Medicines and Poisons (Medicines) Regulation 2021

1Short title

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

2Commencement

This regulation commences on 27 September 2021.

3Application 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.

4Definitions

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

5References 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.

6Exemption 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 1.5.5—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.

7Extended 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 Act for 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.

8Departmental 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 Act for 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.

9Restricted medicines

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

10High-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.

11Diversion-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.

12Monitored 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.

13Approved 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.

14Classes of general approvals—Act, s 68

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

15Acute 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.

16Emergency 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.

17Emergency 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.

18Application 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.

19Application of division

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

20Manufacturing 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).

21Quality 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.

22Open 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.

23Application 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.

24Supply 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.

25Manufacturer 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.

26Delivery 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

27Selling 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.

28Selling 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.

29Open 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.

30Application 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.

31Notification 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.

32Appropriately 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.

33Practitioners 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.

34Appropriately 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.

35Notification 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.

36Practitioners 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.

37Appropriately 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.

38Veterinary 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.

39Application of part

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

40Keeping 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.

41Availability 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.

42Notification 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.

43Stopping 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.

44Application 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 Act to 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 Act in 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 Act which relates to emergency orders.

45Application of part

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

46Compounded 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.

47Compounding 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’.

48Application 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 Act in 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.

49Definitions 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.

50When 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.

51Nature 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

52Information 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.

53Buyer 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.

54Application 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.

55Definitions for part

In this part—

buyer means a person buying stock.

supplier see section 54.

56Supply 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.

57Supply 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.

58Supply 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.

59Supply 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.

60When 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.

61Supplier 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.

62Completing 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.

63Application of division

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

64Secure 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.

65Additional 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.

66Engaging 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.

67Delivery 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.

68Supplier 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.

69Supplier 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.

70Responsibilities 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.

71Compliance 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.

72Supplying 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.

73Labels 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, section 1; 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, section 2; 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.

74Open 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.

75Application 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.

76Storing 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.

77Stock not to be left unattended

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

78Delivery 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).

79Application 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.

80Definitions 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).

81Reasonable 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.

82Application 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.

83Electronic 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.

84Sending 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 for a diversion-risk medicine to a person.

(3)Before sending the digital copy, the prescriber must take all reasonable steps 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.

85Generation 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.

86Content 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.

87Additional 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)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.

88Signing written prescription

A prescriber must sign a prescription.

Note—

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

89Using 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.

90Amending 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.

91Application 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.

92Oral 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.

93Compliance 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’.

94Application 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.

95Content 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.

96Additional 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.

97Signing written prescription

A prescriber must sign a prescription.

Note—

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

98Using 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.

99Application 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.

100Oral 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.

101Meaning 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.

102Application 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.

103Making 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.

104Making 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 to provide 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.

105Safe 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.

106Content 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.

107Additional 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.

108Standing 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.

109Application of division

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

110Contents 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.

111Protocol 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.

112Application 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.

113Dispensing 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.

114Dispensing 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.

115Dispensing 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.

116Digital 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.

117Amending written prescription

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

(2)A dispenser must not amend the prescription other than in accordance with this section or section 229.

(3)The dispenser may amend the prescription before dispensing the medicine by adding additional information to the prescription to clarify the prescriber’s direction.

(4)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 who made the prescription.

(5)When amending the prescription, the dispenser must—

(a)if the dispenser and prescriber agree on a way to amend the prescription—amend the prescription in the way agreed; and

(b)sign and date the amendment in a way that does not obscure the original prescription.

Note—

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

118Labelling 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.

119Expired 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.

120When 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.

121Expired 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.

122Dispensing 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.

123Keeping 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.

124Dispensing 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 section 117—the details of the amendment and the agreement with the prescriber.

(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.

125Application of division

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

126Compliance with monitored medicines standard

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

127Dispensing 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.

128Dispensing 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.

129Application 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.

130Reasonable 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.

131Giving 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.

132Giving 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.

133When 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.

134Labelling 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.

135Information 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.

136Treatment 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.

137Expired 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.

138Expired 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.

139Application of part

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

140Reasonable 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.

141Record 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.

142Expired 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.

143Application 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.

144Application of division

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

145Separation 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.

146Transfer 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.

147Destruction of waste

(1)An approved disposer must not destroy S8 waste unless the approved disposer is—

(a)any of the following persons in charge of disposal at a place—

(i)ambulance officer;

(ii)dentist;

(iii)medical practitioner;

(iv)nurse practitioner, midwife, registered nurse or enrolled nurse;

(v)pharmacist;

(vi)podiatrist or podiatric surgeon;

(vii)veterinary surgeon; or

(b)specifically authorised to supervise the destruction of the waste under a substance authority.

(2)The approved disposer must not destroy the S8 waste unless the destruction is witnessed by a person not related or married to, or in a de facto relationship with, the approved disposer who is—

(a)a member of a class of persons mentioned in subsection (1); or

(b)an inspector; or

(c)a police officer.

148Preventing public access to waste

(1)This section applies in relation to waste from a diversion-risk medicine other than an S8 medicine.

(2)An approved disposer must not leave the waste unattended in a location unless the disposer reasonably believes—

(a)a member of the public could not access the waste without being seen; and

(b)the waste is likely to be taken for destruction as soon as practicable.

149Application 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) of the Act to deal with a medicine, in relation to carrying out the dealing.

(2)This part applies in addition to chapter 4, unless otherwise stated.

Notes—

1See section 91(3) of the Act about the relationship between requirements prescribed under section 91 and other provisions of the Act.

2See also section 31 of the Act for when a person deals with a medicine in the authorised way.

150Application of part

This part applies to a pharmacist who is authorised to deal with a medicine, in relation to carrying out the dealing at a pharmacy.

151Supply for filling another pharmacy client order

(1)This section applies in relation to supplying stock of a medicine to fill an order made by a client of another pharmacist.

(2)The pharmacist supplying the stock must—

(a)be reasonably satisfied the request is for satisfying the client’s order; and

(b)supply the minimum amount of stock necessary to satisfy the client’s order; and

(c)obtain a signed, written request for the stock from the other pharmacist.

152Records when supplying to another pharmacist

(1)This section applies in relation to supplying stock of a medicine to another pharmacist.

(2)The pharmacist supplying the stock must make and keep a record of the following information—

(a)the signed, written request for the stock;

(b)the date on which the stock was supplied;

(c)the type of stock supplied;

(d)the amount of stock supplied.

Note—

See section 224 about keeping records.

153Application of division

This division applies in relation to selling a medicine without a prescription.

154Labelling sold medicine

(1)This section does not apply in relation to an S2 medicine in a manufacturer’s pack.

(2)A pharmacist must not sell 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.

(3)However, if the medicine is an S3 medicine in a manufacturer’s pack, the pharmacist must instead attach a label to the medicine stating the following information—

(a)the date the medicine is sold;

(b)the name of the patient;

(c)the name of the medicine;

(d)if the medicine is mentioned in the Poisons Standard, Appendix K—the warning statement mentioned in Appendix K for the medicine.

155Definition for subdivision

In this subdivision—

oral hormonal contraceptive means an oral preparation of a medicine for preventing pregnancy by interrupting ovulation.

156Selling S4 oral hormonal contraceptive

(1)This section applies in relation to an S4 medicine that is an oral hormonal contraceptive for a patient.

(2)A pharmacist must not sell the medicine unless the pharmacist reasonably believes—

(a)the patient has been treated by a prescriber with the medicine for a continuous period of a reasonable length; and

(b)it is not practicable for the patient to obtain a prescription for the medicine before needing to continue treatment with the medicine; and

(c)the patient has not, in the year before seeking the medicine from the pharmacist, been sold the medicine without a prescription from the pharmacy at which the medicine is sought.

Note—

See section 160(i) about records to be kept when selling a medicine to which this section applies.

157Selling S4 diversion-risk medicine

(1)This section applies in relation to an S4 medicine that is a diversion-risk medicine for a patient, other than a medicine sold under the Continued Dispensing Determination.

(2)A pharmacist must not sell the medicine unless the pharmacist reasonably believes—

(a)the medicine has been previously prescribed to the patient; and

(b)failure to sell the medicine could be life-threatening for the patient; and

(c)it is not practicable for the patient to obtain a prescription for the medicine before needing to continue treatment with the medicine.

158Selling other S4 medicines

(1)This section applies in relation to an S4 medicine, other than a diversion-risk medicine or oral hormonal contraceptive, for a patient.

(2)A pharmacist must not sell the medicine unless the pharmacist reasonably believes—

(a)the medicine has been previously prescribed to the patient; and

(b)continuing the patient’s treatment with the medicine is urgent and essential for the patient’s wellbeing; and

(c)it is not practicable for the patient to obtain a prescription for the medicine before needing to continue treatment with the medicine.

159Amounts when selling S4 medicine

A pharmacist must not sell an amount of an S4 medicine that is more than—

(a)for an S4 medicine that is a prepacked liquid, cream, ointment or aerosol—the minimum standard pack; or

(b)for an S4 medicine that is an oral hormonal contraceptive—a manufacturer’s pack of the medicine; or

(c)for another S4 medicine—3 days’ supply of the medicine.

Note—

See schedule 9, part 1 about pharmacists repackaging medicines.

160Record when selling S4 medicine

As soon as practicable after selling a medicine for a patient, a pharmacist must make and keep a record of the following information—

(a)the name of the pharmacist;

(b)the date the medicine is sold;

(c)the name and address of the patient;

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

(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 sold;

(g)the instructions given for the use of the medicine;

(h)the name of the prescriber who last prescribed the medicine to the person, if known;

(i)for an oral hormonal contraceptive or diversion-risk medicine—a brief description of why the pharmacist is selling the contraceptive or medicine.

Note—

See section 224 about keeping records.

161Selling S3 medicine with instructions for use

(1)A pharmacist must not sell an S3 medicine for a patient unless the pharmacist reasonably believes the patient has a therapeutic need for the medicine.

(2)A pharmacist must not sell an S3 medicine for an animal except to a person the pharmacist reasonably believes is the owner or custodian of the animal.

(3)The pharmacist must give instructions about the appropriate way to use the S3 medicine to the person buying the medicine.

Example for subsection (3)—

A pharmacist instructs a patient’s carer about how to use naloxone to treat an opioid overdose.

162Record keeping for pseudoephedrine

(1)This section applies in relation to an S3 medicine containing pseudoephedrine.

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

(a)the date of the sale;

(b)the name of the medicine;

(c)the amount of the medicine sold;

(d)the name and address of the person who bought the medicine;

(e)the type of document used to identify the person who bought the medicine and an identifier for the document, if applicable.

Examples for paragraph (e)—

driver licence number, passport number

(3)The record must be kept electronically in a way that complies with the departmental standard called ‘Pseudoephedrine recording’.

163Application of part

This part applies to a pharmacy employee who is authorised to deal with a medicine, in relation to dealing with the medicine at a pharmacy.

164Notifying pharmacist of discrepancy

(1)This section applies in relation to stock of S8 medicines received from a wholesale supplier for a pharmacy.

(2)A pharmacy employee in possession of the stock must immediately check the amount of stock received against the amount of stock listed on the invoice from the wholesale supplier.

(3)The pharmacy employee must notify a pharmacist at the pharmacy of any discrepancy between the invoice and stock received.

165Selling S2 medicine in manufacturer’s pack

A pharmacy employee must not sell an S2 medicine other than in a manufacturer’s pack.

166Application of division

This division applies to a veterinary surgeon who is authorised to prescribe a medicine for an animal if the medicine—

(a)is an S4 medicine or medicated feed; and

(b)is to be mixed with food for administration to a group of animals by a farmer of the animals.

167Instructions for administration to food producing animals

(1)This section applies in relation to food producing animals.

(2)A veterinary surgeon must give instructions to the farmer of the food producing animals about how to—

(a)measure and combine an S4 medicine or medicated feed with food to administer to the animals; and

(b)clean any residue from the medicine or feed from any equipment used to administer it to the animals.

(3)This section does not apply if the veterinary surgeon has previously given the farmer the relevant instructions.

168Written prescription for medicine and medicated feed

(1)A veterinary surgeon must make a written prescription for an S4 medicine or medicated feed for a group of animals that states the following information—

(a)a unique identifier for the prescription;

(b)the name of the veterinary surgeon;

(c)the address of the veterinary premises of the veterinary surgeon;

(d)the qualifications of the veterinary surgeon;

(e)the date of the prescription;

(f)the name and address of the farmer of the animals;

(g)the date, no later than 6 months after the date the prescription is given, when the prescription expires;

(h)the species of the animals;

(i)any other details necessary to identify the animals, including, for example, the age, breed or sex of the animals;

(j)a statement that the medicine or feed is for animal treatment only;

(k)for a medicine—

(i)the name of the medicine; and

(ii)the form and strength of the medicine; and

(iii)the final concentration of the medicine to be in the food administered to the animals;

(l)for medicated feed—

(i)the name of the medicine mixed, or to be mixed, into the feed; and

(ii)the form and strength of the medicine mixed, or to be mixed, into the feed; and

(iii)the name and address of the manufacturer to supply the feed; and

(iv)the final concentration of the medicine to be mixed into the feed supplied by the manufacturer; and

(v)how much feed may be supplied by the manufacturer;

(m)the instructions mentioned in section 167 for administering the medicine or feed to the animals, if any.

Note—

See also the Chemical Usage (Agricultural and Veterinary) Control Act 1988, section 12M for additional requirements in relation to prescriptions for medicated feed.

(2)The veterinary surgeon must sign, and keep a copy of, the written prescription.

Note—

See section 224 about keeping records.

169Sending written prescription

(1)This section applies if a veterinary surgeon sends a written prescription for medicated feed to the holder of a manufacturing licence for the feed.

(2)The written prescription must be made and sent to the holder in a way that is reasonably likely to—

(a)minimise fraud or tampering; and

(b)allow the prescription to be amended only by the veterinary surgeon; and

(c)if sent electronically—be transmitted securely.

170Record for veterinary nurse administering on oral prescription

(1)This section applies to a veterinary nurse who is authorised to administer a medicine to an animal, if the medicine is administered on an oral prescription.

(2)The veterinary nurse must make and keep a record of—

(a)the oral prescription; and

(b)the name of the veterinary surgeon who prescribed the medicine; and

(c)the date and time the medicine is administered; and

(d)the amount of medicine administered.

Note—

See section 224 about keeping records.

171Disposal of unused starter packs

(1)This section applies to a wholesale representative who is authorised to dispose of waste from a diversion-risk medicine.

(2)A wholesale representative must return to the representative’s employer any starter pack of a diversion-risk medicine that is unwanted, expired or otherwise unused.

(3)In this section—

employer, of a wholesale representative, means the wholesaler who employs the representative.

Note—

See also section 232 requiring wholesale representatives to complete returns of transactions.

172Regulated places and responsible persons—Act, s 92

(1)For section 92 of the Act, definition regulated place, paragraph (b), each place stated in column 1 of the table in schedule 17, section 2 is prescribed to be a regulated place.

(2)For section 92 of the Act, definition responsible person, the person stated in column 2 of the table in schedule 17, section 2 is prescribed to be the responsible person for the regulated place stated opposite in column 1.

173Matters for plan—Act, s 93

For section 93(2)(b) of the Act, matters stated in the departmental standard called ‘Substance management plans for medicines’ are prescribed.

174Review of plan—Act, s 93

(1)For section 93(3)(b) of the Act, the following times are prescribed for a substance management plan for a regulated place relating to medicines—

(a)as soon as practicable after a review incident happens in relation to the regulated place; and

(b)at least every 5 years after—

(i)the day the substance management plan starts; or

(ii)if the plan is reviewed in any 5-year period after the plan starts—the day the plan was last reviewed.

(2)In this section—

review incident, in relation to a regulated place, means an incident stated to be a review incident for the place in the departmental standard called ‘Substance management plans for medicines’.

175Application to information from other States

(1)This chapter applies in relation to information recorded in another State to the extent the information relates to—

(a)a health practitioner ordinarily practising in Queensland; or

(b)a patient ordinarily residing in Queensland; or

(c)a prescription made in Queensland; or

(d)a medicine dispensed or given in Queensland.

(2)For applying subsection (1), a reference in this chapter to a type of information recorded under the Act is taken to include a reference to the equivalent type of information recorded under a corresponding law, to the extent the context permits.

176Definitions for chapter

In this chapter—

data source entity means any of the following entities—

(a)Fred IT Group Pty Ltd ABN 68 109 546 901;

(b)Medication Knowledge Pty Ltd ABN 47 622 493 967;

(c)the Australian Health Practitioner Regulation Agency;

(d)a government entity in another State responsible for the administration of an equivalent database;

(e)an entity that is a data source entity under a corresponding law;

(f)another entity that provides a prescription exchange system to a health practitioner.

equivalent database means a database kept under a corresponding law that is the same as, or substantially similar to, the monitored medicines database.

prescription exchange system means an electronic system for recording or transmitting prescriptions, or information in prescriptions, for dispensing to patients.

177Additional purposes—Act, s 224

For section 224(2)(g) of the Act, the following purposes are prescribed—

(a)to manage the operation of the database;

(b)to exercise a power, or perform another function, under the Act in relation to a monitored medicine.

178Relevant practitioners—Act, s 41

For section 41(4) of the Act, definition relevant practitioner, each health practitioner stated in schedule 18, part 1 is prescribed to be a relevant practitioner.

