Medicines and Poisons (Medicines) Regulation 2021 (Qld)

Medicines and Poisons (Medicines) Regulation 2021

Chapter 1    Introduction

Part 1    Preliminary

1   Short title

This regulation may be cited as the Medicines and Poisons (Medicines) Regulation 2021.

2   Commencement

This regulation commences on 27 September 2021.

3   Application of regulation

This regulation applies in relation to a regulated activity that is a dealing with a medicine.

Notes—

1See the Medicines and Poisons (Poisons and Prohibited Substances) Regulation 2021 in relation to particular dealings with poisons and prohibited substances.

2See the Medicines and Poisons (Pest Management Activities) Regulation 2021 in relation to pest management activities.

Part 2    Interpretation

4   Definitions

The dictionary in schedule 22 defines particular words used in this regulation.

5   References to registration under Health Practitioner Regulation National Law

(1)A provision of this regulation referring to a person registered under the Health Practitioner Regulation National Law to practise in a profession—

(a)includes a person with provisional registration or limited registration for the profession; but

(b)does not include a person registered to practise in the profession only as a student or for training purposes.

Note—

See schedule 12, part 7 and schedule 11, part 3 in relation to trainees.

(2)However, subsection (1) does not apply in relation to the enrolled nurses division of the nursing profession or the pharmacy profession.

Notes—

1See schedule 7, parts 4 to 6 in relation to enrolled nursing professions.

2See schedule 9 in relation to pharmaceutical professions.

Part 3    Exemptions

6   Exemption for national blood supply arrangements—Act, s 7

(1)For section 7(1) of the Act, each of the following activities with the following substances is prescribed—

(a)buying a listed blood product using the national blood tracking system;

(b)possessing a listed blood product obtained using the national blood tracking system;

(c)supplying, by wholesale, stock of a listed blood product using the national blood tracking system;

(d)dispensing a listed blood product on a prescription made in the national blood tracking system;

(e)giving a treatment dose of a listed blood product on a prescription made in the national blood tracking system;

(f)prescribing a listed blood product using the national blood tracking system;

(g)administering a listed blood product on a prescription made in the national blood tracking system.

(2)However, the activity is prescribed only to the extent—

(a)the activity is carried out by a person performing a function under the national blood supply arrangements; and

(b)for subsection (1)(d) or (e)—the listed blood product is labelled in compliance with—

(i)the labelling requirements stated in the Poisons Standard, Appendix L; or

(ii)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.

(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.

6A   Exemption for S3 naloxone treatment programs—Act, s 7

(1)For section 7(1) of the Act, each of the following activities with the following substances is prescribed—

(a)supplying, by wholesale, stock of S3 naloxone for a naloxone treatment program;

(b)giving 1 or more doses of S3 naloxone obtained under a naloxone treatment program to a person;

(c)administering S3 naloxone obtained under a naloxone treatment program to a person.

(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.

(3)The activity is prescribed only to the extent—

(a)the person is appropriately qualified; and

(b)the person, when carrying out the activity, gives instructions about—

(i)how to recognise signs and symptoms of suspected opioid overdose; and

(ii)how to administer the S3 naloxone.

(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.

6B   Exemption for buying or supplying stock of national stockpile medicines—Act, s 7

(1)For section 7(1) of the Act, the activities prescribed are buying or supplying stock of a national stockpile medicine.

(2)However, each activity is prescribed only to the extent it is carried out by—

(a)a responsible government entity; or

(b)a person acting under a direction given by a responsible government entity.

(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.

6C   Exemption for buying, supplying or possessing stock of immunisation medicines—Act, s 7

(1)For section 7(1) of the Act, the activities prescribed are buying, supplying or possessing stock of an immunisation medicine.

(2)However, each activity is prescribed only to the extent—

(a)the stock is originally supplied to a registered immunisation service provider by the department; and

(b)the activity is for transferring stock from 1 registered immunisation service provider to another registered immunisation service provider; and

(c)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.

Part 4    Approval of documents

7   Extended practice authorities—Act, s 232

(1)For section 232(4) of the Act, each extended practice authority mentioned in schedule 1, part 1 is approved.

Note—

See section 232(4) of the Actfor when an extended practice authority takes effect.

(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—

(a)with that name; and

(b)with the version number mentioned opposite that name.

8   Departmental standards—Act, s 233

(1)For section 233(4) of the Act, each departmental standard mentioned in schedule 1, part 2 is approved.

Note—

See section 233(4) of the Actfor when a departmental standard takes effect.

(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—

(a)with that name; and

(b)with the version number mentioned opposite that name.

Part 5    Categories of medicines

9   Restricted medicines

A medicine mentioned in schedule 2, part 1 is a restricted medicine.

10   High-risk medicines—Act, s 40

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.

11   Diversion-risk medicines—Act, sch 1

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.

12   Monitored medicines—Act, sch 1

For schedule 1 of the Act, definition monitored medicine, a medicine mentioned in schedule 2, part 4 is prescribed to be a monitored medicine.

Chapter 2    Authorisations

Part 1    Approved persons

13   Approved persons—Act, s 54

(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—

(a)as a member of the class of persons; and

(b)within the scope for the dealing, if any.

Examples—

1A 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.

2A 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.

(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.

Part 2    Prescribed classes of general approvals

14   Classes of general approvals—Act, s 68

For section 68(2) of the Act, this part prescribes classes of general approvals.

15   Acute health conditions at isolated sites

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.

16   Emergency first aid

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.

17   Emergency management of animals

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.

Chapter 3    Standard conditions for substance authorities

Part 1    Preliminary

18   Application of chapter—Act, s 70

For section 70(1)(a) of the Act, this chapter prescribes standard conditions applying in relation to substance authorities authorising dealings with medicines.

Note—

See also chapters 4 and 5 about requirements prescribed under section 91(1) of the Act.

Part 2    Manufacturing licences

Division 1 Conditions for all manufacturers

19   Application of division

This division applies in relation to a manufacturing licence authorising the manufacture of a medicine.

20   Manufacturing must be supervised

(1)The holder of a manufacturing licence must appoint an appropriately qualified person to supervise manufacturing under the licence.

(2)The holder must take all reasonable steps to ensure the medicine is manufactured under the supervision of the person mentioned in subsection (1).

21   Quality control

(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.

(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.

22   Open for inspection

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.

Division 2 Particular conditions for manufacturers of medicated feed

23   Application of division

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.

24   Supply on prescriptions

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.

25   Manufacturer must give and keep supply records

(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)a unique identifier for the document;

(b)the date of the supply;

(c)the name and address of the farmer;

(d)the unique identifier on the prescription held by the farmer;

(e)details about the form, strength and amount of the feed supplied.

(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.

(3)The holder must—

(a)keep a copy of the document or a record of the details contained in the document; and

Note—

See section 224 about keeping records.

(b)give a copy of the document to the veterinary surgeon who prescribed the feed, if asked to do so by the veterinary surgeon.

26   Delivery of medicated feed

(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.

(2)The holder must ensure a notice stating the name of the farmer and the street address for delivery—

(a)is attached to the medicated feed; or

(b)if it is not reasonably practicable to attach the notice to the feed—accompanies the medicated feed.

Example for paragraph (b)—

a notice is sent in a truck carrying medicated feed supplied in bulk for delivery directly to a silo

Part 3    Retail licences

27   Selling within 25km from pharmacy

(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.

(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.

(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.

(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.

28   Selling S2 medicines in manufacturer’s pack

The holder of an S2 retail licence must not sell an S2 medicine other than in a manufacturer’s pack.

29   Open for inspection

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.

Part 4    Prescribing approvals for approved opioids

30   Application of part

This part applies in relation to a prescribing approval authorising a dealing with an approved opioid under an opioid treatment program.

Note—

See also the requirements for prescribing medicines under chapter 4, part 6.

31   Notification when starting and stopping treatment

(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.

(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.

(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.

Part 5    General approvals

Division 1 Acute health conditions at isolated sites

32   Appropriately qualified practitioners

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.

33   Practitioners must be contactable

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.

Division 2 Emergency first aid

34   Appropriately qualified practitioners

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.

35   Notification about events

(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.

(2)The notice must be given in the approved form no less than 2 business days before the event happens.

36   Practitioners must be contactable

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.

Division 3 Emergency management of animals

37   Appropriately qualified veterinary surgeons

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.

38   Veterinary surgeons must be contactable

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.

Part 6    All substance authorities

39   Application of part

This part applies in relation to all substance authorities authorising dealings with medicines.

40   Keeping invoices

The holder of a substance authority must keep any invoice received for any medicine supplied to the holder for a dealing under the authority.

41   Availability of records for inspection

(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.

(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.

42   Notification of particular changes affecting authority

(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)a change to an authorised place stated in the authority;

(b)a change to a relevant person stated in the authority;

(c)if the substance authority is a manufacturing licence—a change to the person who is appointed to supervise manufacturing under the licence;

(d)another change to the holder’s circumstances that substantially affects the holder’s ability to comply with a condition of the authority.

Example for paragraph (d)—

a fire at an authorised place stated in a wholesale licence damages stock of medicines and the security system at the place

(2)The notice must be given as soon as practicable, but no later than 5 business days, after the change of circumstances happens.

43   Stopping dealing

(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.

(2)The holder must give the chief executive a notice in the approved form stating the following information—

(a)the day the dealing is proposed to stop;

(b)the amount of medicine that is likely to be unused on the day mentioned in paragraph (a), if any;

(c)how the holder proposes to deal with any unused medicine.

