ch.1-pt.1
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Queensland regulation
**What this regulation does (mechanics)
Establishes detailed rules for any dealing with a medicine: classification, who may do what, how medicines are manufactured, supplied, delivered, stored, prescribed, dispensed, administered, repackaged, recorded and destroyed. (See e.g. parts on manufacturing licences, supplying stock, prescribing, dispensing, storage and medicine registers.)
Creates categories of medicines that attract special controls: restricted, high‑risk, diversion‑risk and monitored medicines (see chapter 1, sections 9–12 and schedule 2). Monitored medicines feed into a central monitored medicines database and trigger mandatory checks for certain practitioners (chapter 7).
Specifies classes of people authorised to deal with particular medicines (schedules 3–15). Those schedules list dozens of professions and roles (doctors, nurses, pharmacists, dentists, allied health, ambulance/first aid workers, veterinary professions, school staff, carriers, wholesale representatives, farmers, etc.) and the precise scope each class has (prescribe, possess, administer, give purchase orders, etc.).
Sets operational requirements for supply chains and logistics: how purchase orders must be made and transmitted securely (secs 50–53), invoicing and marking on supply (secs 61–62), packaging and labelling rules and permitted alternatives (secs 64–66, 72–73, 237), secure delivery and carrier duties (chs 4 & 8), and special constraints for S8 (Schedule 8 / high‑control) medicines (e.g. packaging, separate handling, signed receipts) (secs 65, 68–69, Parts on S8 safes and medicine registers).
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Direct links to the current provisions in Medicines and Poisons (Medicines) Regulation 2021.
This regulation may be cited as the Medicines and Poisons (Medicines) Regulation 2021 .
This regulation commences on 27 September 2021.
This regulation applies in relation to a regulated activity that is a dealing with a medicine. See the Medicines and Poisons (Poisons and Prohibited Substances) Regulation 2021 in relation to particular dealings with poisons and prohibited substances. See the Medicines and Poisons (Pest Management Activities) Regulation 2021 in relation to pest management activities.
The dictionary in schedule 22 defines particular words used in this regulation.
A provision of this regulation referring to a person registered under the Health Practitioner Regulation National Law to practise in a profession— includes a person with provisional registration or limited registration for the profession; but does not include a person registered to practise in the profession only as a student or for training purposes. See schedule 12 , part 7 and schedule 11 , part 3 in relation to trainees. However, subsection (1) does not apply in relation to the enrolled nurses division of the nursing profession or the pharmacy profession. See schedule 7 , parts 4 to 6 in relation to enrolled nursing professions. See schedule 9 in relation to pharmaceutical professions. (sec.5-ssec.1) A provision of this regulation referring to a person registered under the Health Practitioner Regulation National Law to practise in a profession— includes a person with provisional registration or limited registration for the profession; but does not include a person registered to practise in the profession only as a student or for training purposes. See schedule 12 , part 7 and schedule 11 , part 3 in relation to trainees. (sec.5-ssec.2) However, subsection (1) does not apply in relation to the enrolled nurses division of the nursing profession or the pharmacy profession. See schedule 7 , parts 4 to 6 in relation to enrolled nursing professions. See schedule 9 in relation to pharmaceutical professions.
For section 7 (1) of the Act , each of the following activities with the following substances is prescribed— buying a listed blood product using the national blood tracking system; possessing a listed blood product obtained using the national blood tracking system; supplying, by wholesale, stock of a listed blood product using the national blood tracking system; dispensing a listed blood product on a prescription made in the national blood tracking system; giving a treatment dose of a listed blood product on a prescription made in the national blood tracking system; prescribing a listed blood product using the national blood tracking system; administering a listed blood product on a prescription made in the national blood tracking system. However, the activity is prescribed only to the extent— the activity is carried out by a person performing a function under the national blood supply arrangements; and for subsection (1) (d) or (e) —the listed blood product is labelled in compliance with— the labelling requirements stated in the Poisons Standard, Appendix L; or if the listed blood product has been granted a labelling exemption by an appropriate authority under the Poisons Standard, section 39 —any labelling requirements imposed by the appropriate authority for the product. In this section— listed blood product means an S4 medicine that is an immunoglobulin blood product mentioned on the national product price list. National Blood Agreement see the National Blood Authority Act 2003 (Cwlth) , section 3 . national blood supply arrangements means the arrangements made under the National Blood Agreement. national blood tracking system means the system for ordering, or authorising orders for, blood or blood-related products, established for facilitating the national blood supply arrangements. national product price list means the price list for blood products or blood-related products supplied under the National Blood Agreement, approved by the Ministerial Council under that agreement. s 6 amd 2023 SL No. 170 s 4 (sec.6-ssec.1) For section 7 (1) of the Act , each of the following activities with the following substances is prescribed— buying a listed blood product using the national blood tracking system; possessing a listed blood product obtained using the national blood tracking system; supplying, by wholesale, stock of a listed blood product using the national blood tracking system; dispensing a listed blood product on a prescription made in the national blood tracking system; giving a treatment dose of a listed blood product on a prescription made in the national blood tracking system; prescribing a listed blood product using the national blood tracking system; administering a listed blood product on a prescription made in the national blood tracking system. (sec.6-ssec.2) However, the activity is prescribed only to the extent— the activity is carried out by a person performing a function under the national blood supply arrangements; and for subsection (1) (d) or (e) —the listed blood product is labelled in compliance with— the labelling requirements stated in the Poisons Standard, Appendix L; or if the listed blood product has been granted a labelling exemption by an appropriate authority under the Poisons Standard, section 39 —any labelling requirements imposed by the appropriate authority for the product. (sec.6-ssec.3) In this section— listed blood product means an S4 medicine that is an immunoglobulin blood product mentioned on the national product price list. National Blood Agreement see the National Blood Authority Act 2003 (Cwlth) , section 3 . national blood supply arrangements means the arrangements made under the National Blood Agreement. national blood tracking system means the system for ordering, or authorising orders for, blood or blood-related products, established for facilitating the national blood supply arrangements. national product price list means the price list for blood products or blood-related products supplied under the National Blood Agreement, approved by the Ministerial Council under that agreement.
For section 7 (1) of the Act , each of the following activities with the following substances is prescribed— supplying, by wholesale, stock of S3 naloxone for a naloxone treatment program; giving 1 or more doses of S3 naloxone obtained under a naloxone treatment program to a person; administering S3 naloxone obtained under a naloxone treatment program to a person. However, subsection (3) applies to an activity mentioned in subsection (1) (b) carried out by a person performing a function under a naloxone treatment program. The activity is prescribed only to the extent— the person is appropriately qualified; and the person, when carrying out the activity, gives instructions about— how to recognise signs and symptoms of suspected opioid overdose; and how to administer the S3 naloxone. In this section— naloxone treatment program means a program set up by an entity of the State or Commonwealth to make S3 naloxone widely available for treating opioid overdose. S3 naloxone means naloxone in a manufacturer’s pack for the treatment of opioid overdose, other than naloxone that is an S4 medicine. s 6A ins 2023 SL No. 51 s 4 (sec.6A-ssec.1) For section 7 (1) of the Act , each of the following activities with the following substances is prescribed— supplying, by wholesale, stock of S3 naloxone for a naloxone treatment program; giving 1 or more doses of S3 naloxone obtained under a naloxone treatment program to a person; administering S3 naloxone obtained under a naloxone treatment program to a person. (sec.6A-ssec.2) However, subsection (3) applies to an activity mentioned in subsection (1) (b) carried out by a person performing a function under a naloxone treatment program. (sec.6A-ssec.3) The activity is prescribed only to the extent— the person is appropriately qualified; and the person, when carrying out the activity, gives instructions about— how to recognise signs and symptoms of suspected opioid overdose; and how to administer the S3 naloxone. (sec.6A-ssec.4) In this section— naloxone treatment program means a program set up by an entity of the State or Commonwealth to make S3 naloxone widely available for treating opioid overdose. S3 naloxone means naloxone in a manufacturer’s pack for the treatment of opioid overdose, other than naloxone that is an S4 medicine.
For section 7 (1) of the Act , the activities prescribed are buying or supplying stock of a national stockpile medicine. However, each activity is prescribed only to the extent it is carried out by— a responsible government entity; or a person acting under a direction given by a responsible government entity. In this section— Commonwealth health secretary means the secretary of the department of the Commonwealth in which the National Health Security Act 2007 (Cwlth) is administered. national stockpile medicine means a medicine supplied in the first instance from a reserve of stock of medicines held by the Commonwealth health secretary in stockpile for a health emergency. responsible government entity means an entity of the State or Commonwealth responsible for managing the distribution of stock of national stockpile medicines. s 6B ins 2024 SL No. 102 s 4 (sec.6B-ssec.1) For section 7 (1) of the Act , the activities prescribed are buying or supplying stock of a national stockpile medicine. (sec.6B-ssec.2) However, each activity is prescribed only to the extent it is carried out by— a responsible government entity; or a person acting under a direction given by a responsible government entity. (sec.6B-ssec.3) In this section— Commonwealth health secretary means the secretary of the department of the Commonwealth in which the National Health Security Act 2007 (Cwlth) is administered. national stockpile medicine means a medicine supplied in the first instance from a reserve of stock of medicines held by the Commonwealth health secretary in stockpile for a health emergency. responsible government entity means an entity of the State or Commonwealth responsible for managing the distribution of stock of national stockpile medicines.
For section 7 (1) of the Act , the activities prescribed are buying, supplying or possessing stock of an immunisation medicine. However, each activity is prescribed only to the extent— the stock is originally supplied to a registered immunisation service provider by the department; and the activity is for transferring stock from 1 registered immunisation service provider to another registered immunisation service provider; and if the activity is supplying the stock—the registered immunisation service provider supplying the stock notifies the chief executive of the supply as soon as practicable after the supply happens. s 6C ins 2025 SL No. 19 s 4 (sec.6C-ssec.1) For section 7 (1) of the Act , the activities prescribed are buying, supplying or possessing stock of an immunisation medicine. (sec.6C-ssec.2) However, each activity is prescribed only to the extent— the stock is originally supplied to a registered immunisation service provider by the department; and the activity is for transferring stock from 1 registered immunisation service provider to another registered immunisation service provider; and if the activity is supplying the stock—the registered immunisation service provider supplying the stock notifies the chief executive of the supply as soon as practicable after the supply happens.
For section 232 (4) of the Act , each extended practice authority mentioned in schedule 1 , part 1 is approved. See section 232 (4) of the Act for when an extended practice authority takes effect. A reference in this regulation to an extended practice authority by its name is a reference to the extended practice authority mentioned in schedule 1 , part 1 — with that name; and with the version number mentioned opposite that name. (sec.7-ssec.1) For section 232 (4) of the Act , each extended practice authority mentioned in schedule 1 , part 1 is approved. See section 232 (4) of the Act for when an extended practice authority takes effect. (sec.7-ssec.2) A reference in this regulation to an extended practice authority by its name is a reference to the extended practice authority mentioned in schedule 1 , part 1 — with that name; and with the version number mentioned opposite that name.
For section 233 (4) of the Act , each departmental standard mentioned in schedule 1 , part 2 is approved. See section 233 (4) of the Act for when a departmental standard takes effect. A reference in this regulation to a departmental standard by its name is a reference to the standard mentioned in schedule 1 , part 2 — with that name; and with the version number mentioned opposite that name. (sec.8-ssec.1) For section 233 (4) of the Act , each departmental standard mentioned in schedule 1 , part 2 is approved. See section 233 (4) of the Act for when a departmental standard takes effect. (sec.8-ssec.2) A reference in this regulation to a departmental standard by its name is a reference to the standard mentioned in schedule 1 , part 2 — with that name; and with the version number mentioned opposite that name.
A medicine mentioned in schedule 2 , part 1 is a restricted medicine .
For section 40 (3) of the Act , definition high-risk medicine , a medicine mentioned in schedule 2 , part 2 is prescribed to be a high-risk medicine.
For schedule 1 of the Act , definition diversion-risk medicine , a medicine mentioned in schedule 2 , part 3 is prescribed to be a diversion-risk medicine.