179Information recorded in database—Act, s 225

For section 225(1) of the Act, the following information is prescribed—

(a)information given to the chief executive under section 226 of the Act;

(b)information in relation to a patient’s treatment stated in a prescribing approval for a monitored medicine;

(c)the registration details from time to time, under the Health Practitioner Regulation National Law, of a health practitioner given to, or held by, the chief executive;

(d)information about any other qualification of a health practitioner for treating a patient with a monitored medicine given to, or held by, the chief executive;

(e)personal information to identify a health practitioner for accessing or using the monitored medicines database given to, or held by, the chief executive;

(f)information about a health practitioner provided for the purpose of accessing or using the database.

180Information providers and relevant information—Act, s 226

(1)For section 226(2) of the Act, definition information provider, each entity stated in column 1 of the table in schedule 18, part 2 is prescribed to be an information provider.

(2)For section 226(2) of the Act, definition relevant information, the information mentioned in column 2 of the table in schedule 18, part 2 is prescribed to be the relevant information for the information provider mentioned opposite in column 1.

181Method for data source entities giving information—Act, s 226

(1)This section applies in relation to an information provider that is a data source entity.

(2)For section 226(1) of the Act—

(a)the way prescribed is by sending an electronic copy of the relevant information to the monitored medicines database; and

(b)the time prescribed is when the relevant information is received by the information provider.

182Method for dispensers giving information—Act, s 226

(1)This section applies in relation to an information provider who is a dispenser.

(2)For section 226(1) of the Act—

(a)the way prescribed is by using a prescription exchange system; and

(b)the time prescribed is when the information provider is recording the information in the system.

183Users—Act, s 227

(1)For section 227(4) of the Act, definition user, each entity stated in column 1 of the table in schedule 18, part 3 is prescribed to be a user.

(2)For section 227(2) of the Act, each purpose stated in column 2 of the table in schedule 18, part 3 is prescribed to be a purpose for the user opposite in column 1.

184Application of part

(1)This part applies in relation to an entity that establishes or uses an electronic system for—

(a)making or transmitting prescriptions for dispensing medicines; or

(b)retrieving prescriptions for dispensing medicines, including recording information relating to the dispensing of the medicines.

(2)An electronic system mentioned in subsection (1) is an electronic prescription management system.

(3)To remove any doubt, it is declared that the monitored medicines database is not an electronic prescription management system.

185Appointments for managing system

(1)The person in charge of an entity to which this part applies must appoint, in writing, an appropriately qualified person (a system manager) to be responsible for the establishment and operation of the entity’s electronic prescription management system, unless the person has a reasonable excuse.

Maximum penalty—80 penalty units.

(2)The system manager of an entity’s electronic prescription management system must appoint, in writing, 1 or more appropriately qualified persons (each a system administrator) to be responsible for the administration and technical maintenance of the system, unless the manager has a reasonable excuse.

Maximum penalty—80 penalty units.

(3)The system manager must record and keep the name and contact details for each person appointed under subsection (2), unless the manager has a reasonable excuse.

Maximum penalty—80 penalty units.

Note—

See section 224 about keeping records.

(4)The person in charge of the entity must take all reasonable steps to ensure that each person appointed under subsection (1) or (2) is advised, in writing, of the provisions applying to the person under this part.

Maximum penalty—80 penalty units.

186System must comply with departmental standard

The system manager of an entity’s electronic prescription management system must take all reasonable steps to ensure the system complies with the departmental standard called ‘Requirements for an electronic prescription management system’.

Maximum penalty—80 penalty units.

187Security measures required for system

The system manager of an entity’s electronic prescription management system must take all reasonable steps to ensure security measures are embedded in the system to—

(a)prevent a person who is not approved to use the system from accessing or using the system; and

(b)monitor any breaches of the system or events affecting the integrity of the system; and

(c)keep each record made in the system for at least 2 years after the record is created.

Maximum penalty—80 penalty units.

188Giving access to the system

(1)A system administrator of an entity’s electronic prescription management system must not give a person access to the system unless the administrator reasonably believes—

(a)the person works for the entity; and

(b)the access given is limited to the extent required for the person to perform the person’s role or function for the entity; and

(c)the person has appropriate authorisation under the Act to use the system to perform the person’s role or function for the entity.

Maximum penalty—80 penalty units.

Examples of giving access to perform a role or function for the entity—

1A prescriber working for the entity is given access to view information and record prescriptions about the entity’s patients.

2A dispenser working for the entity is given access to retrieve prescriptions and record information when dispensing medicines for the entity’s patients.

3An information technology technician working for the entity is given access to perform administrative or technical tasks to maintain the security of the electronic prescription management system.

(2)A person given access to an entity’s electronic prescription management system under subsection (1) is an approved user of the system.

(3)The system administrator must give each approved user only 1 secure system identifier for the electronic prescription management system.

Maximum penalty—80 penalty units.

189Cancelling access to the system

(1)This section applies if a system administrator of an entity’s electronic prescription management system becomes aware that an approved user of the system has stopped performing the role or function for the entity for which the user was given access.

(2)The system administrator must cancel the approved user’s access to the electronic prescription management system, unless the administrator has a reasonable excuse.

Maximum penalty—80 penalty units.

190Making and keeping records of users

(1)This section applies if a system administrator of an entity’s electronic prescription management system has given or cancelled a person’s access to the system.

(2)Unless the system administrator has a reasonable excuse, the administrator must make and keep a record of any information used in relation to giving or cancelling the access, including—

(a)the name of the person and the person’s secure system identifier; and

(b)the date on which the person was given access; and

(c)the date on which the person’s access was cancelled, if applicable.

Maximum penalty—40 penalty units.

Note—

See section 224 about keeping records.

191Maintaining system

Each system administrator of an entity’s electronic prescription management system must take all reasonable steps to maintain the security of the system and the records kept in the system.

Maximum penalty—40 penalty units.

Examples of reasonable steps—

regularly running virus protection programs, installing software updates

192Reporting system breaches for monitored medicines

(1)This section applies if the system manager, or a system administrator, of an entity’s electronic prescription management system becomes aware of an incident in which the system may have been unlawfully accessed or otherwise unlawfully used to obtain a monitored medicine.

Example of an incident—

virus software enters an electronic prescription management system to create false prescriptions

(2)Within 5 business days after becoming aware of the incident, the system manager or system administrator must give notice to the chief executive about the incident in the approved form, unless the manager or administrator has a reasonable excuse.

Maximum penalty—80 penalty units.

193Protecting secure system identifiers

An approved user of an entity’s electronic prescription management system must take all reasonable steps to prevent the user’s secure system identifier for the system being accessed by another person.

Maximum penalty—20 penalty units.

Examples of reasonable steps—

using a strong password or locking a device on which a secure system identifier is stored

194Non-application of part to animal feed

This part does not apply in relation to—

(a)an S4 medicine or medicated feed to be mixed with food for administration to a group of animals; or

(b)a person who is the farmer of the animals—

(i)possessing the medicine or feed mentioned in paragraph (a); or

(ii)administering the medicine or feed to the animals.

195Definitions for part

In this part—

access, in relation to an S8 safe, means a device or electronic way to open the safe.

assistant, for possessing a medicine, means a person who is authorised to possess the medicine only under the supervision of another person.

authorised user, of a medicine, means a person who is authorised to deal with the medicine, other than a person who is an assistant.

medicine store means any receptacle, structure or part of a vehicle used for the storage or preservation of medicines.

Examples—

chest, cupboard, refrigerator, room, vehicle cage

medicine store establisher, for a place, means—

(a)if the place is a shared clinic—the person appointed under section 196(2)(b) for the clinic; or

(b)otherwise—a person who possesses S2, S3 or S4 medicines at the place for independently practising a profession or performing a function.

S8 safe means a lockable medicine store for S8 medicines or S8 waste.

S8 safe establisher, for a place, means—

(a)if the place is a shared clinic—a person appointed under section 196(2)(a) for the clinic; or

(b)otherwise—a person who possesses S8 medicines at the place for independently practising a profession or performing a function.

shared clinic means a place at which medicines are possessed for more than 1 person to use for supply or administration to more than 1 person.

196Appointing establishers and managers

(1)This section applies in relation to a shared clinic.

(2)The person in charge of the shared clinic must appoint, in writing, an appropriately qualified person to be responsible for establishing and maintaining—

(a)an S8 safe for S8 medicines possessed at the clinic; and

(b)a medicine store for any other medicines possessed at the clinic.

Maximum penalty—40 penalty units.

(3)The person in charge of the shared clinic must also appoint, in writing, an appropriately qualified person to be a manager of the S8 safe or medicine store at the clinic.

Maximum penalty—40 penalty units.

(4)The person in charge of the shared clinic must take all reasonable steps to ensure that each person appointed under subsection (2) or (3) is advised, in writing, of the provisions applying to the person under this part.

Maximum penalty—40 penalty units.

197S8 safe must comply with standard

(1)An S8 safe establisher for a place must establish an S8 safe for S8 medicines at the place in a way that complies with the departmental standard called ‘Secure storage of S8 medicines’.

Maximum penalty—40 penalty units.

(2)The S8 safe establisher must take all reasonable steps to ensure the S8 safe is established and maintained in a way that keeps the medicines in the safe in accordance with the manufacturer’s conditions for the medicines.

Maximum penalty—40 penalty units.

198Storage for safety and quality of medicines

(1)A medicine store establisher for a place must establish and maintain a medicine store for storing S2, S3 and S4 medicines at the place.

Maximum penalty—40 penalty units.

(2)The medicine store establisher must take all reasonable steps to ensure the medicine store is established and maintained in a way that keeps the medicines in the store in accordance with the manufacturer’s conditions for the medicines.

Maximum penalty—40 penalty units.

(3)If pentobarbital is possessed at the place, the medicine store establisher must ensure the medicine store for the pentobarbital is lockable.

Maximum penalty—40 penalty units.

199Preventing unauthorised access to medicines

(1)A medicine store establisher for a place must put each medicine store for the place in an area where the establisher reasonably believes a member of the public could not access the store without being seen by a worker at the place.

Maximum penalty—40 penalty units.

(2)If pseudoephedrine is possessed at the place, the medicine store must also be kept in an area that is out of sight from members of the public.

Maximum penalty—40 penalty units.

200S8 safe establisher giving access to S8 safe

(1)An S8 safe establisher may give a person access to an S8 safe at a place only if—

(a)the person is an authorised user of the S8 medicines kept in the safe at the place; and

(b)if the safe is at a relevant institution or community pharmacy—the person is permitted to open the safe under the substance management plan for the institution or pharmacy.

Examples of giving access to an S8 safe—

1giving a person a key or swipe card that opens the S8 safe

2providing a person with a way to generate a code or password for an electronic keypad that opens the S8 safe

3entering a person’s biometric information into an electronic system that allows the person to open the safe

Maximum penalty—40 penalty units.

(2)The S8 safe establisher may give the access to the authorised user only if the user’s access is subject to any restrictions or controls required under—

(a)the departmental standard called ‘Secure storage of S8 medicines’; and

(b)if the safe is at a relevant institution or community pharmacy—the substance management plan for the institution or pharmacy.

Maximum penalty—40 penalty units.

Examples of restrictions or controls—

1a key or swipe card does not have any marking on it to identify it opens an S8 safe

2a code or password is connected to a system that records when it is used

201Requirements for authorised user accessing S8 safe

(1)This section applies to an authorised user of an S8 medicine who has been given access to an S8 safe to obtain the medicine.

(2)The authorised user must—

(a)keep any device or information that allows the user to access the S8 safe secure; and

Examples of information—

code, identification number, password

(b)comply with any restrictions or controls on the access given in writing to the user by the safe establisher; and

(c)close and lock the safe when the user is no longer using it.

Maximum penalty—40 penalty units.

(3)However, subsection (4) applies if the authorised user is supervising an assistant possessing a medicine.

(4)The authorised user may give the assistant the user’s device for accessing the S8 safe for the purpose for which the assistant is authorised only if—

(a)the device operates solely as a key to open and close the S8 safe, without an additional code or password; and

(b)the user gets the device back from the assistant immediately after the assistant uses it.

Note—

See also division 3 in relation to recording information in the medicine register kept with an S8 safe.

202Taking medicine from S8 safe and medicine store

(1)This section applies to an authorised user of a medicine or an assistant possessing a medicine at a place.

(2)Unless the authorised user or assistant has a reasonable excuse, the user or assistant must not—

(a)take the medicine from an S8 safe or a medicine store at the place unless the medicine is intended for supply or administration; or

(b)leave the medicine unattended in an area other than the S8 safe or medicine store at the place for the medicine.

Maximum penalty—40 penalty units.

203Application of division

(1)This division applies in relation to medicines put in, or taken from, an S8 safe or approved store.

(2)However, this division does not apply in relation to an S8 medicine kept in an S8 safe that has been packed in a dose administration aid.

(3)To remove any doubt, it is declared that this division applies in relation to medicines moved or distributed at or between workplaces.

Note—

See section 29 of the Act about the distribution or transfer of regulated substances at or between workplaces.

204Definitions for division

In this division—

approved store means a medicine store established for dealing with medicines under any of the following general approvals—

(a)a general approval (acute health conditions at isolated sites);

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

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

manager, of an S8 safe or approved store, means—

(a)a person appointed under section 196(3) to be the manager of the safe or store; or

(b)a person who keeps the safe or store for independently practising a profession or performing a function.

type, of a medicine, means each form and strength of a type of the medicine.

Examples of types of medicines—

•morphine sulfate pentahydrate 10mg tablet

•morphine sulfate pentahydrate 10mg modified release tablet

•oxycodone hydrochloride 10mg capsule

•oxycodone hydrochloride 10mg modified release tablet

205Meaning of medicine register

A medicine register, for an S8 safe or approved store, is a document that states—

(a)when each type of medicine is put in, or taken from, the safe or store for a dealing; and

(b)the amount of the type of medicine in the safe or store at any given time.

206Manager must make and keep register with safe or store

A manager of an S8 safe or approved store must take all reasonable steps to—

(a)make and keep a medicine register for the safe or store; and

(b)keep the medicine register with, or as close as practicable to, the safe or store.

Maximum penalty—40 penalty units.

Note—

See section 224 about keeping records.

207Layout of medicine register

(1)A manager of an S8 safe or approved store must organise the information in the medicine register for the safe or store in a way that shows—

(a)the medicines stored in the safe or store at any given time; and

(b)the dealings related to the medicines stored in the safe or store listed consecutively based on the time the dealings occurred, to the extent practicable; and

(c)a separate record for each type of medicine.

Maximum penalty—40 penalty units.

(2)Despite subsection (1)(c), information about medicines disposed of by destruction may be shown in a single, combined record that is separate from the record for a particular type of medicine.

208Electronic register

(1)This section applies to a manager of an S8 safe or approved store who keeps a medicine register for the safe or store in an electronic form (an electronic register).

(2)The manager must take all reasonable steps to ensure the electronic register has the following properties—

(a)a person can not make entries in the register unless the person has a secure system identifier;

(b)a secure system identifier is automatically recorded for every person making every entry in the register;

(c)an entry made by an assistant possessing a medicine is shown as pending in the register until—

(i)an authorised user who is supervising the assistant confirms the entry; or

(ii)if the entry relates to disposal of waste from a diversion-risk medicine by destruction—a witness confirms the entry;

(d)a unique reference number is recorded with the time and date of each entry that is confirmed;

(e)an entry that has been confirmed cannot be deleted from the register;

(f)a hard copy report can be produced at any time from the register to show—

(i)the balance of medicines to which the register applies at that time; or

(ii)the confirmed entries in the register for any particular period of time for which the register applies.

Maximum penalty—40 penalty units.

(3)The manager must not give a secure system identifier for the electronic register to a person unless—

(a)the person is an authorised user of the medicines in the S8 safe or approved store; or

(b)if the person is an assistant dealing with a medicine from the S8 safe or approved store—the person is given a secure system identifier that only permits the person to make entries mentioned in subsection (2)(c) in the register.

Maximum penalty—40 penalty units.

(4)The manager must make and keep a record of each person’s secure system identifier for the electronic register.

Maximum penalty—40 penalty units.

Note—

See section 224 about keeping records.

209Paper register

(1)This section applies to a manager of an S8 safe or approved store who keeps a medicine register for the safe or store on paper.

(2)The manager must take all reasonable steps to ensure the medicine register has the following properties—

(a)a page can not be removed from the register without detection;

Example—

a bound book with consecutively numbered pages

(b)a separate page is used for each type of medicine.

Maximum penalty—40 penalty units.

210Replacing paper register

(1)This section applies if—

(a)a manager of an S8 safe or approved store who keeps a medicine register for the safe or store on paper (the original register); and

(b)the original register has no space or pages remaining to record entries.

(2)Unless the manager has a reasonable excuse, the manager must—

(a)replace the original register with a new medicine register; and

(b)in the new register, record the amount of each type of medicine stated in the last entry of the original register; and

(c)reconcile the record with the amount of medicine physically held in the S8 safe or approved store; and

(d)keep the original register.

Maximum penalty—40 penalty units.

Note—

See section 224 about keeping records.

211Information that must be recorded in register

(1)This section applies if an authorised user or assistant accesses an S8 safe or approved store for a dealing with a type of medicine.

(2)As soon as practicable, but no later than 24 hours, after the dealing, the authorised user or assistant must take all reasonable steps to ensure a record is made in the medicine register of the information mentioned in sections 212 and 213 for the dealing.

Maximum penalty—40 penalty units.

212General information recorded in register

For section 211, the information for any dealing is—

(a)the date of the dealing; and

(b)the amount of the medicine; and

(c)a description of the dealing; and

(d)for an authorised user—the signature of the authorised user; and

(e)for an assistant—

(i)the name of the assistant; and

(ii)the signature of the authorised user supervising the assistant; and

(f)the name and signature of any other person recording the information; and

(g)the amount of medicine remaining after the dealing.