Chapter 4    General requirements for dealings

Part 1    Preliminary

44   Application of chapter—Act, s 91

(1)For section 91(1) of the Act, this chapter prescribes requirements, for a person authorised under section 54(4) or 62 of the Actto deal with a medicine, in relation to carrying out the dealing.

(2)This chapter applies to the person in addition to chapter 5, unless otherwise stated.

Notes—

1See section 91(3) of the Actin relation to the matters to which the requirements under this chapter are subject.

2This chapter does not apply in relation to persons authorised to deal with a medicine under section 57 of the Actwhich relates to emergency orders.

Part 2    Manufacturing by compounding

45   Application of part

This part applies to a person who is authorised to manufacture a medicine by compounding it.

46   Compounded medicine fit for use

A person compounding a medicine must take all reasonable steps to ensure the medicine is fit for its intended use and free from contamination.

47   Compounding for patients under departmental standard

A person compounding a medicine for a patient must compound the medicine in accordance with the departmental standard called ‘Compounding’.

Part 3    Buying by giving purchase orders

48   Application of part

This part applies to a person (a buyer) who is authorised to give a purchase order for stock of an S4 or S8 medicine.

Notes—

1See also section 34 of the Actin relation to exclusions for buying particular S4 and S8 medicines.

2See part 4 for requirements about supplying stock.

3See also chapter 8, part 4 about recording and keeping information.

49   Definitions for part

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.

50   When purchase order must be given

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.

51   Nature of purchase order

(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—

(a)minimise fraud or tampering; and

(b)if sent electronically—be transmitted securely.

Examples for subsection (1)—

•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

(2)The buyer must sign the purchase order or use the buyer’s unique identifier in the purchase order.

Example for subsection (2)—

the buyer has a unique username or account number that is shown on the purchase order when the buyer uses a secure ordering website

(3)The buyer must not amend the purchase order once it is made without clearly showing the amendments in the purchase order.

Example for subsection (3)—

the buyer changes the brand name for a medicine stated in the purchase order and initials the order next to the change

52   Information for inclusion in purchase order

A buyer must state the following information in a purchase order for stock of an S4 or S8 medicine—

(a)a unique identifier for the purchase order;

(b)the date the purchase order is made;

(c)the name and address of the buyer;

(d)if the stock is to be delivered—

(i)the street address of the buyer; or

(ii)an authorised place at which the buyer is authorised to possess the stock; or

(iii)if the stock is to be delivered to a hospital—the name of the hospital;

(e)the details of the buyer’s authorisation to give the purchase order;

(f)the name, form and strength of the stock sought;

(g)the amount of the stock sought.

53   Buyer acknowledging receipt of stock of S8 medicine

(1)This section applies in relation to stock of an S8 medicine.

(2)On the day a buyer receives the stock, the buyer must—

(a)sign the purchase order for the stock or another notice to confirm the buyer has received all of the stock; or

(b)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.

(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.

(4)The buyer must keep a copy of a notice sent to the supplier under subsection (2)(b).

Notes—

1See section 224 about keeping records.

2See also chapter 8, part 2, division 3 about recording stock received in a medicine register.

Part 4    Supplying stock

Division 1 Preliminary

54   Application of part

(1)This part applies to a person who is authorised (a supplier) to supply stock of a medicine.

(2)This part applies in relation to the supply of stock of a medicine for—

(a)retail on-sale; or

(b)use by, or in connection with, carrying on a business, industry, profession or trade.

Examples for paragraph (b)—

•supply to a midwife for a birthing kit

•supply to the principal of a school for stocking the school

(3)However, this part does not apply in relation to the supply of medicated feed to a farmer of a group of animals.

Notes—

1See chapter 3, part 2, division 2 about holders of manufacturing licences supplying medicated feed.

2See also chapter 8, part 4 about recording and keeping information.

55   Definitions for part

In this part—

buyer means a person buying stock.

supplier see section 54.

Division 2 Supplying in appropriate circumstances

56   Supply of S4 or S8 medicine

(1)This section applies in relation to stock of an S4 or S8 medicine.

(2)A supplier must not supply the stock to a buyer unless—

(a)the supplier reasonably believes that the buyer—

(i)is authorised under the Act to give a purchase order or otherwise buy the stock; or

(ii)is permitted under a corresponding law or another law to obtain the stock; and

(b)the supplier obtains a compliant purchase order for the stock from the buyer.

(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.

(4)Subsection (3) does not apply if the stock is required to be kept on the ship under another law.

(5)In this section—

compliant purchase order means—

(a)a purchase order given in compliance with sections 51 and 52; or

(b)an eligible order under the National Health (Remote Area Aboriginal Health Services Program) Special Arrangement 2017 (PB 107 of 2017) (Cwlth); or

(c)an order complying with the National Health (Pharmaceutical Benefits) Regulations 2017 (Cwlth), section 33.

Note—

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.

57   Supply of S2 or S3 medicine for authorised facility

(1)This section applies in relation to stock of an S2 or S3 medicine sought by a buyer for an authorised facility.

(2)A supplier must not supply the stock to the buyer unless—

(a)the supplier reasonably believes the buyer is permitted by the buyer’s employer to buy the stock for the authorised facility; and

(b)the supplier reasonably believes the buyer has a reasonable need for the stock, and the amount of stock sought, for the facility; and

(c)the supplier receives a purchase order for the stock signed by the buyer; and

(d)if the stock is to be delivered—the supplier obtains a street address for delivery of the stock.

(3)In this section—

authorised facility means—

(a)a community pharmacy; or

(b)a specified place.

58   Supply of S2 or S3 medicine for professional practice

(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.

(2)A supplier must not supply the stock to a buyer unless—

(a)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

(b)the supplier reasonably believes the buyer has a reasonable need for the stock and the amount of stock sought; and

(c)the supplier receives a purchase order for the stock signed by the buyer; and

(d)if the stock is to be delivered—the supplier obtains a street address for delivery of the stock.

59   Supply of S2 and S3 medicines to manufacturers, wholesalers or retailers

(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.

(2)A supplier must not supply the stock to a buyer unless—

(a)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

(b)the supplier receives a purchase order for the stock signed by the buyer; and

(c)if the stock is to be delivered—the supplier obtains a street address for delivery of the stock.

60   When supply is not otherwise permitted

(1)This section applies in relation to stock of any medicine.

(2)A supplier must not supply stock of a medicine to a buyer if the supplier reasonably suspects—

(a)the purchase order for the stock has been unlawfully obtained or made; or

(b)the purchase order for the stock has been fulfilled or cancelled.

(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.

Division 3 Documentation for supply

61   Supplier to give invoice or other notice

(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)a unique identifier for the notice;

(b)the date of the supply;

(c)the name and address of the buyer;

(d)if the stock is delivered—the place to which the stock is delivered;

(e)the details of the buyer’s authorisation or permission to buy the stock;

(f)the name, form and strength of the medicine supplied;

(g)the amount of stock of the medicine supplied.

(2)The supplier must keep a copy of the notice or a record of the details contained in the notice.

Note—

See section 224 about keeping records.

62   Completing and keeping purchase orders

When supplying stock of a medicine, a supplier must—

(a)mark the purchase order for the stock in a way that shows the order has been supplied and, if applicable, delivered; and

(b)keep a copy of the marked purchase order.

Division 4 Delivery of supplied stock

63   Application of division

This division applies if a supplier delivers, or arranges delivery of, stock of a medicine to a buyer.

64   Secure packaging for all medicines

A supplier must ensure stock of a medicine is—

(a)sealed in a securely closed package that is likely to show if the package breaks or anyone tampers with it; and

(b)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.

65   Additional requirements for packaging S8 medicines

(1)This section applies in relation to stock that includes an S8 medicine.

(2)A supplier must ensure the stock is packaged for delivery in a way that does not—

(a)mix the S8 medicine with anything other than other S8 medicines; or

(b)label or mark the packaging with a statement indicating it contains an S8 medicine.

66   Engaging carrier

(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—

(a)for stock of an S4 or S8 medicine—the requirements in part 5; or

(b)for stock of an S2 or S3 medicine—section 220.

(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.

Note—

See section 76 about carriers storing medicines within notified temperature limits.

67   Delivery to street address

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.

Notes—

1Under sections 57 to 59, the supplier must obtain the street address for delivery of stock of S2 and S3 medicines.

2Under section 52, the street address for delivery of stock must be stated on the purchase order.

68   Supplier to obtain receipt for stock of S8 medicines

(1)This section applies in relation to stock that includes an S8 medicine.

(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.

(3)The supplier must keep the notice.

Note—

See section 224 about keeping records.

69   Supplier to notify chief executive if no receipt provided

(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.

(2)The supplier must give a notice to the chief executive in the approved form about the buyer’s failure to confirm receipt.

Division 5 Other requirements

70   Responsibilities for employees and representatives

(1)A supplier must take all reasonable steps to—

(a)ensure stock of a medicine is handled for the supplier only by an appropriately qualified adult employed by the supplier; and

(b)make and keep records showing the details of any stock given to a wholesale representative of the supplier; and

Note—

See section 224 about keeping records.

(c)ensure each wholesale representative of the supplier is aware of requirements under the Act applying to the supplier and representative.

(2)This section does not apply to a pharmacist or pharmacy employee dealing with stock at a pharmacy.

Note—

See chapter 5, parts 2 and 3 for requirements that apply to pharmacists and pharmacy employees.

