Health (Drugs and Poisons) Regulation 1996 (QLD)

Health (Drugs and Poisons) Regulation 1996

Chapter 1    Introduction

Part 1    Preliminary

1   Short title

This regulation may be cited as the Health (Drugs and Poisons) Regulation 1996.

Part 2    Interpretation

3   Dictionary

(1)The dictionary in appendix 9 of this regulation defines particular words used in this regulation.

(2)Definitions found elsewhere in this regulation are signposted in the dictionary.

4   Meaning of manufacture

(1)Manufacture, of a controlled drug, restricted drug or a poison, means—

(a)perform a process to produce the drug or poison; or

Example—

mix 2 substances that are not a controlled drug, restricted drug or a poison to produce a controlled drug, restricted drug or a poison

(b)refine the drug or poison; or

(c)convert the drug or poison into another controlled or restricted drug or another poison; or

(d)make or prepare an ampoule, capsule, tablet, vial or other similar article that is or contains the drug or poison; or

(e)mix or compound the drug or poison with another controlled or restricted drug, poison or substance; or

(f)pack or repack the drug or poison.

(2)However, manufacture of a controlled or restricted drug or a poison does not include an act mentioned in subsection (1)(d), (e) or (f) done by a dispenser in relation to or for dispensing the drug or poison.

(3)In addition, manufacture, of a poison, does not include an act mentioned in subsection (1)(e) done—

(a)by a primary producer for use only by the person on the person’s property, other than the act of self-administering the poison or administering the poison to another person; or

(b)by a pest management technician under a licence under the Pest Management Act 2001.

(4)Also, a registered nurse, indigenous health worker or Aboriginal and Torres Strait Islander health practitioner does not manufacture a controlled or restricted drug or a poison only by packing or repacking it under a certified written policy, about packing or repacking controlled or restricted drugs or poisons, published by the department.

4A   Quality standards for dispensing certain drugs and selling certain poisons

(1)A quality standard, for dispensing controlled drugs, dispensing restricted drugs or selling S2 or S3 poisons (each an activity), is a document that states, for the activity—

(a)the standard for carrying out the activity; and

(b)how the standard is met.

(2)A pharmacist may, for an activity—

(a)prepare a quality standard; or

(b)adopt a quality standard prepared by another entity.

(3)If the Pharmacy Board of Australia recognises a quality standard (a PBA standard) for an activity, the quality standard prepared or adopted by a pharmacist, for the activity, must be at least equivalent to the PBA standard for the activity.

(4)A quality standard must be consistent with the following principles—

(a)in selecting a way to manage a person’s condition, a pharmacist should consider appropriate options, including, for example, medicinal and non-medicinal options;

(b)for a medicinal option, the pharmacist should choose the medicine the pharmacist considers is the most appropriate having regard to relevant matters, including, for example, potential risks and benefits of using the medicine;

(c)a medicine should be used in a way that—

(i)maximises the efficacy of the medicine; and

(ii)minimises misuse of the medicine.

(5)In this section—

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

5   Meaning of S2 to S9

(1)The expression S2, S3, S4, S5, S6, S7, S8 or S9, if followed by a controlled drug, restricted drug or a poison, means the drug or poison in the schedule to the current Poisons Standard with the number given in the expression.

(2)The expression S2, S3, S4, S5, S6, S7, S8 or S9, if followed by ‘poison’ or ‘substance’ without naming a poison or substance, means any poison in the schedule to the current Poisons Standard with the number given in the expression.

5A   Meaning of supervision and personal supervision

(1)Supervision, by a person of another person, includes supervision using any technology that allows reasonably contemporaneous and continuous communication between the persons.

(2)Personal supervision, by a person (the supervisor) of another person, includes supervision using any technology that allows reasonably contemporaneous and continuous communication between the persons, and allows reasonably contemporaneous and continuous observation by the supervisor of actions taken by the other person.

Example—

videoconferencing

6   Meaning of transaction

Transaction means an event by which—

(a)a controlled drug, restricted drug or a poison comes into or goes out of a person’s possession; or

(b)the composition, form or strength of, or way of packing, a controlled or restricted drug or a poison is changed.

Examples of transactions—

•obtaining and keeping samples of chemical starting materials used in manufacturing a controlled or restricted drug or a poison

•obtaining and keeping samples of finished products of a manufactured controlled or restricted drug or a poison

•manufacturing, packing and repacking a controlled or restricted drug or a poison

•moving a controlled or restricted drug or a poison from one place to another (with or without a change of ownership)

7   Application of interpretation provisions in current Poisons Standard to regulation

(1)A word used in this regulation that is defined in the current Poisons Standard has the same meaning in this regulation as it does in the current Poisons Standard.

(2)An interpretation provision in the current Poisons Standard applies in the interpretation of this regulation.

(3)However, subsection (1) does not apply to the definition poison in the current Poisons Standard because, as defined in the current Poisons Standard, poison includes all substances to which this regulation applies, whether the substance is a controlled drug, restricted drug or poison under this regulation.

(4)Despite the fact that the definition poison in this regulation does not have the same meaning as it has in the current Poisons Standard, the interpretation provisions in the current Poisons Standard that apply to the definition poison apply to controlled drugs, restricted drugs and poisons as defined in this regulation.

Example of subsection (4)—

Paragraph 1(2) of the current Poisons Standard states that, unless a contrary intention appears, a reference to a poison in a schedule includes a number of other things, including, for example, every salt, active principle or derivative of the poison and every salt of such an active principle or derivative.

Also, paragraph 1(2)(h) and (i) of the current Poisons Standard provides that a reference in a schedule to a poison does not include certain poisons, including, for example, a poison in a product in appendix A of the current Poisons Standard.

8   References to entering details, signing or dating entries etc.

(1)This section applies if a person is required to—

(a)enter details in a document, including writing a prescription; or

(b)sign or date an entry; or

(c)otherwise write on a document.

(2)The person must write—

(a)in ink; and

(b)in a way that the entry or other matter is legible, except the person’s signature.

Maximum penalty—20 penalty units.

(3)This section does not apply to a person when the person uses a computer to keep records or make an electronic prescription.

Part 3    Application of regulation to certain substances

9   Provisions not applied to morphine or opium in certain preparations

The provisions mentioned in appendix 1 of this regulation do not apply to—

(a)morphine in a compounded preparation containing 0.1% or less of morphine calculated as anhydrous morphine; or

(b)opium in a compounded preparation containing 0.1% or less of morphine calculated as anhydrous morphine.

9A   Classification of new drugs and poisons

(1)This section applies to a drug or poison for human or animal therapeutic use (a new drug or poison) if—

(a)the drug or poison becomes available for sale in the State before a decision is made about whether it is to be included in a schedule to the current Poisons Standard; and

(b)the chief executive reasonably believes it will be listed in schedule 4 or schedule 8 of the current Poisons Standard.

(2)The new drug or poison is taken to be a restricted drug until—

(a)the new drug or poison is included in a schedule to the current Poisons Standard; or

(b)the Secretary to the Department in which the Therapeutic Goods Act 1989 (Cwlth) is administered, or the Secretary’s delegate, decides the new drug or poison is not to be included in a schedule.

9B   Reclassifications of poisons

(1)This section applies to a poison if—

(a)any of the following about the poison is varied—

(i)the method of manufacture;

(ii)the composition;

(iii)the dosage;

(iv)how the poison may be administered;

(v)the purposes for which the poison may be used; and

(b)a decision has not been made since the variation about in which schedule to the current Poisons Standard the poison is to be included.

(2)The poison is taken to be a restricted drug until a decision is made about in which schedule to the current Poisons Standard the poison is to be included and the poison is included in the schedule.

Part 4    Packing and labelling

10   Packaging of controlled or restricted drugs or poisons

(1)A person must not sell a controlled drug, restricted drug or a poison, unless the way it is packed complies with part 2 of the current Poisons Standard.

Maximum penalty—20 penalty units.

(2)However, subsection (1) does not apply to a person if the controlled or restricted drug or poison is packed in a way certified under this section.

(3)The chief executive may certify a container for packing a controlled or restricted drug or a poison only if—

(a)it does not comply with the current Poisons Standard because—

(i)it is uncoloured; or

(ii)its shape or dimensions differ from a shape or dimension permitted under the current Poisons Standard; or

(iii)it is designed for a particular purpose; and

(b)the chief executive is reasonably satisfied using the container as a package for a controlled or restricted drug or a poison is as safe as using a container permitted under the current Poisons Standard.

11   Labelling of controlled or restricted drugs or poisons—Act, ss 131I and 132(n)

(1)For section 131I of the Act, a package containing a controlled drug, a restricted drug or a poison must bear a label that complies with the current Poisons Standard, part 2.

(2)For section 132(n) of the Act, a package is exempt from section 131I of the Actif the package is labelled in an alternative way certified for the package under subsection (3).

Note—

See also the current Poisons Standard, section 1.5 for other labelling exemptions.

(3)The chief executive may certify an alternative way of labelling a package if—

(a)the package is for containing a controlled drug, a restricted drug, or an S2 or S3 poison; and

(b)either—

(i)an appropriate authority, for a purpose or in another State, has authorised (whether by approval, exemption or some other way) the package to be labelled in the alternative way for the purpose or other State; or

Note—

For the definition appropriate authority, see the current Poisons Standard, part 1.

(ii)the chief executive is satisfied the alternative way is unlikely to adversely affect public safety, having regard to the nature of the drug or poison and the purpose for which it is to be used.

