) the prescription for the drug is endorsed either "Notified Palliative Care Patient" or "NPCP"; or (c) the drug is for use by a person who is receiving treatment in a hospital or a correctional institution and the duration of treatment of the person with the drug while the person is in the hospital or correctional institution does not exceed 14 days; or (d) the drug is for use by a person who is being discharged from a hospital following treatment in the hospital and the duration of treatment of the person with the drug after discharge does not exceed 14 days. (3) Subregulation (1) does not apply to a person who gives a prescription for a drug if— (b) the provisions of the Commonwealth Regulations applying to the giving of a medication chart prescription for a pharmaceutical benefit are complied with in relation to the giving of the prescription for the drug (whether or not the drug is a pharmaceutical benefit). 35—Dispensing prescriptions (1) If a pharmacist or medical practitioner dispenses a drug pursuant to a prescription, the pharmacist or medical practitioner must— (a) in the case of a written prescription or electronic prescription—record in or on the prescription— (i) the pharmacist's or medical practitioner's name, business name (if any) and business address; and (ii) the date on which the drug is dispensed; and (iii) the unique identifier applicable to the drug; or (b) in the case of a prescription given by fax that is endorsed with the name and address of a single pharmacy at which the prescription is to be dispensed—endorse on the faxed copy— (i) the pharmacist's or medical practitioner's name, business name (if any) and business address; and (ii) the date on which the drug is dispensed; and (iii) the unique identifier applicable to the drug. (2) A pharmacist or medical practitioner who dispenses a drug pursuant to a prescription must, on the day on which the drug is dispensed, record the following information: (a) the unique identifier applicable to the drug dispensed on the prescription; (b) the name of the pharmacist or medical practitioner as the dispenser; (c) the date on which the drug is dispensed; (d) the trade name or the approved name of the drug, or, if it does not have either a trade or approved name, the ingredients of the drug; (e) if the drug is dispensed for a person— (i) the full name and address of the person; and (ii) in the case of a monitored drug—the person's date of birth; (f) if the drug is intended for an animal—the species of animal for which it is intended, the name and address of the owner of the animal and the name (if any) of the animal; (g) the form, strength and quantity of the dispensed drug; (h) the directions given for the safe and proper use of the dispensed drug; (i) the name, address and business telephone number of the person who prescribed the drug; (j) the number of times the prescription may be dispensed and (if the prescription so specifies) the intervals at which the drug may be dispensed; (k) any instructions the prescriber has included in or on the prescription in relation to a specialised supply of the drug; (l) if the prescription is endorsed for dispensing at a single pharmacy—the name and address of that pharmacy. (3) A pharmacist or medical practitioner must not do the following: (a) in the case of a prescription for an S4 poison that does not specify the number of times the drug is to be dispensed—dispense the drug more than once pursuant to the prescription; (b) in the case of a prescription that specifies the number of times and the intervals at which the drug may be dispensed—dispense the drug more times than the number specified or at intervals less than those specified; (c) in the case of a prescription that specifies the number of times, but not the intervals at which, the drug may be dispensed—dispense the drug more frequently than the pharmacist or medical practitioner considers appropriate. (4) Despite subregulation (3)(b), if a pharmacist or medical practitioner is satisfied that a person— (a) has lost a previously dispensed supply of a drug; or (b) will, through absence from the State or otherwise, find it unduly difficult to have future supplies of a drug dispensed as needed, the pharmacist or medical practitioner may (but is not obliged to) dispense a prescription for the person at an interval earlier than that specified in or on the prescription. (5) If, under subregulation (4), a pharmacist or medical practitioner dispenses a drug of dependence at an earlier interval than that specified in or on the prescription, the pharmacist or practitioner must notify the prescriber of that fact in writing. (6) If a prescription given by fax is endorsed with the name and address of a single pharmacy at which the drug may be dispensed, a pharmacist must not dispense the drug unless the pharmacist is on duty at that pharmacy. (7) A pharmacist or medical practitioner must not dispense a drug if— (a) the prescription for the drug— (i) is presented or otherwise sought to be dispensed— (A) in the case of a drug of dependence—more than 6 months after the date on which it was written; or (B) in any other case—more than 12 months after the date on which it was written; or (ii) has been cancelled; or (iii) is partly or wholly illegible; or (iv) does not comply with the Act or these regulations; or (b) there are reasonable grounds for suspecting that the prescription has been altered, forged or obtained by false pretences. (8) If a prescription for a drug that is to be dispensed for the first or only time is given in