71   Compliance with code

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—

(a)was made on 1 April 2011 by the former Commonwealth entity known as the National Coordinating Committee on Therapeutic Goods; and

(b)is published by the Therapeutic Goods Administration.

72   Supplying medicine in manufacturer’s pack

A supplier must not supply stock of medicine other than in a manufacturer’s pack, unless the supplier is authorised to repackage the medicine.

73   Labels and containers must comply with Poisons Standard or approved alternatives

(1)A supplier must not supply stock of a medicine to a buyer unless the labelling on the medicine complies with—

(a)the labelling requirements for the medicine stated in the Poisons Standard, part 2, division 2; or

(b)if an alternative way for labelling the medicine is approved, or taken to be approved, under section 237—the alternative way.

(2)A supplier must not supply stock of a medicine to a buyer unless the container of the medicine complies with—

(a)the requirements for containers for the medicine stated in the Poisons Standard, part 2, division 3; or

(b)if an alternative way for packaging the medicine is approved, or taken to be approved, under section 237—the alternative way.

(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.

74   Open for inspection

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.

Part 5    Possessing stock for delivery

75   Application of part

(1)This part applies to a carrier who is authorised to possess an S4 or S8 medicine for the purposes of delivery.

(2)This part applies in relation to the delivery of stock of an S4 or S8 medicine other than medicated feed.

Note—

See section 220 in relation to carriers delivering stock of S2 and S3 medicines.

76   Storing stock within notified temperature limits

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.

77   Stock not to be left unattended

A carrier must not leave stock of an S4 or S8 medicine unattended, other than in a secure area.

78   Delivery to person at street address

(1)A carrier must deliver stock of an S4 or S8 medicine to the street address stated on the packaging for the stock.

(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—

(a)the person named on the package for the stock; or

(b)an adult at the address acting, or purportedly acting, on behalf of the person mentioned in paragraph (a).

Part 6    Prescribing medicines

Division 1 Preliminary

79   Application of part

(1)This part applies to a person (a prescriber) who is authorised to prescribe a medicine.

(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.

Notes—

1See chapter 5, part 4 about veterinary surgeons prescribing S4 medicine and medicated feed.

2See also chapter 8, part 4 about recording and keeping information.

80   Definitions for part

In this part—

medication chart prescription means—

(a)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

Examples—

a medication chart or clinical record at a relevant institution or a patient record kept by a prescriber

(b)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).

Division 2 Prescribing generally

81   Reasonable necessity for therapeutic treatment

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.

Division 3 Prescribing for dispensing or giving treatment doses

Subdivision 1 Written prescriptions for patients and animals

82   Application of subdivision

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.

Notes—

1See division 4 about prescribing for administration.

2See section 92 about oral prescriptions for dispensing or giving treatment doses of S4 and S8 medicines.

83   Electronic prescription

A prescriber must not make an electronic prescription except by using an electronic prescription management system.

Note—

See chapter 8, part 1 about electronic prescription management systems.

84   Sending prescription electronically

(1)A prescriber must not send a prescription for a medicine to another person using electronic communication except by—

(a)using an electronic prescription management system in accordance with any requirements for using the system; or

(b)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.

(2)Subsections (3) and (4) apply if the prescriber is sending a digital copy of a paper prescription to a person.

(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—

(a)the way in which the digital copy is being sent;

(b)the place to which the digital copy is being sent;

(c)the date on which the digital copy is being sent.

Example for subsection (3)—

A prescriber writes the words ‘emailed to Hypothetical Pharmacy, Brisbane on 1 January 2022’ on a paper prescription.

(4)After sending the digital copy, the prescriber must send the paper prescription to the person as soon as practicable, but no later than—

(a)if the prescription is for an S8 medicine—the end of the next business day after the digital copy was sent; or

(b)otherwise—7 days after the digital copy was sent.

85   Generation of paper prescription using computer

(1)This section applies if a prescriber uses a computer to generate a paper prescription.

(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.

(3)The prescriber must ensure the following things are included on the paper prescription—

(a)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;

(b)a space for the prescriber to include a handwritten signature other than a signature printed by the computer;

(c)either—

(i)the total number of medicines prescribed; or

(ii)scoring or hatching of any blank space below or above the space for the prescriber’s handwritten signature.

86   Content of written prescription

(1)A prescriber must state the following information on a prescription for a medicine—

(a)the prescriber’s name or a unique identifier for the prescriber;

(b)the place where the prescriber usually practices;

(c)the prescriber’s phone number or pager number;

(d)the prescriber’s qualifications;

(e)the date of the prescription;

(f)if the medicine is for a patient—

(i)the patient’s name and address; and

(ii)for a monitored medicine—the patient’s date of birth;

(g)if the medicine is for an animal—

(i)the species of the animal; and

(ii)the name of the animal or another description that identifies the animal; and

(iii)the name and address of the owner or custodian of the animal; and

(iv)a statement that the medicine is for animal treatment only;

(h)the name of the medicine;

Examples—

•the approved name or brand name of the medicine

•a description of the medicine to be compounded

(i)the form and strength of the medicine;

(j)how much of the medicine may be dispensed or given, including the number of repeats for the medicine, if any;

(k)instructions about using the medicine;

(l)the date for dispensing or giving the medicine, if applicable;

(m)if the medicine is a restricted medicine—

(i)the details of the prescriber’s authorisation to prescribe the restricted medicine; or

Examples—

•the identifying number of the prescribing approval held by the prescriber

•the qualifications of the prescriber

(ii)for hydroxychloroquine for treating a patient previously prescribed it by another health practitioner—the words ‘continuing treatment’.

(2)Subsection (1)(b), (c) and (d) do not apply if the prescription is a medication chart prescription.

(3)The prescriber is taken to comply with this section if the prescription is a national medication chart prescription.

87   Additional content of written prescription for S8 medicine

(1)This section applies, in addition to section 86, in relation to a written prescription for an S8 medicine.

(2)A prescriber must also state the following information on the prescription—

(a)if the prescription is a paper prescription—both words and numbers to describe how much of the medicine may be dispensed or given;

(b)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;

(c)if the S8 medicine is amfetamine, dexamfetamine, lisdexamfetamine or methylphenidate—the words ‘specified condition’ or words to indicate the condition being treated.

(3)The prescriber is taken to comply with subsection (2) if the prescription is a national medication chart prescription.

(4)Subsection (5) applies if the prescriber is prescribing an approved opioid, other than on a medication chart prescription.

(5)The prescriber must also state the following information on the prescription—

(a)if the prescriber holds a prescribing approval for prescribing the opioid—the identifying number of the prescribing approval;

(b)the name of the place where the approved opioid is to be dispensed or given;

(c)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;

(d)the start and end dates for when 1 or more doses of the opioid are to be dispensed or given.

(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.

Note—

See section 95 about the content of prescriptions for administration by authorised persons.

88   Signing written prescription

A prescriber must sign a prescription.

Note—

See section 89(2)(d) about signing the prescription when using printed labels.

89   Using printed label on prescription

(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.

(2)The prescriber must—

(a)use a printed label that is legible; and

(b)attach the label to the prescription in a way that it can not be easily removed; and

(c)place the label in a way that clearly connects the information to the patient or animal; and

(d)sign the label in a way that does not obscure the information on the printed label.

90   Amending written prescription

(1)A prescriber must not amend a prescription (the original prescription) unless the prescriber made the prescription in the first instance.

(2)The prescriber must—

(a)sign and date the amendment handwritten on the original prescription; and

(b)ensure the amendment is made in a way that does not obscure the content of the original prescription.

(3)If the original prescription was printed from a computer, the prescription must be amended on a computer and printed again.

(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.

Subdivision 2 Prescribing particular medicines for patients

91   Application of subdivision

This subdivision applies if a prescriber prescribes a medicine for dispensing or giving a treatment dose for a patient.

Notes—

1See subdivision 1 about written prescriptions for dispensing or giving treatment doses for patients and animals.

2See division 4 about prescribing for administration.

92   Oral prescription for S4 or S8 medicine

(1)This section applies in relation to an S4 or S8 medicine.

(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.

(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.

(4)The prescriber must give the written prescription to the person—

(a)for an S4 medicine—7 days after the oral prescription was given; or

(b)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.

(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.

93   Compliance with monitored medicines standard

(1)This section applies if a prescriber prescribes a monitored medicine, whether orally or by written prescription.

(2)The prescriber must prescribe the medicine in accordance with the departmental standard called ‘Monitored medicines’.

Division 4 Prescribing for administration by authorised persons

Subdivision 1 Written prescriptions for patients and animals

94   Application of subdivision

This subdivision applies if a prescriber makes a written prescription for administration of a medicine by another person to a patient or an animal.

Notes—

1See subdivision 2 about oral prescriptions for administration to patients and animals.

2See division 3 about prescribing for dispensing or giving treatment doses for patients and animals.

95   Content of written prescription

A prescriber must state the following information on a prescription for a medicine—

(a)the prescriber’s name or a unique identifier for the prescriber;

(b)the date of the prescription;

(c)if the medicine is to be administered to a patient—

(i)the patient’s name and address; and

(ii)for a monitored medicine—the patient’s date of birth;

(d)if the medicine is to be administered to an animal—

(i)the species of the animal; and

(ii)the name of the animal or another description that identifies the animal; and

(iii)the name and address of the owner or custodian of the animal;

(e)the name of the medicine;

Examples—

•the approved name or brand name of the medicine

•a description of the medicine to be compounded

(f)the form and strength of the medicine;

(g)how much of the medicine may be administered;

(h)instructions about using the medicine.