For schedule 1 of the Act , definition monitored medicine , a medicine mentioned in schedule 2 , part 4 is prescribed to be a monitored medicine.
For section 54 (1) of the Act , a class of persons stated in a relevant schedule is prescribed for the dealing with the medicine stated in the table in the schedule for the class of persons to the extent the dealing is carried out by a person acting— as a member of the class of persons; and within the scope for the dealing, if any. A pharmacist is prescribed for a dealing with a medicine stated in the table in schedule 9 , section 2 to the extent the pharmacist is practising the pharmacy profession and acting within the scope of the dealing stated in column 3 of the table. A principal of a school is prescribed for a dealing with a medicine stated in the table in schedule 13 , section 9 to the extent of acting as the principal for the school within the scope stated for the dealing in column 3 of the table. In this section— relevant schedule means any of schedules 3 to 15 . scope , for a dealing with a medicine, means a circumstance, purpose, extended practice authority or other matter stated in a table in a relevant schedule for the dealing. (sec.13-ssec.1) For section 54 (1) of the Act , a class of persons stated in a relevant schedule is prescribed for the dealing with the medicine stated in the table in the schedule for the class of persons to the extent the dealing is carried out by a person acting— as a member of the class of persons; and within the scope for the dealing, if any. A pharmacist is prescribed for a dealing with a medicine stated in the table in schedule 9 , section 2 to the extent the pharmacist is practising the pharmacy profession and acting within the scope of the dealing stated in column 3 of the table. A principal of a school is prescribed for a dealing with a medicine stated in the table in schedule 13 , section 9 to the extent of acting as the principal for the school within the scope stated for the dealing in column 3 of the table. (sec.13-ssec.2) In this section— relevant schedule means any of schedules 3 to 15 . scope , for a dealing with a medicine, means a circumstance, purpose, extended practice authority or other matter stated in a table in a relevant schedule for the dealing.
For section 68 (2) of the Act , this part prescribes classes of general approvals.
A general approval (acute health conditions at isolated sites) is prescribed for the classes of persons mentioned in column 1 of the table in schedule 16 , section 2 for carrying out the dealings with the medicines mentioned opposite in column 2, for the purpose of treating acute health conditions.
A general approval (emergency first aid) is prescribed for the classes of persons mentioned in column 1 of the table in schedule 16 , section 4 for carrying out the dealings with the medicines mentioned opposite in column 2, for the purpose of providing first aid in an emergency.
A general approval (emergency management of animals) is prescribed for the classes of persons mentioned in column 1 of the table in schedule 16 , section 6 for carrying out the dealings with the medicines mentioned opposite in column 2, for the purpose of the emergency care and treatment of sick, injured or orphaned animals.
For section 70 (1) (a) of the Act , this chapter prescribes standard conditions applying in relation to substance authorities authorising dealings with medicines. See also chapters 4 and 5 about requirements prescribed under section 91 (1) of the Act .
This division applies in relation to a manufacturing licence authorising the manufacture of a medicine.
The holder of a manufacturing licence must appoint an appropriately qualified person to supervise manufacturing under the licence. The holder must take all reasonable steps to ensure the medicine is manufactured under the supervision of the person mentioned in subsection (1) . (sec.20-ssec.1) The holder of a manufacturing licence must appoint an appropriately qualified person to supervise manufacturing under the licence. (sec.20-ssec.2) The holder must take all reasonable steps to ensure the medicine is manufactured under the supervision of the person mentioned in subsection (1) .
The holder of a manufacturing licence must take all reasonable steps to ensure a medicine manufactured under the licence is fit for its intended use and free from contamination. The holder is taken to comply with subsection (1) if the holder complies with a code, guideline, standard or quality assurance scheme that is recognised for promoting best practice in the industry for the type of manufacturing authorised under the licence. (sec.21-ssec.1) The holder of a manufacturing licence must take all reasonable steps to ensure a medicine manufactured under the licence is fit for its intended use and free from contamination. (sec.21-ssec.2) The holder is taken to comply with subsection (1) if the holder complies with a code, guideline, standard or quality assurance scheme that is recognised for promoting best practice in the industry for the type of manufacturing authorised under the licence.
The holder of a manufacturing licence must keep an authorised place stated in the licence open for inspection during the times the place is open for carrying on business or otherwise open for entry.
This division applies in relation to a manufacturing licence authorising the supply of medicated feed to a person who is a farmer of a group of animals.
The holder of a manufacturing licence must not supply medicated feed to a farmer of a group of animals unless the farmer has a written prescription for the feed from a veterinary surgeon.
When supplying medicated feed to a farmer of a group of animals, the holder of a manufacturing licence must give the farmer a document stating the following information— a unique identifier for the document; the date of the supply; the name and address of the farmer; the unique identifier on the prescription held by the farmer; details about the form, strength and amount of the feed supplied. If the medicated feed is to be delivered to the farmer, the address mentioned in subsection (1) (c) must be the street address for delivery of the feed. The holder must— keep a copy of the document or a record of the details contained in the document; and See section 224 about keeping records. give a copy of the document to the veterinary surgeon who prescribed the feed, if asked to do so by the veterinary surgeon. (sec.25-ssec.1) When supplying medicated feed to a farmer of a group of animals, the holder of a manufacturing licence must give the farmer a document stating the following information— a unique identifier for the document; the date of the supply; the name and address of the farmer; the unique identifier on the prescription held by the farmer; details about the form, strength and amount of the feed supplied. (sec.25-ssec.2) If the medicated feed is to be delivered to the farmer, the address mentioned in subsection (1) (c) must be the street address for delivery of the feed. (sec.25-ssec.3) The holder must— keep a copy of the document or a record of the details contained in the document; and See section 224 about keeping records. give a copy of the document to the veterinary surgeon who prescribed the feed, if asked to do so by the veterinary surgeon.
This section applies if the holder of a manufacturing licence delivers, or arranges for delivery of, medicated feed to a farmer of a group of animals. The holder must ensure a notice stating the name of the farmer and the street address for delivery— is attached to the medicated feed; or if it is not reasonably practicable to attach the notice to the feed—accompanies the medicated feed. a notice is sent in a truck carrying medicated feed supplied in bulk for delivery directly to a silo (sec.26-ssec.1) This section applies if the holder of a manufacturing licence delivers, or arranges for delivery of, medicated feed to a farmer of a group of animals. (sec.26-ssec.2) The holder must ensure a notice stating the name of the farmer and the street address for delivery— is attached to the medicated feed; or if it is not reasonably practicable to attach the notice to the feed—accompanies the medicated feed. a notice is sent in a truck carrying medicated feed supplied in bulk for delivery directly to a silo
The holder of an S2 retail licence must not sell an S2 medicine under the licence within 25km in a direct route from a pharmacy. However, subsection (3) applies if, during the term of the S2 retail licence, a new pharmacy opens within 25km in a direct route from an authorised place stated in the licence. For a period of up to 6 months from the day the pharmacy opens, the holder may sell any S2 medicines bought under the licence before the pharmacy opened. In this section— direct route , in relation to 2 places, means the most direct route between the places, calculated using the distance of the roads on the route between the places. (sec.27-ssec.1) The holder of an S2 retail licence must not sell an S2 medicine under the licence within 25km in a direct route from a pharmacy. (sec.27-ssec.2) However, subsection (3) applies if, during the term of the S2 retail licence, a new pharmacy opens within 25km in a direct route from an authorised place stated in the licence. (sec.27-ssec.3) For a period of up to 6 months from the day the pharmacy opens, the holder may sell any S2 medicines bought under the licence before the pharmacy opened. (sec.27-ssec.4) In this section— direct route , in relation to 2 places, means the most direct route between the places, calculated using the distance of the roads on the route between the places.
The holder of an S2 retail licence must not sell an S2 medicine other than in a manufacturer’s pack.
The holder of an S2 retail licence must keep an authorised place stated in the licence open for inspection during the times the place is open for carrying on business or otherwise open for entry.
This part applies in relation to a prescribing approval authorising a dealing with an approved opioid under an opioid treatment program. See also the requirements for prescribing medicines under chapter 4 , part 6 .
If the holder of a prescribing approval starts treating a patient under an opioid treatment program, the holder must ensure notice is given to the chief executive in the approved form. The notice must be given to the chief executive as soon as practicable, but no later than the end of the next business day, after the treatment starts. If the holder stops treating the patient, the holder must ensure notice is given to the chief executive in the approved form as soon as practicable, but no later than 3 business days, after the treatment stops. (sec.31-ssec.1) If the holder of a prescribing approval starts treating a patient under an opioid treatment program, the holder must ensure notice is given to the chief executive in the approved form. (sec.31-ssec.2) The notice must be given to the chief executive as soon as practicable, but no later than the end of the next business day, after the treatment starts. (sec.31-ssec.3) If the holder stops treating the patient, the holder must ensure notice is given to the chief executive in the approved form as soon as practicable, but no later than 3 business days, after the treatment stops.
The holder of a general approval (acute health conditions at isolated sites) must appoint a medical practitioner or nurse practitioner who is appropriately qualified to oversee the dealings authorised under the approval.
The holder of a general approval (acute health conditions at isolated sites) must take all reasonable steps to ensure a medical practitioner or nurse practitioner is available to be contacted when a dealing is carried out under the approval.
The holder of a general approval (emergency first aid) must appoint a medical practitioner or nurse practitioner who is appropriately qualified to oversee the dealings authorised under the approval.
The holder of a general approval (emergency first aid) must give notice to the chief executive if a registered nurse, first aid provider or paramedic intends to attend an event under the approval. The notice must be given in the approved form no less than 2 business days before the event happens. (sec.35-ssec.1) The holder of a general approval (emergency first aid) must give notice to the chief executive if a registered nurse, first aid provider or paramedic intends to attend an event under the approval. (sec.35-ssec.2) The notice must be given in the approved form no less than 2 business days before the event happens.
The holder of a general approval (emergency first aid) must take all reasonable steps to ensure a medical practitioner or nurse practitioner is available to be contacted when a registered nurse, first aid provider or paramedic is attending an event or site under the approval.
The holder of a general approval (emergency management of animals) must appoint a veterinary surgeon who is appropriately qualified to oversee the dealings authorised under the approval.
The holder of a general approval (emergency management of animals) must take all reasonable steps to ensure a veterinary surgeon is available to be contacted when a person is likely to be caring for or treating sick, injured or orphaned animals under the approval.
This part applies in relation to all substance authorities authorising dealings with medicines.
The holder of a substance authority must keep any invoice received for any medicine supplied to the holder for a dealing under the authority.
The holder of a substance authority must ensure any records required to be kept under the Act in relation to an authorised place stated in the authority are available for inspection at the place. However, if the records are kept electronically, the holder must ensure the records for each authorised place stated in the authority are available for inspection from the primary place of business of the holder. (sec.41-ssec.1) The holder of a substance authority must ensure any records required to be kept under the Act in relation to an authorised place stated in the authority are available for inspection at the place. (sec.41-ssec.2) However, if the records are kept electronically, the holder must ensure the records for each authorised place stated in the authority are available for inspection from the primary place of business of the holder.
The holder of a substance authority must give notice to the chief executive in the approved form if any of the following changes are proposed by the holder— a change to an authorised place stated in the authority; a change to a relevant person stated in the authority; if the substance authority is a manufacturing licence—a change to the person who is appointed to supervise manufacturing under the licence; another change to the holder’s circumstances that substantially affects the holder’s ability to comply with a condition of the authority. a fire at an authorised place stated in a wholesale licence damages stock of medicines and the security system at the place The notice must be given as soon as practicable, but no later than 5 business days, after the change of circumstances happens. (sec.42-ssec.1) The holder of a substance authority must give notice to the chief executive in the approved form if any of the following changes are proposed by the holder— a change to an authorised place stated in the authority; a change to a relevant person stated in the authority; if the substance authority is a manufacturing licence—a change to the person who is appointed to supervise manufacturing under the licence; another change to the holder’s circumstances that substantially affects the holder’s ability to comply with a condition of the authority. a fire at an authorised place stated in a wholesale licence damages stock of medicines and the security system at the place (sec.42-ssec.2) The notice must be given as soon as practicable, but no later than 5 business days, after the change of circumstances happens.