(4)The chief executive must publish, on the department’s website—

(a)the alternative way certified under subsection (3); and

(b)the day the certification takes effect; and

(c)the period, if any, for which the certification has effect.

12   Certain containers not to be used

(1)A person must not sell any of the following in a container of a kind mentioned in paragraph 21, 21a, 22 or 23 of the current Poisons Standard or a container that is a certified container under section 10(3) of this regulation—

(a)a drug for internal human use;

(b)a medicine for internal human use;

(c)a poison for internal human use;

(d)food;

(e)a drink;

(f)a condiment.

Maximum penalty—60 penalty units.

Note—

See paragraphs 21 and 22 (Containers for poisons other than Schedule 5 poisons) and paragraph 23 (Containers for Schedule 5 poisons) of the current Poisons Standard.

(2)A person must not use an immediate container permanently marked with the name of a controlled or restricted drug or a poison as a container for a different drug or poison.

Maximum penalty—60 penalty units.

Note—

Part 1 of the current Poisons Standard—
Immediate container includes all forms of containers in which a poison is directly packed but does not include any such container intended for consumption or any immediate wrapper.

13   Camphor and naphthalene

A person must not sell camphor or naphthalene in ball, block, disc or pellet form for domestic use, unless it is in a device that, in normal use, prevents removal or ingestion of the camphor or naphthalene.

Maximum penalty—60 penalty units.

Part 5    Endorsements

Division 1 Preliminary

14   [Repealed]

15   Suitability of person to hold endorsement

(1)In deciding whether a person is a suitable person to hold, or to continue to hold, an endorsement the chief executive may have regard to, and may make inquiries about, the following—

(a)the person’s knowledge and understanding of the person’s obligations under this regulation;

(b)the person’s qualifications and experience;

(c)the person’s character and standing;

(d)any previous convictions the person has under the Act or this regulation;

Example for paragraph (d)—

The chief executive’s inquiries about an applicant’s suitability may include asking the commissioner of the police service for a written report about the applicant’s criminal history.

(e)whether the person engages, or has engaged, in conduct that risks, or is likely to risk, a controlled drug, a restricted drug or a poison being used for a purpose that is unlawful under a law of a State or the Commonwealth.

(2)Subsection (1) does not limit the matter to which the chief executive may have regard in considering the suitability of the person to hold an endorsement.

(3)In this section—

this regulation includes the Poisons Regulation 1973.

16   Inquiries about person’s criminal history

(1)If asked by the chief executive, the commissioner of the police service must give the chief executive a written report about the criminal history of a person who has applied for, or holds, an endorsement.

(2)Subsection (1) applies to the criminal history in the commissioner’s possession or to which the commissioner has access.

Division 2 Applications for endorsements

17   Approved form and fee

(1)A relevant application must be—

(a)in the approved form, if any; and

(b)accompanied by any fee for the relevant application prescribed in appendix 2.

(2)In this section—

relevant application means—

(a)an application for, or renewal of, an endorsement; or

(b)an application for an amendment of, or the repeal of a decision to suspend or cancel, an endorsement.

18   How chief executive may deal with applications

(1)The chief executive must consider an application for an endorsement and either—

(a)grant the endorsement, with or without conditions; or

(b)refuse to grant the endorsement.

(2)Also, the chief executive must consider an application for the renewal of a drug licence, poison licence, treatment approval or wholesale representative licence and either—

(a)renew the licence or approval, with or without conditions; or

(b)refuse to renew the licence or approval.

(3)If the chief executive decides to grant the endorsement or renew an endorsement that is a drug licence, poison licence, treatment approval or wholesale representative licence, the chief executive must promptly give the applicant the relevant endorsement.

(4)If the chief executive decides to state a condition on the endorsement, the chief executive must also give the applicant—

(a)if the endorsement is an endorsement other than a treatment approval, a QCAT information notice about the decision to state the condition on the endorsement; or

(b)if the endorsement is a treatment approval, a notice stating the following—

(i)the decision;

(ii)that the applicant may apply to the chief executive for a statement of reasons for the decision under the QCAT Act, section 158, within the period stated in that provision;

(iii)the person has a right to have the decision reviewed by QCAT;

(iv)how, and the period within which, the person may apply for the review;

(v)the right the person has to have the operation of the decision stayed under the QCAT Act, section 22.

(5)However, if the treatment approval is subject to a condition relating to the treatment of a drug dependent person to ensure the treatment under the approval continues to be for the welfare of the person, including, for example, 1 or more of the following conditions, the applicant may not apply for review of the imposition of the condition—

(a)the way in which the controlled or restricted drug is to be dispensed or prescribed for, or administered or supplied to or for, the drug dependent person;

(b)the applicant must, at stated times, examine the drug dependent person or conduct tests in relation to the drug dependent person—

(i)to ensure the controlled or restricted drug is being used in the way the applicant has directed; or

(ii)for the use or presence of other drugs or poisons.

(6)If the chief executive decides not to grant the endorsement or renew the drug licence, poison licence, treatment approval or wholesale representative licence, the chief executive must promptly give the applicant a QCAT information notice about the decision.

19   Renewal of drug licence, poison licence, treatment approval or wholesale representative licence before expiry

(1)The chief executive may renew a drug licence, poison licence, treatment approval or wholesale representative licence on application made to the chief executive before the licence or approval expires (the expiry day).

(2)However, the chief executive must not renew a general poison licence if, on the expiry day, there is a pharmacy within 25km by road of the licensee’s business premises.

(3)Despite subsection (2), if, during the term of a general poison licence, a pharmacy opens within 25km by road of the licensee’s business premises, the chief executive may renew the licence for up to 6 months to allow the licensee to sell stock on hand.

(4)No fee is payable for a renewal under subsection (3).

20   Renewal of drug licence, poison licence, treatment approval or wholesale representative licence after expiry

(1)This section applies if—

(a)not less than 14 days before the expiry day, the holder of a drug licence, poison licence, treatment approval or wholesale representative licence applies for a renewal of the licence or approval; and

(b)the chief executive has not, before the expiry day, made a decision whether to renew the licence or approval.

(2)The licence or approval continues until the day the applicant receives notice of the decision.

(3)If the chief executive decides to renew the licence or approval, the renewed licence or approval is taken to have been renewed on the expiry day.

Division 2A Applications for operating approvals

20A   Purpose of division

This division states the requirements, in addition to the requirements in division 2, that apply to an application for an operating approval.

20B   Who may apply for an operating approval

A person may apply for an operating approval only if the person is a pharmacist who is authorised, under section 64(1)(f), to administer or supply a controlled drug, under the pharmacist opioid DTP, on the instruction of a doctor.

20C   Additional requirements for applications for operating approvals

(1)A person who applies for an operating approval must publish a notice about the application in a newspaper circulating generally in the area in which it is proposed to operate a controlled drugs administration facility.

(2)The notice must—

(a)invite members of the local community to make written submissions to the applicant about the establishment and operation of the facility; and

(b)state a period of at least 28 days after the notice is published in which submissions under paragraph (a) must be made.

(3)An application for an operating approval must include—

(a)a copy of the notice published under subsection (1); and

(b)copies of any submissions made to the applicant by members of the local community, in response to the notice; and

(c)a statement made by the applicant about the views of members of the local community in relation to the likely impact of the facility on the amenity of the community.

20D   Chief executive may require further information or documents

(1)If the chief executive considers further information or a document is required for deciding an application for an operating approval, the chief executive may—

(a)by written notice given to the applicant, require the applicant to give the information or document to the chief executive within a reasonable period, of at least 21 days, stated in the notice; or

(b)ask another person to give the information or document to the chief executive.

(2)Despite subsection (1)(a), the chief executive and the applicant may, within the period stated in the notice, agree to extend the period for complying with a requirement in the notice to a day (the agreed compliance day) after the end of the period stated in the notice.

(3)If the applicant is given a notice under subsection (1)(a) and does not comply with a requirement under the notice within the period stated in the notice, or if applicable by the agreed compliance day, the applicant is taken to have withdrawn the application.

20E   Deciding applications for operating approvals

(1)The chief executive must not grant an operating approval for a controlled drugs administration facility proposed for an area unless the chief executive is satisfied it is appropriate for the facility to be in the area.

(2)In deciding whether it is appropriate, the chief executive may only consider—

(a)the need for the facility in the area, taking into account the type and availability of health services in and near the area; and

(b)the likely impact of the facility on the amenity of the local community, taking into account the views of members of the community.

20F   Time for deciding applications for operating approvals

(1)The chief executive must decide an application for an operating approval within 30 days after the application is made (the decision period).

(2)However, if the chief executive has given the applicant a notice under section 20D(1)(a), the chief executive may extend the time for deciding the application—

(a)for up to 30 days after the chief executive receives the information or document required under the notice (the extended decision period); or

(b)if the chief executive and the applicant agree—for a reasonable period after the period mentioned in paragraph (a) (the agreed extended decision period).

(3)Also, if the chief executive has asked a person for information or a document under section 20D(1)(b), the chief executive may extend the time for deciding the application—

(a)for up to 60 days after the chief executive receives the application (also the extended decision period); or

(b)if the chief executive and the applicant agree—for a reasonable period after the period mentioned in paragraph (a) (also the agreed extended decision period).

(4)The chief executive must give the applicant a written notice about the extended decision period, or the agreed extended decision period, for a decision.

(5)If the chief executive fails to decide the application within the decision period, or if applicable, the latest extended decision period or agreed extended decision period, the failure is taken to be a decision by the chief executive to refuse to grant the operating approval.