96   Additional content of written prescription for approved opioid

(1)This section applies, in addition to section 95, if—

(a)a prescriber is the holder of a prescribing approval; and

(b)the prescriber is making a written prescription for the administration of an approved opioid, other than a medication chart prescription.

(2)The prescriber must also state the following information on the prescription—

(a)the identifying number of the prescribing approval, if any;

(b)the name of the place where the approved opioid is to be administered;

(c)instructions for how 1 or more doses of the opioid are to be administered;

(d)the start and end dates for when 1 or more doses of the opioid are to be administered.

Note—

See sections 86 and 87 for requirements about prescriptions for dispensing or giving treatment doses.

97   Signing written prescription

A prescriber must sign a prescription.

Note—

See section 98(2)(d) about signing the prescription when using printed labels.

98   Using printed label

(1)This section applies if a prescriber uses a printed label to record any information required under section 95 or 96 on paper prescription.

(2)The prescriber must—

(a)use a printed label that is legible; and

(b)attach the label to the prescription in a way that it can not be easily removed; and

(c)place the label in a way that clearly connects the information to the patient or animal; and

(d)sign the label in a way that does not obscure the information on the printed label.

Subdivision 2 Oral prescriptions for patients and animals

99   Application of subdivision

This subdivision applies if a prescriber orally prescribes a medicine for administration to a patient or an animal.

Notes—

1See subdivision 1 about written prescriptions for administration to patients and animals.

2See division 3 about prescribing for dispensing or giving treatment doses.

100   Oral prescription

(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.

(2)If the medicine is an S8 medicine and the person administers the S8 medicine on the oral prescription, the prescriber must—

(a)give the person a written prescription that confirms the oral prescription; or

(b)sign another record made by the person at the time of the administration on the oral prescription.

(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.

(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.

Part 7    Making standing orders

Division 1 Preliminary

101   Meaning of clinical protocol

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—

(a)clinical perfusion;

(b)orthoptics;

(c)nuclear medicine technology;

(d)respiratory science;

(e)speech pathology.

Division 2 Standing orders

102   Application of division

(1)This division applies to a person (a prescriber) who is authorised to make a standing order.

(2)However, this division does not apply in relation to a standing order that is a clinical protocol.

103   Making standing order for relevant institution

(1)A prescriber must not make a standing order for a relevant institution unless—

(a)a medicines and therapeutics committee of the institution has approved the making of the order; and

(b)the order is signed by a member of the committee who is a prescriber authorised to make standing orders.

(2)In this section—

medicines and therapeutics committee, of a relevant institution, means a committee—

(a)established by the institution to approve standing orders for the administration or giving of treatment doses of medicines to patients at the institution; and

(b)whose members include 1 medical practitioner, 1 registered nurse and 1 pharmacist.

104   Making other standing orders

(1)This section applies in relation to a standing order that is not for a relevant institution.

(2)A prescriber must not make the standing order unless the order relates to—

(a)a place used by an Aboriginal or Torres Strait Islander health service; or

(b)a place or circumstance authorised under—

(i)a general approval (emergency first aid); or

(ii)a general approval (emergency management of animals); or

(c)a place or circumstance otherwise approved by the chief executive.

105   Safe circumstances for making standing order

(1)A prescriber must not make a standing order unless the prescriber is reasonably satisfied that—

(a)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

(b)action taken under the order would be likely to improve the timeliness of treatment and access to care by patients or animals.

(2)The prescriber must ensure the standing order does not apply in relation to—

(a)more than 1 medicine; or

(b)giving a treatment dose of a monitored medicine.

106   Content of standing order

(1)A prescriber must make a standing order in writing and sign the standing order.

(2)The prescriber must state the following information on the standing order—

(a)the name of the prescriber;

(b)the date the standing order is made;

(c)the date, no later than 2 years after the standing order is made, on which the standing order expires;

(d)the single medicine to which the order applies;

(e)the class of persons who may administer or give a treatment dose of the medicine under the order;

(f)the medical conditions to which the order applies;

(g)if the order applies to administration—the way the medicine may be administered under the order;

(h)if the order applies to giving a treatment dose—the maximum amount of the medicine that may be given under the order;

(i)the maximum duration for which treatment of a patient under the order is authorised;

(j)in what circumstances the medicine may be administered or given as a treatment dose, and the recommended dose or dose range for the circumstances;

(k)the circumstances in which the medicine should not be administered or given as a treatment dose;

(l)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;

(m)the day, no later than 2 years after the order is made, by which the order must be reviewed.

107   Additional content of standing order under general approval

(1)This section applies if a standing order is made by a prescriber in relation to—

(a)a general approval (emergency first aid); or

(b)a general approval (emergency management of animals).

(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.

(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—

(a)administration in urgent situations requiring immediate treatment of a patient or an animal; or

(b)administration of 1 of the following medicines—

(i)adrenaline (epinephrine);

(ii)glyceryl trinitrate;

(iii)glucagon;

(iv)naloxone;

(v)nitrous oxide;

(vi)methoxyflurane;

(vii)salbutamol.

108   Standing order available for inspection

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—

(a)any person who may administer or give a treatment dose of a medicine under the order; and

(b)the prescriber’s employer; and

(c)the chief executive; and

(d)an inspector; and

(e)a health ombudsman official.

Division 3 Clinical protocols

109   Application of division

This division applies to a person (a prescriber) who is authorised to make a clinical protocol.

110   Contents of clinical protocol

A prescriber must make a clinical protocol in writing and state the following information—

(a)the name of the prescriber;

(b)the place to which it relates;

(c)the class of persons who may administer a medicine under the protocol;

(d)the circumstances in which the protocol applies;

(e)1 or more medicines to which the protocol applies;

(f)the way each medicine may be administered;

(g)the day, no later than 2 years after the protocol is made, by which the protocol must be reviewed.

111   Protocol available for inspection

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—

(a)any person who may administer a medicine under the protocol; and

(b)the chief executive; and

(c)an inspector; and

(d)a health ombudsman official.

Part 8    Dispensing medicines

Division 1 Patients and animals

Subdivision 1 Preliminary

112   Application of division

This division applies to a person (a dispenser) who is authorised to dispense a medicine on a prescription for a patient or an animal.

Subdivision 2 Prescriptions

113   Dispensing on compliant written prescription

(1)This section applies in relation to a written prescription for a medicine.

(2)A dispenser must not dispense the medicine unless—

(a)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

(b)if the prescription is amended by a person other than the dispenser—it is amended in a way that complies with section 90.

114   Dispensing on electronic prescription

(1)This section applies in relation to an electronic prescription for a medicine.

(2)A dispenser must use an electronic prescription management system to record the dispensing of the medicine.

115   Dispensing on digital copy of paper prescription

(1)This section applies in relation to a digital copy of a paper prescription for a medicine.

(2)A dispenser must not dispense the medicine unless the digital copy is from a prescriber or another dispenser.

116   Digital copy of paper prescription for diversion-risk medicine between dispensers

(1)This section applies in relation to a paper prescription for a diversion-risk medicine.

(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.

(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.

(4)Subsection (5) applies if the diversion-risk medicine is also a monitored medicine.

(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.

(6)The sender must give the paper prescription to the receiver—

(a)if the prescription is for an S8 medicine—the next business day after the digital copy was sent; or

(b)otherwise—7 days after the digital copy was sent.

Subdivision 2A Amending written prescriptions

117   Restrictions on amending written prescriptions

A dispenser must not amend a written prescription for a medicine other than in accordance with this subdivision or section 229.

Note—

Section 229 relates to marking non-compliant paper prescriptions.

117A    Clarifying prescriber’s direction

(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.

(2)Before amending the prescription, the dispenser must—

(a)obtain consent to the amendment from the person obtaining the medicine; and

(b)have agreement to the amendment from the prescriber.

(3)The dispenser must make the amendment—

(a)in the way agreed by the prescriber; and

(b)by signing and dating the amendment; and

(c)in a way that does not obscure the information originally stated on the prescription before the amendment.

Note—

See section 124(1)(m) about records of amendments required to be kept by dispensers.

117B    Dispensing an equivalent medicine

(1)This section applies to a dispenser if—

(a)the dispenser is a pharmacist; and

(b)the dispenser is dispensing a medicine for a patient, other than a restricted medicine or diversion-risk medicine, on a written prescription; and

(c)the dispenser proposes to dispense an equivalent medicine as a substitute to the medicine stated on the prescription (the original medicine).

(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.

(3)Before amending the prescription, the dispenser must obtain consent to the amendment from the person obtaining the medicine.

(4)The dispenser must make the amendment—

(a)by recording the following details on the prescription—

(i)the name of the dispenser;

(ii)the place where the dispenser usually practices;

(iii)the dispenser’s phone number;

(iv)the dispenser’s qualifications;

(v)the details of the change made to the original medicine; and

(b)by signing and dating the amendment; and

(c)in a way that does not obscure the information originally stated on the prescription before the amendment.

Note—

See section 124(1)(m) about records of amendments required to be kept by dispensers.

(5)The dispenser must take all reasonable steps to ensure the prescriber who made the prescription is—

(a)advised of the details recorded on the prescription under subsection (4)(a); and

(b)given a brief description of why the dispenser amended the prescription.

(6)In this section—

equivalent medicine, to the original medicine, means a medicine that—

(a)is listed on the register under the Therapeutic Goods Act 1989 (Cwlth) for the same indication as the original medicine; and

(b)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

(c)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).