This section applies if a holder of a substance authority proposes to stop carrying out a dealing with a medicine under the substance authority. The holder must give the chief executive a notice in the approved form stating the following information— the day the dealing is proposed to stop; the amount of medicine that is likely to be unused on the day mentioned in paragraph (a) , if any; how the holder proposes to deal with any unused medicine. (sec.43-ssec.1) This section applies if a holder of a substance authority proposes to stop carrying out a dealing with a medicine under the substance authority. (sec.43-ssec.2) The holder must give the chief executive a notice in the approved form stating the following information— the day the dealing is proposed to stop; the amount of medicine that is likely to be unused on the day mentioned in paragraph (a) , if any; how the holder proposes to deal with any unused medicine.
For section 91 (1) of the Act , this chapter prescribes requirements, for a person authorised under section 54 (4) or 62 of the Act to deal with a medicine, in relation to carrying out the dealing. This chapter applies to the person in addition to chapter 5 , unless otherwise stated. See section 91 (3) of the Act in relation to the matters to which the requirements under this chapter are subject. This chapter does not apply in relation to persons authorised to deal with a medicine under section 57 of the Act which relates to emergency orders. (sec.44-ssec.1) For section 91 (1) of the Act , this chapter prescribes requirements, for a person authorised under section 54 (4) or 62 of the Act to deal with a medicine, in relation to carrying out the dealing. (sec.44-ssec.2) This chapter applies to the person in addition to chapter 5 , unless otherwise stated.
This part applies to a person who is authorised to manufacture a medicine by compounding it.
A person compounding a medicine must take all reasonable steps to ensure the medicine is fit for its intended use and free from contamination.
A person compounding a medicine for a patient must compound the medicine in accordance with the departmental standard called ‘Compounding’.
This part applies to a person (a buyer ) who is authorised to give a purchase order for stock of an S4 or S8 medicine. See also section 34 of the Act in relation to exclusions for buying particular S4 and S8 medicines. See part 4 for requirements about supplying stock. See also chapter 8 , part 4 about recording and keeping information.
buyer see section 48 . supplier means a person authorised under the Act , or permitted under a corresponding law or another law, to supply stock of an S4 or S8 medicine.
A buyer must give a supplier of an S4 or S8 medicine a purchase order before or at the time of supply of the stock.
A buyer must make a written purchase order for stock of an S4 or S8 medicine and send it to the supplier in a way that is reasonably likely to— minimise fraud or tampering; and if sent electronically—be transmitted securely. the white space on the purchase order is marked with hatching to prevent additional information being added the purchase order is sent using an electronic system which locks when not in use by a person with a unique identifier The buyer must sign the purchase order or use the buyer’s unique identifier in the purchase order. the buyer has a unique username or account number that is shown on the purchase order when the buyer uses a secure ordering website The buyer must not amend the purchase order once it is made without clearly showing the amendments in the purchase order. the buyer changes the brand name for a medicine stated in the purchase order and initials the order next to the change (sec.51-ssec.1) A buyer must make a written purchase order for stock of an S4 or S8 medicine and send it to the supplier in a way that is reasonably likely to— minimise fraud or tampering; and if sent electronically—be transmitted securely. the white space on the purchase order is marked with hatching to prevent additional information being added the purchase order is sent using an electronic system which locks when not in use by a person with a unique identifier (sec.51-ssec.2) The buyer must sign the purchase order or use the buyer’s unique identifier in the purchase order. the buyer has a unique username or account number that is shown on the purchase order when the buyer uses a secure ordering website (sec.51-ssec.3) The buyer must not amend the purchase order once it is made without clearly showing the amendments in the purchase order. the buyer changes the brand name for a medicine stated in the purchase order and initials the order next to the change
A buyer must state the following information in a purchase order for stock of an S4 or S8 medicine— a unique identifier for the purchase order; the date the purchase order is made; the name and address of the buyer; if the stock is to be delivered— the street address of the buyer; or an authorised place at which the buyer is authorised to possess the stock; or if the stock is to be delivered to a hospital—the name of the hospital; the details of the buyer’s authorisation to give the purchase order; the name, form and strength of the stock sought; the amount of the stock sought.
This section applies in relation to stock of an S8 medicine. On the day a buyer receives the stock, the buyer must— sign the purchase order for the stock or another notice to confirm the buyer has received all of the stock; or if the stock is delivered to the buyer—ensure a signed notice is sent to the supplier to confirm the buyer has received all of the stock. If the stock is bought for a pharmacy, a pharmacist from the pharmacy must sign the purchase order or notice confirming receipt of the stock. The buyer must keep a copy of a notice sent to the supplier under subsection (2) (b) . See section 224 about keeping records. See also chapter 8 , part 2 , division 3 about recording stock received in a medicine register. (sec.53-ssec.1) This section applies in relation to stock of an S8 medicine. (sec.53-ssec.2) On the day a buyer receives the stock, the buyer must— sign the purchase order for the stock or another notice to confirm the buyer has received all of the stock; or if the stock is delivered to the buyer—ensure a signed notice is sent to the supplier to confirm the buyer has received all of the stock. (sec.53-ssec.3) If the stock is bought for a pharmacy, a pharmacist from the pharmacy must sign the purchase order or notice confirming receipt of the stock. (sec.53-ssec.4) The buyer must keep a copy of a notice sent to the supplier under subsection (2) (b) .
This part applies to a person who is authorised (a supplier ) to supply stock of a medicine. This part applies in relation to the supply of stock of a medicine for— retail on-sale; or use by, or in connection with, carrying on a business, industry, profession or trade. supply to a midwife for a birthing kit supply to the principal of a school for stocking the school However, this part does not apply in relation to the supply of medicated feed to a farmer of a group of animals. See chapter 3 , part 2 , division 2 about holders of manufacturing licences supplying medicated feed. See also chapter 8 , part 4 about recording and keeping information. (sec.54-ssec.1) This part applies to a person who is authorised (a supplier ) to supply stock of a medicine. (sec.54-ssec.2) This part applies in relation to the supply of stock of a medicine for— retail on-sale; or use by, or in connection with, carrying on a business, industry, profession or trade. supply to a midwife for a birthing kit supply to the principal of a school for stocking the school (sec.54-ssec.3) However, this part does not apply in relation to the supply of medicated feed to a farmer of a group of animals.
In this part— buyer means a person buying stock. supplier see section 54 .
This section applies in relation to stock of an S4 or S8 medicine. A supplier must not supply the stock to a buyer unless— the supplier reasonably believes that the buyer— is authorised under the Act to give a purchase order or otherwise buy the stock; or is permitted under a corresponding law or another law to obtain the stock; and the supplier obtains a compliant purchase order for the stock from the buyer. If the buyer is the master of a ship mentioned in schedule 13 , section 19 , the supplier must not supply the stock unless the purchase order is also signed by a medical practitioner. Subsection (3) does not apply if the stock is required to be kept on the ship under another law. In this section— compliant purchase order means— a purchase order given in compliance with sections 51 and 52 ; or an eligible order under the National Health (Remote Area Aboriginal Health Services Program) Special Arrangement 2017 (PB 107 of 2017) (Cwlth) ; or an order complying with the National Health (Pharmaceutical Benefits) Regulations 2017 (Cwlth) , section 33 . The National Health (Pharmaceutical Benefits) Regulations 2017 (Cwlth) , section 33 allows particular pharmaceutical benefits to be supplied by pharmacists to particular health practitioners using an order complying with that section. (sec.56-ssec.1) This section applies in relation to stock of an S4 or S8 medicine. (sec.56-ssec.2) A supplier must not supply the stock to a buyer unless— the supplier reasonably believes that the buyer— is authorised under the Act to give a purchase order or otherwise buy the stock; or is permitted under a corresponding law or another law to obtain the stock; and the supplier obtains a compliant purchase order for the stock from the buyer. (sec.56-ssec.3) If the buyer is the master of a ship mentioned in schedule 13 , section 19 , the supplier must not supply the stock unless the purchase order is also signed by a medical practitioner. (sec.56-ssec.4) Subsection (3) does not apply if the stock is required to be kept on the ship under another law. (sec.56-ssec.5) In this section— compliant purchase order means— a purchase order given in compliance with sections 51 and 52 ; or an eligible order under the National Health (Remote Area Aboriginal Health Services Program) Special Arrangement 2017 (PB 107 of 2017) (Cwlth) ; or an order complying with the National Health (Pharmaceutical Benefits) Regulations 2017 (Cwlth) , section 33 . The National Health (Pharmaceutical Benefits) Regulations 2017 (Cwlth) , section 33 allows particular pharmaceutical benefits to be supplied by pharmacists to particular health practitioners using an order complying with that section.
This section applies in relation to stock of an S2 or S3 medicine sought by a buyer for an authorised facility. A supplier must not supply the stock to the buyer unless— the supplier reasonably believes the buyer is permitted by the buyer’s employer to buy the stock for the authorised facility; and the supplier reasonably believes the buyer has a reasonable need for the stock, and the amount of stock sought, for the facility; and the supplier receives a purchase order for the stock signed by the buyer; and if the stock is to be delivered—the supplier obtains a street address for delivery of the stock. In this section— authorised facility means— a community pharmacy; or a specified place. (sec.57-ssec.1) This section applies in relation to stock of an S2 or S3 medicine sought by a buyer for an authorised facility. (sec.57-ssec.2) A supplier must not supply the stock to the buyer unless— the supplier reasonably believes the buyer is permitted by the buyer’s employer to buy the stock for the authorised facility; and the supplier reasonably believes the buyer has a reasonable need for the stock, and the amount of stock sought, for the facility; and the supplier receives a purchase order for the stock signed by the buyer; and if the stock is to be delivered—the supplier obtains a street address for delivery of the stock. (sec.57-ssec.3) In this section— authorised facility means— a community pharmacy; or a specified place.
This section applies in relation to stock of an S2 or S3 medicine sought by a buyer for practising a buyer’s profession, other than at an authorised facility under section 57 . A supplier must not supply the stock to a buyer unless— the supplier reasonably believes the buyer is authorised under the Act , or permitted under a corresponding law or another law, to administer the medicine without a prescription; and the supplier reasonably believes the buyer has a reasonable need for the stock and the amount of stock sought; and the supplier receives a purchase order for the stock signed by the buyer; and if the stock is to be delivered—the supplier obtains a street address for delivery of the stock. (sec.58-ssec.1) This section applies in relation to stock of an S2 or S3 medicine sought by a buyer for practising a buyer’s profession, other than at an authorised facility under section 57 . (sec.58-ssec.2) A supplier must not supply the stock to a buyer unless— the supplier reasonably believes the buyer is authorised under the Act , or permitted under a corresponding law or another law, to administer the medicine without a prescription; and the supplier reasonably believes the buyer has a reasonable need for the stock and the amount of stock sought; and the supplier receives a purchase order for the stock signed by the buyer; and if the stock is to be delivered—the supplier obtains a street address for delivery of the stock.
This section applies in relation to stock of an S2 or S3 medicine sought by a buyer for manufacture or on-sale, other than at an authorised facility under section 57 . A supplier must not supply the stock to a buyer unless— the supplier reasonably believes the buyer is authorised under the Act , or permitted under a corresponding law or another law, to manufacture or sell the medicine; and the supplier receives a purchase order for the stock signed by the buyer; and if the stock is to be delivered—the supplier obtains a street address for delivery of the stock. (sec.59-ssec.1) This section applies in relation to stock of an S2 or S3 medicine sought by a buyer for manufacture or on-sale, other than at an authorised facility under section 57 . (sec.59-ssec.2) A supplier must not supply the stock to a buyer unless— the supplier reasonably believes the buyer is authorised under the Act , or permitted under a corresponding law or another law, to manufacture or sell the medicine; and the supplier receives a purchase order for the stock signed by the buyer; and if the stock is to be delivered—the supplier obtains a street address for delivery of the stock.