Division 3 Other provisions about endorsements

21   Holder of endorsement must comply with conditions

The holder of an endorsement must not contravene a condition of the endorsement.

Maximum penalty—80 penalty units.

22   Term of drug licence, poison licence or wholesale representative licence

A drug licence, poison licence or wholesale representative licence has effect for 1 year from the day stated in the licence.

Division 4 Suspension or cancellation of endorsement

23   Grounds for suspension or cancellation of endorsement

Each of the following is a ground for the suspension or cancellation of an endorsement—

(a)the endorsement has been obtained on the basis of incorrect or misleading information;

(b)the holder of the endorsement is not a suitable person to hold the endorsement;

(c)if the endorsement is granted by the chief executive and states premises for the conduct of business under the endorsement—the premises are unfit for use under the endorsement;

(d)the holder of the endorsement has breached a condition stated in the endorsement;

(e)the holder of the endorsement has contravened a provision of this regulation;

(f)if the endorsement is an operating approval—the authority of the holder of the endorsement under section 64(1)(f) is suspended, cancelled or otherwise ceases.

24   Procedure for suspension or cancellation of endorsement

(1)If the chief executive considers there is a ground to suspend or cancel an endorsement (the proposed action), the chief executive may give the holder of the endorsement (the endorsement holder) a written notice that—

(a)states the proposed action; and

(b)states the grounds for the proposed action; and

(c)outlines the facts and circumstances forming the basis for the grounds; and

(d)if the proposed action is suspension of the endorsement—states the proposed suspension period; and

(e)invites the endorsement holder to show, in writing and within a stated time of at least 28 days, why the proposed action should not be taken.

(2)The notice must state whether the proposed action relates to—

(a)all controlled drugs, restricted drugs, poisons or activities permitted under the endorsement; or

(b)a stated controlled drug, restricted drug or poison or a stated activity permitted under the endorsement.

(3)If, after considering all written representations made within the stated time, the chief executive still considers there is a ground to take the proposed action, the chief executive may—

(a)if the proposed action was to suspend the endorsement for all controlled drugs, restricted drugs, poisons or activities permitted under the endorsement for a stated period—suspend the endorsement, for not longer than the proposed suspension period, for—

(i)all controlled drugs, restricted drugs, poisons or activities permitted under the endorsement; or

(ii)a stated controlled drug, restricted drug or poison or a stated activity; or

(b)if the proposed action was to suspend the endorsement for a stated controlled drug, restricted drug or poison or a stated activity for a stated period—suspend the endorsement for the controlled drug, restricted drug, poison or activity for not longer than the proposed suspension period; or

(c)if the proposed action was to cancel the endorsement—

(i)for a stated controlled drug, restricted drug or poison or a stated activity—either cancel the endorsement, or suspend it for a stated period, for the controlled drug, restricted drug, poison or activity; or

(ii)if subparagraph (i) does not apply—either cancel the endorsement or suspend it for a stated period.

(4)Within 10 days after the chief executive makes the decision, the chief executive must give written notice of the decision to the endorsement holder.

(5)If the chief executive decides to suspend or cancel the endorsement, the notice must—

(a)be a QCAT information notice for the decision; and

(b)state the day before which the endorsement holder is not permitted to apply to the chief executive under section 26A.

(5A)The day mentioned in subsection (5)(b) must be a day the chief executive believes is reasonable having regard to the grounds for the suspension or cancellation.

(6)The decision takes effect on the later of—

(a)the day the notice is given to the endorsement holder; or

(b)the day of effect stated in the notice.

(7)However, if the endorsement is suspended or cancelled because of a conviction—

(a)the suspension or cancellation does not take effect until—

(i)the end of the time to appeal against the conviction; or

(ii)if an appeal is made against the conviction—the appeal is finally decided; and

(b)the suspension or cancellation has no effect if the conviction is quashed.

25   Urgent suspension or cancellation of endorsement

(1)This section applies if the chief executive is reasonably satisfied—

(a)urgent action about a particular endorsement is necessary in the circumstances; and

(b)undue delay in suspending or cancelling the endorsement may cause harm to the public.

(2)The chief executive may suspend or cancel the endorsement even though the chief executive has not given notice to the endorsement holder under section 30.

(3)However, the chief executive must immediately give written notice of the decision to the endorsement holder.

(4)The notice must—

(a)be a QCAT information notice for the decision; and

(b)state the day before which the endorsement holder is not permitted to apply to the chief executive under section 26A.

(4A)The day mentioned in subsection (4)(b) must be a day the chief executive believes is reasonable having regard to the grounds for the suspension or cancellation.

(5)The notice must also state whether the urgent suspension or cancellation relates to—

(a)all controlled drugs, restricted drugs, poisons, business premises or activities permitted under the endorsement; or

(b)a stated controlled drug, restricted drug or poison, stated business premises or a stated activity permitted under the endorsement.

(6)The decision takes effect on the later of—

(a)the day the notice is given to the endorsement holder; or

(b)the day of effect stated in the notice.

25A   Urgent cancellation of certain approvals

(1)This section applies to each of the following approvals (a specified approval)—

(a)an approval mentioned in section 78(1)(a) for the treatment of a person by a doctor;

(b)an approval under section 122, other than an approval for the treatment of a class of drug dependent persons;

(c)an approval under section 213, other than an approval for the treatment of a class of drug dependent persons.

(2)The chief executive may cancel a specified approval if the chief executive is reasonably satisfied—

(a)the holder of the specified approval (the former approval holder) has ceased to treat the person to whom the approval relates; and

(b)it is reasonably necessary, for the welfare of the person, for the chief executive to urgently give a specified approval to a doctor other than the former approval holder.

(3)The chief executive must immediately give written notice of the decision to the former approval holder.

(4)The notice must be a QCAT information notice for the decision.

(5)The decision takes effect on the later of—

(a)the day the notice is given to the former approval holder; or

(b)the day of effect stated in the notice.

(6)For subsection (2)(a), the chief executive may be reasonably satisfied a former approval holder has ceased to treat a person regardless of—

(a)the reason the treatment ceased; or

(b)when the former approval holder last treated the person.

26   Return of endorsement

(1)The holder of a suspended endorsement, or the former holder of a cancelled endorsement, must return the endorsement to the chief executive within 14 days after the suspension or cancellation takes effect, unless the person has a reasonable excuse for not returning it within the 14 days.

Maximum penalty—20 penalty units.

(2)If a suspended endorsement is returned to the chief executive, the chief executive must return it to the endorsement holder at the end of the suspension period.

26A   Application for amendment or repeal of decision to suspend or cancel endorsement

(1)The holder of an endorsement that is suspended or cancelled may apply to the chief executive in writing for an amendment or repeal of the decision to suspend or cancel the endorsement.

(2)This part applies to an application made under subsection (1) in the same way as it would if it were an application for an endorsement.

Division 5 Replacement, amendment, return and surrender of endorsements

27   Replacement of endorsement

(1)The holder of an endorsement may apply to the chief executive for the replacement of a lost, stolen or destroyed endorsement.

(2)If the chief executive is reasonably satisfied the endorsement has been lost, stolen or destroyed, the chief executive must replace the endorsement.

(3)If the chief executive is not satisfied the endorsement has been lost, stolen or destroyed, the chief executive must—

(a)refuse to replace the endorsement; and

(b)give the applicant a QCAT information notice about the decision to refuse to replace the endorsement.

28   Amendment of endorsement on application

(1)The holder of an endorsement may apply to the chief executive for an amendment of the endorsement.

(2)The chief executive must decide the application by—

(a)amending the endorsement in the way sought; or

(b)refusing to amend the endorsement.

(3)The chief executive may amend the endorsement only if the chief executive is reasonably satisfied the amendment is necessary or desirable in the interests of the effective administration of this regulation.

(4)If the chief executive refuses to amend the endorsement, the chief executive must give the applicant a QCAT information notice about the decision to refuse to amend the endorsement.

29   Amendment of endorsement without application

(1)The chief executive may amend an endorsement if—

(a)the holder of the endorsement agrees to the amendment; or

(b)the chief executive is reasonably satisfied the endorsement should be amended.

(2)If the chief executive is reasonably satisfied the endorsement should be amended, the chief executive must give the endorsement holder a written notice that—

(a)states the proposed amendment and the reasons for the amendment; and

(b)outlines the facts and circumstances that form the basis for the reasons; and

(c)invites the endorsement holder to make written representations to the chief executive, within a stated time of at least 28 days, to show why the endorsement should not be amended.

(3)If, after considering the representations properly made by the endorsement holder, the chief executive is still reasonably satisfied the endorsement should be amended in the way mentioned in the notice, or in another way having regard to the representations, the chief executive must give the endorsement holder—

(a)a new endorsement; and

(b)a written notice that states—

(i)the old endorsement has been cancelled; and

(ii)the way in which the new endorsement is different from the old endorsement; and

(iii)the reasons for the amendment; and

(iv)the endorsement holder has a right to have the decision reviewed by QCAT; and

(v)how, and the period within which, the person may apply for the review; and

(vi)the right the endorsement holder has to have the operation of the decision stayed under the QCAT Act, section 22.

30   Minor amendment of endorsement

(1)This section applies if—

(a)the chief executive is reasonably satisfied an endorsement should be amended; and

(b)the proposed amendment does not adversely affect the endorsement holder’s interests, including, for example—

(i)by omitting a condition; or

(ii)by correcting an error; or

(iii)by making another change, other than a change of substance.

(2)The chief executive may amend the endorsement by written notice given to the endorsement holder.