213Specific information for particular dealings recorded in register

For section 211, the information for each of the following particular dealings is—

(a)for stock of a medicine put in or taken from the S8 safe or approved store to which the register applies—

(i)the name and address of the supplier of the stock; and

(ii)the unique identifier of the notice mentioned in section 61(1) for the supply of the stock; and

(iii)the name and address of the person to whom the stock was supplied; and

(iv)the unique identifier (if any) of the purchase order for the supply;

(b)for administration—

(i)if the administration is to a person—the name of the person; and

(ii)if the administration is to an animal—the name of the owner or custodian of the animal; and

(iii)if the administration happens at a specified place—the time of the administration;

(c)for dispensing or giving a treatment dose on a prescription—

(i)the name of the prescriber; and

(ii)the unique identifier (if any) of the prescription; and

(iii)if the medicine is dispensed or given to a person—the name and address of the person; and

(iv)if the medicine is dispensed or given to an animal—the name and address of the owner or custodian of the animal;

(d)for a dealing under a general approval—the name of the person who authorised the dealing;

(e)for possession by distribution—the name of the person to whom the medicine was given or the place where the medicine was moved;

(f)for disposal of waste from a diversion-risk medicine by transfer—the name and signature of the person to whom the waste was transferred;

Note—

See also section 146 for the requirement for the transferee to sign the medicine register in particular circumstances.

(g)for disposal of waste from a diversion-risk medicine by destruction—

(i)the name and signature of the person who witnessed the destruction of the medicine; and

(ii)information stating the person’s authority to witness the destruction.

Note—

See also section 147 in relation to destruction.

214Amending register

(1)A person must not amend the medicine register for an S8 safe or approved store unless the person is correcting the register in the way mentioned in subsection (2) and (3) or has a reasonable excuse.

Maximum penalty—40 penalty units.

(2)The person may correct an entry in the medicine register by making a record of the following information with the entry—

(a)the date the correction is made;

(b)the name and position of the person making the correction;

(c)the reason for the correction;

(d)if the correction relates to the disposal of waste from a diversion-risk medicine by destruction—the name and position of the person who witnessed the destruction of the medicine.

(3)The person must not cancel, delete or obscure an original entry when making the correction.

215Keeping secure system identifier secure

A person given a secure system identifier for a medicine register for an S8 safe or an approved store kept in an electronic form must take all reasonable steps to keep the identifier secure from access by another person.

Maximum penalty—20 penalty units.

Examples of reasonable steps—

using a strong password or locking a device on which the secure system identifier is stored

216Making entries in paper register

A person must not make an entry in a medicine register for an S8 safe or approved store kept on paper unless the person—

(a)is permitted to make the entry by a manager of the safe or store; and

(b)signs the entry, including any corrections to the entry; and

(c)does not remove or tamper with pages in the register.

Maximum penalty—40 penalty units.

217Reconciling with medicines on hand

(1)A manager of an S8 safe or approved store must—

(a)reconcile the register for the safe or store at least monthly with the amount of medicines physically held in the safe or store; and

(b)record the date the reconciliation is done in the medicine register.

Maximum penalty—40 penalty units.

(2)However, if a substance management plan applies to the place at which the S8 safe or approved store is located, the reconciliation must be done at the times stated in the substance management plan.

Note—

See section 210 about reconciling a replacement paper register.

218Reporting lost, stolen or destroyed register

(1)This section applies if a medicine register for an S8 safe or approved store is lost, stolen or destroyed (each an incident).

(2)A manager of the safe or store must give notice about the incident to the chief executive in the approved form as soon as practicable, but no later than the end of the next business day, after the incident.

Maximum penalty—40 penalty units.

219Systems for tracking stock of medicines

(1)Subsection (2) applies to a person (a carrier) who operates a business for delivering stock of medicines.

(2)The carrier must take all reasonable steps to establish a tracking system to track stock of any medicines being delivered by the carrier.

Maximum penalty—40 penalty units.

(3)Subsection (4) applies to a person (an employee) employed by the carrier to deliver stock of medicines.

(4)When delivering the stock, the employee must use any tracking system established by the carrier in the way advised to the employee, unless the employee has a reasonable excuse.

Maximum penalty—40 penalty units.

(5)In this section—

tracking system, for stock of medicines, means a system designed to electronically track the location of the stock from time to time while the stock is in transit.

220Safe delivery of stock of S2 or S3 medicines

(1)This section applies if a carrier is delivering stock of an S2 or S3 medicine.

Note—

See chapter 4, part 5 in relation to requirements for persons who are authorised to possess stock of an S4 or S8 medicine for delivering the stock.

(2)The carrier must take all reasonable steps to keep the stock within any temperature limits for the stock notified to the carrier by the person who engaged the carrier to deliver it.

Maximum penalty—40 penalty units.

(3)The carrier must not leave the stock unattended, other than in a secure area.

Maximum penalty—40 penalty units.

(4)A carrier must deliver the stock to the street address stated on the packaging for the stock.

Maximum penalty—40 penalty units.

(5)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).

Maximum penalty—40 penalty units.

221Restriction on used containers

A person preparing a medicine for supply must not use an immediate container to package the medicine if the person knows the container has previously been used.

Maximum penalty—20 penalty units.

Note—

See the Poisons Standard, part 1 for the definition immediate container.

222Writing paper documents

(1)This section applies to a person writing on paper to comply with a requirement mentioned in this regulation, including writing a prescription or purchase order.

(2)The person must write—

(a)in ink; and

(b)legibly, other than the person’s signature; and

(c)in English or use terms or symbols, including Latin terms, used in the ordinary practice of the person’s profession.

Maximum penalty—40 penalty units.

223Writing electronic documents

(1)This section applies to a person writing an electronic document to comply with a requirement mentioned in this regulation, including writing an electronic prescription or electronic purchase order.

(2)The person must—

(a)write in English or use terms or symbols, including Latin terms, used in the ordinary practice of the person’s profession; and

(b)if the entry relates to another document—link or attach the other document to the electronic document.

Maximum penalty—40 penalty units.

(3)This section does not apply if the person uses an electronic prescription management system to make the document.

224Period and way of keeping records

(1)This section applies to a person if a provision of this regulation states the person is required to keep a record.

(2)However, this section does not apply to—

(a)a pharmacist keeping a record under section 162; or

(b)the chief executive keeping information in the monitored medicines database.

(3)The person must keep the record for—

(a)if the record is the details of an appointment of a system administrator under section 185—2 years after the appointment ends; or

(b)if the record is an entry in a medicine register kept on paper—2 years after the last entry in the register is made; or

(c)otherwise—2 years after the record is made.

Maximum penalty—40 penalty units.

(4)During the period for which the record must be kept, the person must take all reasonable steps to ensure the record is—

(a)kept in a retrievable form; and

(b)kept securely to ensure it can not be altered, obscured, deleted or removed without detection.

Maximum penalty—40 penalty units.

(5)If the record is kept electronically, the person must—

(a)ensure any data stored in the record is secure and tamper-proof in accordance with acceptable industry standards; and

(b)backup the record regularly during the period for which the record must be kept.

Maximum penalty—40 penalty units.

(6)However, subsection (5) does not apply if the record is kept in an electronic prescription management system.

Note—

See chapter 8, part 1 for requirements for electronic prescription management systems.

(7)In this section—

record includes a copy of a record or information contained in a record.

225Securing prescription stationery

A prescriber must take all reasonable steps to keep secure any stationery used, or to be used, by the prescriber for prescribing.

Maximum penalty—40 penalty units.

226Reporting lost or stolen medicine

(1)This section applies to each of the following persons in the following circumstances (each an incident)—

(a)a person, in the course of acting as an approved person, reasonably suspects an S8 medicine has been lost or stolen;

(b)a person, in the course of acting as an approved person, reasonably suspects pentobarbital has been lost or stolen;

(c)a pharmacist, in the course of practising the pharmacist’s profession, reasonably suspects pseudoephedrine has been lost or stolen;

(d)a person, dealing with a diversion-risk medicine under a general approval, reasonably suspects the medicine has been lost or stolen.

(2)As soon as practicable, but no later than the end of the next business day, after the incident, the person must—

(a)give notice about the incident to the chief executive in the approved form; and

(b)notify the police service about the incident.

Maximum penalty—40 penalty units.

(3)Subsection (2) does not apply if—

(a)the medicine is lost or stolen from an RFDS medicine chest kept by the Royal Flying Doctor Service of Australia; and

(b)a report about the incident is given to the senior medical officer of the Royal Flying Doctor Service of Australia.

227Reporting failure to give written prescription

(1)This section applies if—

(a)a prescriber fails to comply with a relevant provision relating to a prescription for a medicine; and

(b)a person dispenses, gives or administers the medicine on the prescription; and

(c)the person is not aware of a reasonable excuse for the prescriber’s failure to comply.

(2)The person must give notice about the prescriber’s failure to comply with the relevant provision—

(a)if the person is employed by the same entity as the prescriber—to the relevant manager of the prescriber as soon as practicable;

(b)otherwise—to the chief executive in the approved form within 48 hours after the end of the period for compliance mentioned in subsection (1).

Maximum penalty—20 penalty units.

(3)Subsection (4) applies if—

(a)the person notifies the relevant manager of the prescriber of the prescriber’s failure to comply; and

(b)the prescriber does not rectify the failure within 48 hours after the notification.

(4)The relevant manager must give notice about the failure to the chief executive in the approved form as soon as practicable.

Maximum penalty—20 penalty units.

(5)In this section—

relevant manager, of a prescriber, means a person who is responsible for managing the prescriber’s compliance with a relevant provision.

relevant provision means section 84(4), 92(3) or (4), or 100(2) or (3).

228Reporting and preventing use of unlawful document

(1)This section applies if a person who is authorised to deal with a medicine receives any of the following documents—

(a)a purchase order for stock of a medicine;

(b)a prescription for dispensing a medicine;

(c)a prescription for giving a treatment dose of a medicine.

(2)If the person reasonably believes the document has been unlawfully obtained or made, the person must take the following action—

(a)record the name and address of whoever gave the person the document;

(b)notify the police service as soon as practicable;

(c)if the document is for a diversion-risk medicine—give notice to the chief executive in the approved form as soon as practicable;

(d)for a hard copy of a purchase order—keep the purchase order or a copy of the order;

(e)for a purchase order given electronically—process the purchase order in the system in which it is kept to prevent stock of the medicine being supplied;

(f)for a paper prescription—keep the prescription or a copy of the prescription;

(g)for an electronic prescription—process the prescription in the system in which it is kept to prevent the medicine being dispensed or given.

Maximum penalty—60 penalty units.

(3)The person is required to comply with subsection (2) only to the extent it is safe for the person to comply.

229Marking non-compliant paper prescription

(1)This section applies if—

(a)a person who is authorised to dispense a medicine, or give a treatment dose of a medicine, does not dispense or give the medicine on a paper prescription; and

(b)the person did not take the action mentioned in paragraph (a) because the person reasonably suspects—

(i)the prescription has been unlawfully obtained or made; or

(ii)the prescription has been given 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.

(2)The person must mark the prescription with—

(a)a statement that the prescription is cancelled or not to be dispensed or given; and

(b)the date of marking the prescription; and

(c)the person’s name or signature; and

(d)the address of the place where the prescription was presented.

Maximum penalty—60 penalty units.

(3)The person is required to comply with subsection (2) only to the extent it is safe for the person to comply.

230Reporting supply on false prescription or purchase order for diversion-risk medicine

(1)This section applies if, after supplying a diversion-risk medicine on a prescription or purchase order, the supplier of the medicine reasonably suspects any of the following incidents has happened—

(a)false information, material to the prescription or purchase order, was given to the person who prescribed the medicine or gave the purchase order;

(b)the prescription or purchase order was changed by a person other than—

(i)for a prescription—the prescriber of the prescription or the dispenser of the medicine for the prescription; or

(ii)for a purchase order—the person who gave the purchase order;

(c)the prescription or purchase order was false in any material particular.

(2)The supplier must give notice about the incident to the chief executive in the approved form and to the police service no later than 24 hours after becoming aware of the incident.

Maximum penalty—60 penalty units.

(3)In this section—

supplier, in relation to a medicine, means a person who is authorised to supply the medicine.

231Notification of loss or theft

(1)This section applies to a person (each the wholesaler) who—

(a)is authorised to supply medicines by wholesale; or

(b)is a wholesale representative.

(2)The wholesaler must report the loss or theft of a diversion-risk medicine that was in the possession of the wholesaler immediately before the loss or theft.

Maximum penalty—40 penalty units.

(3)The report must be made as soon as practicable, but no later than the end of the next business day, after the loss or theft—

(a)to the police service; and

(b)to the chief executive in the approved form.

Maximum penalty—40 penalty units.

232Return of transactions for wholesale representatives

(1)A wholesale representative must, periodically but at least every 3 months, give the representative’s employer a return complying with subsection (2) about the transactions carried out by the representative for the period.

Maximum penalty—40 penalty units.

(2)The return must state the following information—

(a)the period of the return;

(b)the total amount of each type of medicine in the representative’s possession at the start and end of the period;

(c)the amount of each type of medicine received by the representative;

(d)the amount of each type of medicine given as a sample, or returned, by the representative;

(e)the invoice number for each medicine given as a sample or return.

(3)The wholesale representative must keep a copy of each return sent to the representative’s employer.

Maximum penalty—40 penalty units.

Note—

See section 224 about keeping records.

(4)The wholesale representative’s employer must also keep a copy of each return received from the wholesale representative.

Maximum penalty—40 penalty units.

(5)In this section—

employer, of a wholesale representative, means the wholesaler that the representative acts as an agent or representative for.

233Giving chief executive information about particular diversion-risk medicines

(1)This section applies if—

(a)a person seeks a supply of a diversion-risk medicine from a pharmacist, other than a medicine that is also a monitored medicine; and

(b)the pharmacist reasonably suspects the amount of the medicine sought exceeds the amount or frequency of doses that the person could reasonably be seeking for the therapeutic treatment of the person or the person’s animal.

(2)The pharmacist must give notice to the chief executive in the approved form unless the pharmacist has a reasonable excuse.

Maximum penalty—40 penalty units.

234Unlawful advertising of medicines

(1)A person must not advertise, or cause a person to advertise, an S3, S4 or S8 medicine.

Maximum penalty—80 penalty units.

(2)However, subsection (1) does not apply in relation to—

(a)an advertisement of an S3, S4 or S8 medicine—

(i)in a journal, a price list or other promotional material that relates only to the therapeutic use of the medicine in the practise of a profession; or

(ii)in accordance with the document called ‘Price information code of practice’, published by the Therapeutic Goods Administration; or

(b)an advertisement of an S3 medicine listed in the Poisons Standard, Appendix H.

235Offence to install medicine vending machines

(1)A person who is the owner or occupier of premises must not install a medicine vending machine on the premises.

Maximum penalty—30 penalty units.

(2)In this section—

medicine vending machine means a machine or device that supplies a medicine to a person on the payment of money.

236Matters to be considered before making particular extended practice authorities—Act, s 232

For section 232(3) of the Act, the following matters are prescribed in relation to a dealing with a medicine—

(a)the nature of the dealing;

(b)whether there is a community need for any service to be facilitated by the extended practice authority;

(c)the way in which any health risks associated with the dealing are to be managed under the authority;

(d)whether there is a need for a review of the authority and the timing of any review needed;

(e)if the approved person is subject to the governance of an entity under the authority—the governance capability of the entity;

(f)if the medicine is a restricted medicine or unregistered medicine—whether it is in the public interest to make the authority, considering the particular health risks associated with restricted medicines and unregistered medicines.

237Chief executive may approve alternative ways of labelling or packaging medicines

(1)The chief executive may approve a way (an alternative way) of labelling or packaging a medicine that is different to the Poisons Standard.

(2)However, the chief executive may approve the alternative way only if the chief executive is satisfied it is unlikely to adversely affect public safety, having regard to the nature of the medicine and the purpose for which it is to be used.

(3)The chief executive must publish, on the department’s website, a notice stating—

(a)the requirements of the alternative way; and

(b)the day, no earlier than the day the notice is published, that the approval of the alternative way takes effect; and

(c)the period, if any, for which the approval of the alternative way has effect.

(4)Subsection (5) applies if an appropriate authority, for a purpose or in another State, has authorised (whether by approval, exemption or some other way) another way to label or package a medicine for the purpose or other State.

Note—

See the Poisons Standard, part 1 for the definition appropriate authority.

(5)To the extent authorised by the appropriate authority, the other way is taken to be an alternative way approved under this section, unless the chief executive publishes a notice on the department’s website stating the other way is not approved for Queensland.

238Definitions for part and schedule 19

In this part and schedule 19—

licensing fee means a fee for an application relating to a substance authority stated in schedule 19, items 1 to 8.

site, for a substance authority, means a place at which a dealing with a medicine is, or is proposed to be, carried out under the authority.

239Fees payable generally

(1)The fees payable under the Act in relation to a substance authority for a dealing with a medicine are stated in schedule 19.

(2)A licensing fee for a substance authority is payable for each site for the authority for each year of the term of the authority.

(3)However, for any part of the term of a substance authority that is not a full year, the licensing fee payable in relation to that part of the term is the proportion of the licensing fee attributable to the number of months, rounded up to whole months, of that year that are in the term.