Subdivision 3 Medicines

118   Labelling dispensed medicine

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.

119   Expired medicine

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.

Subdivision 4 Dispensing in appropriate circumstances

120   When dispensing is not otherwise permitted

A dispenser must not dispense a medicine on a written prescription if—

(a)information on or with the prescription shows it has been fulfilled or cancelled; or

(b)for a digital copy of a paper prescription for a diversion-risk medicine—the prescription states it has been sent to another place; or

(c)the dispenser reasonably suspects—

(i)the prescription is a document that has been unlawfully prepared or obtained; or

(ii)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

(iii)the prescription does not otherwise comply with the Act.

121   Expired written prescription

A dispenser must not dispense a medicine on a written prescription if—

(a)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

(b)for an S8 medicine—the prescription was made more than 6 months before the day the medicine is to be dispensed.

Subdivision 5 Records

122   Dispensing information on or with written prescription

(1)When dispensing a medicine on a written prescription, a dispenser must record the following information on or with the prescription—

(a)the date the medicine is dispensed;

(b)the dispensary where the medicine is dispensed;

(c)if the medicine is dispensed on a repeat—the number of the repeat dispensed;

(d)the dispenser’s signature.

(2)If the medicine is an S8 medicine, the dispenser must record the cancellation of the prescription on or with the prescription after dispensing—

(a)if the prescription is for a single supply of the medicine—the single supply; or

(b)if the prescription is a national medication chart prescription—the last supply of the medicine; or

(c)otherwise—the final repeat for the medicine.

123   Keeping fulfilled paper prescription

(1)This section applies in relation to a paper prescription for a medicine.

(2)A dispenser must keep the paper prescription, or a copy of the prescription, after the dispenser—

(a)has fulfilled the entire prescription for a single supply of the medicine; or

(b)has dispensed the final repeat of the medicine.

124   Dispensing record for dispensed medicine

(1)As soon as practicable after dispensing a medicine, a dispenser must make and keep a record of the following information—

(a)the name of the dispenser;

(b)the dispensary where the medicine was dispensed;

(c)the date the medicine was dispensed;

(d)if the medicine was dispensed for a patient—

(i)the name and address of the patient; and

(ii)for a monitored medicine—the date of birth of the patient;

(e)if the medicine was dispensed for an animal—

(i)the species of the animal; and

(ii)the name of the animal or another description to identify the animal; and

(iii)the name and address of the owner or custodian of the animal;

(f)the name of the medicine or other sufficient information to accurately identify the medicine;

Examples—

•the approved name or brand name of the medicine

•a description of the medicine compounded

(g)the form, strength and amount of the medicine;

(h)the name of the prescriber of the medicine;

(i)the date of the prescription for the medicine;

(j)a unique identifier given to the prescription by the dispenser;

(k)if instructions for use of the medicine are stated in the prescription—the instructions;

(l)if the medicine was dispensed on a repeat—the number of the repeat dispensed;

(m)if the prescription was amended by the dispenser in accordance with subdivision 2A—

(i)for an amendment mentioned in section 117A—the details of the amendment and the agreement with the prescriber; or

(ii)for an amendment mentioned in section 117B—the details of the amendment and a brief description of why the dispenser made the amendment.

(2)A record made under subsection (1) is a dispensing record.

Notes—

1See section 123 about keeping fulfilled paper prescriptions.

2See section 224 about keeping records.

Division 2 Patients only

125   Application of division

This division applies to a person (a dispenser) who is authorised to dispense a medicine for a patient.

126   Compliance with monitored medicines standard

A dispenser must dispense a monitored medicine in accordance with the departmental standard called ‘Monitored medicines’.

127   Dispensing diversion-risk medicine

(1)This section applies in relation to a written prescription for a diversion-risk medicine.

(2)A dispenser must take all reasonable steps to ensure the named prescriber on the prescription is genuinely the prescriber of the diversion-risk medicine.

(3)The dispenser is taken to comply with subsection (2) if—

(a)the dispenser is familiar with information on the prescription identifying the named prescriber to the dispenser; or

(b)the dispenser contacts the named prescriber and confirms the prescription was made by the named prescriber.

(4)Subsection (5) applies if the diversion-risk medicine is also a monitored medicine.

(5)The dispenser is taken to comply with subsection (2) if the dispenser checks the monitored medicines database and information in the database indicates the medicine was prescribed by the named prescriber.

(6)In this section—

named prescriber, on a prescription, means the person named as prescribing the medicine on the prescription.

128   Dispensing generic medicine

(1)This section applies if a medicine (the prescribed medicine) is prescribed for a patient using an approved name or brand name but the medicine (the generic medicine) is also available under another brand name or without a brand name.

(2)A dispenser must not dispense the generic medicine for the patient instead of the prescribed medicine unless—

(a)the generic medicine is, in the reasonable opinion of the dispenser, physiologically equivalent to the prescribed medicine in its clinical effect and has the same active ingredients; and

Examples of medicines that may be physiologically equivalent—

•a medicine approved by the Therapeutic Goods Administration for sale as a generic medicine to substitute for a brand name medicine

•a medicine flagged in the ‘Schedule of pharmaceutical benefits’ as biosimilar or equivalent to another medicine

(b)the prescriber of the prescribed medicine did not specifically state that only the prescribed medicine is to be dispensed; and

(c)the patient asks for, or agrees to, the dispensing of the generic medicine instead of the prescribed medicine.

(3)Subsection (2)(b) and (c) does not apply if the medicine is dispensed to the patient at a public sector hospital.

Note—

See also the Therapeutic Goods Act 1989 (Cwlth), sections 30EK and 30EL about pharmacists dispensing scarce medicines.

Part 9    Giving treatment doses of medicines

Division 1 Preliminary

129   Application of part

This part applies to a person (an authorised person) who is authorised to give a treatment dose of a medicine for a patient or an animal.

Division 2 Giving treatment doses generally

130   Reasonable necessity for therapeutic treatment

(1)This section applies to an authorised person who is authorised to give a treatment dose of a medicine without a prescription for a patient or an animal.

(2)The authorised person must not give the treatment dose unless the person assesses the medicine to be reasonably necessary for the therapeutic treatment of the patient or animal.

131   Giving medicine in manufacturer’s pack

An authorised person must not give a treatment dose of a medicine other than in a manufacturer’s pack, unless the person is authorised to repackage the medicine.

132   Giving diversion-risk medicine

(1)This section applies in relation to a diversion-risk medicine for a patient being given on a written prescription.

(2)An authorised person must take all reasonable steps to ensure the named prescriber on the prescription is genuinely the prescriber of the diversion-risk medicine.

(3)The authorised person is taken to comply with subsection (2) if—

(a)the person is familiar with information on the prescription identifying the named prescriber to the person; or

(b)the person contacts the named prescriber and confirms the prescription was given by the named prescriber.

(4)Subsection (5) applies if the diversion-risk medicine is also a monitored medicine.

(5)The authorised person is taken to comply with subsection (2) if the person checks the monitored medicines database and information in the database indicates the medicine was prescribed by the named prescriber.

(6)In this section—

named prescriber, on a prescription, means the person named as prescribing the medicine on the prescription.

133   When giving treatment dose is not otherwise permitted

An authorised person must not give a treatment dose of a medicine on a written prescription if—

(a)information on or with the prescription shows it has been fulfilled or cancelled; or

(b)the authorised person reasonably suspects—

(i)the prescription is a document that has been unlawfully prepared or obtained; or

(ii)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

(iii)the prescription does not otherwise comply with the Act.

Division 3 Labelling and records

134   Labelling treatment dose of medicine

(1)An authorised person must not give a treatment dose of 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.

(2)However, subsection (1) does not apply in relation to an S2 or S3 medicine given in a manufacturer’s pack.

135   Information on or with prescription

(1)When giving a treatment dose of a medicine on a written prescription, an authorised person must record the following information on or with the prescription—

(a)the date the treatment dose is given;

(b)the authorised person’s name and signature;

(c)that the prescription has been fulfilled or cancelled.

(2)However, if the prescription is a medication chart prescription, the authorised person must record only the following information on the prescription—

(a)the date the medicine is given;

(b)the amount of the medicine given;

(c)the authorised person’s signature.

136   Treatment dose record

(1)This section applies to an authorised person giving a treatment dose of a medicine that is—

(a)an S3 medicine containing pseudoephedrine; or

(b)an S4 or S8 medicine.

(2)As soon as practicable after giving the treatment dose, the authorised person must make and keep a record of the following information—

(a)the name of the authorised person;

(b)the date the medicine was given;

(c)if the medicine was given for a patient—

(i)the name and address of the patient; and

(ii)for a monitored medicine—the date of birth of the patient;

(d)if the medicine was given for an animal—the name and address of the owner or custodian of the animal;

(e)the name of the medicine or other sufficient information to accurately identify the medicine;

Examples—

•the approved name or brand name of the medicine

•a description of the medicine compounded

(f)the form, strength and amount of the medicine;

(g)if the treatment dose was given on a prescription—the name of the prescriber who prescribed the medicine.

Notes—

1See section 224 about keeping records.

2See chapter 5, part 2, division 3 for additional requirements that apply to pharmacists selling medicines without a prescription.

(3)This section does not apply in relation to a treatment dose given—

(a)on a medication chart prescription; or

(b)from an RFDS medicine chest kept by the Royal Flying Doctor Service of Australia.