(3)The notice must state the reasons for the decision.

(4)Section 29(2) and (3) do not apply to the amendment.

31   Date amendment of endorsement takes effect

A decision to amend an endorsement under section 28, 29 or 30 takes effect on the later of—

(a)the day the notice of the amendment is given to the endorsement holder; or

(b)the day of effect stated in the notice.

32   Surrender of endorsement

(1)The holder of an endorsement may surrender the endorsement by written notice given to the chief executive.

(2)The endorsement holder must return the endorsement with the notice, unless the endorsement holder has a reasonable excuse.

Maximum penalty—20 penalty units.

(3)The surrender takes effect on the day the notice is given.

(4)Subsection (2) does not apply to an endorsement holder if the endorsement is an authority.

Part 6    External review

33   Decisions that may be reviewed

(1)An applicant for an endorsement may apply, as provided under the QCAT Act, to QCAT for review of the chief executive’s decision to refuse to grant the endorsement or to grant an endorsement subject to conditions.

(2)An endorsement holder may apply, as provided under the QCAT Act, to QCAT for review of the following decisions of the chief executive—

(a)a decision to refuse to renew a drug licence, poison licence, treatment approval or wholesale representative licence;

(b)a decision to renew a drug licence, poison licence, treatment approval or wholesale representative licence on new conditions;

(c)a decision to suspend or cancel an endorsement;

(d)a decision to refuse to amend an endorsement;

(e)a decision to amend an endorsement without application, including a decision to make a minor amendment.

34   [Repealed]

35   [Repealed]

36   [Repealed]

37   [Repealed]

38   [Repealed]

39   [Repealed]

Chapter 2    Controlled drugs

Part 1    Licences

Division 1 Preliminary

40   Application of pt 1

This part applies to the following types of licences—

(a)controlled drug manufacturer licences;

(b)controlled drug wholesaler licences.

41   Licence to state business premises and other particulars

(1)A licence under this chapter applies only to the place stated in the licence as the licensee’s business premises.

(2)The chief executive must not state more than 1 place in the licence as the licensee’s business premises.

(3)For a controlled drug manufacturer licence, the chief executive must also state in the licence—

(a)the controlled drug or drugs the licensee may manufacture under the licence at the premises; and

(b)the title of the position that has responsibility for supervising the manufacture of the controlled drug or drugs at the premises.

(4)For a controlled drug wholesaler licence, the chief executive may state in the licence the controlled drug or drugs the licensee is authorised to sell under the licence.

Division 2 Controlled drug manufacturer licence

42   Restrictions on grant of controlled drug manufacturer licence

The chief executive may grant a controlled drug manufacturer licence to a person only if the chief executive is reasonably satisfied—

(a)the person—

(i)intends to carry on business as a controlled drug manufacturer; and

(ii)is a suitable person to manufacture and sell controlled drugs; and

(b)an individual who holds the position responsible for supervising the manufacture of the controlled drug or drugs has the qualifications and experience necessary to effectively supervise the manufacture; and

(c)the premises to be used for manufacturing the controlled drug or drugs are suitable for the purpose.

43   Controlled drug manufacturer licence

A controlled drug manufacturer—

(a)may manufacture only the controlled drugs stated in the manufacturer’s licence; and

(b)is taken to hold the following licences—

(i)a controlled drug wholesaler licence;

(ii)a restricted drug wholesaler licence;

(iii)a poison wholesaler licence.

44   General conditions that apply to controlled drug manufacturer licence

A controlled drug manufacturer—

(a)must not manufacture, have, keep or sell a controlled drug at a place other than the manufacturer’s business premises; and

(b)must ensure each controlled drug manufactured under the manufacturer’s licence is manufactured under the personal supervision of the individual who holds the position named in the licence; and

(c)must ensure a controlled drug at the manufacturer’s business premises is not handled by a person other than the manufacturer or a competent adult employee of the manufacturer.

Maximum penalty—80 penalty units.

45   Offence to manufacture controlled drugs without licence

A person must not manufacture a controlled drug unless the person—

(a)holds a controlled drug manufacturer licence for the drug; or

(b)is a State analyst, or a trainee State analyst under the supervision of a State analyst, who manufactures the controlled drug for the analyst’s, or trainee’s, official duties; or

(c)holds an endorsement under section 18(1) to manufacture the controlled drug.

Maximum penalty—80 penalty units.

Division 3 Controlled drug wholesaler licence

46   Restrictions on grant of controlled drug wholesaler licence

The chief executive may grant a controlled drug wholesaler licence to a person only if the chief executive is reasonably satisfied—

(a)the person intends to carry on business as a controlled drug wholesaler; and

(b)the person is a suitable person to sell controlled drugs; and

(c)the premises to be used for wholesaling the controlled drugs are suitable for the purpose.

47   Controlled drug wholesaler licence

(1)A controlled drug wholesaler may sell a controlled drug (whether or not for resale) to—

(a)an authorised person; or

(b)someone in another State who may obtain the drug under the law of the other State.

(2)Also, a controlled drug wholesaler may sell a controlled drug by wholesale to a person in another country who may lawfully obtain the drug in the other country.

(3)Subsection (2) does not apply to a controlled drug that is a prohibited export under the Customs Act 1901 (Cwlth).

48   General conditions that apply to controlled drug wholesaler licence

(1)A controlled drug wholesaler—

(a)must not have, keep or sell a controlled drug at a place other than the wholesaler’s business premises; and

(b)must ensure a controlled drug at the wholesaler’s business premises is not handled by a person other than the wholesaler or a competent adult employee of the wholesaler; and

(c)must not sell a controlled drug to anyone other than someone to whom the wholesaler may sell the drug under this regulation.

Maximum penalty—80 penalty units.

(2)Subject to subsection (3), a controlled drug wholesaler must, in carrying on business under the wholesaler’s licence, comply with the wholesaling practice code.

Maximum penalty—80 penalty units.

Editor’s note—

The code is available from the Therapeutic Goods Administration’s website.

(3)Subsection (2) does not apply to a controlled drug wholesaler to the extent the wholesaler carries on business under the wholesaler’s licence in a way that does not require the wholesaler to store, handle or transport a controlled drug.

49   Offence to wholesale controlled drugs without licence

A person must not sell a controlled drug by wholesale unless the person holds a controlled drug manufacturer licence or controlled drug wholesaler licence for the drug.

Maximum penalty—80 penalty units.

Division 4 General

49A   Licensee to give invoice when selling controlled drug

(1)A licensee must, when selling a controlled drug to a person, give the person an invoice for the sale of the drug.

Maximum penalty—40 penalty units.

(2)The licensee must ensure the invoice—

(a)has a unique number; and

(b)states—

(i)the date of the sale; and

(ii)the name and address of the person to whom the controlled drug is sold; and

(c)describes the controlled drug and the quantity or volume of the drug sold.

Maximum penalty—40 penalty units.

50   Records of transactions to be kept by licensee

(1)A licensee must keep a record of controlled drugs (a controlled drugs register)—

(a)as written entries in a book; or

(b)in an electronic form; or

(c)in another certified way.

Maximum penalty—40 penalty units.

(2)If the controlled drugs register is a book, the licensee must ensure each page of the register—

(a)has a general heading describing the class and measurement unit of the controlled drug recorded on the page; and

(b)is ruled into columns with headings describing the nature of the details to be recorded in each column.

Maximum penalty—40 penalty units.

(2A)If the controlled drugs register is in an electronic form, the licensee must ensure the entries in the register are stored in a computer system that has enough capacity and backup capability for the purpose.

Maximum penalty—40 penalty units.

(3)The licensee must—

(a)use a separate page, or a separate part of the drugs register, for each class of controlled drug; and

(b)enter in the register the following details of each transaction for a controlled drug—

(i)the date of the transaction;

(ii)the name and address of the person who sold the controlled drug to the licensee;

(iii)the name and address of the person to whom the controlled drug was sold;

(iv)the invoice or other number of the transaction;

(v)the quantity or volume of the controlled drug obtained or sold;

(vi)the quantity or volume of the controlled drug in stock after the transaction; and

(c)ensure each transaction is recorded in the order in which it happens.

Maximum penalty—40 penalty units.

(4)A licensee must not make entries about a restricted drug or a poison in the controlled drugs register.

Maximum penalty—40 penalty units.

(5)The licensee must keep the controlled drugs register at the licensee’s business premises.

Maximum penalty—40 penalty units.

(6)If the licensee has more than 1 licence and the licensee’s records are kept on a computer at the licensee’s central or main office, the licensee must keep the records for each licence at the relevant business premises.

Maximum penalty—40 penalty units.

50A   Discrepancy to be immediately reported to chief executive

(1)This section applies if a licensee—

(a)finds a discrepancy between—

(i)the quantity or volume of a class of controlled drug held by the licensee; and

(ii)the balance shown in the licensee’s controlled drugs register for the drug; or

(b)knows, or reasonably suspects, a controlled drug has been lost, misappropriated or stolen.

(2)The licensee must immediately give the chief executive written notice about the discrepancy, loss, misappropriation or theft.

Maximum penalty—40 penalty units.

Part 2    Endorsements

Division 1 Preliminary

51   Endorsement needed for controlled drugs

(1)A person must not have in the person’s possession a controlled drug unless the person is, under this regulation, endorsed to possess the drug.

Maximum penalty—80 penalty units.

(2)A person must not obtain a controlled drug unless the person is, under this regulation, endorsed to obtain the drug.

Maximum penalty—80 penalty units.