This section applies in relation to stock of any medicine. A supplier must not supply stock of a medicine to a buyer if the supplier reasonably suspects— the purchase order for the stock has been unlawfully obtained or made; or the purchase order for the stock has been fulfilled or cancelled. Also, the supplier must not supply the stock if the date stated on the purchase order is more than 1 year before the day on which the stock is proposed to be supplied. (sec.60-ssec.1) This section applies in relation to stock of any medicine. (sec.60-ssec.2) A supplier must not supply stock of a medicine to a buyer if the supplier reasonably suspects— the purchase order for the stock has been unlawfully obtained or made; or the purchase order for the stock has been fulfilled or cancelled. (sec.60-ssec.3) Also, the supplier must not supply the stock if the date stated on the purchase order is more than 1 year before the day on which the stock is proposed to be supplied.
On the supply of stock of a medicine to a buyer, a supplier must give the buyer an invoice or other notice (a notice ) stating the following information— a unique identifier for the notice; the date of the supply; the name and address of the buyer; if the stock is delivered—the place to which the stock is delivered; the details of the buyer’s authorisation or permission to buy the stock; the name, form and strength of the medicine supplied; the amount of stock of the medicine supplied. The supplier must keep a copy of the notice or a record of the details contained in the notice. See section 224 about keeping records. (sec.61-ssec.1) On the supply of stock of a medicine to a buyer, a supplier must give the buyer an invoice or other notice (a notice ) stating the following information— a unique identifier for the notice; the date of the supply; the name and address of the buyer; if the stock is delivered—the place to which the stock is delivered; the details of the buyer’s authorisation or permission to buy the stock; the name, form and strength of the medicine supplied; the amount of stock of the medicine supplied. (sec.61-ssec.2) The supplier must keep a copy of the notice or a record of the details contained in the notice. See section 224 about keeping records.
When supplying stock of a medicine, a supplier must— mark the purchase order for the stock in a way that shows the order has been supplied and, if applicable, delivered; and keep a copy of the marked purchase order.
This division applies if a supplier delivers, or arranges delivery of, stock of a medicine to a buyer.
A supplier must ensure stock of a medicine is— sealed in a securely closed package that is likely to show if the package breaks or anyone tampers with it; and clearly labelled with the name of the buyer of the medicine and street address for delivery stated on the purchase order for the stock or otherwise obtained by the supplier.
This section applies in relation to stock that includes an S8 medicine. A supplier must ensure the stock is packaged for delivery in a way that does not— mix the S8 medicine with anything other than other S8 medicines; or label or mark the packaging with a statement indicating it contains an S8 medicine. (sec.65-ssec.1) This section applies in relation to stock that includes an S8 medicine. (sec.65-ssec.2) A supplier must ensure the stock is packaged for delivery in a way that does not— mix the S8 medicine with anything other than other S8 medicines; or label or mark the packaging with a statement indicating it contains an S8 medicine.
A supplier must not engage a carrier to deliver stock of a medicine unless the supplier reasonably considers the carrier is capable of complying with— for stock of an S4 or S8 medicine—the requirements in part 5 ; or for stock of an S2 or S3 medicine— section 220 . Before arranging with the carrier to deliver the stock, the supplier must notify the carrier of the temperature limits for the stock that are recommended by the manufacturer of the medicine. See section 76 about carriers storing medicines within notified temperature limits. (sec.66-ssec.1) A supplier must not engage a carrier to deliver stock of a medicine unless the supplier reasonably considers the carrier is capable of complying with— for stock of an S4 or S8 medicine—the requirements in part 5 ; or for stock of an S2 or S3 medicine— section 220 . (sec.66-ssec.2) Before arranging with the carrier to deliver the stock, the supplier must notify the carrier of the temperature limits for the stock that are recommended by the manufacturer of the medicine. See section 76 about carriers storing medicines within notified temperature limits.
A supplier must deliver, or arrange delivery of, stock of a medicine to the street address stated on the purchase order for the stock or otherwise obtained by the supplier. Under sections 57 to 59 , the supplier must obtain the street address for delivery of stock of S2 and S3 medicines. Under section 52 , the street address for delivery of stock must be stated on the purchase order.
This section applies in relation to stock that includes an S8 medicine. A supplier must obtain a signed notice acknowledging receipt of the delivery of the stock from the buyer of the stock, or from an adult acting, or purportedly acting, on behalf of the buyer at the buyer’s street address. The supplier must keep the notice. See section 224 about keeping records. (sec.68-ssec.1) This section applies in relation to stock that includes an S8 medicine. (sec.68-ssec.2) A supplier must obtain a signed notice acknowledging receipt of the delivery of the stock from the buyer of the stock, or from an adult acting, or purportedly acting, on behalf of the buyer at the buyer’s street address. (sec.68-ssec.3) The supplier must keep the notice. See section 224 about keeping records.
This section applies if a supplier has not received from a buyer a notice of receipt mentioned in section 53 within 5 business days after the date of delivery of stock of a medicine. The supplier must give a notice to the chief executive in the approved form about the buyer’s failure to confirm receipt. (sec.69-ssec.1) This section applies if a supplier has not received from a buyer a notice of receipt mentioned in section 53 within 5 business days after the date of delivery of stock of a medicine. (sec.69-ssec.2) The supplier must give a notice to the chief executive in the approved form about the buyer’s failure to confirm receipt.
A supplier must take all reasonable steps to— ensure stock of a medicine is handled for the supplier only by an appropriately qualified adult employed by the supplier; and make and keep records showing the details of any stock given to a wholesale representative of the supplier; and See section 224 about keeping records. ensure each wholesale representative of the supplier is aware of requirements under the Act applying to the supplier and representative. This section does not apply to a pharmacist or pharmacy employee dealing with stock at a pharmacy. See chapter 5 , parts 2 and 3 for requirements that apply to pharmacists and pharmacy employees. (sec.70-ssec.1) A supplier must take all reasonable steps to— ensure stock of a medicine is handled for the supplier only by an appropriately qualified adult employed by the supplier; and make and keep records showing the details of any stock given to a wholesale representative of the supplier; and See section 224 about keeping records. ensure each wholesale representative of the supplier is aware of requirements under the Act applying to the supplier and representative. (sec.70-ssec.2) This section does not apply to a pharmacist or pharmacy employee dealing with stock at a pharmacy. See chapter 5 , parts 2 and 3 for requirements that apply to pharmacists and pharmacy employees.
A supplier must comply with, and take all reasonable steps to ensure a person employed by the supplier complies with, the document called the ‘Australian code of good wholesaling practice for medicines in schedules 2, 3, 4 and 8 ’ that— was made on 1 April 2011 by the former Commonwealth entity known as the National Coordinating Committee on Therapeutic Goods; and is published by the Therapeutic Goods Administration.
A supplier must not supply stock of medicine other than in a manufacturer’s pack, unless the supplier is authorised to repackage the medicine.
A supplier must not supply stock of a medicine to a buyer unless the labelling on the medicine complies with— the labelling requirements for the medicine stated in the Poisons Standard, part 2 , division 2 ; or if an alternative way for labelling the medicine is approved, or taken to be approved, under section 237 —the alternative way. A supplier must not supply stock of a medicine to a buyer unless the container of the medicine complies with— the requirements for containers for the medicine stated in the Poisons Standard, part 2 , division 3 ; or if an alternative way for packaging the medicine is approved, or taken to be approved, under section 237 —the alternative way. To remove any doubt, it is declared that subsections (1) (a) and (2) (a) do not apply to the supplier to the extent an exemption mentioned in the Poisons Standard applies to the labelling or packaging for the medicine. s 73 amd 2023 SL No. 170 s 5 (sec.73-ssec.1) A supplier must not supply stock of a medicine to a buyer unless the labelling on the medicine complies with— the labelling requirements for the medicine stated in the Poisons Standard, part 2 , division 2 ; or if an alternative way for labelling the medicine is approved, or taken to be approved, under section 237 —the alternative way. (sec.73-ssec.2) A supplier must not supply stock of a medicine to a buyer unless the container of the medicine complies with— the requirements for containers for the medicine stated in the Poisons Standard, part 2 , division 3 ; or if an alternative way for packaging the medicine is approved, or taken to be approved, under section 237 —the alternative way. (sec.73-ssec.3) To remove any doubt, it is declared that subsections (1) (a) and (2) (a) do not apply to the supplier to the extent an exemption mentioned in the Poisons Standard applies to the labelling or packaging for the medicine.
A supplier must keep an authorised place where the stock is kept open for inspection during the times the place is open for carrying on business or otherwise open for entry.
This part applies to a carrier who is authorised to possess an S4 or S8 medicine for the purposes of delivery. This part applies in relation to the delivery of stock of an S4 or S8 medicine other than medicated feed. See section 220 in relation to carriers delivering stock of S2 and S3 medicines. (sec.75-ssec.1) This part applies to a carrier who is authorised to possess an S4 or S8 medicine for the purposes of delivery. (sec.75-ssec.2) This part applies in relation to the delivery of stock of an S4 or S8 medicine other than medicated feed. See section 220 in relation to carriers delivering stock of S2 and S3 medicines.
A carrier must take all reasonable steps to keep stock of an S4 or S8 medicine being delivered by the carrier within any temperature limits for the stock notified to the carrier by the person who engaged the carrier to deliver the stock.
A carrier must not leave stock of an S4 or S8 medicine unattended, other than in a secure area.
A carrier must deliver stock of an S4 or S8 medicine to the street address stated on the packaging for the stock. The carrier must not leave the stock at the street address unless the carrier obtains a written receipt for the delivery of the stock from— the person named on the package for the stock; or an adult at the address acting, or purportedly acting, on behalf of the person mentioned in paragraph (a) . (sec.78-ssec.1) A carrier must deliver stock of an S4 or S8 medicine to the street address stated on the packaging for the stock. (sec.78-ssec.2) The carrier must not leave the stock at the street address unless the carrier obtains a written receipt for the delivery of the stock from— the person named on the package for the stock; or an adult at the address acting, or purportedly acting, on behalf of the person mentioned in paragraph (a) .
This part applies to a person (a prescriber ) who is authorised to prescribe a medicine. However, this part does not apply in relation to prescribing an S4 medicine or medicated feed for administration to a group of animals by a farmer of the animals. See chapter 5 , part 4 about veterinary surgeons prescribing S4 medicine and medicated feed. See also chapter 8 , part 4 about recording and keeping information. (sec.79-ssec.1) This part applies to a person (a prescriber ) who is authorised to prescribe a medicine. (sec.79-ssec.2) However, this part does not apply in relation to prescribing an S4 medicine or medicated feed for administration to a group of animals by a farmer of the animals. See chapter 5 , part 4 about veterinary surgeons prescribing S4 medicine and medicated feed. See also chapter 8 , part 4 about recording and keeping information.
In this part— medication chart prescription means— a prescription contained in a record for a patient or an animal that is kept at a place where a medicine is prescribed for the patient or animal and is not given to the patient or owner or custodian of the animal; or a medication chart or clinical record at a relevant institution or a patient record kept by a prescriber a national medication chart prescription. national medication chart prescription means a medication chart prescription under the National Health (Pharmaceutical Benefits) Regulations 2017 (Cwlth) , section 41 (1) .
A prescriber must not prescribe a medicine for a patient or an animal unless the prescriber assesses the medicine to be reasonably necessary for the therapeutic treatment of the patient or animal.
This subdivision applies if a prescriber makes a written prescription for dispensing or giving a treatment dose of a medicine for a patient or an animal. See division 4 about prescribing for administration. See section 92 about oral prescriptions for dispensing or giving treatment doses of S4 and S8 medicines.
A prescriber must not make an electronic prescription except by using an electronic prescription management system. See chapter 8 , part 1 about electronic prescription management systems.