writing, a pharmacist or medical practitioner must not dispense the drug unless the original written prescription for the drug is presented to the pharmacist or medical practitioner. (9) If a prescription for a drug that is to be dispensed for the first or only time is given by fax, a pharmacist or medical practitioner must not dispense the drug unless the faxed prescription is endorsed with the name and address of a single pharmacy at which the drug may be dispensed. (10) If a prescription for a drug that is to be dispensed for the second or subsequent time is given in writing, a pharmacist or medical practitioner must not dispense the drug unless— (a) the original written prescription for the drug and a written record (whether made on the prescription or on a separately attached repeat authorisation) of the number of times the drug has been dispensed are presented to the pharmacist or medical practitioner; or (b) a duplicate or copy of the written prescription for the drug and a written record (made both on the duplicate or copy (as the case may be) and on a separately attached repeat authorisation) of the number of times the drug has been dispensed are presented to the pharmacist or medical practitioner. (11) If a pharmacist or medical practitioner— (a) dispenses a drug pursuant to a written prescription; and the pharmacist or medical practitioner must endorse the prescription with the word "CANCELLED" on the day on which the drug is dispensed. (12) If a pharmacist— (a) dispenses a drug pursuant to a prescription given by fax that is endorsed with the name of a single pharmacy at which the prescription may be dispensed; and the pharmacist must endorse the faxed copy of the prescription with the word "CANCELLED" on the day on which the drug is dispensed. (13) If a pharmacist or medical practitioner— (a) dispenses a drug pursuant to an electronic prescription; and the pharmacist or medical practitioner must record in or on the prescription, on the day that the prescription is dispensed, that the prescription is cancelled. (14) A pharmacist or medical practitioner who dispenses a prescription for an S4 poison must, unless the prescription is for any reason forwarded to the Department or the Minister— (a) in the case of a written prescription— (i) retain the original or duplicate prescription for at least 1 year; and (ii) keep the original or duplicate prescription readily available for inspection by an authorised officer during that period; or (b) in the case of a prescription given by fax— (i) retain the faxed copy of the prescription for at least 1 year; and (ii) keep the faxed copy of the prescription readily available for inspection by an authorised officer during that period; or (c) in the case of an electronic prescription— (i) retain the electronic prescription or a computer‑generated printed copy of it for at least 1 year; and (ii) keep the electronic prescription or a computer‑generated printed copy of it readily available for inspection by an authorised officer during that period. (15) If a prescription has been issued in duplicate and the original is retained by the pharmacist or medical practitioner, it is sufficient compliance with this regulation if the required information is marked on the duplicate prescription. (16) For the purposes of this regulation, a prescription for a drug is fully dispensed if— (a) in the case of a prescription authorising dispensing of the drug once only—the drug has been dispensed on 1 occasion; or (b) in the case of a prescription authorising dispensing of the drug more than once—the drug has been dispensed for the last time. (17) This regulation (other than subregulations (2), (7)(a) and (7)(b)) does not apply to a pharmacist or medical practitioner who dispenses a drug on a prescription if— (b) the provisions of the Commonwealth Regulations applying to the sale or supply of a pharmaceutical benefit have been complied with in relation to the sale or supply of the drug (whether or not the drug is a pharmaceutical benefit). 35A—Dispensing prescriptions for drugs of dependence and other monitored drugs—special provisions (1) A pharmacist who dispenses a monitored drug on prescription must— (a) each time that the drug is dispensed—make a record in electronic form that complies with regulation 35(2); and (b) transmit that record electronically to a data source entity at, or immediately following, the time the record is created (unless subregulation (2) applies). (2) If a pharmacist is unable to transmit a record relating to a prescription in accordance with subregulation (1)(b) because the electronic system used to make the record is not compatible with the electronic system of a data source entity, the pharmacist must transmit the record electronically to the Chief Executive so that it is received no later than— (a) if the drug is dispensed on a day falling within the first 14 days of a month—the 21st day of that month; or (b) if the drug is dispensed on any other day—the 7th day of the month following the month in which the drug was dispensed; or (3) A pharmacist or medical practitioner who dispenses a drug of dependence on prescription must— (a) in the case of a written prescription— (i) retain the original prescription or a copy of the prescription for at least 2 years; and (ii) keep it readily available for inspection by an authorised officer during that period; and (iii) on request by an authorised officer—send a copy of the prescription to the authorised officer; or (b) in the case of a prescription given by fax— (i) retain the