Division 4 Expired prescriptions and medicines

137   Expired written prescription

An authorised person must not give a treatment dose of a medicine on a written prescription if—

(a)for an S2, S3 or S4 medicine—the prescription was made more than 1 year before the day the medicine is to be given; or

(b)for an S8 medicine—the prescription was made more than 6 months before the day the medicine is to be given.

138   Expired medicine

An authorised person must not give a treatment dose of a medicine on a day that is after the expiry date stated on the container or label of the medicine.

Part 10    Administering medicines

139   Application of part

This part applies to a person (an authorised person) who is authorised to administer a medicine to a patient or an animal.

140   Reasonable necessity for therapeutic treatment

(1)This section applies to an authorised person who is authorised to administer a medicine to a patient or an animal without a prescription.

(2)The authorised person must not administer the medicine unless the person assesses the medicine to be reasonably necessary for the therapeutic treatment of the patient or animal.

141   Record for administering on standing order

(1)This section applies to an authorised person who is authorised to administer a medicine on a standing order.

(2)As soon as practicable after administering the medicine, the authorised person must make and keep a record of the following information—

(a)the name of the authorised person;

(b)the date the medicine was administered;

(c)if the medicine was administered to a patient—

(i)the name and address of the patient; and

(ii)for a monitored medicine—the date of birth of the patient;

(d)if the medicine was administered to an animal—the name and address of the owner or custodian of the animal;

(e)the name of the medicine or other sufficient information to accurately identify the medicine;

Examples—

•the approved name or brand name of the medicine

•a description of the medicine compounded

(f)the form, strength and amount of the medicine;

(g)the name of the prescriber who made the standing order.

Note—

See section 224 about keeping records.

142   Expired written prescription

An authorised person must not administer a medicine on a written prescription if—

(a)for an S2, S3 or S4 medicine—the prescription was made more than 1 year before the day the medicine is to be administered; or

(b)for an S8 medicine—the prescription was made more than 6 months before the day the medicine is to be administered.

Part 11    Disposing of waste from diversion-risk medicines

Division 1 Preliminary

143   Application of part

(1)This part applies to a person (an approved disposer) who is authorised to dispose of waste from a diversion-risk medicine.

(2)However, this part does not apply in relation to waste that is—

(a)residue from a diversion-risk medicine in the form of—

(i)an unused portion of a tablet; or

(ii)the unused partial contents of a previously sterile ampoule or container; or

(iii)a used transdermal patch; and

(b)destroyed immediately after the medicine is no longer required for administration.

(3)Also, this part does not apply in relation to waste from a diversion-risk medicine from an RFDS medicine chest kept by the Royal Flying Doctor Service of Australia under a general approval for the service.

Division 2 S8 diversion-risk medicine waste

144   Application of division

This division applies in relation to waste (S8 waste) from a diversion-risk medicine that is an S8 medicine.

145   Separation of waste

An approved disposer must ensure S8 waste is—

(a)placed in an S8 safe; and

(b)separated from other medicines in the safe; and

(c)clearly marked for destruction.

146   Transfer of waste for destruction

(1)An approved disposer (a giver) must not transfer S8 waste for destruction other than to another person (a receiver) who the disposer reasonably believes is an approved disposer authorised to destroy the S8 waste.

(2)The receiver must acknowledge receipt of the S8 waste by—

(a)signing an entry for the transfer of the waste in the medicine register for the S8 safe in which the waste was kept before the transfer; or

Note—

See also chapter 8, part 2, division 3 about recording dealings in a medicine register.

(b)signing a separate notice for the giver.

(3)The giver must keep a notice provided to the giver under subsection (2)(b).

Note—

See section 224 about keeping records.

147   Destruction of waste

6   Classes of persons and dealings

Column 1 Class of person	Column 2 Dealing with medicine
1	a veterinary surgeon working for the holder of an approval	(a)  give a purchase order for stock of medicines for a location stated in the approval
		(b)  make a standing order under the approval
2	a senior person at a location stated in the approval, working for the holder of an approval	possess stock of medicines at the location
3	a qualified person working for the holder of an approval	(a)  possess stock of medicines
		(b)  administer a medicine on an oral prescription or a standing order from a veterinary surgeon working under the approval
4	a person training to become a qualified person for the holder of an approval	administer or possess a medicine under the direct supervision of a veterinary surgeon working under the approval
5	a person working for the holder of an approval	possess stock of medicines for working under the approval

Schedule 17 Substance management plans—regulated places and responsible persons

section 172

1   Definitions for schedule

In this schedule—

manager, of a regulated place, means the person who is responsible for the day-to-day management of the place.

senior officer, of a regulated place, means a person who holds an office that is sufficiently senior to supervise compliance with a substance management plan made for the place.

specified pharmacy means—

(a)a community pharmacy operated by a friendly society or the Mater Misericordiae Health Services Brisbane Limited; or

(b)a pharmacy supplying medicines only to inpatients of a hospital.

2   Regulated places and responsible persons

Column 1 Regulated place	Column 2 Responsible person
a place where a medicine is manufactured under a manufacturing licence	if the holder of the licence is an individual—the individual if the holder of the licence is a body corporate—each executive officer of the body corporate otherwise—the manager of the place where the medicine is manufactured
a place where a medicine is stored for supply by wholesale, other than— •  a community pharmacy •  a specified pharmacy •  a place at which a wholesale representative works independently	if the wholesaler of the medicine is an individual—the individual if the wholesaler of the medicine is a body corporate—each executive officer of the body corporate otherwise—the manager of the place where the medicine is stored
a place required to have a substance management plan under a condition of a substance authority	if the holder of the authority is an individual—the individual if the holder of the authority is a body corporate—each executive officer of the body corporate otherwise—the manager of the place
an isolated site stated in a general approval (acute health conditions at isolated sites)	the holder of the general approval
a site stated in a general approval (emergency first aid) or at which an event notified to the chief executive under section 35 takes place	the holder of the general approval
a location stated in a general approval (emergency management of animals)	the holder of the general approval
an aged care facility	the nurse manager of the aged care facility
an ambulance station	the ambulance officer in charge of the ambulance station
a child care facility	the senior officer of the child care facility employed by the approved provider of the facility
a community pharmacy other than a specified pharmacy	each pharmacist who owns the community pharmacy
a specified pharmacy	the pharmacist who is the manager of the pharmacy
a detention centre	the executive director of the detention centre
a non-State school	the principal of the non-State school or, if a person has not been appointed to be the principal, the manager of the non-State school
a prison	the manager of the prison and the senior officer of the prison responsible for health services at the prison
a private health facility	if the holder of the licence for the private health facility is an individual—the individual if the holder of the licence for the private health facility is a body corporate—each executive officer of the body corporate
a public sector hospital	each senior officer of the hospital appointed by the board of a Hospital and Health Service for the hospital
a State school	the principal of the State school

Schedule 18 Monitored medicines database

sections 178, 178A, 180 and 183

Part 1    Relevant practitioners required to check database

dentist

medical practitioner

nurse practitioner

endorsed midwife

pharmacist and intern pharmacist

endorsed podiatrist and podiatric surgeon

Part 1A    Exempt circumstances

Column 1 Proposed dealing	Column 2 Circumstances
1	prescribe or dispense a monitored medicine	the proposed dealing is— (a)  for a patient being treated at a hospital; and (b)  for administration of the medicine to the patient while the patient is at the hospital
2	prescribe, dispense or give a treatment dose of a monitored medicine	the proposed dealing is for a patient being treated at an aged care facility
3	prescribe, dispense or give a treatment dose of a monitored medicine	the proposed dealing is— (a)  for a patient being treated at a custodial facility; and (b)  for administration of the medicine to the patient, or for the patient to take the medicine, while the patient is detained (whether or not at the custodial facility)
4	prescribe, dispense or give a treatment dose of a monitored medicine	the proposed dealing is for a patient being treated urgently in an emergency
5	prescribe a monitored medicine	the proposed dealing is for a patient assessed, under the Voluntary Assisted Dying Act 2021, by a consulting practitioner as eligible for access to voluntary assisted dying
6	prescribe a monitored medicine	the proposed dealing is for a patient who has a life expectancy of less than 12 months
7	prescribe a monitored medicine	the proposed dealing is for a patient being given palliative care
8	dispense or give a treatment dose of a monitored medicine	the proposed dealing is on a prescription for a patient mentioned in this column for item 5, 6 or 7
9	prescribe a monitored medicine	the proposed dealing is— (a)  for a circumstance not otherwise mentioned in this column; and (b)  for administration of the medicine to a patient only by a person authorised to administer the medicine

Part 2    Information providers and relevant information

Column 1 Information providers	Column 2 Relevant information
a data source entity	(a)  information in a prescription made for dispensing a monitored medicine for a patient
	(b)  information in a dispensing record for a monitored medicine for a patient
a dispenser, other than a dispenser practising in a public sector hospital	information in a dispensing record for a monitored medicine for a patient

Part 3    Users and purposes for disclosure

Column 1 User	Column 2 Purpose
a health practitioner	(a)  to record and review information for the therapeutic treatment of patients (b)  to comply with requirements under the Act applying to the health practitioner
a data source entity	to enable a health practitioner to access the database for purposes mentioned in this column for the practitioner
a health ombudsman official	to facilitate— (a)  the assessment or investigation of health service complaints under the Health Ombudsman Act 2013; and (b)  the investigation or monitoring of persons subject to actions or orders under that Act
the Australian Health Practitioner Regulation Agency	to ensure health practitioners are complying with the Act, a corresponding law or any applicable requirements under the Health Practitioner Regulation National Law
a government entity in another State responsible for the administration of an equivalent database	to facilitate national consistency in the therapeutic use of monitored medicines
a person conducting research	to facilitate evaluation and research into monitored medicines
a person employed by the chief executive	(a)  to manage the operation of the monitored medicines database (b)  to exercise a power, or perform a function, under the Act relating to monitored medicines