A prescriber must not send a prescription for a medicine to another person using electronic communication except by— using an electronic prescription management system in accordance with any requirements for using the system; or sending a digital copy of a paper prescription to a person the prescriber reasonably believes is authorised to dispense or give a treatment dose of the medicine. Subsections (3) and (4) apply if the prescriber is sending a digital copy of a paper prescription to a person. If the medicine is a diversion-risk medicine, the prescriber must take all reasonable steps, before sending the digital copy, to ensure the following details are written on the paper prescription— the way in which the digital copy is being sent; the place to which the digital copy is being sent; the date on which the digital copy is being sent. A prescriber writes the words ‘emailed to Hypothetical Pharmacy, Brisbane on 1 January 2022’ on a paper prescription. After sending the digital copy, the prescriber must send the paper prescription to the person as soon as practicable, but no later than— if the prescription is for an S8 medicine—the end of the next business day after the digital copy was sent; or otherwise—7 days after the digital copy was sent. s 84 amd 2022 SL No. 77 s 4 (sec.84-ssec.1) A prescriber must not send a prescription for a medicine to another person using electronic communication except by— using an electronic prescription management system in accordance with any requirements for using the system; or sending a digital copy of a paper prescription to a person the prescriber reasonably believes is authorised to dispense or give a treatment dose of the medicine. (sec.84-ssec.2) Subsections (3) and (4) apply if the prescriber is sending a digital copy of a paper prescription to a person. (sec.84-ssec.3) If the medicine is a diversion-risk medicine, the prescriber must take all reasonable steps, before sending the digital copy, to ensure the following details are written on the paper prescription— the way in which the digital copy is being sent; the place to which the digital copy is being sent; the date on which the digital copy is being sent. A prescriber writes the words ‘emailed to Hypothetical Pharmacy, Brisbane on 1 January 2022’ on a paper prescription. (sec.84-ssec.4) After sending the digital copy, the prescriber must send the paper prescription to the person as soon as practicable, but no later than— if the prescription is for an S8 medicine—the end of the next business day after the digital copy was sent; or otherwise—7 days after the digital copy was sent.
This section applies if a prescriber uses a computer to generate a paper prescription. However, this section does not apply if a prescribing approval held by the prescriber states another way to use a computer to generate a paper prescription. The prescriber must ensure the following things are included on the paper prescription— a unique identifier that allows the prescription to be matched to a record kept by the prescriber for the patient or animal for which the medicine is prescribed; a space for the prescriber to include a handwritten signature other than a signature printed by the computer; either— the total number of medicines prescribed; or scoring or hatching of any blank space below or above the space for the prescriber’s handwritten signature. (sec.85-ssec.1) This section applies if a prescriber uses a computer to generate a paper prescription. (sec.85-ssec.2) However, this section does not apply if a prescribing approval held by the prescriber states another way to use a computer to generate a paper prescription. (sec.85-ssec.3) The prescriber must ensure the following things are included on the paper prescription— a unique identifier that allows the prescription to be matched to a record kept by the prescriber for the patient or animal for which the medicine is prescribed; a space for the prescriber to include a handwritten signature other than a signature printed by the computer; either— the total number of medicines prescribed; or scoring or hatching of any blank space below or above the space for the prescriber’s handwritten signature.
A prescriber must state the following information on a prescription for a medicine— the prescriber’s name or a unique identifier for the prescriber; the place where the prescriber usually practices; the prescriber’s phone number or pager number; the prescriber’s qualifications; the date of the prescription; if the medicine is for a patient— the patient’s name and address; and for a monitored medicine—the patient’s date of birth; if the medicine is for an animal— the species of the animal; and the name of the animal or another description that identifies the animal; and the name and address of the owner or custodian of the animal; and a statement that the medicine is for animal treatment only; the name of the medicine; the approved name or brand name of the medicine a description of the medicine to be compounded the form and strength of the medicine; how much of the medicine may be dispensed or given, including the number of repeats for the medicine, if any; instructions about using the medicine; the date for dispensing or giving the medicine, if applicable; if the medicine is a restricted medicine—the details of the prescriber’s authorisation to prescribe the restricted medicine. the identifying number of the prescribing approval held by the prescriber the qualifications of the prescriber Subsection (1) (b) , (c) and (d) do not apply if the prescription is a medication chart prescription. The prescriber is taken to comply with this section if the prescription is a national medication chart prescription. s 86 amd 2025 SL No. 148 s 4 (sec.86-ssec.1) A prescriber must state the following information on a prescription for a medicine— the prescriber’s name or a unique identifier for the prescriber; the place where the prescriber usually practices; the prescriber’s phone number or pager number; the prescriber’s qualifications; the date of the prescription; if the medicine is for a patient— the patient’s name and address; and for a monitored medicine—the patient’s date of birth; if the medicine is for an animal— the species of the animal; and the name of the animal or another description that identifies the animal; and the name and address of the owner or custodian of the animal; and a statement that the medicine is for animal treatment only; the name of the medicine; the approved name or brand name of the medicine a description of the medicine to be compounded the form and strength of the medicine; how much of the medicine may be dispensed or given, including the number of repeats for the medicine, if any; instructions about using the medicine; the date for dispensing or giving the medicine, if applicable; if the medicine is a restricted medicine—the details of the prescriber’s authorisation to prescribe the restricted medicine. the identifying number of the prescribing approval held by the prescriber the qualifications of the prescriber (sec.86-ssec.2) Subsection (1) (b) , (c) and (d) do not apply if the prescription is a medication chart prescription. (sec.86-ssec.3) The prescriber is taken to comply with this section if the prescription is a national medication chart prescription.
This section applies, in addition to section 86 , in relation to a written prescription for an S8 medicine. A prescriber must also state the following information on the prescription— if the prescription is a paper prescription—both words and numbers to describe how much of the medicine may be dispensed or given; the minimum number of days, of at least 1 day, before the medicine may be further dispensed or given on any repeats on the prescription; if the S8 medicine is a psychostimulant medicine— words to indicate the condition being treated; or the words ‘specified condition’ if the medicine is for the treatment of a specified condition. The prescriber is taken to comply with subsection (2) if the prescription is a national medication chart prescription. Subsection (5) applies if the prescriber is prescribing an approved opioid, other than on a medication chart prescription. The prescriber must also state the following information on the prescription— if the prescriber holds a prescribing approval for prescribing the opioid—the identifying number of the prescribing approval; the name of the place where the approved opioid is to be dispensed or given; instructions for how 1 or more doses of the medicine are to be dispensed or given, including the circumstances (if any) in which the patient may be given a dose; the start and end dates for when 1 or more doses of the opioid are to be dispensed or given. The prescriber may state different forms of a particular type of S8 medicine on the prescription but must not state more than 1 type of S8 medicine. In this section— specified condition means— ADHD; or brain injury; or narcolepsy. See section 95 about the content of prescriptions for administration by authorised persons. s 87 amd 2022 SL No. 77 s 5 ; 2025 SL No. 148 s 5 (sec.87-ssec.1) This section applies, in addition to section 86 , in relation to a written prescription for an S8 medicine. (sec.87-ssec.2) A prescriber must also state the following information on the prescription— if the prescription is a paper prescription—both words and numbers to describe how much of the medicine may be dispensed or given; the minimum number of days, of at least 1 day, before the medicine may be further dispensed or given on any repeats on the prescription; if the S8 medicine is a psychostimulant medicine— words to indicate the condition being treated; or the words ‘specified condition’ if the medicine is for the treatment of a specified condition. (sec.87-ssec.3) The prescriber is taken to comply with subsection (2) if the prescription is a national medication chart prescription. (sec.87-ssec.4) Subsection (5) applies if the prescriber is prescribing an approved opioid, other than on a medication chart prescription. (sec.87-ssec.5) The prescriber must also state the following information on the prescription— if the prescriber holds a prescribing approval for prescribing the opioid—the identifying number of the prescribing approval; the name of the place where the approved opioid is to be dispensed or given; instructions for how 1 or more doses of the medicine are to be dispensed or given, including the circumstances (if any) in which the patient may be given a dose; the start and end dates for when 1 or more doses of the opioid are to be dispensed or given. (sec.87-ssec.6) The prescriber may state different forms of a particular type of S8 medicine on the prescription but must not state more than 1 type of S8 medicine. (sec.87-ssec.7) In this section— specified condition means— ADHD; or brain injury; or narcolepsy.
A prescriber must sign a prescription. See section 89 (2) (d) about signing the prescription when using printed labels.
This section applies if a prescriber uses a printed label to record any information required under section 86 or 87 on a paper prescription. The prescriber must— use a printed label that is legible; and attach the label to the prescription in a way that it can not be easily removed; and place the label in a way that clearly connects the information to the patient or animal; and sign the label in a way that does not obscure the information on the printed label. (sec.89-ssec.1) This section applies if a prescriber uses a printed label to record any information required under section 86 or 87 on a paper prescription. (sec.89-ssec.2) The prescriber must— use a printed label that is legible; and attach the label to the prescription in a way that it can not be easily removed; and place the label in a way that clearly connects the information to the patient or animal; and sign the label in a way that does not obscure the information on the printed label.
A prescriber must not amend a prescription (the original prescription ) unless the prescriber made the prescription in the first instance. The prescriber must— sign and date the amendment handwritten on the original prescription; and ensure the amendment is made in a way that does not obscure the content of the original prescription. If the original prescription was printed from a computer, the prescription must be amended on a computer and printed again. If the original prescription was contained in an electronic prescription management system, the prescription must be cancelled in the system and remade if it needs amendment. (sec.90-ssec.1) A prescriber must not amend a prescription (the original prescription ) unless the prescriber made the prescription in the first instance. (sec.90-ssec.2) The prescriber must— sign and date the amendment handwritten on the original prescription; and ensure the amendment is made in a way that does not obscure the content of the original prescription. (sec.90-ssec.3) If the original prescription was printed from a computer, the prescription must be amended on a computer and printed again. (sec.90-ssec.4) If the original prescription was contained in an electronic prescription management system, the prescription must be cancelled in the system and remade if it needs amendment.
This subdivision applies if a prescriber prescribes a medicine for dispensing or giving a treatment dose for a patient. See subdivision 1 about written prescriptions for dispensing or giving treatment doses for patients and animals. See division 4 about prescribing for administration.
This section applies in relation to an S4 or S8 medicine. A prescriber must not give an oral prescription for the medicine except to a person whom the prescriber reasonably believes is authorised to dispense or give a treatment dose of the medicine. If the person dispenses or gives the medicine on the oral prescription, the prescriber must give the person a written prescription that confirms the oral prescription. The prescriber must give the written prescription to the person— for an S4 medicine—7 days after the oral prescription was given; or for an S8 medicine—as soon as practicable, but no later than the end of the next business day, after the oral prescription was given. This section does not apply if the medicine being prescribed is from an RFDS medicine chest kept by the Royal Flying Doctor Service of Australia. (sec.92-ssec.1) This section applies in relation to an S4 or S8 medicine. (sec.92-ssec.2) A prescriber must not give an oral prescription for the medicine except to a person whom the prescriber reasonably believes is authorised to dispense or give a treatment dose of the medicine. (sec.92-ssec.3) If the person dispenses or gives the medicine on the oral prescription, the prescriber must give the person a written prescription that confirms the oral prescription. (sec.92-ssec.4) The prescriber must give the written prescription to the person— for an S4 medicine—7 days after the oral prescription was given; or for an S8 medicine—as soon as practicable, but no later than the end of the next business day, after the oral prescription was given. (sec.92-ssec.5) This section does not apply if the medicine being prescribed is from an RFDS medicine chest kept by the Royal Flying Doctor Service of Australia.
This section applies if a prescriber prescribes a monitored medicine, whether orally or by written prescription. The prescriber must prescribe the medicine in accordance with the departmental standard called ‘Monitored medicines’. (sec.93-ssec.1) This section applies if a prescriber prescribes a monitored medicine, whether orally or by written prescription. (sec.93-ssec.2) The prescriber must prescribe the medicine in accordance with the departmental standard called ‘Monitored medicines’.
This subdivision applies if a prescriber makes a written prescription for administration of a medicine by another person to a patient or an animal. See subdivision 2 about oral prescriptions for administration to patients and animals. See division 3 about prescribing for dispensing or giving treatment doses for patients and animals.