240Manufacturing licence for S2, S3 or S4 medicines

No licensing fee is payable for an initial application or renewal application for a manufacturing licence for an S2, S3 or S4 medicine (each a later application) if—

(a)an initial application or renewal application for a manufacturing licence for an S7 poison (each a first application) has been made, and not withdrawn or refused, under the Medicines and Poisons (Poisons and Prohibited Substances) Regulation 2021; and

(b)the site the subject of the later application is the same as the site the subject of the first application; and

(c)the term proposed for the later application ends no later than the last month of—

(i)the term proposed for the first application; or

(ii)if the chief executive has granted the first application—the term of the substance authority granted on the first application; and

(d)all fees payable under the Act for the first application have been paid.

241Wholesale licence for S2, S3 or S4 medicines

No licensing fee is payable for an initial application or renewal application for a wholesale licence for an S2, S3 or S4 medicine (each a later application) if—

(a)an initial application or renewal application for a manufacturing licence or wholesale licence for an S7 poison (each a first application) has been made, and not withdrawn or refused, under the Medicines and Poisons (Poisons and Prohibited Substances) Regulation 2021; and

(b)the site the subject of the later application is the same as the site the subject of the first application; and

(c)the term proposed for the later application ends no later than the last month of—

(i)the term proposed for the first application; or

(ii)if the chief executive has granted the first application—the term of the substance authority granted on the first application; and

(d)all fees payable under the Act for the first application have been paid.

242Rejected or withdrawn application

(1)This section applies if—

(a)an applicant has paid the licensing fee for an application for a substance authority for a medicine; and

(b)the application is refused by the chief executive or withdrawn by the applicant.

(2)The chief executive must refund the applicant the licensing fee for the application.

243Authority granted for shorter term

(1)This section applies if—

(a)an applicant has paid the licensing fee for an application for a substance authority for a medicine for a particular term (the proposed term); and

(b)the application is granted for a period (the granted term) that is shorter than the proposed term.

(2)The chief executive must refund the applicant the amount that is the proportion of the paid licensing fee attributable to the number of months, rounded up to whole months, that is the difference between the proposed term and granted term.

(3)No refund is payable if the amount under subsection (2) is zero or less than zero.

244Surrender of authority

(1)This section applies if—

(a)the holder of a substance authority for a medicine paid the licensing fee for an application for the authority for a particular term (the granted term); and

(b)the substance authority is surrendered before the end of the granted term.

(2)The chief executive must refund the applicant the amount that is the proportion of the paid licensing fee attributable to the number of months, rounded up to whole months, remaining in the granted term after the surrender.

(3)No refund is payable if the amount under subsection (2) is zero or less than zero.

245Repeal

The Medicines and Poisons (Monitored Medicines Database Testing) Regulation 2020, SL No. 59 is repealed.

246Prescribed day when database is fully operational—Act, s 281

For section 281(1)(b) of the Act, 27 October 2021 is prescribed to be the day that the monitored medicines database is fully operational.

247Information transitioned to database—Act, s 225

(1)This section applies in relation to information—

(a)recorded in the monitored medicines database under the repealed Medicines and Poisons (Monitored Medicines Database Testing) Regulation 2020 immediately before the repeal of that regulation; and

(b)given to, or held by, the chief executive under section 281 of the Act relating to an approval in effect during the transition period under that section.

(2)The information is prescribed for section 225(1) of the Act.

248Sending and keeping particular prescriptions during special arrangement period

(1)This section applies if, during the special arrangement period, a prescriber gives a digital copy of a paper prescription for an S4 medicine, other than a diversion-risk medicine, to a dispenser.

(2)The prescriber is taken to have complied with section 84(4) if the prescriber keeps the paper prescription for a period of 2 years after giving the dispenser a digital copy of the paper prescription.

(3)In this section—

special arrangement period means the period—

(a)starting on the commencement of this section; and

(b)ending at the end of the day the special arrangement the National Health (COVID-19 Supply of Pharmaceutical Benefits) Special Arrangement 2020 (Cwlth) is repealed or expires.

249Definitions for division

In this division—

HDPR means the repealed Health (Drugs and Poisons) Regulation 1996.

new clinical protocol means a clinical protocol made under chapter 4, part 7, division 3.

250Certified way of packaging

(1)This section applies if—

(a)the chief executive certified a container for packing a medicine under the HDPR, section 10(3); and

(b)the certification was in effect immediately before the commencement.

(2)The certification is taken to be an alternative way for packaging the medicine approved under section 237 until—

(a)if an expiry day is stated in the certification—the stated day; or

(b)otherwise—the day that is 1 year after the commencement.

251Certified way of labelling

(1)This section applies if—

(a)the chief executive certified an alternative way of labelling a package for a medicine under the HDPR, section 11(3); and

(b)the certification was in effect immediately before the commencement.

(2)The certification is taken to be an alternative way of labelling a package for the medicine approved under section 237 until—

(a)if an expiry day is stated in the certification—the stated day; or

(b)otherwise—the day that is 1 year after the commencement.

252Controlled drugs registers

(1)This section applies if, immediately before the commencement, a person kept a controlled drugs register under the HDPR, section 50.

(2)The controlled drugs register is taken to be a medicine register for S8 medicines.

253Clinical protocols

(1)This section applies if, immediately before the commencement, an existing clinical protocol was in effect for a person practising a profession at a place.

(2)The existing clinical protocol is taken to be a new clinical protocol for the person practising the profession at the place until the earlier of—

(a)the day the existing protocol is revoked; or

(b)the day stated to be the expiry date in the existing clinical protocol.

(3)In this section—

existing clinical protocol means a clinical protocol made under the HDPR.

254Orthoptist protocols

(1)This section applies if—

(a)immediately before the commencement, a health management protocol was in effect for a person who was an orthoptist under the HDPR practising orthoptics; and

(b)on the commencement, the person is an orthoptist mentioned in schedule 8, section 6.

(2)The health management protocol is taken to be a new clinical protocol applying to the person for practising orthoptics until the earlier of—

(a)the day the protocol is revoked; or

(b)the day stated to be the expiry date in the health management protocol.

(3)In this section—

health management protocol means a document called a ‘health management protocol’ made under the orthoptist DTP.

orthoptist DTP see the HDPR, appendix 9.

255Practice plans

(1)This section applies if, immediately before the commencement, a practice plan was in effect under the HDPR for either—

(a)an Aboriginal and Torres Strait Islander health practitioner; or

(b)a physician’s assistant.

(2)The practice plan is—

(a)if the practitioner is an Aboriginal and Torres Strait Islander health practitioner mentioned in schedule 3, part 1 on or after the commencement—taken to be a practice plan for the practitioner under that part; or

(b)if the practitioner is a physician assistant mentioned in schedule 6, part 3 on or after the commencement—taken to be a practice plan for the practitioner under that part.

256Chief executive’s approvals or certifications for bodies and facilities

(1)This section applies if, immediately before the commencement, an approval or certification by the chief executive was in effect under the HDPR for—

(a)a professional body; or

(b)a facilities accreditation body; or

(c)a laboratory; or

(d)another facility.

(2)The approval or certification continues in effect—

(a)to the extent the chief executive’s approval is required for the same purpose under this regulation for which the body or facility was approved or certified for; and

(b)until it is revoked by the chief executive.

257Regulation amended

This part amends the Planning Regulation 2017.

258Amendment of s 20A (When material change of use for providing COVID-19 vaccination service is not assessable development)

Section 20A(3)—
omit, insert—

(3)This section expires on the COVID-19 legislation expiry day.

259Amendment of sch 6 (Development local categorising instrument is prohibited from stating is assessable development)

Schedule 6, section 7C(2) and (3)—
omit, insert—

(2)This section expires on the COVID-19 legislation expiry day.

(3)In this section—

COVID-19 vaccination service means a service stated to be a COVID-19 vaccination service in an emergency order—

(a)made under the Medicines and Poisons Act 2019, section 58; and

(b)that applies to the event that is the declared public health emergency under the Public Health Act 2005 relating to COVID-19.

260Amendment of sch 7 (Accepted development)

Schedule 7, section 4A(2)—
omit, insert—

(2)This section expires on the COVID-19 legislation expiry day.

261Regulation amended

This part amends the State Penalties Enforcement Regulation 2014.

262Amendment of sch 1 (Infringement notice offences and fines for nominated laws)

(1)Schedule 1, entries for Pest Management Act 2001 and Pest Management Regulation 2003—
omit.

(2)Schedule 1—
insert—

Medicines and Poisons Act 2019

Column 1 Infringement notice offence		Column 2 Infringement notice fine (penalty units)
		Individual	Corporation
s 41(2)		2	-
s 71		5	25
s 93(1)	if the contravention is because— •  a substance management plan is not made under section 93(1); or •  the substance management plan made under section 93(1) fails to comply with section 93(2)(a)	6	30
s 137		1	-
s 226(1)		10	-

Authorised person for service of infringement notices—an inspector appointed under the Medicines and Poisons Act 2019, section 131

263Other regulations amended

Schedule 23 amends the regulations mentioned in it.

sections 7 and 8

sections 9 to 12

acitretin

ambrisentan

amfetamines

bexarotene

bosentan

buprenorphine when used for treating opioid dependency

clomifene

clozapine

corifollitropin alfa

cyclofenil or any other substance specifically prepared to stimulate ovulation

dinoprost

dinoprostone

enzalutamide

etretinate

follitropin alpha

follitropin beta

hydroxychloroquine

isotretinoin for human oral use

lenalidomide

luteinising hormone

macitentan

methadone when used for treating opioid dependency

methylphenidate

pomalidomide

riociguat

sodium oxybate

teriparatide

thalidomide

tretinoin for human oral use

urofollitropin (human follicle stimulating hormone)

all S8 medicines

all benzodiazepines

codeine

gabapentin

pregabalin

quetiapine

tramadol

zolpidem

zopiclone

all S8 medicines

adiphenine

alkyl nitrites other than amyl nitrite when it is an S3 medicine

anabolic steroidal agents

androgenic steroidal agents

AOD-9604 (CAS No. 221231-10-3)

barbiturates

all benzodiazepines

chloral hydrate

chlordiazepoxide

CJC-1295 (CAS No. 863288-34-0)

clorazepate

codeine

darbepoetin

dexfenfluramine

dextromethorphan

dextropropoxyphene

dextrorphan

diethylproprion

dihydrocodeine

ephedrine

epoetins

all erythropoietins

ethylmorphine

fenfluramine

fibroblast growth factors

follistatin

gabapentin

glutethimide

growth hormone releasing hormones

all growth hormone releasing peptides

growth hormone releasing secretagogues

hexarelin

ibutamoren

insulin-like growth factors

ipamorelin

mazindol

meprobamate

perampanel for human use

phentermine

pralmorelin (growth hormone releasing peptide-2)

pregabalin

propofol

propylhexedrine

pseudoephedrine

quetiapine

selective androgen receptor modulators

somatropin (human growth hormone)

stenabolic (SR9009) and other synthetic REV-ERB agonists

TB-500

thymosin beta 4

tianeptine

tramadol

trihexyphenidyl

zolpidem

zopiclone

all S8 medicines

all benzodiazepines

codeine

gabapentin

pregabalin

quetiapine

tramadol

zolpidem

zopiclone

section 13

1Definitions for part

In this part—

Aboriginal and Torres Strait Islander health practitioner means a person registered under the Health Practitioner Regulation National Law to practise in the Aboriginal and Torres Strait Islander health practice profession.

practice plan, for an Aboriginal and Torres Strait Islander health practitioner, means a document in the approved form—

(a)developed and signed by the health practitioner and the primary clinical supervisor for the practitioner; and

(b)stating the circumstances and conditions for the practitioner to administer or give a treatment dose of a medicine.

primary clinical supervisor, for an Aboriginal and Torres Strait Islander health practitioner, means the person who has primary responsibility for supervising the clinical work performed by the health practitioner for the practitioner’s employment in a relevant health service.

relevant health service means—

(a)a Hospital and Health Service; or

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

2Class of person

An Aboriginal and Torres Strait Islander health practitioner who is—

(a)employed by a relevant health service; and

(b)practising in an isolated practice area.

3Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	give a treatment dose	a medicine mentioned in the extended practice authority called ‘Aboriginal and Torres Strait Islander health practitioners’	the medicine is given— •  under the extended practice authority; and •  in accordance with a practice plan for the Aboriginal and Torres Strait Islander health practitioner
2	repackage	a medicine mentioned in the extended practice authority called ‘Aboriginal and Torres Strait Islander health practitioners’	the medicine is repackaged for giving a treatment dose under the extended practice authority
3	administer	a medicine mentioned in the extended practice authority called ‘Aboriginal and Torres Strait Islander health practitioners’	the medicine is administered— •  under the extended practice authority; and •  in accordance with a practice plan for the Aboriginal and Torres Strait Islander health practitioner
4	give a purchase order	stock of a medicine mentioned in the extended practice authority called ‘Aboriginal and Torres Strait Islander health practitioners’	the purchase order is given under the extended practice authority
5	possess	an S4 or S8 medicine mentioned in this column	the medicine is possessed for a purpose mentioned in this column
6	dispose	waste from a diversion-risk medicine mentioned in this column

4Definition for part

In this part—

Indigenous health worker means a person who—

(a)holds a Diploma of Health Science ATSI Primary Health Care (Generalist) ASF 5 from a college of technical and further education or an equivalent qualification approved by the chief executive; and

(b)has successfully completed the North Queensland Rural Health Training Unit Isolated Practice Course, or an equivalent course of training approved by the chief executive, for the accreditation of registered nurses for practice in an isolated practice area.

5Class of person

An Indigenous health worker who—

(a)is practising in an isolated practice area; and

(b)is employed by any of the following Hospital and Health Services—

(i)Cairns and Hinterland Hospital and Health Service;

(ii)North West Hospital and Health Service;

(iii)Torres and Cape Hospital and Health Service.

6Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	give a treatment dose	a medicine mentioned in the extended practice authority called ‘Indigenous health workers’	the medicine is given for a patient under the extended practice authority
2	repackage	a medicine mentioned in the extended practice authority called ‘Indigenous health workers’	the medicine is repackaged for giving a treatment dose under the extended practice authority
3	administer	a medicine mentioned in the extended practice authority called ‘Indigenous health workers’	the medicine is administered under the extended practice authority
4	possess	an S4 or S8 medicine mentioned in this column	the medicine is possessed for a purpose mentioned in this column
5	dispose	waste from a diversion-risk medicine mentioned in this column

7Class of person

A person who is employed by an approved Aboriginal health service under the National Health (Remote Area Aboriginal Health Services Program) Special Arrangement 2017 (PB 107 of 2017) (Cwlth).

8Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	give a purchase order	stock of an S4 or S8 medicine	the stock is for the approved Aboriginal health service
2	possess	stock of an S4 or S8 medicine	the stock is possessed for the approved Aboriginal health service
3	dispose	waste from a diversion-risk medicine mentioned in this column

section 13

1Definition for division

In this division—

immediate release formulation, of a medicine, means a formulation of the medicine in which the rate of release and absorption of the medicine is not appreciably or intentionally modified by the way in which it is formulated.

2Class of person

A person (a dentist) who is registered under the Health Practitioner Regulation National Law to practise in the dentists division of the dental profession.

3Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	prescribe	(a)  an S2, S3 or S4 medicine, other than a restricted medicine
		(b)  any of the following S8 medicines— •  codeine; •  hydromorphone; •  morphine; •  oxycodone	the medicine is in an immediate release formulation— •  for which a repeat prescription is not given; and •  that is no more than 3 days supply
2	give a treatment dose	an S2, S3 or S4 medicine, other than a restricted medicine
3	repackage	an S2, S3 or S4 medicine, other than a restricted medicine	the medicine is repackaged for giving a treatment dose for a patient
4	administer	(a)  an S2, S3 or S4 medicine, other than a restricted medicine
		(b)  any of the following S8 medicines— •  codeine; •  hydromorphone; •  morphine; •  oxycodone	the medicine is in an immediate release formulation
5	give a purchase order	stock of an S4 or S8 medicine mentioned in this column	the stock is not for a specified place
6	possess	an S4 or S8 medicine mentioned in this column	the medicine is possessed for a purpose mentioned in this column
7	dispose	waste from a diversion-risk medicine mentioned in this column

4Class of person

A dentist who is endorsed for conscious sedation.

5Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	administer	fentanyl or pethidine
2	give a purchase order	stock of fentanyl or pethidine	the stock is not for a specified place
3	possess	fentanyl or pethidine

6Class of person

A dentist who is a specialist registrant in oral medicine.

7Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	prescribe	hydroxychloroquine
2	give a treatment dose	hydroxychloroquine
3	administer	hydroxychloroquine
4	give a purchase order	stock of hydroxychloroquine	the stock is not for a specified place
5	possess	hydroxychloroquine

8Class of person

A person (a dental hygienist) who is registered under the Health Practitioner Regulation National Law to practise in the dental hygienists division of the dental profession.

9Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	administer	(a)  any of the following S2 or S3 medicines— •  an adrenaline (epinephrine) autoinjector; •  local anaesthetics in preparations for topical human therapeutic use (other than eye drops); •  fluorides in preparations for topical human therapeutic use; •  silver salts
		(b)  local anaesthetics, whether alone or in combination with adrenaline (epinephrine) or felypressin
2	give a purchase order	an S4 medicine that is a local anaesthetic	the stock is not for a specified place
3	possess	an S4 medicine that is a local anaesthetic

10Class of person

A person (a dental therapist) who is registered under the Health Practitioner Regulation National Law to practise in the dental therapists division of the dental profession.

11Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	administer	(a)  any of the following S2 or S3 medicines— •  an adrenaline (epinephrine) autoinjector; •  local anaesthetics in preparations for topical human therapeutic use (other than eye drops); •  ether; •  ferric sulphate; •  fluorides in preparations for topical human therapeutic use; •  phenol; •  silver salts
		(b)  any of the following S4 medicines— •  local anaesthetics, whether alone or in combination with adrenaline (epinephrine) or felypressin; •  antibiotics and corticosteroids in combination for topical endodontic use; •  mercury for human therapeutic use
2	give a purchase order	an S4 medicine mentioned in this column	the stock is not for a specified place
3	possess	an S4 medicine mentioned in this column

12Class of person

A person (an oral health therapist) who is registered under the Health Practitioner Regulation National Law to practise in the oral health therapists division of the dental profession.

13Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	administer	(a)  any of the following S2 or S3 medicines— •  an adrenaline (epinephrine) autoinjector; •  local anaesthetics in preparations for topical human therapeutic use (other than eye drops); •  ether; •  ferric sulphate; •  fluorides in preparations for topical human therapeutic use; •  phenol; •  silver salts
		(b)  any of the following S4 medicines— •  local anaesthetics, whether alone or in combination with adrenaline (epinephrine) or felypressin; •  antibiotics and corticosteroids in combination for topical endodontic use; •  mercury for human therapeutic use
2	give a purchase order	an S4 medicine mentioned in this column	the stock is not for a specified place
3	possess	an S4 medicine mentioned in this column

section 13

1Class of person

A person who is the commissioner of the Queensland Ambulance Service under the Ambulance Service Act 1991 or is exercising a power under that Act as the commissioner’s delegate.

2Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	give a purchase order	stock of an S4 or S8 medicine	the purchase order is given for the Queensland Ambulance Service
2	possess	stock of an S4 or S8 medicine	the stock is possessed for the Queensland Ambulance Service
3	dispose	waste from a diversion-risk medicine that is an S4 or S8 medicine

3Class of person

A person who is an ambulance officer under the Ambulance Service Act 1991.

4Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	give a treatment dose	a medicine mentioned in the extended practice authority called ‘Queensland Ambulance Service’	the medicine is given under the extended practice authority
2	administer	a medicine mentioned in the extended practice authority called ‘Queensland Ambulance Service’	the medicine is administered under the extended practice authority
3	possess	an S4 or S8 medicine mentioned in the extended practice authority called ‘Queensland Ambulance Service’	the medicine is possessed under the extended practice authority
4	dispose	waste from a diversion-risk medicine mentioned in this column

5Class of person

A person (a first aid provider) who has a current certificate granted by a registered training organisation for the provision of first aid.

6Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	administer	(a)  methoxyflurane	•  the medicine is administered on a prescription •  the first aid provider has completed methoxyflurane training
		(b)  adrenaline (epinephrine) autoinjector	the first aid provider has completed anaphylaxis training
		(c)  naloxone	the first aid provider has completed naloxone training
		(d)  inhaled asthma reliever, other than an S4 medicine	the first aid provider has completed asthma training
2	possess	an S4 medicine mentioned in this column	the medicine is possessed for a purpose mentioned in this column

7Definition for part

In this part—

RFDS medicine chest means a medicine chest kept at a place for the Royal Flying Doctor Service of Australia if the medicine chest is approved by a medical practitioner who is—

(a)employed by the Royal Flying Doctor Service of Australia; and

(b)authorised in writing by the Royal Flying Doctor Service of Australia to approve the keeping of medicine chests.

8Class of person

A person who—

(a)is a worker for the Royal Flying Doctor Service of Australia; and

(b)is in charge of an RFDS medicine chest.

9Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	give a treatment dose	a medicine from the RFDS medicine chest	the medicine is given on a prescription
2	administer	a medicine from the RFDS medicine chest	the medicine is administered on a prescription
3	possess	an S4 or S8 medicine from the RFDS medicine chest	the medicine is possessed for a purpose mentioned in this column

section 13

Note—

See also sections 56 and 67 of the Act about prescribing approvals and the relationship between different authorisations.

1Class of person

A person (a medical practitioner) who is registered under the Health Practitioner Regulation National Law to practise in the medical profession.

2Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	prescribe	a non-restricted medicine
2	make a standing order	a non-restricted medicine
3	dispense	a non-restricted medicine
4	give a treatment dose	a non-restricted medicine
5	administer	a non-restricted medicine
6	repackage	a non-restricted medicine
7	give a purchase order	stock of an S4 or S8 medicine that is a non-restricted medicine	the stock is not for a specified place
8	possess	an S4 or S8 medicine that is a non-restricted medicine
9	dispose	waste from a diversion-risk medicine

3Class of person

A medical practitioner.

4Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	dispense	a restricted medicine	the medicine is dispensed on a prescription from another medical practitioner
2	repackage	a restricted medicine	the medicine is repackaged for a patient to dispense a prescription from another medical practitioner
3	give a purchase order	stock of a restricted medicine	the stock— (a)  is required for dispensing prescriptions from other medical practitioners; and (b)  is not for a specified place
4	possess	a restricted medicine	the medicine is possessed for a purpose mentioned in this column

5Definition for division

In this division—

continuing institutional treatment, by a medical practitioner of a patient, means—

(a)the practitioner is treating the patient in a hospital, prison, watch-house or detention centre; and

(b)the patient was being treated with the medicine prior to the admission.

6Class of person

A medical practitioner.

7Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	prescribe	a restricted medicine	the medicine is prescribed, under the supervision of a registrar or specialist medical practitioner authorised to prescribe the medicine, for— (a)  administration by a health practitioner; and (b)  the continuing institutional treatment of a patient
2	administer	a restricted medicine	the medicine is administered, under the supervision of a registrar or specialist medical practitioner authorised to administer the medicine, for the continuing institutional treatment of a patient
3	possess	a restricted medicine	the medicine is possessed, under the supervision of a registrar or specialist medical practitioner authorised to possess the medicine, for the continuing institutional treatment of a patient

8Definition for division

In this division—

continuing hydroxychloroquine treatment, by a medical practitioner of a patient, means—

(a)the practitioner is treating the patient; and

(b)prior to being treated by the practitioner, the patient was prescribed hydroxychloroquine by another health practitioner authorised to prescribe hydroxychloroquine.

9Class of person

A medical practitioner.

10Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	prescribe	hydroxychloroquine	the medicine is prescribed for the continuing hydroxychloroquine treatment of a patient
2	give a treatment dose	hydroxychloroquine	the medicine is given for the continuing hydroxychloroquine treatment of a patient
3	dispense	hydroxychloroquine	the medicine is dispensed for the continuing hydroxychloroquine treatment of a patient
4	administer	hydroxychloroquine	the medicine is administered for the continuing hydroxychloroquine treatment of a patient
5	give a purchase order	stock of hydroxychloroquine	the stock is purchased for the continuing hydroxychloroquine treatment of patients, other than patients at a specified place
6	possess	hydroxychloroquine	the medicine is possessed for a purpose mentioned in this column

11Definition for division

In this division—

relevant condition means—

(a)narcolepsy; or

(b)brain damage, or attention deficit disorder, of a child patient who is at least 4 years.

12Class of person

A medical practitioner.

13Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	prescribe	amfetamine or methylphenidate	the medicine is prescribed for the treatment of a relevant condition
2	give a treatment dose	amfetamine or methylphenidate	the medicine is given for the treatment of a relevant condition
3	dispense	amfetamine or methylphenidate	the medicine is dispensed for the treatment of a relevant condition
4	administer	amfetamine or methylphenidate	the medicine is administered for the treatment of a relevant condition
5	give a purchase order	stock of amfetamine or methylphenidate	the stock is for the treatment of relevant conditions, other than at a specified place
6	possess	amfetamine or methylphenidate	the medicine is possessed for a purpose mentioned in this column

14Class of person

A medical practitioner who is in charge of clinical or medical services at a relevant institution.

15Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	give a purchase order	stock of an S4 or S8 medicine	•  the purchase order is given for the relevant institution; and •  the purchase order is given for the therapeutic treatment of patients at the relevant institution
2	possess	stock of an S4 or S8 medicine	the stock is possessed at the relevant institution

16Definition for division

In this division—

relevant restricted medicine, for a registrar, means a restricted medicine relating to the specialty area of practice in which the registrar is working.

17Class of person

A medical practitioner (a registrar) employed as a registrar in a hospital working under the supervision of a medical practitioner who is a specialist in the specialty area of practice in which the registrar is working.

18Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	prescribe	a relevant restricted medicine
2	give a treatment dose	a relevant restricted medicine
3	dispense	a relevant restricted medicine
4	administer	a relevant restricted medicine
5	give a purchase order	stock of a relevant restricted medicine	the stock is not for a specified place
6	possess	a relevant restricted medicine

19Class of person

A medical practitioner who is a specialist registrant in cardiology.

20Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	prescribe	ambrisentan, bosentan, macitentan or riociguat
2	give a treatment dose	ambrisentan, bosentan, macitentan or riociguat
3	dispense	ambrisentan, bosentan, macitentan or riociguat
4	administer	ambrisentan, bosentan, macitentan or riociguat
5	give a purchase order	stock of a medicine mentioned in this column	the stock is not for a specified place
6	possess	a medicine mentioned in this column

21Class of person

A medical practitioner who is a specialist registrant in dermatology.

22Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	prescribe	acitretin, bexarotene, etretinate, hydroxychloroquine, isotretinoin for human oral use, thalidomide or tretinoin for human oral use
2	give a treatment dose	acitretin, bexarotene, etretinate, hydroxychloroquine, isotretinoin for human oral use, thalidomide or tretinoin for human oral use
3	dispense	acitretin, bexarotene, etretinate, hydroxychloroquine, isotretinoin for human oral use, thalidomide or tretinoin for human oral use
4	administer	acitretin, bexarotene, etretinate, hydroxychloroquine, isotretinoin for human oral use, thalidomide or tretinoin for human oral use
5	give a purchase order	stock of a medicine mentioned in this column	the stock is not for a specified place
6	possess	a medicine mentioned in this column

23Class of person

A medical practitioner who is a specialist registrant in emergency medicine.

24Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	prescribe	hydroxychloroquine
2	give a treatment dose	hydroxychloroquine
3	dispense	hydroxychloroquine
4	administer	hydroxychloroquine
5	give a purchase order	stock of hydroxychloroquine	the stock is not for a specified place
6	possess	hydroxychloroquine

25Class of person

A medical practitioner who is a specialist registrant in endocrinology.

26Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	prescribe	clomifene, corifollitropin alfa, cyclofenil, dinoprost, dinoprostone, follitropin alpha, follitropin beta, luteinising hormone, teriparatide or urofollitropin (human follicle stimulating hormone)
2	give a treatment dose	clomifene, corifollitropin alfa, cyclofenil, dinoprost, dinoprostone, follitropin alpha, follitropin beta, luteinising hormone, teriparatide or urofollitropin (human follicle stimulating hormone)
3	dispense	clomifene, corifollitropin alfa, cyclofenil, dinoprost, dinoprostone, follitropin alpha, follitropin beta, luteinising hormone, teriparatide or urofollitropin (human follicle stimulating hormone)
4	administer	clomifene, corifollitropin alfa, cyclofenil, dinoprost, dinoprostone, follitropin alpha, follitropin beta, luteinising hormone, teriparatide or urofollitropin (human follicle stimulating hormone)
5	give a purchase order	stock of a medicine mentioned in this column	the stock is not for a specified place
6	possess	a medicine mentioned in this column

27Class of person

A medical practitioner who is a specialist registrant in geriatrics.

28Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	prescribe	teriparatide
2	give a treatment dose	teriparatide
3	dispense	teriparatide
4	administer	teriparatide
5	give a purchase order	stock of teriparatide	the stock is not for a specified place
6	possess	teriparatide

29Class of person

A medical practitioner who is a specialist registrant in gynaecology or obstetrics.

30Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	prescribe	clomifene, corifollitropin alfa, cyclofenil, dinoprost, dinoprostone, follitropin alpha, follitropin beta, luteinising hormone or urofollitropin (human follicle stimulating hormone)
2	give a treatment dose	clomifene, corifollitropin alfa, cyclofenil, dinoprost, dinoprostone, follitropin alpha, follitropin beta, luteinising hormone or urofollitropin (human follicle stimulating hormone)
3	dispense	clomifene, corifollitropin alfa, cyclofenil, dinoprost, dinoprostone, follitropin alpha, follitropin beta, luteinising hormone or urofollitropin (human follicle stimulating hormone)
4	administer	clomifene, corifollitropin alfa, cyclofenil, dinoprost, dinoprostone, follitropin alpha, follitropin beta, luteinising hormone or urofollitropin (human follicle stimulating hormone)
5	give a purchase order	stock of a medicine mentioned in this column	the stock is not for a specified place
6	possess	a medicine mentioned in this column

31Class of person

A medical practitioner who is a specialist registrant in haematology.

32Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	prescribe	bexarotene, hydroxychloroquine, lenalidomide, pomalidomide, thalidomide or tretinoin for human oral use
2	give a treatment dose	bexarotene, hydroxychloroquine, lenalidomide, pomalidomide, thalidomide or tretinoin for human oral use
3	dispense	bexarotene, hydroxychloroquine, lenalidomide, pomalidomide, thalidomide or tretinoin for human oral use
4	administer	bexarotene, hydroxychloroquine, lenalidomide, pomalidomide, thalidomide or tretinoin for human oral use
5	give a purchase order	stock of a medicine mentioned in this column	the stock is not for a specified place
6	possess	a medicine mentioned in this column

33Class of person

A medical practitioner who is a specialist registrant in immunology and allergy.

34Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	prescribe	hydroxychloroquine
2	give a treatment dose	hydroxychloroquine
3	dispense	hydroxychloroquine
4	administer	hydroxychloroquine
5	give a purchase order	stock of hydroxychloroquine	the stock is not for a specified place
6	possess	hydroxychloroquine

35Class of person

A medical practitioner who is a specialist registrant in infectious diseases.

36Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	prescribe	hydroxychloroquine or thalidomide
2	give a treatment dose	hydroxychloroquine or thalidomide
3	dispense	hydroxychloroquine or thalidomide
4	administer	hydroxychloroquine or thalidomide
5	give a purchase order	stock of hydroxychloroquine or thalidomide	the stock is not for a specified place
6	possess	hydroxychloroquine or thalidomide

37Class of person

A medical practitioner who is a specialist registrant in intensive care medicine.

38Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	prescribe	hydroxychloroquine
2	give a treatment dose	hydroxychloroquine
3	dispense	hydroxychloroquine
4	administer	hydroxychloroquine
5	give a purchase order	stock of hydroxychloroquine	the stock is not for a specified place
6	possess	hydroxychloroquine

39Class of person

A medical practitioner who is a specialist registrant in medical oncology.

40Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	prescribe	bexarotene, enzalutamide, lenalidomide, pomalidomide, thalidomide
2	give a treatment dose	bexarotene, enzalutamide, lenalidomide, pomalidomide, thalidomide
3	dispense	bexarotene, enzalutamide, lenalidomide, pomalidomide, thalidomide
4	administer	bexarotene, enzalutamide, lenalidomide, pomalidomide, thalidomide
5	give a purchase order	stock of a medicine mentioned in this column	the stock is not for a specified place
6	possess	a medicine mentioned in this column

41Class of person

A medical practitioner who is a specialist registrant in nephrology.

42Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	prescribe	hydroxychloroquine
2	give a treatment dose	hydroxychloroquine
3	dispense	hydroxychloroquine
4	administer	hydroxychloroquine
5	give a purchase order	stock of hydroxychloroquine	the stock is not for a specified place
6	possess	hydroxychloroquine

43Class of person

A medical practitioner who is a specialist registrant in neurology.

44Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	prescribe	sodium oxybate
2	give a treatment dose	sodium oxybate
3	dispense	sodium oxybate
4	administer	sodium oxybate
5	give a purchase order	stock of sodium oxybate	the stock is not for a specified place
6	possess	sodium oxybate

45Definition for division

In this division—

relevant child condition means brain damage, or attention deficit disorder, of a child patient.

46Class of person

A medical practitioner who is a specialist registrant in paediatrics.

47Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	prescribe	(a)  amfetamine or methylphenidate	the medicine is prescribed for the treatment of a relevant child condition
		(b)  hydroxychloroquine or sodium oxybate
2	give a treatment dose	(a)  amfetamine or methylphenidate	the medicine is given for the treatment of a relevant child condition
		(b)  hydroxychloroquine or sodium oxybate
3	dispense	(a)  amfetamine or methylphenidate	the medicine is dispensed for the treatment of a relevant child condition
		(b)  hydroxychloroquine or sodium oxybate
4	administer	(a)  amfetamine or methylphenidate	the medicine is administered for the treatment of a relevant child condition
		(b)  hydroxychloroquine or sodium oxybate
5	give a purchase order	(a)  stock of amfetamine or methylphenidate	the stock is for the treatment of relevant child conditions, other than at a specified place
		(b)  stock of hydroxychloroquine or sodium oxybate	the stock is not for a specified place
6	possess	(a)  amfetamine or methylphenidate	the medicine is possessed for a purpose mentioned in this column
		(b)  hydroxychloroquine or sodium oxybate

48Definitions for division

In this division—

maximum dosage, of a medicine, means—

(a)if the medicine is dexamfetamine—a dose of the medicine that does not exceed 40mg a day; or

(b)if the medicine is lisdexamfetamine—a dose of the medicine that does not exceed 70mg a day; or

(c)if the medicine is methylphenidate—a dose of the medicine that does not exceed 80mg a day.

relevant adult condition means attention deficit disorder of an adult patient.

relevant child condition means brain damage, or attention deficit disorder, of a child patient.