Schedule 19 Fees

section 239

Fee units
1	Initial application for a manufacturing licence or wholesale licence for an S8 medicine (Act, s 75(c))	603.50
2	Initial application for a manufacturing licence or wholesale licence for an S2, S3 or S4 medicine (Act, s 75(c))	603.50
3	Initial application for an S2 retail licence (Act, s 75(c))	210.50
4	Amendment application for a manufacturing licence or wholesale licence for a medicine to add another site (Act, s 78(2)(c))	603.50
5	Amendment application for an S2 retail licence to add another site (Act, s 78(2)(c))	210.50
6	Renewal application for a manufacturing licence or wholesale licence for an S8 medicine (Act, s 82(2)(c))	603.50
7	Renewal application for a manufacturing licence or wholesale licence for an S2, S3 or S4 medicine (Act, s 82(2)(c))	603.50
8	Renewal application for an S2 retail licence (Act, s 82(2)(c))	210.50
9	Processing fee for an initial application for a substance authority for a dealing with a medicine	140.50

Schedule 20 Isolated practice areas—local governments

schedule 22, definition isolated practice area

Aurukun, Balonne, Banana, Barcaldine, Barcoo, Blackall-Tambo, Boulia, Bulloo, Burke, Carpentaria, Central Highlands, Charters Towers, Cherbourg, Cloncurry, Cook, Croydon, Diamantina, Doomadgee, Douglas, Etheridge, Flinders, Goondiwindi, Hope Vale, Isaac, Kowanyama, Lockhart River, Longreach, Maranoa, Mareeba, McKinlay, Mornington, Mount Isa, Murweh, Napranum, North Burnett, Northern Peninsula Area, Palm Island, Paroo, Pormpuraaw, Quilpie, Richmond, Tablelands, Torres, Torres Strait Island, Western Downs, Winton, Woorabinda, Wujal Wujal, Yarrabah

Schedule 21 Rural hospitals—places

schedule 22, definition rural hospital

Atherton, Ayr, Babinda, Baralaba, Barcaldine, Beaudesert, Biggenden, Biloela, Blackall, Blackwater, Boonah, Bowen, Caboolture, Capella, Charleville, Charters Towers, Cherbourg, Childers, Chinchilla, Clermont, Collinsville, Cooktown, Cracow, Cunnamulla, Dalby, Dingo, Dunwich, Dysart, Eidsvold, Emerald, Emu Park, Esk, Gatton, Gayndah, Gin Gin, Gladstone, Goondiwindi, Gordonvale, Gympie, Hervey Bay, Home Hill, Hughenden, Ingham, Inglewood, Injune, Innisfail, Jandowae, Kilcoy, Kingaroy, Laidley, Longreach, Magnetic Island, Malanda, Many Peaks, Mareeba, Maryborough, Miles, Millaa Millaa, Millmerran, Mitchell, Monto, Moranbah, Mossman, Mount Morgan, Mount Perry, Moura, Mundubbera, Murgon, Nanango, Oakey, Proserpine, Proston, Quilpie, Ravenshoe, Richmond, Roma, Sapphire, Sarina, Springsure, Stanthorpe, St George, Tara, Taroom, Texas, Theodore, Thursday Island, Tully, Wandoan, Warwick, Weipa, Winton, Wondai, Yeppoon

Schedule 22 Dictionary

section 4

Note—

See the Poisons Standard, section 6 for the definition approved name.

Aboriginal or Torres Strait Islander health service means either of the following entities providing a service for maintaining, improving, restoring or managing the health of Aboriginal people or Torres Strait Islanders—

(a)a corporation registered under the Corporations (Aboriginal and Torres Strait Islander) Act 2006 (Cwlth); or

(b)a registered entity under the Australian Charities and Not-for-profits Commission Act 2012 (Cwlth).

access, in relation to an S8 safe, for chapter 8, part 2, see section 195.

adrenaline (epinephrine) autoinjector means an S3 medicine that is adrenaline (epinephrine)—

(a)preloaded into an autoinjector to a strength of 0.1% or less for the purpose of managing anaphylaxis or allergic reactions; and

(b)registered on the Australian Register of Therapeutic Goods.

aged care facility means a place where nursing and personal care services are provided to persons living at the place by an approved provider under the Aged Care Act 1997 (Cwlth).

ambulance officer see the Ambulance Service Act 1991.

amount, of a medicine, includes a volume or quantity of the medicine.

anaphylaxis training means training in the following matters—

(a)recognition of the symptoms and signs of anaphylaxis;

(b)knowledge of the appropriate use of adrenaline (epinephrine), including competency in using an adrenaline (epinephrine) autoinjector;

(c)implementing an anaphylaxis first aid plan.

approved disposer, for chapter 4, part 11, see section 143.

approved health facility means a laboratory or facility, other than a private health facility, at which clinical procedures are carried out, that is approved by—

(a)the chief executive; or

(b)another entity responsible for accrediting the compliance of the laboratory or facility with regulatory or professional standards under another Act or a law of the Commonwealth.

approved opioid means a medicine approved for treating patients under an opioid treatment program.

approved store, for chapter 8, part 2, division 3, see section 204.

approved user, of an entity’s electronic prescription management system, for chapter 8, part 1, see section 188(2).

assistant, for possessing a medicine, for chapter 8, part 2, see section 195.

asthma training means training in the following matters—

(a)recognition of the symptoms and signs of asthma;

(b)knowledge of the appropriate use of asthma reliever medication, including competency in using a spacer device;

(c)implementing an asthma first aid plan.

Australian Health Practitioner Regulation Agency means the Australian Health Practitioner Regulation Agency established under the Health Practitioner Regulation National Law, section 23.

Australian Register of Therapeutic Goods means the Australian Register of Therapeutic Goods maintained under the Therapeutic Goods Act 1989 (Cwlth).

authorised person—

(a)for chapter 4, part 9—see section 129; or

(b)for chapter 4, part 10—see section 139.

authorised place means a place stated in this regulation or a substance authority to be a place at which a dealing is authorised with a medicine.

authorised user, of a medicine, for chapter 8, part 2, see section 195.

buyer—

(a)for chapter 4, part 3—see section 48; or

(b)for chapter 4, part 4—see section 55.

carrier means a person engaged to deliver a medicine from place to place.

child care facility means a place at which either of the following services is provided—

(a)an education and care service under the Education and Care Services National Law (Queensland);

(b)a Queensland education and care service under the Education and Care Services Act 2013.

clinical protocol see section 101.

community pharmacy means—

(a)a place at which a person owns and carries on a pharmacy business under the Pharmacy Business Ownership Act 2001; or

(b)if the Pharmacy Business Ownership Act 2024, section 19 has commenced—

(i)the licensed premises for a licensed pharmacy business under that Act; or

(ii)a place at which a person may continue to own and carry on a pharmacy business, without holding a pharmacy business licence, under that Act.

compound, a medicine—

(a)means mixing, compounding, formulating or reconstituting a medicine with any other substance for a particular patient or animal; but

(b)does not include—

(i)reconstituting a medicine that is included in a product on the Australian Register of Therapeutic Goods for a particular patient or animal in accordance with the manufacturer’s instructions for reconstituting the medicine; or

(ii)mixing a medicine with feed for administration to a group of animals on a prescription.

computer includes an application or program installed on the computer.

Continued Dispensing Determination means a legislative instrument made under the National Health Act 1953 (Cwlth), section 89A(3).

corrective services facility see the Corrective Services Act 2006, schedule 4.

custodial facility means a corrective services facility, detention centre or watch-house.

data source entity see section 176.

dentist see schedule 4, section 2.

destroy, a medicine, means render the medicine unusable and unidentifiable.

detention centre means a detention centre under the Youth Justice Act 1992.

digital copy, of a paper prescription, means a copy of the prescription that is a digital image or facsimile sent by electronic communication.

Examples—

•a scan of the prescription sent in an email

•a digital photograph of the prescription sent in a text message

•a copy of the prescription sent on a fax machine

direct supervision, by a supervisor of another person, means supervision of the other person—

(a)by the supervisor being in physical proximity to the other person; or

(b)by the supervisor using technology that allows the supervisor to see and communicate with the other person in real time.

Examples for paragraph (b)—

video conferencing, online streaming

dispensary means the area within a pharmacy or other place used to store and dispense regulated substances.

dispenser—

(a)for chapter 4, part 8, division 1—see section 112; or

(b)for chapter 4, part 8, division 2—see section 125; or

(c)generally, in relation to a medicine, means a person who is authorised under the Act, or permitted under a corresponding law or another law, to dispense the medicine.

dispensing record see section 124(2).

dose administration aid means a tamper-evident container or packaging used to separate doses of a medicine for administration at particular times.

electronic prescription—

(a)means a prescription in electronic form, including a prescription made in an electronic prescription management system; but

(b)does not include a digital copy of a paper prescription.

electronic prescription management system see section 184(2).

endorsed, in relation to a health practitioner, means the practitioner is endorsed under the Health Practitioner Regulation National Law, section 94 as being qualified to administer, obtain, possess, prescribe, sell, supply or use a medicine.

enrolled nurse see schedule 7, section 18.

equivalent database see section 176.

farmer, of a group of animals, means the owner or custodian of the group of animals, whether or not the animals are food producing animals.

food producing animal see the Biosecurity Regulation 2016, schedule 3, section 3.

function includes a power.

general approval (acute health conditions at isolated sites) see section 15.

general approval (emergency first aid) see section 16.

general approval (emergency management of animals) see section 17.

hospital means—

(a)a public sector hospital; or

(b)a private health facility.