A prescriber must state the following information on a prescription for a medicine— the prescriber’s name or a unique identifier for the prescriber; the date of the prescription; if the medicine is to be administered to a patient— the patient’s name and address; and for a monitored medicine—the patient’s date of birth; if the medicine is to be administered to an animal— the species of the animal; and the name of the animal or another description that identifies the animal; and the name and address of the owner or custodian of the animal; the name of the medicine; the approved name or brand name of the medicine a description of the medicine to be compounded the form and strength of the medicine; how much of the medicine may be administered; instructions about using the medicine.
This section applies, in addition to section 95 , if— a prescriber is the holder of a prescribing approval; and the prescriber is making a written prescription for the administration of an approved opioid, other than a medication chart prescription. The prescriber must also state the following information on the prescription— the identifying number of the prescribing approval, if any; the name of the place where the approved opioid is to be administered; instructions for how 1 or more doses of the opioid are to be administered; the start and end dates for when 1 or more doses of the opioid are to be administered. See sections 86 and 87 for requirements about prescriptions for dispensing or giving treatment doses. (sec.96-ssec.1) This section applies, in addition to section 95 , if— a prescriber is the holder of a prescribing approval; and the prescriber is making a written prescription for the administration of an approved opioid, other than a medication chart prescription. (sec.96-ssec.2) The prescriber must also state the following information on the prescription— the identifying number of the prescribing approval, if any; the name of the place where the approved opioid is to be administered; instructions for how 1 or more doses of the opioid are to be administered; the start and end dates for when 1 or more doses of the opioid are to be administered. See sections 86 and 87 for requirements about prescriptions for dispensing or giving treatment doses.
A prescriber must sign a prescription. See section 98 (2) (d) about signing the prescription when using printed labels.
This section applies if a prescriber uses a printed label to record any information required under section 95 or 96 on paper prescription. The prescriber must— use a printed label that is legible; and attach the label to the prescription in a way that it can not be easily removed; and place the label in a way that clearly connects the information to the patient or animal; and sign the label in a way that does not obscure the information on the printed label. (sec.98-ssec.1) This section applies if a prescriber uses a printed label to record any information required under section 95 or 96 on paper prescription. (sec.98-ssec.2) The prescriber must— use a printed label that is legible; and attach the label to the prescription in a way that it can not be easily removed; and place the label in a way that clearly connects the information to the patient or animal; and sign the label in a way that does not obscure the information on the printed label.
This subdivision applies if a prescriber orally prescribes a medicine for administration to a patient or an animal. See subdivision 1 about written prescriptions for administration to patients and animals. See division 3 about prescribing for dispensing or giving treatment doses.
A prescriber must not give an oral prescription for a medicine except to a person whom the prescriber reasonably believes is authorised to administer the medicine. If the medicine is an S8 medicine and the person administers the S8 medicine on the oral prescription, the prescriber must— give the person a written prescription that confirms the oral prescription; or sign another record made by the person at the time of the administration on the oral prescription. The written prescription must be given, or the signature made, as soon as practicable, but no later than the end of the next business day, after the medicine was administered. This section does not apply if the medicine being prescribed is from an RFDS medicine chest kept by the Royal Flying Doctor Service of Australia. (sec.100-ssec.1) A prescriber must not give an oral prescription for a medicine except to a person whom the prescriber reasonably believes is authorised to administer the medicine. (sec.100-ssec.2) If the medicine is an S8 medicine and the person administers the S8 medicine on the oral prescription, the prescriber must— give the person a written prescription that confirms the oral prescription; or sign another record made by the person at the time of the administration on the oral prescription. (sec.100-ssec.3) The written prescription must be given, or the signature made, as soon as practicable, but no later than the end of the next business day, after the medicine was administered. (sec.100-ssec.4) This section does not apply if the medicine being prescribed is from an RFDS medicine chest kept by the Royal Flying Doctor Service of Australia.
A clinical protocol is a standing order applying in relation to an approved person performing a procedure or diagnostic test at a place for practising any of the following professions— clinical perfusion; orthoptics; nuclear medicine technology; respiratory science; speech pathology.
This division applies to a person (a prescriber ) who is authorised to make a standing order. However, this division does not apply in relation to a standing order that is a clinical protocol. (sec.102-ssec.1) This division applies to a person (a prescriber ) who is authorised to make a standing order. (sec.102-ssec.2) However, this division does not apply in relation to a standing order that is a clinical protocol.
A prescriber must not make a standing order for a relevant institution unless— a medicines and therapeutics committee of the institution has approved the making of the order; and the order is signed by a member of the committee who is a prescriber authorised to make standing orders. In this section— medicines and therapeutics committee , of a relevant institution, means a committee— established by the institution to approve standing orders for the administration or giving of treatment doses of medicines to patients at the institution; and whose members include 1 medical practitioner, 1 registered nurse and 1 pharmacist. (sec.103-ssec.1) A prescriber must not make a standing order for a relevant institution unless— a medicines and therapeutics committee of the institution has approved the making of the order; and the order is signed by a member of the committee who is a prescriber authorised to make standing orders. (sec.103-ssec.2) In this section— medicines and therapeutics committee , of a relevant institution, means a committee— established by the institution to approve standing orders for the administration or giving of treatment doses of medicines to patients at the institution; and whose members include 1 medical practitioner, 1 registered nurse and 1 pharmacist.
This section applies in relation to a standing order that is not for a relevant institution. A prescriber must not make the standing order unless the order relates to— a place used by an Aboriginal or Torres Strait Islander health service; or a place or circumstance authorised under— a general approval (emergency first aid); or a general approval (emergency management of animals); or a place or circumstance otherwise approved by the chief executive. s 104 amd 2023 SL No. 6 s 4 (sec.104-ssec.1) This section applies in relation to a standing order that is not for a relevant institution. (sec.104-ssec.2) A prescriber must not make the standing order unless the order relates to— a place used by an Aboriginal or Torres Strait Islander health service; or a place or circumstance authorised under— a general approval (emergency first aid); or a general approval (emergency management of animals); or a place or circumstance otherwise approved by the chief executive.
A prescriber must not make a standing order unless the prescriber is reasonably satisfied that— the order would not allow a person to administer or give a treatment dose of a medicine in a way that exceeds the person’s authorisation or training; and action taken under the order would be likely to improve the timeliness of treatment and access to care by patients or animals. The prescriber must ensure the standing order does not apply in relation to— more than 1 medicine; or giving a treatment dose of a monitored medicine. (sec.105-ssec.1) A prescriber must not make a standing order unless the prescriber is reasonably satisfied that— the order would not allow a person to administer or give a treatment dose of a medicine in a way that exceeds the person’s authorisation or training; and action taken under the order would be likely to improve the timeliness of treatment and access to care by patients or animals. (sec.105-ssec.2) The prescriber must ensure the standing order does not apply in relation to— more than 1 medicine; or giving a treatment dose of a monitored medicine.
A prescriber must make a standing order in writing and sign the standing order. The prescriber must state the following information on the standing order— the name of the prescriber; the date the standing order is made; the date, no later than 2 years after the standing order is made, on which the standing order expires; the single medicine to which the order applies; the class of persons who may administer or give a treatment dose of the medicine under the order; the medical conditions to which the order applies; if the order applies to administration—the way the medicine may be administered under the order; if the order applies to giving a treatment dose—the maximum amount of the medicine that may be given under the order; the maximum duration for which treatment of a patient under the order is authorised; in what circumstances the medicine may be administered or given as a treatment dose, and the recommended dose or dose range for the circumstances; the circumstances in which the medicine should not be administered or given as a treatment dose; the reference charts for dose calculation, if required, the monitoring requirements, if required, and the type of equipment and management procedures required for management of an emergency associated with the use of the medicine; the day, no later than 2 years after the order is made, by which the order must be reviewed. (sec.106-ssec.1) A prescriber must make a standing order in writing and sign the standing order. (sec.106-ssec.2) The prescriber must state the following information on the standing order— the name of the prescriber; the date the standing order is made; the date, no later than 2 years after the standing order is made, on which the standing order expires; the single medicine to which the order applies; the class of persons who may administer or give a treatment dose of the medicine under the order; the medical conditions to which the order applies; if the order applies to administration—the way the medicine may be administered under the order; if the order applies to giving a treatment dose—the maximum amount of the medicine that may be given under the order; the maximum duration for which treatment of a patient under the order is authorised; in what circumstances the medicine may be administered or given as a treatment dose, and the recommended dose or dose range for the circumstances; the circumstances in which the medicine should not be administered or given as a treatment dose; the reference charts for dose calculation, if required, the monitoring requirements, if required, and the type of equipment and management procedures required for management of an emergency associated with the use of the medicine; the day, no later than 2 years after the order is made, by which the order must be reviewed.
This section applies if a standing order is made by a prescriber in relation to— a general approval (emergency first aid); or a general approval (emergency management of animals). The prescriber must state in the standing order that a person proposing to administer, or give a treatment dose of, a medicine under the order must first attempt to contact the prescriber or another person authorised to prescribe the medicine, before administering or giving the treatment dose. However, the prescriber must also state in the standing order that the requirement stated in the standing order under subsection (2) does not apply in relation to— administration in urgent situations requiring immediate treatment of a patient or an animal; or administration of 1 of the following medicines— adrenaline (epinephrine); glyceryl trinitrate; glucagon; naloxone; nitrous oxide; methoxyflurane; salbutamol. (sec.107-ssec.1) This section applies if a standing order is made by a prescriber in relation to— a general approval (emergency first aid); or a general approval (emergency management of animals). (sec.107-ssec.2) The prescriber must state in the standing order that a person proposing to administer, or give a treatment dose of, a medicine under the order must first attempt to contact the prescriber or another person authorised to prescribe the medicine, before administering or giving the treatment dose. (sec.107-ssec.3) However, the prescriber must also state in the standing order that the requirement stated in the standing order under subsection (2) does not apply in relation to— administration in urgent situations requiring immediate treatment of a patient or an animal; or administration of 1 of the following medicines— adrenaline (epinephrine); glyceryl trinitrate; glucagon; naloxone; nitrous oxide; methoxyflurane; salbutamol.
A prescriber must take all reasonable steps to ensure a standing order made by the prescriber is available for inspection at a place to which the order relates by— any person who may administer or give a treatment dose of a medicine under the order; and the prescriber’s employer; and the chief executive; and an inspector; and a health ombudsman official.
This division applies to a person (a prescriber ) who is authorised to make a clinical protocol.
A prescriber must make a clinical protocol in writing and state the following information— the name of the prescriber; the place to which it relates; the class of persons who may administer a medicine under the protocol; the circumstances in which the protocol applies; 1 or more medicines to which the protocol applies; the way each medicine may be administered; the day, no later than 2 years after the protocol is made, by which the protocol must be reviewed.
A prescriber must take all reasonable steps to ensure a clinical protocol made by the prescriber is readily available for inspection at the place to which it relates by— any person who may administer a medicine under the protocol; and the chief executive; and an inspector; and a health ombudsman official.
This division applies to a person (a dispenser ) who is authorised to dispense a medicine on a prescription for a patient or an animal.
This section applies in relation to a written prescription for a medicine. A dispenser must not dispense the medicine unless— the prescription contains the information mentioned in sections 86 to 88 , to the extent the information is required under the sections for the medicine; and if the prescription is amended by a person other than the dispenser—it is amended in a way that complies with section 90 . (sec.113-ssec.1) This section applies in relation to a written prescription for a medicine. (sec.113-ssec.2) A dispenser must not dispense the medicine unless— the prescription contains the information mentioned in sections 86 to 88 , to the extent the information is required under the sections for the medicine; and if the prescription is amended by a person other than the dispenser—it is amended in a way that complies with section 90 .
This section applies in relation to an electronic prescription for a medicine. A dispenser must use an electronic prescription management system to record the dispensing of the medicine. (sec.114-ssec.1) This section applies in relation to an electronic prescription for a medicine. (sec.114-ssec.2) A dispenser must use an electronic prescription management system to record the dispensing of the medicine.