(3)A person must not dispense, issue, prescribe, purport to prescribe or sell a controlled drug unless the person is, under this regulation, endorsed to dispense, issue, prescribe or sell the drug.

Maximum penalty—80 penalty units.

(4)A person must not administer a controlled drug to someone else unless the person is, under this regulation, endorsed to administer the drug to the other person.

Maximum penalty—80 penalty units.

(5)A person who may, under an endorsement, administer, dispense, issue, obtain, possess, prescribe or sell a controlled drug, or write a written instruction or give an oral instruction for a controlled drug, must not destroy a controlled drug unless the person is endorsed to destroy the drug.

Maximum penalty—80 penalty units.

(6)A person must not write a written instruction or give an oral instruction for a controlled drug unless the person is endorsed to write the written instruction or give the oral instruction.

Maximum penalty—80 penalty units.

(7)Subsection (8) applies to a person who may only administer, destroy, dispense, issue, obtain, possess, prescribe or sell a controlled drug, or write a written instruction or give an oral instruction for a controlled drug, at a stated place or under stated conditions.

(8)The person must not administer, destroy, dispense, issue, obtain, possess, prescribe or sell the drug or write a written instruction or give an oral instruction for the drug at another place or in contravention of the conditions.

Maximum penalty—80 penalty units.

Division 2 Particular authorities

52   Anaesthetic assistants and enrolled nurses

(1)Subsection (2) applies to the following persons—

(a)an anaesthetic assistant holding a qualification acceptable to the Australian and New Zealand College of Anaesthetists;

(b)an enrolled nurse.

(2)The anaesthetic assistant or enrolled nurse is authorised to possess, under the written instruction of a doctor administering anaesthesia, a controlled drug at a hospital when preparing for, and during, anaesthetic procedures.

(3)Subsection (4) applies to a person (a trainee) who is undergoing a course of training, the successful completion of which will qualify the trainee to practise as an anaesthetic assistant.

(4)To the extent necessary to undergo the course of training, the trainee is authorised to possess a controlled drug, only if the trainee possesses the drug—

(a)at a hospital, when preparing for, or during, an anaesthetic procedure; and

(b)under the written instruction of a doctor administering anaesthesia; and

(c)under the direction and personal supervision of an anaesthetic assistant mentioned in subsection (1)(a).

53   [Repealed]

54   Bases and outposts of Royal Flying Doctor Service

(1)The person in charge of a base of the Royal Flying Doctor Service of Australia is authorised to—

(a)obtain a controlled drug that a doctor employed by the service considers necessary; or

(b)possess a controlled drug obtained under paragraph (a).

(2)The person in charge of an outpost of the Royal Flying Doctor Service of Australia is authorised to—

(a)possess a controlled drug that a doctor employed by the service considers necessary; or

(b)administer or supply a controlled drug at the outpost under a doctor’s oral or written instruction.

55   Carriers

(1)To the extent necessary to transport and deliver a controlled drug, the following persons are authorised to possess a controlled drug—

(a)a person engaged by an authorised person to transport and deliver the controlled drug;

(b)an adult acting for a person engaged by an authorised person to transport and deliver the controlled drug.

(2)In this section—

authorised person means a person who is authorised under this regulation to dispense, issue, sell or supply the controlled drug.

55A   Clinical perfusionists

To the extent necessary to practise perfusion, a clinical perfusionist is authorised to—

(a)possess a controlled drug at a place where the clinical perfusionist practises perfusion; or

(b)introduce a controlled drug into extracorporeal circulation equipment if the drug is introduced under—

(i)a clinical protocol for the clinical perfusionist at the place; and

(ii)the supervision of an anaesthetist or cardiothoracic surgeon.

56   Dentists

(1)To the extent necessary to practise dentistry, a dentist is authorised to—

(a)obtain codeine, morphine, oxycodone, papaveretum, pentazocine or pethidine; or

(b)possess codeine, morphine, oxycodone, papaveretum, pentazocine or pethidine at the place where the dentist practises dentistry; or

(c)administer codeine, morphine, oxycodone, papaveretum, pentazocine or pethidine to a person while treating the person; or

(d)prescribe not more than 3 days supply of codeine or pentazocine for a person’s dental treatment; or

(e)give someone who may administer a controlled drug an oral or written instruction to administer codeine, morphine, oxycodone, papaveretum, pentazocine or pethidine at the place where the dentist practises dentistry.

(2)Also, to the extent necessary to practise dentistry, a dentist who has successfully completed a certified course of training relating to the use of fentanyl is authorised to—

(a)obtain fentanyl; or

(b)possess fentanyl at the place where the dentist practises dentistry; or

(c)administer fentanyl to a person while treating the person.

(3)Subsection (4) applies to a person (a trainee) who is undergoing a course of training, the successful completion of which will qualify the trainee to practise dentistry.

(4)To the extent necessary to undergo the course of training, the trainee is authorised to—

(a)possess codeine, morphine, oxycodone, papaveretum, pentazocine or pethidine under a dentist’s direction at the place where the dentist practises dentistry; or

(b)administer codeine, morphine, oxycodone, papaveretum, pentazocine or pethidine, under a dentist’s personal supervision, while the dentist is treating a person.

57   Detention centres

(1)The manager of a detention centre is authorised to—

(a)obtain a controlled drug for use at the detention centre on a purchase order complying with part 5; or

(b)possess a controlled drug at the detention centre; or

(c)issue a controlled drug to an authorised person who may administer or supply it for the treatment of a child detained at the detention centre.

(2)A detention centre’s director of nursing or medical superintendent, or the pharmacist in charge of a detention centre’s dispensary, is authorised to—

(a)obtain a controlled drug for use at the detention centre on a purchase order complying with part 5; or

(b)possess a controlled drug at the detention centre; or

(c)issue a controlled drug to an authorised person who may administer or supply it for the treatment of a child detained at the detention centre.

58   Doctors

(1)To the extent necessary to practise medicine, a doctor is authorised to—

(a)obtain a controlled drug; or

(b)possess a controlled drug at a place occupied by the doctor; or

(c)if the doctor is reasonably satisfied a person the doctor is treating needs a controlled drug for a therapeutic use as part of the person’s medical treatment—

(i)administer the drug to the person; or

(ii)dispense or prescribe the drug to or for the person; or

(iii)supply the drug to or for the person; or

(iv)obtain the drug for the person; or

(d)give someone who may administer or supply a controlled drug an oral or written instruction to administer or supply the drug.

(2)A doctor is authorised to obtain, possess or use a controlled drug, other than a regulated controlled drug, for a genuine research or teaching purpose.

58A   Enrolled nurses

(1)To the extent necessary to practise nursing, an enrolled nurse is authorised to—

(a)possess a controlled drug at the place where the enrolled nurse practises nursing; or

(b)administer a controlled drug, other than an anaesthetic—

(i)on the written instruction of a dentist, doctor, endorsed midwife, nurse practitioner, physician’s assistant or surgical podiatrist; and

(ii)under the supervision of a dentist, doctor, midwife or registered nurse; or

(c)administer a controlled drug to a person for whom it has been dispensed and under the supervision of a dentist, doctor, midwife or registered nurse.

(2)Subsection (1) does not apply if the registration of the enrolled nurse under the Health Practitioner Regulation National Law is subject to a condition that the enrolled nurse is not qualified to administer controlled drugs.

(3)Subsection (4) applies to a person (a trainee) who is undergoing a course of training, the successful completion of which will qualify the trainee to practise as an enrolled nurse.

(4)To the extent necessary to undergo the course of training, the trainee is authorised to—

(a)possess a controlled drug under the direction of a registered nurse at the place where the registered nurse practises nursing; or

(b)administer a controlled drug, other than an anaesthetic—

(i)on the written instruction of a dentist, doctor, endorsed midwife, nurse practitioner or physician’s assistant; and

(ii)under the personal supervision of a dentist, doctor, midwife or registered nurse; or

(c)administer a controlled drug to a person for whom it has been dispensed and under the personal supervision of a dentist, doctor or registered nurse.

58B   Hospital pharmaceutical assistants

To the extent necessary to perform the person’s pharmaceutical imprest duties in a hospital, a hospital pharmaceutical assistant acting under the supervision of a pharmacist, is authorised to—

(a)possess a controlled drug at the hospital; or

(b)issue a controlled drug to an authorised person for treatment of the hospital’s patients.

59   Hospitals

(1)The persons authorised to do an authorised thing at a hospital are—

(a)the medical superintendent of the hospital; and

(b)a doctor nominated by the medical superintendent; and

(c)if there is a pharmacist in charge of the hospital’s dispensary—

(i)the pharmacist in charge; and

(ii)a pharmacist nominated in writing by the pharmacist in charge.

(2)Subsection (3) applies if none of the persons mentioned in subsection (1) are present at the hospital.

(3)The director of nursing of the hospital is authorised to do an authorised thing.

(4)If subsection (2) applies and the director of nursing is not present at the hospital, the registered nurse in charge of the hospital is authorised to do an authorised thing.

(5)In this section—

do an authorised thing, at a hospital, means—

(a)obtain a controlled drug for use at the hospital; or

(b)possess a controlled drug at the hospital; or

(c)issue a controlled drug for treatment of the hospital’s patients.

59A   Indigenous health workers

An indigenous health worker, while practising in an Aboriginal or Torres Strait Islander community in an isolated practice area in a specified Hospital and Health Service, is authorised—

(a)to obtain and possess a controlled drug; or

(b)to administer a controlled drug, under the indigenous health worker isolated practice area DTP, on the oral or written instruction of a doctor, nurse practitioner or physician’s assistant.