49Class of person

A medical practitioner who is a specialist registrant in psychiatry.

50Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	prescribe	(a)  clozapine
		(b)  amfetamine or methylphenidate	the medicine is prescribed, within the maximum dosage, for the treatment of a relevant adult condition
		(c)  amfetamine or methylphenidate	the medicine is prescribed for the treatment of a relevant child condition
2	give a treatment dose	(a)  clozapine
		(b)  amfetamine or methylphenidate	the medicine is given, within the maximum dosage, for the treatment of a relevant adult condition
		(c)  amfetamine or methylphenidate	the medicine is given on a prescription for the treatment of a relevant child condition
3	dispense	(a)  clozapine
		(b)  amfetamine or methylphenidate	the medicine is dispensed, within the maximum dosage, for the treatment of a relevant adult condition
		(c)  amfetamine or methylphenidate	the medicine is dispensed on a prescription for the treatment of a relevant child condition
4	administer	(a)  clozapine
		(b)  amfetamine or methylphenidate	the medicine is administered, within the maximum dosage, for the treatment of a relevant adult condition
		(c)  amfetamine or methylphenidate	the medicine is administered on a prescription for the treatment of a relevant child condition
5	give a purchase order	(a)  stock of clozapine	the stock is not for a specified place
		(b)  stock of amfetamine or methylphenidate	the stock is for treating relevant adult or child conditions, other than at a specified place
6	possess	clozapine, amfetamine or methylphenidate

51Class of person

A medical practitioner who is a specialist registrant in respiratory medicine or sleep medicine.

52Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	prescribe	sodium oxybate
2	give a treatment dose	sodium oxybate
3	dispense	sodium oxybate
4	administer	sodium oxybate
5	give a purchase order	stock of sodium oxybate	the stock is not for a specified place
6	possess	sodium oxybate

53Class of person

A medical practitioner who is a specialist registrant in rheumatology.

54Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	prescribe	ambrisentan, bosentan, hydroxychloroquine, macitentan, riociguat or teriparatide
2	give a treatment dose	ambrisentan, bosentan, hydroxychloroquine, macitentan, riociguat or teriparatide
3	dispense	ambrisentan, bosentan, hydroxychloroquine, macitentan, riociguat or teriparatide
4	administer	ambrisentan, bosentan, hydroxychloroquine, macitentan, riociguat or teriparatide
5	give a purchase order	stock of a medicine mentioned in this column	the stock is not for a specified place
6	possess	a medicine mentioned in this column

55Class of person

A medical practitioner who, under the Health Practitioner Regulation National Law—

(a)is a specialist general practitioner; and

(b)has advanced skills in gynaecology.

56Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	prescribe	dinoprost or dinoprostone
2	give a treatment dose	dinoprost or dinoprostone
3	dispense	dinoprost or dinoprostone
4	administer	dinoprost or dinoprostone
5	give a purchase order	stock of dinoprost or dinoprostone	the stock is not for a specified place
6	possess	dinoprost or dinoprostone

57Class of person

A medical practitioner who is a specialist registrant in general medicine.

58Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	prescribe	acitretin, ambrisentan, bexarotene, bosentan, enzalutamide, etretinate, hydroxychloroquine, isotretinoin for human oral use, lenalidomide, macitentan, pomalidimide, riociguat, teriparatide, thalidomide or tretinoin for human oral use
2	give a treatment dose	acitretin, ambrisentan, bexarotene, bosentan, enzalutamide, etretinate, hydroxychloroquine, isotretinoin for human oral use, lenalidomide, macitentan, pomalidimide, riociguat, teriparatide, thalidomide or tretinoin for human oral use
3	dispense	acitretin, ambrisentan, bexarotene, bosentan, enzalutamide, etretinate, hydroxychloroquine, isotretinoin for human oral use, lenalidomide, macitentan, pomalidimide, riociguat, teriparatide, thalidomide or tretinoin for human oral use
4	administer	acitretin, ambrisentan, bexarotene, bosentan, enzalutamide, etretinate, hydroxychloroquine, isotretinoin for human oral use, lenalidomide, macitentan, pomalidimide, riociguat, teriparatide, thalidomide or tretinoin for human oral use
5	give a purchase order	stock of a medicine mentioned in this column	the stock is not for a specified place
6	possess	a medicine mentioned in this column

59Class of person

A medical practitioner who is a specialist registrant in urology.

60Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	prescribe	enzalutamide
2	give a treatment dose	enzalutamide
3	dispense	enzalutamide
4	administer	enzalutamide
5	give a purchase order	stock of enzalutamide	the stock is not for a specified place
6	possess	enzalutamide

61Definition for part

In this part—

practice plan, for a physician assistant, means a document in the approved form—

(a)developed and signed by the physician assistant and the medical practitioner supervising the assistant; and

(b)stating the circumstances and conditions for the physician assistant to prescribe, administer, or give a treatment dose, of a medicine.

62Class of person

A person (a physician assistant) appointed and employed as a physician assistant by a Hospital and Health Service or the chief executive.

63Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	prescribe	a non-restricted medicine	the medicine is prescribed under— •  the supervision of a medical practitioner; and •  a practice plan for the physician assistant
2	give a treatment dose	a non-restricted medicine	the medicine is given under— •  the supervision of a medical practitioner; and •  a practice plan for the physician assistant
3	administer	a non-restricted medicine	the medicine is administered under— •  the supervision of a medical practitioner; and •  a practice plan for the physician assistant
4	possess	an S4 or S8 non-restricted medicine	the medicine is possessed for a purpose mentioned in this column

section 13

Note—

See also sections 56 and 67 of the Act about prescribing approvals and the relationship between different authorisations.

1Definitions for part

In this part—

continuing hydroxychloroquine treatment, by a nurse practitioner of a patient, means—

(a)the practitioner is treating the patient; and

(b)prior to being treated by the practitioner, the patient was prescribed hydroxychloroquine by another health practitioner authorised to prescribe hydroxychloroquine.

continuing institutional treatment, by a nurse practitioner of a patient, means—

(a)the practitioner is treating the patient in a hospital, prison, watch-house or detention centre; and

(b)the patient was being treated with a medicine prior to admission to the hospital, prison, watch-house or detention centre; and

(c)the treatment with the medicine is under the supervision of a registrar or specialist medical practitioner authorised to deal with the medicine.

2Class of person

A person (a nurse practitioner) who is a registered nurse and endorsed under the Health Practitioner Regulation National Law as being qualified to practise as a nurse practitioner.

3Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	prescribe	(a)  a registered medicine, other than a restricted medicine or hydroxychloroquine
		(b)  any restricted medicine other than hydroxychloroquine	the medicine is prescribed for administration for the continuing institutional treatment of a patient
		(c)  hydroxychloroquine	the medicine is prescribed for the continuing hydroxychloroquine treatment of a patient
2	make a standing order, other than a clinical protocol	an S2, S3 or S4 medicine, other than an S4 diversion-risk medicine or restricted medicine
3	give a treatment dose	(a)  a registered medicine, other than a restricted medicine
		(b)  a restricted medicine, other than hydroxychloroquine	the medicine is given for the continuing institutional treatment of a patient
		(c)  hydroxychloroquine	the medicine is given for the continuing hydroxychloroquine treatment of a patient
4	administer	(a)  a registered medicine, other than a restricted medicine
		(b)  a restricted medicine, other than hydroxychloroquine	the medicine is administered for the continuing institutional treatment of a patient
		(c)  hydroxychloroquine	the medicine is administered for the continuing hydroxychloroquine treatment of a patient
		(d)  any medicine, including a restricted medicine	the medicine is administered on a prescription
5	repackage	any medicine	the medicine is repackaged for giving a treatment dose for a patient
6	give a purchase order	(a)  stock of an S4 or S8 medicine that is a registered medicine	the stock is not for a specified place
		(b)  stock of hydroxychloroquine	the stock is for the continuing hydroxychloroquine treatment of patients
7	possess	an S4 or S8 medicine mentioned in this column	the medicine is possessed for a purpose mentioned in this column
8	dispose	waste from an diversion-risk medicine mentioned in this column

4Definition for part

In this part—

childbirth means the process of labour and delivery beginning with uterine contractions and ending with the expulsion of the placenta and membranes from the woman giving birth.

5Class of person

A person (a midwife) who is registered under the Health Practitioner Regulation National Law to practise in the midwifery profession as a midwife.

6Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	give a treatment dose	(a)  an S2 or S3 medicine	the medicine is given at a rural hospital or in an isolated practice area
		(b)  any medicine	the medicine is given on a standing order
		(c)  an S4 or S8 medicine	the medicine is given on a prescription
		(d)  an S4 or S8 medicine mentioned in the extended practice authority called ‘Midwives’	the medicine is given under the extended practice authority
2	administer	(a)  an S2 or S3 medicine
		(b)  a nitrous oxide mixture	the medicine is administered as an analgesic to treat a woman during childbirth
		(c)  any medicine	the medicine is administered on a standing order
		(d)  an S4 or S8 medicine	the medicine is administered on a prescription
		(e)  an S4 or S8 medicine	the medicine is administered in accordance with the medicine’s approved label
		(f)  an S4 or S8 medicine mentioned in the extended practice authority called ‘Midwives’	the medicine is administered under the extended practice authority
3	repackage	any medicine	the medicine is repackaged for giving a treatment dose for a patient on a prescription
4	give a purchase order	stock of a medicine mentioned in the extended practice authority called ‘Midwives’	the purchase order is given under the extended practice authority
5	possess	an S4 or S8 medicine mentioned in this column	the medicine is possessed for a purpose mentioned in this column
6	dispose	waste from a diversion-risk medicine mentioned in this column

7Class of person

A midwife who is endorsed.

8Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	prescribe	a medicine, other than a restricted medicine
2	give a treatment dose	a medicine, other than a restricted medicine
3	administer	a medicine, other than a restricted medicine
4	repackage	a medicine	the medicine is repackaged for giving a treatment dose for a patient
5	give a purchase order	stock of an S4 or S8 medicine mentioned in this column	the stock is not for a specified place
6	possess	an S4 or S8 medicine mentioned in this column	the medicine is possessed for a purpose mentioned in this column
7	dispose	waste from a diversion-risk medicine mentioned in this column

9Definitions for part

In this part—

dose administration aid repackaging guidelines means the document called ‘Repackaging medicines into a dose administration aid: Guidelines for registered nurses’, version 1, made by the chief executive and published on the department’s website.

prison patient means—

(a)a patient released from a prison into the custody of the court; or

(b)a patient transferred from 1 prison to another prison; or

(c)a patient released from a prison into the community.

rural discharge circumstances, in relation to a patient at a rural hospital or a hospital in an isolated practice area, means—

(a)the patient is being discharged from, or is an outpatient of, the hospital; and

(b)the hospital does not employ a pharmacist or the pharmacist is absent from the hospital when it is necessary to give a treatment dose of a medicine.

10Class of person

A person (a registered nurse) who is registered under the Health Practitioner Regulation National Law to practise in the registered nurses division of the nursing profession.

11Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	give a treatment dose	a medicine mentioned in the extended practice authority called ‘Registered nurses’	the treatment dose is given under the extended practice authority
2	administer	(a)  an S2 or S3 medicine
		(b)  any medicine	the medicine is administered on a standing order
		(c)  an S4 or S8 medicine	the medicine is administered on a prescription
		(d)  an S4 or S8 medicine	the medicine is administered in accordance with the medicine’s approved label
		(e)  an S4 or S8 medicine mentioned in the extended practice authority called ‘Registered nurses’	the medicine is administered under the extended practice authority
3	give a purchase order	stock of an S4 or S8 medicine mentioned in the extended practice authority called ‘Registered nurses’	the purchase order is given under the extended practice authority
4	possess	an S4 or S8 medicine mentioned in this column	the medicine is possessed for a purpose mentioned in this column
5	dispose	waste from a diversion-risk medicine mentioned in this column

12Class of person

A registered nurse who is a nurse manager at a relevant institution.

13Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	give a purchase order	stock of an S4 or S8 medicine	•  the purchase order is given for the relevant institution; and •  the purchase order is given for the therapeutic treatment of patients at the relevant institution
2	possess	stock of an S4 or S8 medicine	the stock is possessed at the relevant institution

14Class of person

A registered nurse who—

(a)is employed at a rural hospital or at a hospital in an isolated practice area; and

(b)is the hospital’s nurse manager.

15Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	give a treatment dose	any medicine	the medicine is given on a prescription in rural discharge circumstances
2	repackage	any medicine	the medicine is repackaged— (a)  for giving a treatment dose for a patient on a prescription; and (b)  if repackaged in a dose administration aid—under the dose administration aid repackaging guidelines
3	possess	an S4 or S8 medicine	the medicine is possessed for a purpose mentioned in this column

16Class of person

A registered nurse who is employed at a prison.

17Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	give a treatment dose	an S2, S3 or S4 medicine	the medicine is given— (a)  for a prison patient on a prescription from a prescriber employed to provide health services at the prison; and (b)  in an amount that is not more than 7 days’ supply
2	repackage	any medicine	the medicine is repackaged— (a)  for giving a treatment dose for a prison patient on a prescription; and (b)  if repackaged in a dose administration aid—under the dose administration aid repackaging guidelines
3	possess	an S4 medicine	the medicine is possessed for a purpose mentioned in this column

18Class of person

A person (an enrolled nurse) who is registered under the Health Practitioner Regulation National Law to practise in the enrolled nurses division of the nursing profession—

(a)including a person with provisional registration or limited registration; but

(b)not including a person—

(i)who is registered to practise in the profession only as a student or for training purposes; or

(ii)whose registration contains a notation indicating the enrolled nurse is not qualified to administer medicines.

19Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	administer	(a)  any medicine	the medicine is administered— •  under the direct supervision of a medical practitioner administering anaesthesia; and •  for the safety of the patient before, or during, the patient’s anaesthetic procedure at a hospital
		(b)  any medicine	the medicine is administered— •  under the supervision of a dentist, medical practitioner, midwife or registered nurse; and •  in accordance with the medicine’s approved label or on a prescription or a standing order
2	possess	an S4 or S8 medicine	the medicine is possessed for a purpose mentioned in this column
3	dispose	waste from a diversion-risk medicine that is an S4 or S8 medicine

20Class of person

A person who is registered in the enrolled nurses division of the nursing provision but whose registration contains a notation indicating the enrolled nurse is not qualified to administer S4 or S8 medicines.

21Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	administer	an S2 or S3 medicine	the medicine is administered— •  under the supervision of a dentist, medical practitioner, midwife or registered nurse; and •  in accordance with the medicine’s approved label or on a prescription or a standing order

22Class of person

A person who is undertaking training to obtain a qualification required to be registered under the Health Practitioner Regulation National Law to practise in the enrolled nurses division of the nursing profession.

23Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	administer	any medicine	the medicine is administered to the extent authorised for an enrolled nurse— •  under the direct supervision of a dentist, medical practitioner, midwife or registered nurse; and •  in accordance with the medicine’s approved label or on a prescription or a standing order
2	possess	an S4 or S8 medicine	the medicine is possessed to the extent authorised for an enrolled nurse under the direct supervision of a registered nurse at the place where the registered nurse is practising

section 13

1Definitions for schedule

In this schedule—

ophthalmologist means a person who is registered under the Health Practitioner Regulation National Law to practise in the specialty of ophthalmology.

Optometry Board means the Optometry Board of Australia established under the Health Practitioner Regulation National Law.

optometry guidelines means the document called ‘Guidelines for use of scheduled medicines’ made by the Optometry Board and stated to have effect from 10 September 2018.

2Class of person

A person (an optometrist) who is registered under the Health Practitioner Regulation National Law to practise in the optometry profession.

3Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	administer	a topical S2, S3 or S4 medicine mentioned in appendix B of the optometry guidelines	the medicine is administered under the guidelines
2	give a purchase order	stock of an S4 medicine mentioned in this column	the stock is not for a specified place
3	possess	an S4 medicine mentioned in this column	the medicine is possessed for a purpose mentioned in this column

4Class of person

An endorsed optometrist.

5Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	prescribe	an S2, S3 or S4 medicine mentioned in appendix B or appendix C of the optometry guidelines	the medicine is prescribed under the guidelines
2	give a treatment dose	an S2, S3 or S4 medicine mentioned in appendix B or appendix C of the optometry guidelines	the medicine is given under the guidelines
3	administer	an S2, S3 or S4 medicine mentioned in appendix B or appendix C of the optometry guidelines	the medicine is administered under the guidelines
4	give a purchase order	stock of an S4 medicine mentioned in this column	the stock is not for a specified place
5	possess	an S4 medicine mentioned in this column	the medicine is possessed for a purpose mentioned in this column

6Class of person

A person (an orthoptist) whose name is recorded in the register of orthoptists kept by the Australian Orthoptists Registration Body Pty Ltd ACN 095 117 678.

7Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	administer	(a)  a topical ophthalmic preparation	the medicine is administered on a prescription from an ophthalmologist
		(b)  any of the following S4 medicines— •  proxymetacaine hydrochloride of a strength of 0.5% or less •  oxybuprocaine hydrochloride of a strength of 0.4% or less •  amethocaine hydrochloride of a strength of 0.5% or less •  lidocaine (lignocaine) of a strength of 4% or less combined with fluorescein of a strength of 0.25% •  cyclopentolate hydrochloride of a strength of 1% or less •  homatropine hydrobromide of a strength of 2% or less •  atropine of a strength of 1% or less •  tropicamide of a strength of 1% or less •  pilocarpine hydrochloride nitrate of a strength of 4% or less •  phenylephrine of a strength of 2.5% or less in eye drops	the medicine is administered on a clinical protocol made by an ophthalmologist
2	give a purchase order	stock of an S4 medicine mentioned in this column	the stock is not for a specified place
3	possess	an S4 medicine mentioned in this column	the medicine is possessed for a purpose mentioned in this column

section 13

1Class of person

A person (a pharmacist) who is registered under the Health Practitioner Regulation National Law to practise in the pharmacy profession but not including an intern pharmacist or a trainee pharmacist.