faxed copy of the prescription for at least 2 years; and (ii) keep the faxed copy of the prescription readily available for inspection by an authorised officer during that period; and (iii) on request by an authorised officer—send a copy of the faxed copy of the prescription to the authorised officer; or (c) in the case of an electronic prescription— (i) retain the electronic prescription or a computer‑generated printed copy of it for at least 2 years; and (ii) keep the electronic prescription or a computer‑generated printed copy of it readily available for inspection by an authorised officer during that period; and (iii) on request by an authorised officer—send a computer‑generated printed copy of the electronic prescription to the authorised officer. (4) A pharmacist or medical practitioner must not— (aa) dispense a monitored drug unless the pharmacist or practitioner has taken all reasonable steps to check relevant information held in the monitored drugs database relating to the person for whom the drug is to be dispensed; or (a) dispense more than 2 days supply of a drug of dependence unless at least 1 of the following applies: (i) the person for whose use the drug is prescribed is known to the pharmacist or practitioner; (ii) the pharmacist or practitioner recognises the signature on the prescription as that of the prescriber who purportedly gave the prescription; (iii) the pharmacist or practitioner has verified with the prescriber who purportedly gave the prescription that the prescription was in fact given by that prescriber; or (b) hand over a drug of dependence dispensed by the pharmacist or medical practitioner until— (i) the person for whose use the drug is dispensed— (A) has signed and dated the prescription or, if the prescription was given by fax, the faxed copy of the prescription; and (B) has, unless the person is known to the pharmacist or practitioner, produced satisfactory evidence of his or her identity; or (ii) the person for whose use the drug is dispensed— (A) has signed a computer‑generated printed copy of the prescription that includes all the information required to be provided on a written prescription; and (B) has, unless known to the pharmacist or practitioner, produced satisfactory evidence of his or her identity; or (iii) an agent acting on behalf of the person for whose use the drug is intended— (A) has signed and dated the prescription or, if the prescription was given by fax, the faxed copy of the prescription; and (B) has, unless the agent is known to the pharmacist or practitioner, produced satisfactory evidence of his or her identity; or (iv) an agent acting on behalf of the person for whose use the drug is intended— (A) has signed a computer‑generated printed copy of the prescription that includes all the information required to be provided on a written prescription; and (B) has, unless known to the pharmacist or practitioner, produced satisfactory evidence of his or her identity. (5) This regulation (other than subregulation (3)) does not apply to a pharmacist or medical practitioner who dispenses a monitored drug on prescription if— (b) the provisions of the Commonwealth Regulations applying to the sale or supply of a pharmaceutical benefit have been complied with in relation to the sale or supply of the drug (whether or not the drug is a pharmaceutical benefit). (6) Subregulation (4)(aa) does not apply if— (b) the prescription for the drug (not being dextromoramide or pethidine) is endorsed either "Notified Palliative Care Patient" or "NPCP"; or (c) the drug is for use by a person who is receiving treatment in a hospital or a correctional institution and the duration of treatment of the person with the drug while the person is in the hospital or correctional institution does not exceed 14 days; or (d) the drug is for use by a person who is being discharged from a hospital following treatment in the hospital and the duration of treatment of the person with the drug after discharge does not exceed 14 days. 35B—Dispensing prescriptions—S4 drugs in serious shortage (1) If— (a) a prescription for an S4 drug is presented to a pharmacist for dispensing; and (b) the drug to which the prescription relates is a medicine in respect of which a Serious Shortage Medicine Substitution Notice issued by the TGA under the Commonwealth Act is in force; and (c) the pharmacist is unable to dispense the prescription because the pharmacist does not have, and cannot obtain, the drug to which the prescription relates in the strength, release form or dose form specified in the prescription; and (d) the person for whom the prescription has been given consents to receiving the drug in a strength, release form or dose form specified in the Notice instead; and (e) the pharmacist is of the opinion that it is appropriate to supply the person with the drug in a strength, release form or dose form specified in the Notice, the pharmacist may supply the person with the drug in a strength, release form or dose form specified in the Notice in accordance with the conditions stated in the Notice. (2) If a pharmacist supplies a drug as authorised by subregulation (1), the pharmacist must, as soon as practicable, give the prescriber of the drug notice in writing of the strength, release form and dose form in which the drug was supplied. Maximum penalty: $3 000. (3) For the purposes of these regulations, if a pharmacist supplies a drug as authorised by subregulation (1), the pharmacist will be taken to have dispensed the prescription for the drug presented to the pharmacist.