This section applies in relation to a digital copy of a paper prescription for a medicine. A dispenser must not dispense the medicine unless the digital copy is from a prescriber or another dispenser. (sec.115-ssec.1) This section applies in relation to a digital copy of a paper prescription for a medicine. (sec.115-ssec.2) A dispenser must not dispense the medicine unless the digital copy is from a prescriber or another dispenser.
This section applies in relation to a paper prescription for a diversion-risk medicine. A dispenser (the sender ) must not send a digital copy of the paper prescription to another person other than a person the sender reasonably believes is another dispenser (the receiver ) authorised to dispense the diversion-risk medicine. Before dispensing on the prescription, the receiver must make reasonable attempts to contact the sender and check whether the diversion-risk medicine has already been dispensed. Subsection (5) applies if the diversion-risk medicine is also a monitored medicine. The dispenser is taken to comply with subsection (3) if the dispenser checks the monitored medicines database and information in the database indicates the medicine has not been dispensed on the same prescription or the same repeat of the prescription. The sender must give the paper prescription to the receiver— if the prescription is for an S8 medicine—the next business day after the digital copy was sent; or otherwise—7 days after the digital copy was sent. (sec.116-ssec.1) This section applies in relation to a paper prescription for a diversion-risk medicine. (sec.116-ssec.2) A dispenser (the sender ) must not send a digital copy of the paper prescription to another person other than a person the sender reasonably believes is another dispenser (the receiver ) authorised to dispense the diversion-risk medicine. (sec.116-ssec.3) Before dispensing on the prescription, the receiver must make reasonable attempts to contact the sender and check whether the diversion-risk medicine has already been dispensed. (sec.116-ssec.4) Subsection (5) applies if the diversion-risk medicine is also a monitored medicine. (sec.116-ssec.5) The dispenser is taken to comply with subsection (3) if the dispenser checks the monitored medicines database and information in the database indicates the medicine has not been dispensed on the same prescription or the same repeat of the prescription. (sec.116-ssec.6) The sender must give the paper prescription to the receiver— if the prescription is for an S8 medicine—the next business day after the digital copy was sent; or otherwise—7 days after the digital copy was sent.
A dispenser must not amend a written prescription for a medicine other than in accordance with this subdivision or section 229 . Section 229 relates to marking non-compliant paper prescriptions. s 117 amd 2023 SL No. 170 s 14 sub 2025 SL No. 60 s 5
A dispenser may amend a written prescription for a medicine before dispensing the medicine by adding additional information to the prescription to clarify the direction of the prescriber who made the prescription. Before amending the prescription, the dispenser must— obtain consent to the amendment from the person obtaining the medicine; and have agreement to the amendment from the prescriber. The dispenser must make the amendment— in the way agreed by the prescriber; and by signing and dating the amendment; and in a way that does not obscure the information originally stated on the prescription before the amendment. See section 124 (1) (m) about records of amendments required to be kept by dispensers. s 117A ins 2025 SL No. 60 s 5 (sec.117A-ssec.1) A dispenser may amend a written prescription for a medicine before dispensing the medicine by adding additional information to the prescription to clarify the direction of the prescriber who made the prescription. (sec.117A-ssec.2) Before amending the prescription, the dispenser must— obtain consent to the amendment from the person obtaining the medicine; and have agreement to the amendment from the prescriber. (sec.117A-ssec.3) The dispenser must make the amendment— in the way agreed by the prescriber; and by signing and dating the amendment; and in a way that does not obscure the information originally stated on the prescription before the amendment. See section 124 (1) (m) about records of amendments required to be kept by dispensers.
This section applies to a dispenser if— the dispenser is a pharmacist; and the dispenser is dispensing a medicine for a patient, other than a restricted medicine or diversion-risk medicine, on a written prescription; and the dispenser proposes to dispense an equivalent medicine as a substitute to the medicine stated on the prescription (the original medicine ). The dispenser may amend the prescription to dispense the equivalent medicine if the dispenser assesses the amendment to be reasonably necessary for the therapeutic treatment of the patient. Before amending the prescription, the dispenser must obtain consent to the amendment from the person obtaining the medicine. The dispenser must make the amendment— by recording the following details on the prescription— the name of the dispenser; the place where the dispenser usually practices; the dispenser’s phone number; the dispenser’s qualifications; the details of the change made to the original medicine; and by signing and dating the amendment; and in a way that does not obscure the information originally stated on the prescription before the amendment. See section 124 (1) (m) about records of amendments required to be kept by dispensers. The dispenser must take all reasonable steps to ensure the prescriber who made the prescription is— advised of the details recorded on the prescription under subsection (4) (a) ; and given a brief description of why the dispenser amended the prescription. In this section— equivalent medicine , to the original medicine, means a medicine that— is listed on the register under the Therapeutic Goods Act 1989 (Cwlth) for the same indication as the original medicine; and is able to be dispensed in a dose and for a duration that is intended to have a therapeutic effect equivalent to the therapeutic effect of the original medicine; and has the same or similar chemical composition or pharmacological means of action as the original medicine. indication means an indication within the meaning of the Therapeutic Goods Act 1989 (Cwlth) . s 117B ins 2025 SL No. 60 s 5 (sec.117B-ssec.1) This section applies to a dispenser if— the dispenser is a pharmacist; and the dispenser is dispensing a medicine for a patient, other than a restricted medicine or diversion-risk medicine, on a written prescription; and the dispenser proposes to dispense an equivalent medicine as a substitute to the medicine stated on the prescription (the original medicine ). (sec.117B-ssec.2) The dispenser may amend the prescription to dispense the equivalent medicine if the dispenser assesses the amendment to be reasonably necessary for the therapeutic treatment of the patient. (sec.117B-ssec.3) Before amending the prescription, the dispenser must obtain consent to the amendment from the person obtaining the medicine. (sec.117B-ssec.4) The dispenser must make the amendment— by recording the following details on the prescription— the name of the dispenser; the place where the dispenser usually practices; the dispenser’s phone number; the dispenser’s qualifications; the details of the change made to the original medicine; and by signing and dating the amendment; and in a way that does not obscure the information originally stated on the prescription before the amendment. See section 124 (1) (m) about records of amendments required to be kept by dispensers. (sec.117B-ssec.5) The dispenser must take all reasonable steps to ensure the prescriber who made the prescription is— advised of the details recorded on the prescription under subsection (4) (a) ; and given a brief description of why the dispenser amended the prescription. (sec.117B-ssec.6) In this section— equivalent medicine , to the original medicine, means a medicine that— is listed on the register under the Therapeutic Goods Act 1989 (Cwlth) for the same indication as the original medicine; and is able to be dispensed in a dose and for a duration that is intended to have a therapeutic effect equivalent to the therapeutic effect of the original medicine; and has the same or similar chemical composition or pharmacological means of action as the original medicine. indication means an indication within the meaning of the Therapeutic Goods Act 1989 (Cwlth) .
A dispenser must not dispense a medicine unless the labelling on the medicine complies with the labelling requirements for the medicine under the Poisons Standard, Appendix L and, if applicable to the medicine, Appendix K.
A dispenser must not dispense a medicine on a day that is after the expiry date stated on the container or label of the medicine.
A dispenser must not dispense a medicine on a written prescription if— information on or with the prescription shows it has been fulfilled or cancelled; or for a digital copy of a paper prescription for a diversion-risk medicine—the prescription states it has been sent to another place; or the dispenser reasonably suspects— the prescription is a document that has been unlawfully prepared or obtained; or the prescription has been made by a person who is not authorised under the Act , or permitted under a corresponding law or another law, to prescribe the medicine; or the prescription does not otherwise comply with the Act .
A dispenser must not dispense a medicine on a written prescription if— for an S2, S3 or S4 medicine—the prescription was made more than 1 year before the day the medicine is to be dispensed; or for an S8 medicine—the prescription was made more than 6 months before the day the medicine is to be dispensed.
When dispensing a medicine on a written prescription, a dispenser must record the following information on or with the prescription— the date the medicine is dispensed; the dispensary where the medicine is dispensed; if the medicine is dispensed on a repeat—the number of the repeat dispensed; the dispenser’s signature. If the medicine is an S8 medicine, the dispenser must record the cancellation of the prescription on or with the prescription after dispensing— if the prescription is for a single supply of the medicine—the single supply; or if the prescription is a national medication chart prescription—the last supply of the medicine; or otherwise—the final repeat for the medicine. (sec.122-ssec.1) When dispensing a medicine on a written prescription, a dispenser must record the following information on or with the prescription— the date the medicine is dispensed; the dispensary where the medicine is dispensed; if the medicine is dispensed on a repeat—the number of the repeat dispensed; the dispenser’s signature. (sec.122-ssec.2) If the medicine is an S8 medicine, the dispenser must record the cancellation of the prescription on or with the prescription after dispensing— if the prescription is for a single supply of the medicine—the single supply; or if the prescription is a national medication chart prescription—the last supply of the medicine; or otherwise—the final repeat for the medicine.
This section applies in relation to a paper prescription for a medicine. A dispenser must keep the paper prescription, or a copy of the prescription, after the dispenser— has fulfilled the entire prescription for a single supply of the medicine; or has dispensed the final repeat of the medicine. (sec.123-ssec.1) This section applies in relation to a paper prescription for a medicine. (sec.123-ssec.2) A dispenser must keep the paper prescription, or a copy of the prescription, after the dispenser— has fulfilled the entire prescription for a single supply of the medicine; or has dispensed the final repeat of the medicine.
Sourced from Queensland Legislation (legislation.qld.gov.au), CC BY 4.0.
This regulation may be cited as the Medicines and Poisons (Medicines) Regulation 2021 .
This regulation commences on 27 September 2021.
This regulation applies in relation to a regulated activity that is a dealing with a medicine. See the Medicines and Poisons (Poisons and Prohibited Substances) Regulation 2021 in relation to particular dealings with poisons and prohibited substances. See the Medicines and Poisons (Pest Management Activities) Regulation 2021 in relation to pest management activities.
The dictionary in schedule 22 defines particular words used in this regulation.
A provision of this regulation referring to a person registered under the Health Practitioner Regulation National Law to practise in a profession— includes a person with provisional registration or limited registration for the profession; but does not include a person registered to practise in the profession only as a student or for training purposes. See schedule 12 , part 7 and schedule 11 , part 3 in relation to trainees. However, subsection (1) does not apply in relation to the enrolled nurses division of the nursing profession or the pharmacy profession. See schedule 7 , parts 4 to 6 in relation to enrolled nursing professions. See schedule 9 in relation to pharmaceutical professions. (sec.5-ssec.1) A provision of this regulation referring to a person registered under the Health Practitioner Regulation National Law to practise in a profession— includes a person with provisional registration or limited registration for the profession; but does not include a person registered to practise in the profession only as a student or for training purposes. See schedule 12 , part 7 and schedule 11 , part 3 in relation to trainees. (sec.5-ssec.2) However, subsection (1) does not apply in relation to the enrolled nurses division of the nursing profession or the pharmacy profession. See schedule 7 , parts 4 to 6 in relation to enrolled nursing professions. See schedule 9 in relation to pharmaceutical professions.
Describes record‑keeping, inspection and reporting obligations: what records must be kept, for how long, how to secure electronic records, and mandatory event reporting (lost/stolen medicines, supply on suspicious prescriptions, system breaches) (secs 224, 226–233, ch.8). Medicine registers and S8 safes have detailed layout, reconciliation and audit rules (secs 203–218).
Regulates electronic prescription systems: who must manage them, required security and audit functionality, user management, breach reporting and system standards (chapter 8, parts 1–2; secs 184–193, 185–192, 186–191).
Provides exemptions and special arrangements for public health or emergency activities: national blood supply tracking (s 6), S3 naloxone treatment programs (s 6A), national stockpile medicines during health emergencies (s 6B), and restricted transfers of immunisation stock between registered immunisation service providers (s 6C).