Hospital and Health Service see the Hospital and Health Boards Act 2011, section 17.

immunisation medicine means a medicine that—

(a)is a vaccine; or

(b)includes immunoglobulins or monoclonal antibodies for the prevention of an infectious disease.

inhaled asthma reliever means an S3 or S4 medicine that is a bronchodilator in a metered dose inhaler.

intern pharmacist see schedule 9, section 5.

isolated practice area means—

(a)a place that is at Cow Bay, Mapoon or Weipa; or

(b)a place that is—

(i)within the area of a local government mentioned in schedule 20; and

(ii)remote from pharmaceutical services; or

(c)a clinic conducted by the Royal Flying Doctor Service of Australia (Qld section) in an area isolated from medical, pharmaceutical and hospital services; or

(d)a plane operated by the Royal Flying Doctor Service of Australia (Qld section).

licensing fee, for chapter 9, part 2 and schedule 19, see section 238.

manager, of an S8 safe or approved store, see section 204.

manufacturer means the holder of a manufacturing licence or a person permitted under a Commonwealth law to manufacture a medicine.

manufacturer’s conditions, for a medicine, means the environmental conditions recommended by the manufacturer for maintaining the therapeutic quality and stability of the medicine.

manufacturer’s pack, of a medicine, means a primary pack of the medicine supplied by the manufacturer of the medicine.

Note—

See the Poisons Standard, section 6 for the definition primary pack.

mark, in relation to recording information on a document, includes making an entry in an electronic system.

MDMA means the substance N, a-dimethyl-3,4-(methylenedioxy)phenylethylamine.

medical practitioner see schedule 6, section 1.

medicated feed means feed for an animal that contains an S4 medicine.

medication chart prescription see section 80.

medicine register, for an S8 safe or approved store, see section 205.

medicine store, for chapter 8, part 2, see section 195.

medicine store establisher, for chapter 8, part 2, see section 195.

methoxyflurane training means training in the use and administration of methoxyflurane provided by a registered training organisation.

midwife see schedule 7, section 5.

mine means a place where activities are permitted under—

(a)a mining tenement within the meaning of the Mineral Resources Act 1989, other than a prospecting permit or water monitoring authority within the meaning of that Act; or

(b)a GHG authority within the meaning of the Greenhouse Gas Storage Act 2009; or

(c)a geothermal tenure within the meaning of the Geothermal Energy Act 2010; or

(d)a petroleum authority under the Petroleum and Gas (Production and Safety) Act 2004, other than an authority to prospect or water monitoring authority within the meaning of that Act.

naloxone training means training in the following matters—

(a)recognition of the symptoms and signs of suspected opioid overdose;

(b)knowledge of the appropriate use of naloxone, including competency in administering naloxone;

(c)implementing an opioid first aid plan.

national medication chart prescription see section 80.

nitrous oxide mixture means a substance containing a mixture of nitrous oxide and oxygen in which the concentration of nitrous oxide is not more than 70%.

non-restricted medicine means a medicine other than a restricted medicine.

non-State school means an accredited school under the Education (Accreditation of Non-State Schools) Act 2017.

nurse manager, in relation to a place, means the registered nurse in charge from time to time for the provision of nursing services at the place.

nurse practitioner see schedule 7, section 2.

opioid treatment program means a program, for the treatment of persons dependent on opioids, administered in Queensland under the National Health Act 1953 (Cwlth), section 100.

oral hormonal contraceptive, for chapter 5, part 2, division 3, subdivision 3, see section 155.

paper prescription—

(a)means a prescription in paper form; and

(b)includes a prescription generated by printing out the prescription on paper from a computer.

paramedic see schedule 16, section 3.

patient—

1

Patient generally—

(i)means a person seeking or receiving therapeutic treatment or the supply or administration of a medicine; and

(ii)includes someone else seeking the supply for the person.

2

Patient—

(i)in relation to an aged care facility—means a person living at the facility; or

(ii)in relation to a custodial facility—means a person detained at the facility.

pharmacist see schedule 9, section 1.

pharmacy means a community pharmacy or a place in a relevant institution where medicines are supplied by a pharmacist to the public.

pharmacy employee means a person, other than a pharmacist, mentioned in schedule 9 who is employed at a pharmacy.

podiatric surgeon see schedule 10, section 1.

podiatrist see schedule 10, section 2.

pre-packed, in relation to a medicine, for chapter 5, part 2, division 3, subdivision 3, see section 155.

prescriber—

(a)for chapter 4, part 6—see section 79(1); or

(b)for chapter 4, part 7, division 2—see section 102; or

(c)for chapter 4, part 7, division 3—see section 109; or

(d)generally, in relation to a medicine, means a person who is authorised under the Act, or permitted under a corresponding law or another law, to prescribe the medicine.

prescription exchange system, for chapter 7, see section 176.

prison means a place declared to be a prison under the Corrective Services Act 2006, section 149.

private health facility see the Private Health Facilities Act 1999, section 8.

public sector hospital see the Hospital and Health Boards Act 2011, schedule 2.

reconstituting, a medicine for supply, means mixing a formulated medicine with another substance for a particular patient or animal in accordance with the manufacturer’s instructions for the medicine.

registered immunisation service provider means an entity—

(a)approved by the chief executive to carry out activities for an immunisation program managed by an entity of the State or Commonwealth; and

(b)listed on a register, maintained by the chief executive, that states the entities approved as mentioned in paragraph (a).

registered medicine ...

registered nurse see schedule 7, section 10.

registered training organisation see the National Vocational Education and Training Regulator Act 2011 (Cwlth), section 3.

relevant health service means—

(a)a Hospital and Health Service; or

(b)an Aboriginal or Torres Strait Islander health service.

relevant institution means an aged care facility, hospital, prison or detention centre.

repackage, a medicine for supply for a patient or animal, means manufacturing the medicine by taking a particular dose of the medicine for the patient or animal from a manufacturer’s pack and repackaging the particular dose.

repeat, for a medicine, means the number of times the medicine may be dispensed or given after the first time it is dispensed or given.

restricted ivermectin ...

restricted medicine see section 9.

RFDS medicine chest see schedule 5, section 7.

rural hospital means—

(a)a public sector hospital at a place mentioned in schedule 21; or

(b)Maleny Soldiers Memorial Hospital.

S4 diversion-risk medicine means an S4 medicine that is a diversion-risk medicine.

S8 safe see section 195.

S8 safe establisher, for a place, for chapter 8, part 2, see section 195.

S8 waste see section 144.

school means a State school or a non-State school.

secure area means an area, or receptacle in an area, that is locked or otherwise secured in a way that is designed to prevent access to the area or receptacle by a person who is not authorised to access the area or receptacle.

Examples—

•a padlocked cupboard or chest

•a room that can only be accessed with an electronic code

•a locked cage in a vehicle

secure system identifier, for a person, means a unique number or word to identify the person that can only be used in combination with a password.

shared clinic, for chapter 8, part 2, see section 195.

sign or signature includes using initials or signing in an electronic form.

site, for chapter 9, part 2 and schedule 19, see section 238.

specialist registrant, in relation to a person for a field of practice, means the person is registered as a specialist in the field under the Health Practitioner Regulation National Law.

specified place means—

(a)a health service that is an approved Aboriginal health service under the National Health (Remote Area Aboriginal Health Services Program) Special Arrangement 2017 (PB 107 of 2017) (Cwlth); or

(b)an aged care facility; or

(c)a hospital; or

(d)a school or child care facility; or

(e)a prison, detention centre or watch-house; or

(f)a mine; or

(g)a place stated in a substance authority to be a place where a dealing is authorised.

starter pack, for a medicine, means a small pack of the medicine supplied as a sample or at no cost.

State school means a school established under the Education (General Provisions) Act 2006, section 13.

supervision, by a supervisor of another person, means the oversight by the supervisor of the dealings of the other person for—

(a)directing, demonstrating and monitoring the dealings; and

(b)checking the other person’s level of competency for the dealings.

supplier—

(a)for chapter 4, part 3—see section 49; or

(b)for chapter 4, part 4—see section 54.

system administrator, of an entity’s electronic prescription management system, see section 185(2).

system manager, of an entity’s electronic prescription management system, see section 185(1).

Therapeutic Goods Administration means the entity known as the ‘Therapeutic Goods Administration’ within the Commonwealth department responsible for administration of the Therapeutic Goods Act 1989 (Cwlth).

therapeutic nicotine means nicotine in a therapeutic vaping good.

therapeutic vaping good see the Therapeutic Goods Regulations 1990 (Cwlth), section 2.

trainee pharmacist see schedule 9, section 7.

type, of a medicine, for chapter 8, part 2, division 3, see section 204.

unique identifier, for a person or document, means a particular code, letter, number, mark, or combination of those things, used to identify the person or document, including in a digital form.

veterinary premises see the Veterinary Surgeons Act 1936, schedule.

wholesale representative see schedule 14, section 7.

written prescription means a prescription in writing, whether in the form of an electronic prescription, medication chart prescription or paper prescription.