59B   Aboriginal and Torres Strait Islander health practitioners

(1)An Aboriginal and Torres Strait Islander health practitioner, while practising in an isolated practice area in a Hospital and Health Service or Aboriginal and Torres Strait Islander community controlled health service, is authorised—

(a)to obtain and possess a controlled drug; or

(b)to administer a controlled drug—

(i)under the Aboriginal and Torres Strait Islander health practitioner DTP and the practice plan for the practitioner; and

(ii)on the oral or written instruction of a doctor or nurse practitioner.

(2)Subsection (3) applies to a person (a trainee) who is undergoing a course of training, the successful completion of which will qualify the trainee to practise as an Aboriginal and Torres Strait Islander health practitioner.

(3)To the extent necessary to undergo the course of training, the trainee is authorised to—

(a)possess a controlled drug under the direction of an authorised person carrying out a relevant occupation; or

(b)administer a controlled drug under the personal supervision of an authorised person carrying out a relevant occupation.

(4)However, a trainee may possess or administer a controlled drug under subsection (3) only if—

(a)the authorised person is authorised under this regulation to possess or administer the drug; and

(b)the trainee possesses or administers the drug under—

(i)the conditions, if any, that would apply to the possession or administration of the drug by the authorised person; and

(ii)the Aboriginal and Torres Strait Islander health practitioner DTP.

(5)In this section—

relevant occupation means an occupation as an Aboriginal and Torres Strait Islander health practitioner, an indigenous health worker, a doctor, a registered nurse or a midwife.

60   Inspectors

To the extent necessary to perform an inspector’s official duties, an inspector is authorised—

(a)to obtain a controlled drug; or

(b)to possess a controlled drug; or

(c)in a disaster or emergency situation—to destroy a controlled drug.

61   Manufacturer or wholesaler of controlled drugs

(1)A controlled drug manufacturer is authorised to—

(a)obtain a controlled drug (an ingredient drug) for manufacturing a different controlled drug stated in the manufacturer’s licence; or

(b)possess an ingredient drug at the manufacturer’s business premises.

(2)A controlled drug wholesaler is authorised to—

(a)obtain a controlled drug; or

(b)possess a controlled drug at the wholesaler’s business premises.

(3)An adult employee of a controlled drug manufacturer or wholesaler is authorised to possess a controlled drug at the manufacturer’s or wholesaler’s business premises if—

(a)the drug is packed in the way required under chapter 1, part 4; and

(b)the employee is acting within the scope of the employment; and

(c)the possession is reasonably necessary for the employee to deliver the drug to an authorised person under a lawful transaction between the employer and the authorised person.

62   Midwives

To the extent necessary to practise midwifery, a midwife is authorised to—

(a)obtain a controlled drug; and

(b)possess a controlled drug at the place where the person practises midwifery; and

(c)administer a controlled drug to the person for whom it has been dispensed under the instructions stated by the dispenser; and

(d)administer or supply a controlled drug—

(i)on the oral or written instruction of a doctor, endorsed midwife, nurse practitioner or physician’s assistant; or

(ii)under the midwives DTP.

62A   Endorsed midwives

(1)To the extent necessary to practise midwifery, an endorsed midwife is authorised to—

(a)prescribe a controlled drug for midwifery; or

(b)administer or supply a controlled drug; or

(c)give someone who may administer or supply a controlled drug an oral or written instruction to administer or supply the drug.

(2)An endorsed midwife’s authority under this section is in addition to the endorsed midwife’s authority as a midwife under section 62.

62B   Nurse practitioners

(1)To the extent necessary to practise nursing, a nurse practitioner is authorised to—

(a)obtain a controlled drug; or

(b)prescribe a controlled drug; or

(c)administer or supply a controlled drug; or

(d)give someone who may administer or supply a controlled drug an oral or written instruction to administer or supply the drug.

(2)Subsection (1) applies only if—

(a)the controlled drug is mentioned in the Australian Register of Therapeutic Goods; and

(b)the use of the controlled drug is within the scope of practice of the nurse practitioner; and

(c)for prescribing, administering or supplying the controlled drug to or for a person the nurse practitioner is treating—the practitioner is reasonably satisfied the person needs the drug for a therapeutic use as part of the person’s medical treatment.

(3)A nurse practitioner’s authority under this section is in addition to the nurse practitioner’s authority as a registered nurse under section 67.

63   Nursing homes

(1)This section applies to the following persons—

(a)a nursing home’s director of nursing or medical superintendent;

(b)the registered nurse in charge of a nursing home;

(c)the pharmacist in charge of a nursing home’s dispensary.

(2)A person to whom this section applies is authorised to—

(a)obtain a controlled drug for use at the nursing home on a purchase order complying with part 5; or

(b)possess a controlled drug at the nursing home; or

(c)issue a controlled drug to an authorised person who may administer or supply it for the treatment of a resident of the nursing home.

64   Pharmacists

(1)To the extent necessary to practise pharmacy, a pharmacist is authorised to—

(a)obtain a controlled drug; or

(b)dispense a controlled drug; or

(c)sell a controlled drug (other than by wholesale) on a purchase order; or

(d)possess a controlled drug at a dispensary, an institution or another place at which the pharmacist administers or supplies a controlled drug under paragraph (f); or

(e)for a pharmacist practising pharmacy at a public sector hospital—supply a controlled drug, on the oral or written instruction of a doctor, nurse practitioner or physician’s assistant, to a person being discharged from the hospital or an outpatient of the hospital; or

(f)administer or supply a controlled drug, under the pharmacist opioid DTP, on the oral or written instruction of a relevant practitioner who holds a treatment approval or an oral approval under section 122(6).

(2)A pharmacist is authorised to obtain, possess or use a controlled drug, other than a regulated controlled drug, for a genuine research or teaching purpose.

(3)A trainee pharmacist is authorised to do, under a pharmacist’s direction and personal supervision, anything a pharmacist is authorised to do under subsection (1).

64AA   Physician’s assistants

To the extent necessary to perform duties under a practice plan for a physician’s assistant, the physician’s assistant acting under the supervision of his or her supervising medical officer is authorised to—

(a)possess a controlled drug at the place where the physician’s assistant practices; or

(b)administer, prescribe or supply a controlled drug; or

(c)give someone who may administer or supply a controlled drug an oral or written instruction to administer or supply the drug.

64A   Surgical podiatrists

(1)To the extent necessary to practise podiatry, a surgical podiatrist is authorised to—

(a)prescribe oxycodone (in short-acting form) as an oral preparation; or

(b)give someone, who may administer oxycodone (in short-acting form), a written instruction to administer the drug as an oral preparation.

(2)A surgical podiatrist must not prescribe or give a written instruction to administer more than 10 doses of 5mg each to a person for a relevant condition.

64B   Endorsed podiatrists

(1)To the extent necessary to practise podiatry, an endorsed podiatrist is authorised to—

(a)obtain a podiatry controlled drug; or

(b)possess a podiatry controlled drug at a place where the endorsed podiatrist practises podiatry; or

(c)prescribe a podiatry controlled drug for the treatment of a person’s podiatric condition; or

(d)administer or supply a podiatry controlled drug for the treatment of a person’s podiatric condition; or

(e)give someone who is authorised to administer or supply a podiatry controlled drug a written instruction to administer or supply the drug.

(2)If the endorsed podiatrist is also a surgical podiatrist, the endorsed podiatrist’s authority under this section is in addition to the endorsed podiatrist’s authority as a surgical podiatrist under section 64A.

(3)In this section—

podiatry controlled drug means a controlled drug mentioned in the national podiatry scheduled medicines list, to the extent mentioned.

65   Prisons

(1)The general manager of a prison is authorised to—

(a)obtain a controlled drug for use at the prison on a purchase order complying with part 5; or

(b)possess a controlled drug at the prison; or

(c)issue a controlled drug to an authorised person who may administer or supply it for the treatment of a prisoner at the prison.

(2)A prison’s director of nursing or medical superintendent, or the pharmacist in charge of a prison’s dispensary, is authorised to—

(a)obtain a controlled drug for use at the prison on a purchase order complying with part 5; or

(b)possess a controlled drug at the prison; or

(c)issue a controlled drug to an authorised person who may administer or supply it for the treatment of a prisoner at the prison.

66   Queensland Ambulance Service

(1)To the extent necessary for performing ambulance duties for the Queensland Ambulance Service, an ambulance officer mentioned in appendix 2A, part 1, column 2 is authorised to obtain, possess or administer, under a clinical practice protocol approved by the Queensland Ambulance Service, a controlled drug set out opposite in appendix 2A, part 1, column 1.

(2)However, an ambulance officer who is a paramedic 3 (ECP) may administer a controlled drug to a person only if the officer—

(a)is working in an ECP area; and

(b)is acting on a doctor’s oral or written instruction to administer the drug to a person.

(3)An ambulance officer who is undergoing a certified course of training, upon the successful completion of which the officer would be authorised to obtain, possess or administer a controlled drug mentioned in appendix 2A, part 1, column 1, is authorised to administer the controlled drug to a person under the supervision of someone who—

(a)has completed the training; and

(b)is—

(i)acting under a clinical practice protocol approved by the Queensland Ambulance Service; and

(ii)working in an ECP area and acting on a doctor’s oral or written instruction if required by subsection (2).