Note—

See division 3 in relation to intern pharmacists and division 4 in relation to trainee pharmacists.

2Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	dispense	any medicine
2	supply	(a)  stock of any medicine	the stock is supplied on a compliant purchase order to a person under the National Health (Pharmaceutical Benefits) Regulations 2017 (Cwlth), section 33
		(b)  stock of any medicine	the stock is supplied to another pharmacist— •  to urgently fill a shortage of stock held by the other pharmacist; or •  as part of an arrangement with the pharmacist to prevent the stock from expiring; or •  for satisfying an order made by a client of the other pharmacist
		(c)  stock of any medicine	the stock is supplied from a pharmacy to an approved person, other than a pharmacist, who is authorised to give a purchase order for the medicine or administer the medicine
3	sell, other than on a prescription	(a)  an S2, S3 or S4 medicine
		(b)  a medicine that is mentioned as a pharmaceutical benefit in a Continued Dispensing Determination	the medicine is sold in the circumstances mentioned in the Continued Dispensing Determination
		(c)  a medicine mentioned in the extended practice authority called ‘Pharmacists’	the medicine is sold under the extended practice authority
4	give a treatment dose	any medicine	the medicine is given on a standing order at a public hospital
5	administer	(a)  a medicine mentioned in the extended practice authority called ‘Pharmacists’	the medicine is administered under the extended practice authority
		(b)  an approved opioid	the medicine is administered on a prescription
6	repackage	any medicine	the medicine is repackaged for— •  selling to a patient; or •  supply to an approved person, other than another pharmacist; or •  supply to, or possession of stock at, a clinical area of a hospital
7	compound	(a)  an S2 or S3 medicine	the medicine is compounded for the treatment of a patient
		(b)  an S4 or S8 medicine	the medicine is compounded to fulfil a prescription from a prescriber for a patient
8	give a purchase order	stock of an S4 or S8 medicine	the stock is not for a specified place
9	possess	an S4 or S8 medicine	the medicine is possessed for a purpose mentioned in this column
10	dispose	waste from a diversion-risk medicine that is an S4 or S8 medicine

3Class of person

A pharmacist who is in charge of a dispensary at a relevant institution.

4Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	give a purchase order	stock of an S4 or S8 medicine	•  the purchase order is given for the relevant institution; and •  the purchase order is given for the therapeutic treatment of patients at the relevant institution
2	possess	stock of an S4 or S8 medicine	the stock is possessed at the relevant institution

5Class of person

A person (an intern pharmacist) who is—

(a)registered under the Health Practitioner Regulation National Law to practise in the pharmacy profession with provisional registration; and

(b)employed as an intern undertaking supervised practice.

6Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	a dealing mentioned in the table in division 1	a medicine mentioned in the table in division 1	the dealing with the medicine is carried out to the extent authorised for a pharmacist under the supervision of a pharmacist

7Class of person

A person (a trainee pharmacist) who is registered under the Health Practitioner Regulation National Law to practise in the pharmacy profession as a student or for training purposes.

8Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	sell by retail	a medicine mentioned in the table in division 1	the sale is carried out to the extent authorised for a pharmacist under the direct supervision of a pharmacist
2	administer	a medicine mentioned in the table in division 1	the medicine is administered to the extent authorised for a pharmacist under the direct supervision of a pharmacist
3	compound	a medicine mentioned in the table in division 1	the medicine is compounded to the extent authorised for a pharmacist under the direct supervision of a pharmacist
4	possess	a medicine mentioned in the table in division 1	the medicine is possessed to the extent authorised for a pharmacist under the direct supervision of a pharmacist

9Definitions for part

In this part—

pharmaceutical imprest duties means duties related to keeping an inventory of stock of medicines possessed for a specific health service or supplied for treatment of patients of the service.

specific health service means a Hospital and Health Service or private health facility.

10Class of person

A person (a hospital pharmaceutical technician) who—

(a)has a qualification, or statement of attainment, recognising the person has the skills and knowledge required to carry out pharmaceutical imprest duties for a specific health service; and

(b)carries out pharmaceutical imprest duties for a specific health service.

11Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	give a purchase order	stock of an S4 or S8 medicine	•  the purchase order is given under the supervision of a pharmacist in charge of a dispensary for a specific health service; and •  the purchase order is given for the therapeutic treatment of patients of the specific health service
2	possess	an S4 or S8 medicine	the medicine is possessed under the supervision of a pharmacist

12Class of person

A person who—

(a)is 16 years or more and employed at a pharmacy; and

(b)is appropriately qualified to assist with compounding at the pharmacy.

13Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	compound	a medicine	the medicine is compounded under the direct supervision of a pharmacist

14Class of person

A person (a general pharmacy assistant) who is 16 years or more and employed at a pharmacy.

15Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	sell by retail	an S2 medicine	the medicine is sold under the direct supervision of a pharmacist
2	give a purchase order	stock of an S4 or S8 medicine	the purchase order is given, under the direct supervision of a pharmacist, for stock of medicines for the pharmacy to be delivered to the pharmacy
3	possess	an S4 or S8 medicine	the medicine is possessed under the direct supervision of a pharmacist

section 13

1Definitions for schedule

In this schedule—

endorsed podiatrist standard means the document called ‘Registration standard: endorsement for scheduled medicines’, made by the Podiatry Board on 1 August 2018.

podiatric surgeon means a person who is a specialist registrant in the specialty of podiatric surgery.

Podiatry Board means the Podiatry Board of Australia established under the Health Practitioner Regulation National Law.

2Class of person

A person (a podiatrist) who is registered under the Health Practitioner Regulation National Law to practise in the podiatry profession.

3Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	administer	(a)  an S2 medicine
		(b)  an adrenaline (epinephrine) autoinjector
		(c)  any of the following medicines, other than when combined with adrenaline (epinephrine) or another vasoconstrictor medicine— •  bupivacaine of a strength of 0.5% or less •  levobupivacaine of a strength of 0.5% or less •  lidocaine (lignocaine) of a strength of 2% or less •  prilocaine of a strength of 2% or less
2	give a purchase order	stock of an S4 medicine mentioned in this column	the stock is not for a specified place
3	possess	an S4 medicine mentioned in this column

4Class of person

An endorsed podiatrist, whether or not the podiatrist is also a podiatric surgeon.

5Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	prescribe	a medicine mentioned in attachment A of the endorsed podiatrist standard	the medicine is prescribed under the standard
2	give a treatment dose	a medicine mentioned in attachment A of the endorsed podiatrist standard	the medicine is given under the standard
3	administer	a medicine mentioned in attachment A of the endorsed podiatrist standard	the medicine is administered under the standard
4	give a purchase order	stock of an S4 or S8 medicine mentioned in this column	the stock is not for a specified place
5	possess	an S4 or S8 medicine mentioned in this column	the medicine is possessed for a purpose mentioned in this column
6	dispose	waste from a diversion-risk medicine mentioned in this column

6Class of person

A podiatric surgeon who is not endorsed.

7Dealing

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	prescribe	diclofenac, fexofenadine, ibuprofen, loratadine, naproxen, promethazine	the medicine is prescribed as an oral preparation for no more than a 10 day course of treatment
		hydrocortisone	the medicine is prescribed as a topical preparation for no more than a 10 day course of treatment with each dose being of a strength of 1% or less
		amoxycillin or amoxycillin with clavulanic acid, cephalexin, dicloxacillin, doxycycline, erythromycin, metronidazole, roxithromycin	the medicine is prescribed as an oral preparation for no more than a 10 day course of treatment
		codeine	the medicine is prescribed as an oral preparation of no more than 20 doses with each dose being not more than 30mg in combination with each 500mg of paracetamol
		diazepam	the medicine is prescribed as an oral preparation of no more than 10 doses of 5mg each
		mupirocin	the medicine is prescribed as a topical preparation for no more than a 10 day course of treatment
		temazepam	the medicine is prescribed as an oral preparation of no more than 2 doses of 10mg each
		oxycodone	the medicine is prescribed as an oral preparation in a short acting form of no more than 10 doses of 5mg each
2	administer	any of the following S4 medicines— •  dexamethasone as a local injection •  ropivacaine of a strength of 1% or less •  epinephrine (adrenaline) when combined with lidocaine (lignocaine), bupivacaine or prilocaine
3	give a purchase order	stock of an S4 medicine the podiatric surgeon may administer	the stock is not for a specified place
4	possess	an S4 or S8 medicine mentioned in this column	the medicine is possessed for a purpose mentioned in this column
5	dispose	waste from a diversion-risk medicine mentioned in this column

section 13

1Class of person

A veterinary surgeon.

2Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	prescribe	a non-restricted medicine, other than a diversion-risk medicine
		a diversion-risk medicine	the medicine prescribed is no more than the amount necessary for treating an animal for 6 months
2	dispense	a non-restricted medicine, other than a diversion-risk medicine
		a non-restricted diversion-risk medicine	the medicine dispensed is no more than the amount necessary for treating an animal for 6 months
3	give a treatment dose	a non-restricted medicine, other than a diversion-risk medicine
		a diversion-risk medicine	the medicine given is no more than the amount necessary for treating an animal for 6 months
4	supply	an S4 medicine or medicated feed	the medicine or feed is to be mixed with food for administration to a group of animals by the farmer of the animals
5	administer	any medicine
6	compound	a non-restricted medicine	the medicine is compounded for the treatment of an animal
7	repackage	a non-restricted medicine	the medicine is repackaged for an animal
8	give a purchase order	stock of an S4 or S8 medicine that is a non-restricted medicine	the stock is not for a specified place
9	possess	an S4 or S8 medicine	the medicine is possessed for a purpose mentioned in this column
10	dispose	waste from a diversion-risk medicine

3Class of person

A person (a veterinary nurse) who—

(a)is employed to practise veterinary nursing; and

(b)holds a qualification that makes the person eligible for full membership of the Veterinary Nurses Council of Australia Inc.

4Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	administer	(a)  an S8 medicine	the medicine is administered at veterinary premises— (a)  when a veterinary surgeon is not able to be physically present but is available to be contacted using technology to communicate with a veterinary nurse in real time; and (b)  the medicine has been pre-prepared into a treatment dose by a veterinary surgeon or a pharmacist; and (c)  the medicine is administered on a prescription or in accordance with the medicine’s approved label
		(b)  an S2, S3 or S4 medicine	the medicine is administered at veterinary premises— (a)  under the supervision of a veterinary surgeon; and (b)  on a prescription or in accordance with the medicine’s approved label
		(c)  an S2, S3 or S4 medicine	the medicine is administered— (a)  under the direct supervision of a veterinary surgeon; and (b)  on a prescription or in accordance with the medicine’s approved label
2	possess	an S4 or S8 medicine	the medicine is possessed for a purpose mentioned in this column

5Class of person

A person undertaking training to obtain a qualification required to be a veterinary surgeon.

6Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	administer	a medicine mentioned in the table in part 1	the medicine is administered— •  to the extent authorised for a veterinary surgeon; and •  under the direct supervision of a veterinary surgeon
2	possess	a medicine mentioned in the table in part 1	the medicine is possessed— •  to the extent authorised for a veterinary surgeon; and •  under the direct supervision of a veterinary surgeon

7Class of person

A person undertaking training to obtain a qualification required to be a veterinary nurse.

8Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	administer	a medicine mentioned in the table in part 2	the medicine is administered under the direct supervision of a veterinary surgeon
2	possess	a medicine mentioned in the table in part 2	the medicine is possessed under the direct supervision of a veterinary surgeon at the place where the veterinary surgeon is practising

9Class of person

A person (a veterinary assistant) assisting a veterinary surgeon to manage stock of medicines at veterinary premises.

10Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	possess	an S4 medicine, other than pentobarbital	the medicine is possessed under the direct supervision of a veterinary surgeon

section 13

1Class of person

A person (an anaesthetic technician) who holds a qualification acceptable to the Australian and New Zealand College of Anaesthetists to be an anaesthetic technician.

2Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	administer	any medicine	the medicine is administered at a hospital under the direct supervision of a medical practitioner to ensure the safety of a patient in relation to an anaesthetic procedure
2	possess	an S4 or S8 medicine	the medicine is possessed for administration to the extent mentioned in this column
3	dispose	waste from a diversion-risk medicine mentioned in this column

3Class of person

A person (a clinical perfusionist) who is—

(a)employed as a clinical perfusionist at a Hospital and Health Service, private health facility or approved health facility; or

(b)accredited or certified to work as a clinical perfusionist by a professional body approved by the chief executive.

4Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	administer	any medicine	the medicine is administered into extracorporeal circulation equipment to prepare for an anaesthetic, intensive care or surgical procedure for a patient— •  under the supervision of an anaesthetist, cardiothoracic surgeon or another intensive care physician; or •  on a clinical protocol applying to the clinical perfusionist
2	possess	an S4 or S8 medicine	the medicine is possessed for administration to the extent mentioned in this column
3	dispose	waste from a diversion-risk medicine mentioned in this column

5Class of person

A person (a nuclear medicine technologist) who is registered under the Health Practitioner Regulation National Law to practise in the nuclear medicine technology division of the medical radiation practice profession.

6Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	administer	(a)  an S2 or S3 medicine, other than an adrenaline (epinephrine) autoinjector	the medicine is administered— •  on a clinical protocol applying to the nuclear medicine technologist; or •  on a written prescription
		(b)  an adrenaline (epinephrine) autoinjector	the nuclear medicine technologist has completed anaphylaxis training and the medicine is administered to treat anaphylaxis— •  on a clinical protocol applying to the technologist; or •  on a written prescription
		(c)  an S4 medicine that is— •  an angiotensin- converting enzyme inhibitor or angiotensin II receptor atagonist, whether alone or in combination with a diuretic; or •  a diuretic; or •  a histamine H2 receptor antagonist	the medicine is administered— •  on a clinical protocol applying to the nuclear medicine technologist; or •  on a written prescription
2	possess	an S4 medicine mentioned in this column	the medicine is possessed for administration to the extent mentioned in this column

7Class of person

A person (a physiotherapist) who is registered with the Physiotherapy Board of Australia, established under the Health Practitioner Regulation National Law, to practise in the physiotherapy profession.

8Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	prescribe	a medicine mentioned in the extended practice authority called ‘Physiotherapists’	the medicine is prescribed under the extended practice authority
2	administer	(a)  an S2 medicine
		(b)  a nitrous oxide mixture	the medicine is administered in a hospital on a written prescription
		(c)  an S3 medicine for pain relief	the medicine— •  is administered on a written prescription; or •  has been lawfully supplied to the patient being treated with the medicine
		(d)  an S3 or S4 medicine for the physiotherapy treatment of a respiratory condition	the medicine— •  is administered on a written prescription; or •  has been lawfully supplied to the patient being treated with the medicine
		(e)  a medicine mentioned in the extended practice authority called ‘Physiotherapists’	the medicine is administered under the extended practice authority
3	possess	an S4 medicine mentioned in this column	the medicine is possessed for a purpose mentioned in this column
4	dispose	waste from a diversion-risk medicine mentioned in this column

9Class of person

A person (a respiratory scientist) who—

(a)is employed as a respiratory scientist at a Hospital and Health Service, private health facility or approved health facility; or

(b)is accredited or certified to work as a respiratory scientist by a professional body approved by the chief executive.

10Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	administer	(a)  an S2 or S3 medicine, other than an adrenaline (epinephrine) autoinjector	the medicine is administered— •  on a clinical protocol applying to the respiratory scientist; or •  on a written prescription
		(b)  an adrenaline (epinephrine) autoinjector	the respiratory scientist has completed anaphylaxis training and the medicine is administered to treat anaphylaxis— •  on a clinical protocol applying to the scientist; or •  on a written prescription
		(c)  an S4 medicine that is an anti-histamine for systemic use or a broncho-constrictor agent or bronchodilator agent	the medicine is administered— •  on a clinical protocol applying to the respiratory scientist; or •  on a written prescription
2	possess	an S4 medicine mentioned in this column	the medicine is possessed for a purpose mentioned in this column

11Definition for part

In this part—

medication safety course means the online course called ‘Medication safety’ provided by NPS MedicineWise ABN 61 082 034 393.

12Class of person

A person (a speech pathologist) who has completed the medication safety course and is—

(a)employed as a speech pathologist at a Hospital and Health Service, private health facility or in another government entity under the Public Service Act 2008, section 24; or

(b)accredited or certified to work as a speech pathologist by a professional body approved by the chief executive.

13Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	administer	(a)  an S2 or S3 medicine, other than an adrenaline (epinephrine) autoinjector	the medicine is administered— •  on a clinical protocol applying to the speech pathologist; or •  on a written prescription
		(b)  an adrenaline (epinephrine) autoinjector	the speech pathologist has completed anaphylaxis training and the medicine is administered to treat anaphylaxis— •  on a clinical protocol applying to the pathologist; or •  on a written prescription
		(c)  an S4 medicine that is a topical antibiotic or a topical corticosteroid	the medicine is administered— •  on a clinical protocol applying to the speech pathologist; or •  on a written prescription
2	possess	an S4 medicine mentioned in this column	the medicine is possessed for a purpose mentioned in this column

Notes—

1See schedule 7, part 6 in relation to trainee enrolled nurses.