Authorises the chief executive of the health department to approve alternative labelling/packaging and to make or approve extended practice authorities and departmental standards (secs 7–8, 237). It also prescribes fees and refund rules for licences (chapter 9).
Who is affected
Businesses in the medicine supply chain: manufacturers, wholesalers, pharmacies, repackagers, carriers and wholesale representatives. They face compliance duties on orders, packaging, delivery, safes/registers, and reporting.
Health practitioners: doctors, nurse practitioners, pharmacists, dentists, allied health (optometrists, physiotherapists, speech pathologists, etc.), and many specified auxiliary workers. For each role the regulation lists exactly which medicines can be prescribed, possessed, administered or ordered and under which conditions (see schedules 3–15).
Institutions and public bodies: hospitals, clinics, schools, detention centres, RFDS, ambulance services and government entities that run immunisation, stockpile or emergency programs.
Patients and the public: via limits on advertising (s 234), vending machines (s 235), restrictions on retail selling near pharmacies (s 27), and enhanced tracking of monitored medicines.
Why it matters (intended purposes and the trade-offs)
Safety, traceability and control: the regulation implements a system of classification, supervised dealing rights, mandatory records and a monitored medicines database to reduce diversion, ensure correct therapeutic use and enable audits and recalls (see chs 7–8, s 179–186, ss 203–218). That is the primary mechanism for preventing misuse of controlled medicines.
Enabling public health responses: special exemptions and transfer rules (secs 6, 6A, 6B, 6C) allow nationally coordinated blood product handling, naloxone programs, stockpile distribution, and immunisation program logistics without triggering ordinary licence barriers. Mechanism: carve‑outs tied to specific systems (e.g. national blood tracking) and to responsible government entities.
Digital transition and operational modernisation: mandatory use of secure electronic prescription management systems and detailed system governance aims to make prescribing and supply more efficient and traceable (secs 83–85, 114, ch.8). This shifts implementation risk into IT security, availability and inter‑operability.
Costs, incentives and trade‑offs to watch (mechanisms, not judgments)
Compliance costs are concentrated on private suppliers and health employers: secure packaging, specialised safes, medicine registers, IT for electronic prescription systems, staff training and increased record‑keeping (many provisions in chapters 4, 8 and 224). These are recurring and may raise operating costs (see secs 197–208, 224, 185–192).
Competitive effects and constraints on private choice: a 25 km restriction on S2 sales near pharmacies (s 27) and the requirement that many medicines be sold only in manufacturer’s packs (secs 28, 72) limit non‑pharmacy retail options. Advertising bans (s 234) constrain commercial promotion of S3–S8 medicines.
Discretion and central control: the chief executive has power to approve alternative labelling/packaging, to publish departmental standards and to grant extended practice authorities (secs 7–8, 237, 236). These create administrative gates that can speed or block private initiatives depending on approvals processes and resourcing.
Implementation risk from technology: mandated electronic systems require robust access control, secure identifiers, breach monitoring and reporting (secs 186–192, 188–192). A failure or security breach creates operational and legal exposure (breach reporting and penalties are specified).
Enforcement and behavioural incentives: mandatory reporting duties, medicine register reconciliations and substantial penalties (up to 80 penalty units for some breaches) give regulators enforcement leverage; this creates incentives to invest in compliance but also risks conservative practice (e.g. refusals to supply when in doubt) that could affect timely patient care (see reporting and prohibition sections throughout chs 4–8).
Concentrated benefits and diffuse costs
Concentrated benefits accrue to entities running authorised programs (e.g. National Blood Authority, immunisation services, ambulance services) through tailored exemptions and operational rules (secs 6, 6C, 6B).
Costs and administrative burdens are dispersed across pharmacies, wholesalers, carriers, health facilities and many practitioners who must implement the record, security and IT measures.
Key behavioural changes the regulation requires
Suppliers and buyers must use secure, auditable written or electronic purchase orders for S4/S8 stock and keep records (secs 50–53, 61–62).
Dispensers and prescribers must follow strict prescription content, transmission and retention rules for S4/S8 and other controlled medicines (secs 83–92, 86–89, 95–100, 116–124).
Pharmacies and institutions must install and manage secure S8 safes, maintain medicine registers and reconcile stock regularly (secs 196–217).
Electronic prescription systems must be governed, secured, and audited; users are tightly managed and breaches reported (ch.8, secs 184–193).
Practical implementation risks and opportunity costs
Time and money spent on IT upgrades, staff training and physical infrastructure (safes, tamper‑evident packaging) is diverted from other services.
The chief executive’s approval processes (alternative labelling, extended practice authorities) centralise decision making; their timeliness and consistency will determine how quickly legitimate practice innovations can scale.
Tight procedural rules (e.g. secure transmission, signature rules, prescription form constraints) can slow down urgent care unless exceptions (e.g. emergency orders, RFDS medicine chests) are properly used and understood (see sections on oral prescriptions, RFDS exemptions and emergency approvals).
Overall: the regulation is a comprehensive operational rulebook that rebalances clinical delegation, supply‑chain controls and digital systems towards traceability and prevention of misuse while also providing targeted exceptions for national programs and emergency needs. It imposes significant compliance and governance obligations on private and public providers, and gives the chief executive structured discretion to approve alternatives or extended practices (see secs 236–237).
For section 7 (1) of the Act , each of the following activities with the following substances is prescribed— buying a listed blood product using the national blood tracking system; possessing a listed blood product obtained using the national blood tracking system; supplying, by wholesale, stock of a listed blood product using the national blood tracking system; dispensing a listed blood product on a prescription made in the national blood tracking system; giving a treatment dose of a listed blood product on a prescription made in the national blood tracking system; prescribing a listed blood product using the national blood tracking system; administering a listed blood product on a prescription made in the national blood tracking system. However, the activity is prescribed only to the extent— the activity is carried out by a person performing a function under the national blood supply arrangements; and for subsection (1) (d) or (e) —the listed blood product is labelled in compliance with— the labelling requirements stated in the Poisons Standard, Appendix L; or if the listed blood product has been granted a labelling exemption by an appropriate authority under the Poisons Standard, section 39 —any labelling requirements imposed by the appropriate authority for the product. In this section— listed blood product means an S4 medicine that is an immunoglobulin blood product mentioned on the national product price list. National Blood Agreement see the National Blood Authority Act 2003 (Cwlth) , section 3 . national blood supply arrangements means the arrangements made under the National Blood Agreement. national blood tracking system means the system for ordering, or authorising orders for, blood or blood-related products, established for facilitating the national blood supply arrangements. national product price list means the price list for blood products or blood-related products supplied under the National Blood Agreement, approved by the Ministerial Council under that agreement. s 6 amd 2023 SL No. 170 s 4 (sec.6-ssec.1) For section 7 (1) of the Act , each of the following activities with the following substances is prescribed— buying a listed blood product using the national blood tracking system; possessing a listed blood product obtained using the national blood tracking system; supplying, by wholesale, stock of a listed blood product using the national blood tracking system; dispensing a listed blood product on a prescription made in the national blood tracking system; giving a treatment dose of a listed blood product on a prescription made in the national blood tracking system; prescribing a listed blood product using the national blood tracking system; administering a listed blood product on a prescription made in the national blood tracking system. (sec.6-ssec.2) However, the activity is prescribed only to the extent— the activity is carried out by a person performing a function under the national blood supply arrangements; and for subsection (1) (d) or (e) —the listed blood product is labelled in compliance with— the labelling requirements stated in the Poisons Standard, Appendix L; or if the listed blood product has been granted a labelling exemption by an appropriate authority under the Poisons Standard, section 39 —any labelling requirements imposed by the appropriate authority for the product. (sec.6-ssec.3) In this section— listed blood product means an S4 medicine that is an immunoglobulin blood product mentioned on the national product price list. National Blood Agreement see the National Blood Authority Act 2003 (Cwlth) , section 3 . national blood supply arrangements means the arrangements made under the National Blood Agreement. national blood tracking system means the system for ordering, or authorising orders for, blood or blood-related products, established for facilitating the national blood supply arrangements. national product price list means the price list for blood products or blood-related products supplied under the National Blood Agreement, approved by the Ministerial Council under that agreement.
For section 7 (1) of the Act , each of the following activities with the following substances is prescribed— supplying, by wholesale, stock of S3 naloxone for a naloxone treatment program; giving 1 or more doses of S3 naloxone obtained under a naloxone treatment program to a person; administering S3 naloxone obtained under a naloxone treatment program to a person. However, subsection (3) applies to an activity mentioned in subsection (1) (b) carried out by a person performing a function under a naloxone treatment program. The activity is prescribed only to the extent— the person is appropriately qualified; and the person, when carrying out the activity, gives instructions about— how to recognise signs and symptoms of suspected opioid overdose; and how to administer the S3 naloxone. In this section— naloxone treatment program means a program set up by an entity of the State or Commonwealth to make S3 naloxone widely available for treating opioid overdose. S3 naloxone means naloxone in a manufacturer’s pack for the treatment of opioid overdose, other than naloxone that is an S4 medicine. s 6A ins 2023 SL No. 51 s 4 (sec.6A-ssec.1) For section 7 (1) of the Act , each of the following activities with the following substances is prescribed— supplying, by wholesale, stock of S3 naloxone for a naloxone treatment program; giving 1 or more doses of S3 naloxone obtained under a naloxone treatment program to a person; administering S3 naloxone obtained under a naloxone treatment program to a person. (sec.6A-ssec.2) However, subsection (3) applies to an activity mentioned in subsection (1) (b) carried out by a person performing a function under a naloxone treatment program. (sec.6A-ssec.3) The activity is prescribed only to the extent— the person is appropriately qualified; and the person, when carrying out the activity, gives instructions about— how to recognise signs and symptoms of suspected opioid overdose; and how to administer the S3 naloxone. (sec.6A-ssec.4) In this section— naloxone treatment program means a program set up by an entity of the State or Commonwealth to make S3 naloxone widely available for treating opioid overdose. S3 naloxone means naloxone in a manufacturer’s pack for the treatment of opioid overdose, other than naloxone that is an S4 medicine.
For section 7 (1) of the Act , the activities prescribed are buying or supplying stock of a national stockpile medicine. However, each activity is prescribed only to the extent it is carried out by— a responsible government entity; or a person acting under a direction given by a responsible government entity. In this section— Commonwealth health secretary means the secretary of the department of the Commonwealth in which the National Health Security Act 2007 (Cwlth) is administered. national stockpile medicine means a medicine supplied in the first instance from a reserve of stock of medicines held by the Commonwealth health secretary in stockpile for a health emergency. responsible government entity means an entity of the State or Commonwealth responsible for managing the distribution of stock of national stockpile medicines. s 6B ins 2024 SL No. 102 s 4 (sec.6B-ssec.1) For section 7 (1) of the Act , the activities prescribed are buying or supplying stock of a national stockpile medicine. (sec.6B-ssec.2) However, each activity is prescribed only to the extent it is carried out by— a responsible government entity; or a person acting under a direction given by a responsible government entity. (sec.6B-ssec.3) In this section— Commonwealth health secretary means the secretary of the department of the Commonwealth in which the National Health Security Act 2007 (Cwlth) is administered. national stockpile medicine means a medicine supplied in the first instance from a reserve of stock of medicines held by the Commonwealth health secretary in stockpile for a health emergency. responsible government entity means an entity of the State or Commonwealth responsible for managing the distribution of stock of national stockpile medicines.
For section 7 (1) of the Act , the activities prescribed are buying, supplying or possessing stock of an immunisation medicine. However, each activity is prescribed only to the extent— the stock is originally supplied to a registered immunisation service provider by the department; and the activity is for transferring stock from 1 registered immunisation service provider to another registered immunisation service provider; and if the activity is supplying the stock—the registered immunisation service provider supplying the stock notifies the chief executive of the supply as soon as practicable after the supply happens. s 6C ins 2025 SL No. 19 s 4 (sec.6C-ssec.1) For section 7 (1) of the Act , the activities prescribed are buying, supplying or possessing stock of an immunisation medicine. (sec.6C-ssec.2) However, each activity is prescribed only to the extent— the stock is originall
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