(4)To the extent necessary to perform ambulance duties for the Queensland Ambulance Service, an isolated practice area paramedic at an isolated practice area (paramedics) is authorised to—

(a)obtain a controlled drug; or

(b)possess a controlled drug at a place in the isolated practice area (paramedics); or

(c)administer or supply a controlled drug to a person—

(i)on the oral or written instruction of a doctor, nurse practitioner or physician’s assistant; or

(ii)under the isolated practice area paramedic DTP.

67   Registered nurses

(1)To the extent necessary to practise nursing, a registered nurse is authorised to—

(a)possess a controlled drug at a place where he or she practises nursing; or

(b)administer a controlled drug—

(i)on the oral or written instruction of a dentist, doctor, endorsed midwife, nurse practitioner or physician’s assistant; or

(ii)on the written instruction of a surgical podiatrist or an endorsed podiatrist; or

(iii)to the person for whom it has been dispensed under the instructions stated by the dispenser.

(2)To the extent necessary to practise nursing in a rural hospital or an isolated practice area, a rural and isolated practice area endorsed nurse is authorised to—

(a)obtain a controlled drug; or

(b)supply a controlled drug to a person—

(i)on the oral or written instruction of a doctor, nurse practitioner or physician’s assistant; or

(ii)under the rural and isolated practice area endorsed nurse DTP; or

(c)administer a controlled drug to a person under the rural and isolated practice area endorsed nurse DTP.

(3)To the extent necessary to practise nursing at a hospital within an isolated practice area, a registered nurse is authorised to supply a controlled drug, on the oral or written instruction of a doctor, endorsed midwife, nurse practitioner or physician’s assistant, to a person being discharged from the hospital or to an outpatient of the hospital.

68   Certain registered nurses at rural hospitals

(1)To the extent necessary to practise nursing at a rural hospital, the following persons are authorised to supply a controlled drug, on the oral or written instruction of a doctor, endorsed midwife, nurse practitioner or physician’s assistant, to a person being discharged from the hospital or an outpatient of the hospital—

(a)the hospital’s director of nursing;

(b)a registered nurse nominated by the hospital’s director of nursing.

(2)However, subsection (1) applies only if—

(a)the hospital does not employ a pharmacist; or

(b)if the hospital employs a pharmacist—the pharmacist is absent from the hospital at the time the controlled drug is supplied.

69   Ship’s master

(1)The master of a ship in the State is authorised to obtain a controlled drug for use on the ship, or possess a controlled drug on the ship, to the extent necessary to comply with the Navigation Act 2012 (Cwlth), the domestic commercial vessel national law or the Transport Operations (Marine Safety) Act 1994.

(2)Otherwise, the master of a ship in the State is authorised to obtain, possess or administer a controlled drug, only if—

(a)for obtaining a controlled drug—

(i)the purchase order for the drug is signed by a doctor; and

(ii)the drug is obtained for use on the ship; or

(b)for possessing a controlled drug—the drug is possessed for use on the ship; or

(c)for administering a controlled drug—the drug is administered on the ship—

(i)for the treatment of a person in an emergency; and

(ii)on a doctor’s oral or written instruction.

70   State analysts

(1)To the extent necessary to perform a State analyst’s official duties, a State analyst is authorised to—

(a)obtain or manufacture a controlled drug; or

(b)possess a controlled drug at the place where the analyst is performing official duties; or

(c)use a controlled drug for official purposes or destroy it.

(2)A trainee State analyst under the personal supervision of a State analyst is authorised to—

(a)obtain or manufacture a controlled drug; or

(b)possess a controlled drug at the place where the trainee is performing official duties; or

(c)use a controlled drug for official purposes or destroy it.

70AA   State forensic and scientific service facilities

(1)To the extent necessary to perform the person’s official duties, the person in charge of a forensic and scientific facility operated by the State is authorised to—

(a)possess a controlled drug; or

(b)destroy a controlled drug.

(2)The person in charge may delegate the authority to an appropriately qualified officer of the department.

(3)In this section—

appropriately qualified, for an officer of the department, includes having the qualifications, experience or standing appropriate to the exercise of the authority.

70A   Trainees in certain occupations

(1)This section applies to a person (a trainee) who is undergoing a course of training, the successful completion of which will qualify the trainee to carry out a relevant occupation.

(2)To the extent necessary to undergo the course of training, the trainee is authorised to—

(a)possess a controlled drug under the direction of an authorised person carrying out the relevant occupation; or

(b)administer a controlled drug under the personal supervision of an authorised person carrying out the relevant occupation.

(3)However, a trainee may only possess or administer a controlled drug under subsection (2), if—

(a)the authorised person is authorised under this regulation to possess or administer the drug; and

(b)the trainee possesses or administers the drug under the conditions (if any) that would apply to the possession or administration of the drug by the authorised person.

(4)In this section—

relevant occupation means an occupation as a clinical perfusionist, doctor, indigenous health worker, midwife, endorsed midwife, nurse practitioner, endorsed podiatrist, registered nurse or veterinary surgeon.

71   Veterinary surgeons

(1)To the extent necessary to practise veterinary medicine, a veterinary surgeon is authorised to—

(a)obtain a controlled drug; or

(b)possess a controlled drug at a place occupied by the veterinary surgeon; or

(c)if the veterinary surgeon is reasonably satisfied that an animal the veterinary surgeon is treating needs a controlled drug for a therapeutic use as part of the animal’s medical treatment—

(i)administer the drug to the animal; or

(ii)dispense or prescribe the drug for the animal; or

(iii)obtain the drug for the animal; or

(iv)sell a controlled drug to a person for the person’s animal.

(2)A veterinary surgeon is authorised to obtain, possess or use a controlled drug, other than a regulated controlled drug, for a genuine research or teaching purpose.

72   Watch house keepers etc.

To the extent necessary for ensuring a person detained at a watch house or police establishment receives a controlled drug lawfully prescribed or supplied for the person as a dispensed medicine, the watch house keeper, or the person performing the duties of watch house keeper at a police establishment, is authorised to—

(a)possess the controlled drug at the watch house or police establishment; or

(b)supply the controlled drug to the person for whom it was prescribed or supplied under the directions stated on the label attached to the medicine’s container.

73   [Repealed]

Division 3 General

74   When endorsement is not needed

(1)A person does not need an endorsement under this regulation merely to deliver a controlled drug to a person for whom it has been dispensed, or the person’s agent.

(2)A person (a carer) does not need an endorsement under this regulation to help another person (an assisted person) to take a controlled drug that has been supplied for the assisted person as a dispensed medicine, if—

(a)the assisted person asks for the carer’s help to take the dispensed medicine; and

(b)the carer helps the assisted person to take the dispensed medicine under the directions on the label attached to the dispensed medicine’s container.

(3)A person does not need an endorsement to administer, dispense, issue, manufacture, obtain, possess, prescribe, supply or use a controlled drug for an approved clinical trial.

75   [Repealed]

76   [Repealed]

Part 3    Regulated controlled drugs

77   [Repealed]

78   Specified condition drugs—amphetamine, dexamphetamine, lisdexamfetamine, methylamphetamine, methylphenidate

(1)Subject to section 74(3), a person must not dispense, obtain, prescribe, sell or use a specified condition drug unless the person—

(a)dispenses, obtains, prescribes, sells or uses the specified condition drug under an approval; or

(b)is a doctor and dispenses, obtains or prescribes the specified condition drug for the treatment of—

(i)narcolepsy; or

(ii)brain damage in a child at least 4 years; or

(iii)attention deficit disorder in a child at least 4 years; or

(c)is a paediatrician or psychiatrist and prescribes the specified condition drug for the treatment of brain damage or attention deficit disorder in a child.

Maximum penalty—80 penalty units.

(2)The chief executive may give an approval mentioned in subsection (1)(a) only to—

(a)a doctor; or

(b)a person who satisfies the chief executive that the specified condition drug is to be used for a genuine analytical or research purpose.

(3)In this section—

specified condition drug means the following controlled drugs—

(a)amphetamine;

(b)dexamphetamine;

(c)lisdexamfetamine;

(d)methylamphetamine;

(e)methylphenidate.

78A   Medicinal cannabis

Subject to section 74(3), a person must not dispense, obtain, prescribe, sell or use a controlled drug that is medicinal cannabis unless the person—

(a)is a doctor; and

(b)is dispensing, obtaining, prescribing or supplying the drug for another person being medically treated by the doctor.

Maximum penalty—80 penalty units.

78B   Exemptions for some acts involving regulated controlled drugs

This part does not prevent—

(a)a person dispensing a regulated controlled drug on a lawful prescription written by someone who may prescribe the drug; or

(b)a controlled drug manufacturer or wholesaler selling a regulated controlled drug; or

(c)a person under medical treatment who is lawfully supplied with a regulated controlled drug using the drug in the way directed.

Part 3A    [Expired]

Division 1 [Expired]

78C   [Expired]

78D   [Expired]

Division 2 [Expired]

78E   [Expired]

Division 3 [Expired]

78F   [Expired]

78G   [Expired]

78GA    [Expired]

78GB    [Expired]

78GC    [Expired]

78H   [Expired]

78I   [Expired]

78IA    [Expired]

78J   [Expired]

78K   [Expired]

Division 4 [Expired]

78L   [Expired]

78M   [Expired]

78N   [Expired]

78O   [Expired]

Division 5 [Expired]

78P   [Expired]

Part 4    Prescribing and dispensing controlled drugs

Division 1 Prescribing controlled drugs

79   Prescribing controlled drugs

(1)A prescriber must not prescribe a controlled drug unless the prescription is made in a way that complies with this section.

Maximum penalty—60 penalty units.