2See schedule 9, part 1, division 4, in relation to trainee pharmacists.

3See schedule 11, part 3 in relation to trainee veterinary surgeons and veterinary nurses.

14Definitions for part

In this part—

health trainee means a person undertaking training to obtain a qualification required to become a member of a relevant class of health practitioner mentioned in schedules 3 to 11, 13 or 15, other than an enrolled nurse or pharmacist.

relevant class, in relation to a health trainee, means the class of health practitioner for which the trainee is undertaking training to become.

15Class of person

A health trainee.

16Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	administer	a medicine mentioned in the table for the relevant class in relation to the health trainee	the medicine is administered to the extent authorised for the relevant class under the direct supervision of a person authorised to administer the medicine, other than a person who is— •  another health trainee; or •  authorised to administer the medicine only under the supervision of someone else
2	possess	a medicine mentioned in the table for the relevant class in relation to the health trainee	the medicine is possessed to the extent authorised for the relevant class under the direct supervision of a person authorised to possess the medicine, other than a person who is— •  another health trainee; or •  authorised to possess the medicine only under the supervision of someone else

section 13

Notes—

1See schedule 3, part 3 about approved Aboriginal health services.

2See also other schedules in relation to dealings for other health practitioners at relevant institutions.

1Class of person

A person who is the executive director of a detention centre.

2Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	give a purchase order	stock of an S4 or S8 medicine	the purchase order is given for medicines for the therapeutic treatment of children detained at the detention centre
2	possess	stock of an S4 or S8 medicine	the stock is possessed at the detention centre

3Class of person

A person who is the general manager of a prison.

4Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	give a purchase order	stock of an S4 or S8 medicine	the purchase order is given for medicines for the therapeutic treatment of persons detained at the prison or children accommodated with the person detained
2	possess	stock of an S4 or S8 medicine	the stock is possessed at the prison

Note—

See also sections 34 and 51 of the Act about temporary possession and administration of medicines as an agent or carer.

5Definitions for division

In this division—

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

court see the Corrective Services Act 2006, schedule 4.

proper officer, of a court, see the Corrective Services Act 2006, schedule 4.

6Class of person

A person (a custodial officer) who is—

(a)a proper officer of a court; or

(b)a corrective services officer.

7Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	supply	any medicine	the medicine— •  is supplied by giving it to a police officer or another custodial officer to possess for the therapeutic treatment of a person in custody; and •  was lawfully supplied to the person in custody for the therapeutic treatment of the person

8Class of person

A person who is the principal of a school or the principal’s delegate.

9Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	administer	any medicine	the medicine— (a)  was dispensed for a child attending the school or supplied for the child by the child’s parent or guardian; and (b)  is administered in accordance with the medicine’s approval label or on a written instruction from the prescriber of the medicine
2	possess	an S4 or S8 medicine	the medicine is possessed for administration to the extent mentioned in this column

10Class of person

A person who is employed at a school.

11Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	administer	(a)  an adrenaline (epinephrine) autoinjector	the medicine is administered to a child attending the school and the person has completed anaphylaxis training
		(b)  an inhaled asthma reliever, other than an S4 medicine	the medicine is administered to a child attending the school and the person has completed asthma training
2	possess	a medicine mentioned in this column	the medicine is possessed for administration to the extent mentioned in this column

12Definition for division

In this division—

head, of a child care facility, means—

(a)if the facility provides an education and care service under the Education and Care Services National Law (Queensland)—an approved provider or nominated supervisor for the service within the meaning of the Education and Care Services National Law (Queensland), section 5(1); or

(b)if the facility provides a Queensland education and care service under the Education and Care Services Act 2013—an approved provider or supervisor within the meaning of the Education and Care Services Act 2013, schedule 1.

13Class of person

A person who is the head of a child care facility or the head’s delegate.

14Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	administer	any medicine	the medicine— (a)  was dispensed for a child attending the child care facility or supplied for the child by the child’s parent or guardian; and (b)  is administered in accordance with the medicine’s approval label or on a written instruction from the prescriber of the medicine
2	possess	an S4 or S8 medicine	the medicine is possessed for administration to the extent mentioned in this column

15Class of person

A person who is employed at a child care facility.

16Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	administer	(a)  an adrenaline (epinephrine) autoinjector	the medicine is administered to a child attending the child care facility and the person has completed anaphylaxis training
		(b)  an inhaled asthma reliever, other than an S4 medicine	the medicine is administered to a child attending the child care facility and the person has completed asthma training
2	possess	a medicine mentioned in this column	the medicine is possessed for administration to the extent mentioned in this column

17Class of person

A person who is an adult employed at a hospital whose duties include storing and distributing medical gas at the hospital.

18Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	possess	an S4 medical gas	the medicine is possessed in accordance with any procedures in place at the hospital for the possession of the medicine

19Definitions for part

In this part—

master, of a ship, means the person having command or charge of the ship.

ship see the Transport Operations (Marine Safety) Act 1994, section 10.

20Class of person

A person who is the master of a ship.

21Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	administer	any medicine	the medicine is administered— (a)  to a person on the ship who it is necessary to treat; and (b)  in accordance with the medicine’s approved label
2	give a purchase order	stock of an S4 or S8 medicine	the purchase order is given for medicines for ensuring the health or safety of persons on the ship
3	possess	stock of an S4 or S8 medicine	the stock is possessed on the ship

22Definition for division

In this division—

ship’s medicine means an S2 or S3 medicine kept on a ship under any of the following laws—

(a)the Transport Operations (Marine Safety) Act 1994;

(b)the Marine Safety (Domestic Commercial Vessel) National Law Act 2012 (Cwlth);

(c)the Navigation Act 2012 (Cwlth).

23Class of person

A person who is employed on a ship.

24Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	administer	a ship’s medicine	the medicine is administered— (a)  to a person on the ship who it is necessary to treat; and (b)  in accordance with the medicine’s approved label
2	possess	a ship’s medicine	the medicine is possessed for administration to a person on the ship

25Definition for part

In this part—

S4 inhaled analgesic means an S4 medicine analgesic that is administered by inhalation.

26Class of person

A person who is in charge of a mine.

27Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	give a purchase order	stock of an S4 inhaled analgesic	the purchase order is given for the medicines for the first aid treatment of persons at the mine
2	possess	stock of an S4 inhaled analgesic	the stock is possessed at the mine

28Class of person

A first aid provider employed at a mine who has completed training from a registered training organisation about using an S4 inhaled analgesic.

29Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	administer	(a)  an S4 inhaled analgesic that does not include methoxyflurane	the medicine is administered for the first aid treatment of a person at the mine
		(b)  an S4 inhaled analgesic that includes methoxyflurane	the medicine is administered— •  for the first aid treatment of a person at the mine; and •  in 1 dose of no greater than 3 millilitres unless the medicine is administered on a prescription
2	possess	a medicine mentioned in this column	the medicine is possessed for administration to a person at the mine

30Definition for part

In this part—

registered vaccine service provider means an entity approved by the chief executive to carry out an immunisation program.

31Class of person

A person who is—

(a)employed in the department; and

(b)approved by the chief executive to deal with vaccines for an immunisation program.

32Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	supply	stock of a vaccine	the stock is supplied to a registered vaccine service provider
2	give a purchase order	stock of a vaccine	the stock is to supply a registered vaccine service provider
3	possess	stock of a vaccine	the stock is possessed for an immunisation program

33Class of person

A person who is employed as an environmental health officer for a local government.

34Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	give a purchase order	stock of an S4 medicine that is a vaccine for human therapeutic use	the purchase order is given for medicines for an immunisation program carried out by the department, the local government or a Hospital and Health Service
2	possess	stock of an S4 medicine that is a vaccine for human therapeutic use	the stock is possessed for the immunisation program

section 13

1Class of person

A person who is permitted under a Commonwealth law to manufacture a medicine.

2Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	supply	stock of any medicine	(a)  the stock is supplied in compliance with any conditions of the person’s permission under the Commonwealth law; and (b)  the stock is supplied from a place where the person is permitted to manufacture the medicine under the Commonwealth law; and (c)  the supply is not otherwise authorised under section 50 of the Act
2	give a purchase order	stock of an S4 or S8 medicine	the purchase order is given for stock required for an activity permitted in the person’s permission under the Commonwealth law, to the extent not otherwise authorised under section 50 of the Act
3	dispose	waste from a diversion-risk medicine mentioned in this column

3Class of person

A person permitted under a corresponding law to supply a medicine by wholesale.

4Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	supply	stock of any medicine	(a)  the stock is supplied in compliance with any conditions of the entity’s permission under the corresponding law; and (b)  the person arranges the delivery of the medicine only to a someone within Queensland who is authorised, or for whom it is not unlawful, to buy the medicine; and (c)  the person does not— (i)  possess the medicine by storing it at a place in Queensland; or (ii)  arrange for the medicine to be collected from a storage facility located in Queensland; and (d)  the supply is not otherwise authorised under section 50 of the Act

5Class of person

A person permitted under a corresponding law to supply a medicine by retail.

6Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	supply by retail	stock of any medicine	(a)  the stock is supplied in compliance with any conditions of the entity’s permission under the corresponding law; and (b)  the person arranges the delivery of the medicine only to a person within Queensland who is authorised to buy the medicine; and (c)  the person does not— (i)  possess the medicine by storing it at a place in Queensland; or (ii)  arrange for the medicine to be collected from a storage facility located in Queensland; and (d)  the supply is not otherwise authorised under section 50 of the Act

7Definition for part

In this part—

authorised practitioner, for a medicine, means a health practitioner or veterinary surgeon who is authorised to prescribe the medicine or supply the medicine without a prescription from another practitioner.

8Class of person

A person (a wholesale representative) employed to display or give starter packs of medicines for—

(a)an entity, other than a pharmacist, authorised to supply a medicine by wholesale under the Act; or

(b)a person otherwise permitted under a corresponding law to supply a medicine by wholesale.

9Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	supply	stock of an S2, S3 or S4 medicine in a starter pack, other than a monitored medicine	the stock is supplied— (a)  to an authorised practitioner for the medicine; and (b)  to the extent stated in the purchase order for the medicine from the practitioner
2	possess	an S4 medicine in a starter pack, other than a monitored medicine	the medicine possessed is not more than is reasonably necessary to meet the business needs of the representative for a 6-month period

section 13

1Class of person

A person engaged to deliver a medicine from place to place.

2Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	possess	an S4 or S8 medicine	the medicine is possessed for the purposes of delivery of the medicine

3Class of person

A person assisting a health practitioner to manage stock of medicines as part of the person’s employment at a place.

4Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	possess	an S4 medicine	the medicine is possessed at the place under the direct supervision of the health practitioner

Note—

See also sections 34 and 51 of the Act excluding particular buying, possessing and administering of medicines for the treatment of animals.

5Class of person

A farmer of a group of animals who has a prescription for an S4 medicine or medicated feed to be mixed with food for administering to the animals.

6Dealing authorised

	Column 1 Dealing	Column 2 Medicine	Column 3 Scope of dealing
1	administer	an S4 medicine or medicated feed	the medicine or feed is administered to the group of animals on the prescription
2	possess	an S4 medicine or medicated feed	the medicine or feed is possessed for administering to the group of animals

sections 15, 16 and 17

1Definitions for part

In this part—

isolated site means a remote site for which limited medical and pharmaceutical services are available.

Examples—

mine sites, island resorts

senior person, at an isolated site, means a person who is responsible for daily operations at the site.

2Classes of persons and dealings

	Column 1 Class of person	Column 2 Dealing with medicine
1	a medical practitioner employed by the holder of an approval	give a purchase order for stock of medicines for an isolated site stated in the approval
2	a nurse practitioner employed by the holder of an approval	give a purchase order for stock of medicines for an isolated site stated in the approval
3	a senior person at an isolated site stated in an approval who is employed by the holder of the approval	possess stock of medicines for the isolated site
4	a registered nurse employed by the holder of an approval	(a)  possess stock of medicines for an isolated site stated in the approval
		(b)  give a treatment dose of an S2, S3 or S4 medicine stated in the approval on a prescription from a medical practitioner or nurse practitioner

3Definitions for part

In this part—

emergency medicine, in relation to a general approval (emergency first aid), means—

(a)each of the following medicines—

•adrenaline (epinephrine);

•atropine;

•benzatropine;

•ceftriaxone;

•furosemide (frusemide);

•glucagon;

•glyceryl trinitrate;

•hydrocortisone;

•ipratropium bromide monohydrate;

•lidocaine (lignocaine);

•methoxyflurane;

•metoclopramide;

•midazolam;

•morphine;

•naloxone;

•nitrous oxide;

•promethazine;

•salbutamol; or

(b)another medicine for emergencies stated in the approval.

first aid provider means a person who has a current certificate granted by a registered training organisation for the provision of first aid.

paramedic means a person registered under the Health Practitioner Regulation National Law as being qualified to practise as a paramedic.

senior person, in relation to a general approval (emergency first aid), means a person who is responsible for daily operations at a site stated in the approval.

site, in relation to an approval, means—

(a)a place at which an event, notified to the chief executive by the holder of the approval under section 35, takes place; or

(b)a place stated in the approval.

4Classes of person and dealings

	Column 1 Class of person	Column 2 Dealing with medicine
1	a medical practitioner working for the holder of an approval	give a purchase order for stock of medicines for a site for the approval
2	a nurse practitioner working for the holder of an approval	give a purchase order for stock of medicines for a site for the approval
3	a senior person at a site for an approval, working for the holder of the approval	possess stock of medicines at the site
4	a paramedic working at a site for an approval	(a)  administer an emergency medicine on an oral prescription or a standing order made under the approval
		(b)  possess an emergency medicine under the approval
		(c)  dispose of waste from an emergency medicine that is a diversion-risk medicine under the approval
5	a registered nurse working at a site for an approval	(a)  administer an emergency medicine on an oral prescription or a standing order made under the approval
		(b)  possess an emergency medicine under the approval
6	a first aid provider working at a site for an approval	(a)  administer glyceryl trinitrate on a prescription from a medical practitioner or nurse practitioner made under the approval
		(b)  possess glyceryl trinitrate under the approval

5Definitions for part

In this part—

qualified person means a person who has—

(a)completed a training course approved by the chief executive about the safe administration of medicines to animals; or

(b)skills and knowledge equivalent to the competency the person would achieve by completing the training course mentioned in paragraph (a), as stated in writing by a veterinary surgeon.

senior person, at a location stated in a general approval (emergency management of animals), means a person who is responsible for daily operations at the location.

6Classes 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

section 172

1Definitions for schedule

In this schedule—

manager, of a regulated place, means the person who is responsibile 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.

2Regulated 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

sections 178, 180 and 183

dentist

medical practitioner

nurse practitioner

endorsed midwife

pharmacist and intern pharmacist

endorsed podiatrist and podiatric surgeon

section 239

schedule 22, definition isolated practice area

Aurukun, Balonne, Banana, Barcaldine, Barcoo, Blackall-Tambo, Boulia, Bulloo, Burke, Carpentaria, Central Highlands, Charters Towers, Cloncurry, Cook, Croydon, Diamantina, Doomadgee, Douglas, Etheridge, Flinders, 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 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

section 4

Note—

See the Poisons Standard, part 1 for the definition approved name.

Aboriginal or Torres Strait Islander health service means a service for maintaining, improving, restoring or managing the health of Aboriginal people or Torres Strait Islanders provided by—

(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 maintained under the Therapeutic Goods Act 1989 (Cwlth).

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.

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 place at which a pharmacy business under the Pharmacy Business Ownership Act 2001 operates.

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 registered medicine 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).

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 established under the Youth Justice Act 1992, section 262.

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 16.

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.

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, part 1 for the definition primary pack.

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

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, in relation to a relevant institution, means a person detained or living at the institution.

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.

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 medicine means a medicine included in a product on the Australian Register of Therapeutic Goods maintained under the Therapeutic Goods Act 1989 (Cwlth).

registered nurse see schedule 7, section 10.

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

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 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).

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.

section 263

1Schedule 2, section 8, note—

omit, insert—

Note—

The Medicines and Poisons Act 2019 regulates the administration of particular medicines.

1Section 3A(3), definition Australian COVID-19 vaccination arrangements—

omit, insert—

Australian COVID-19 vaccination arrangements means the arrangements made—

(a)to provide COVID-19 vaccines for vaccinating members of the public; and

(b)under the document called ‘Australian COVID-19 Vaccination Policy’, published by the Australian Government.

1Schedule 19, part 2, definition pharmaceutical product, from ‘a restricted drug’—

omit, insert—

an S4 medicine under the Medicines and Poisons Act 2019.

1Schedule 3, ‘Health Act 1937’—

omit.

2Schedule 3—

insert—

Medicines and Poisons Act 2019

1Schedule 1, entry for the Health Act 1937—

omit.

2Schedule 1, before the entry for the Planning Act—

insert—

•the Medicines and Poisons Act 2019

1Section 27—

omit, insert—

27Prescribed drugs and poisons—Act, s 25

For section 25 of the Act, definition disqualifying offence, paragraph (e), the following drugs and poisons are prescribed—

(a)a substance that is a medicine, poison or prohibited substance under the Medicines and Poisons Act 2019; or

(b)a substance that was a controlled drug, restricted drug or poison under the repealed Health (Drugs and Poisons) Regulation 1996.

1Schedule 9, definition pharmaceutical product—

omit, insert—

pharmaceutical product means an S4 medicine under the Medicines and Poisons Act 2019.