(2)Subject to subsection (3), a prescription for a controlled drug must not prescribe more than 1 item.

(3)A prescription for a controlled drug may prescribe more than 1 item if each item is for the same controlled drug, including different forms of the drug.

(4)The following particulars must appear on the front of a paper prescription or in an electronic prescription—

(a)the prescriber’s name, professional qualifications and address;

(b)the date it is made;

(c)if the controlled drug is for human use—the name, address and date of birth of the person for whose use it is prescribed;

(d)if the controlled drug is for an animal—the name and address of the animal’s owner;

(e)the description of the controlled drug or the name of the preparation and the quantity or volume (in words and figures) of the drug or preparation;

(f)adequate directions about the use of the controlled drug;

(g)the dose to be taken or administered and if more than 1 item is prescribed the dose to be taken or administered for each item;

(h)if a doctor, nurse practitioner or physician’s assistant prescribes a dose that is more than the official dose—

(i)for a paper prescription—a direction, to dispense the higher dose, that is underlined and initialled by the doctor, nurse practitioner or physician’s assistant; or

(ii)for an electronic prescription—an indication that the prescription is for a dose that is more than the official dose;

(i)if a doctor, nurse practitioner, physician’s assistant or veterinary surgeon intends that the controlled drug be dispensed more than once—a direction stating—

(i)the number of times (after the first) the drug may be dispensed; and

(ii)the time that must elapse between each dispensing of the drug;

(j)if the controlled drug is medicinal cannabis—‘Approved’;

approved electronic form means—

(a)for a prescription—

(i)an entry in an approved prescription exchange system for the prescription; or

(ii)an electronic form approved by the chief executive for the prescription; or

(b)for another document or information—an electronic form approved by the chief executive for the document or information.

approved prescription exchange system, for a prescription, means an electronic system for recording or transferring prescriptions, or information in prescriptions, that is—

(a)approved by the chief executive for prescriptions of the same kind; and

(b)provided by another entity.

approved program of study ...

approved provider see the Education and Care Services National Law (Queensland), section 5(1).

Australian COVID-19 vaccination arrangements means the arrangements made under the Australian COVID-19 vaccination policy to provide COVID-19 vaccines for vaccinating members of the public.

Australian COVID-19 vaccination policy means the document called ‘Australian COVID-19 Vaccination Policy’, published by the Australian Government.

Note—

The Australian COVID-19 vaccination policy was first endorsed by the National Cabinet on 13 November 2020.

Australian Register of Therapeutic Goods means the register maintained under the Therapeutic Goods Act 1989 (Cwlth), section 9A.

authorised person means the following—

(a)for chapter 2, a person who may, under chapter 2, perform a stated act involving a controlled drug or a regulated controlled drug;

(b)for chapter 3, a person who may, under chapter 3, perform a stated act involving a restricted drug or a regulated restricted drug;

(c)for chapter 4, a person who may, under chapter 4, perform a stated act involving a poison or a regulated poison.

authority means an authority a person has under this regulation—

(a)because of the person’s occupation; or

(b)because the person holds an office.

Examples of occupations—

doctor, dentist, midwife

Examples of offices—

person in charge of a base of the Royal Flying Doctor Service of Australia, general manager of a prison

business premises, of a licensee or holder of an endorsement, means the premises stated in the relevant licence or endorsement under chapter 2, 3 or 4 as the business premises of the licensee or endorsement holder.

cabinet, for appendix 6, part 1, see appendix 6, section 1AA.

cannabis product means a product—

(a)that is or was any part of a plant of the genus Cannabis, whether living or dead; or

(b)otherwise derived, wholly or in part, from any part of a plant of the genus Cannabis, whether living or dead; or

(c)that has, or is intended by the manufacturer of the product to have, a pharmacological effect that is substantially similar to the pharmacological effect of a product mentioned in paragraph (a) or (b).

carer ...

certification ...

certified means approved by the chief executive.

chief health officer means the chief health officer under the Hospital and Health Boards Act 2011, section 52.

child care service ...

class, of a controlled or restricted drug or poison, means controlled or restricted drugs or poisons of the same nominal description.

clinical perfusionist means a person—

(a)employed as a clinical perfusionist in—

(i)a Hospital and Health Service; or

(ii)a private health facility; or

(iii)a laboratory, or other facility, approved by the chief executive or by a facilities accreditation body approved by the chief executive; or

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

clinical pharmacologist ...

clinical protocol, for a person at a place, means a document—

(a)stating the circumstances in which the person may use a controlled drug, restricted drug or poison; and

(b)stating the procedure for using the controlled drug, restricted drug or poison; and

(c)approved by the head of the group in which the person is employed at the place.

clinical supervisor, for an Aboriginal and Torres Strait Islander health practitioner, means a person who has primary responsibility for the supervision of the work performed by the practitioner in the practitioner’s employment in the department, a Hospital and Health Service or an Aboriginal and Torres Strait Islander community controlled health service.

communicable diseases DTP means the drug therapy protocol called ‘Drug Therapy Protocol–Communicable Diseases Program’.

compounded, for a substance combined with a therapeutically active substance, means the way the substances are combined prevents their separation by simple dissolution or in another simple physical way.

controlled drug means an S8 substance.

controlled drug manufacturer means a person who holds a controlled drug manufacturer licence.

controlled drugs administration facility means a facility of which the primary purpose is administering controlled drugs under a drug therapy protocol.

controlled drugs book ...

controlled drugs record see section 86.

controlled drugs register see section 50.

controlled drug wholesaler means a person who holds a controlled drug wholesaler licence.

conviction includes a plea of guilty or finding of guilt by a court even though a conviction is not recorded.

COVID-19 vaccination centre, for chapter 3, part 9A, see section 213D.

COVID-19 vaccination code, for chapter 3, part 9A, see section 213E(1).

COVID-19 vaccination service, for chapter 3, part 9A, see section 213D.

COVID-19 vaccine means a vaccine for COVID-19.

criminal history of a person means the person’s criminal history within the meaning of the Criminal Law (Rehabilitation of Offenders) Act 1986.

current Poisons Standard see the Therapeutic Goods Act 1989 (Cwlth), section 52A.

cyanide, for chapter 4, part 2, means cyanide of potassium or sodium, and any other inorganic salt of hydrocyanic acid that is a poison, but does not include ferricyanide salts and ferrocyanide salts.

cyanide permit means a permit granted by the chief executive under this regulation for a person to obtain, possess or use cyanide.

declared provider, of a COVID-19 vaccination service, for chapter 3, part 9A, see section 213D.

declared public health emergency means a declared public health emergency under the Public Health Act 2005.

dental hygienist means a person registered under the Health Practitioner Regulation National Law—

(a)to practise in the dental profession, other than as a student; and

(b)in the dental hygienists division of that profession.

dental therapist means a person registered under the Health Practitioner Regulation National Law—

(a)to practise in the dental profession, other than as a student; and

(b)in the dental therapists division of that profession.

dentist means a person registered under the Health Practitioner Regulation National Law—

(a)to practise in the dental profession, other than as a student; and

(b)in the dentists division of that profession.

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

dispensary see the Health Regulation 1996.

dispense means sell on prescription.

dispensed medicine means a medicine that is or contains a controlled or restricted drug or a poison and is—

(a)supplied for human therapeutic use by a registered nurse or midwife who may supply the medicine while practising nursing or midwifery; or

(b)supplied for human therapeutic use by a dentist who may supply the medicine while practising dentistry; or

(c)supplied for human therapeutic use by a doctor who may supply the medicine while practising medicine; or

(d)supplied for human therapeutic use by an optometrist who may supply the medicine while practising optometry; or

(e)supplied for human therapeutic use by a podiatrist who may supply the medicine while practising podiatry; or

(f)supplied for human therapeutic use by an Aboriginal and Torres Strait Islander health practitioner who may supply the medicine while practising; or

(g)supplied for human therapeutic use by an indigenous health worker who may supply the medicine while practising; or

(h)supplied for animal use by a veterinary surgeon who may supply the medicine while practising veterinary medicine; or

(i)dispensed for human therapeutic use or animal use; or

(j)prepared for dispensing or supply, for human or animal use, by a pharmacist.

dispenser means a person who may dispense a controlled or restricted drug or a poison.

domestic commercial vessel national law see the Transport Operations (Marine Safety—Domestic Commercial Vessel National Law Application) Act 2016, section 20.

drug authority committee ...

drug licence means—

(a)a controlled drug manufacturer licence; or

(b)a controlled drug wholesaler licence; or

(c)a restricted drug manufacturer licence; or

(d)a restricted drug wholesaler licence.

drug therapy protocol means a certified document published by the department stating circumstances in which, and conditions under which, a person who may act under the protocol may use a stated controlled or restricted drug or poison for stated purposes.

Editor’s note—

Copies of the drug therapy protocols published by the department are available on the department’s website.

ECP means the acronym used by the Queensland Ambulance Service for the expression ‘extended care program’.

ECP area means an area of the State classified as an ECP area by the Queensland Ambulance Service.

education and care service see the Education and Care Services National Law (Queensland), section 5(1).

education and care service premises see the Education and Care Services National Law (Queensland), section 5(1).

educator—

(a)for an approved education and care service under the Education and Care Services National Law (Queensland)—see the Education and Care Services National Law (Queensland), section 5(1); and

(b)for a QEC approved service—see the Education and Care Services Act 2013, schedule 1.

electronically sign, for an electronic prescription, means to use an electronic form of signature approved by the chief executive.

electronic communication means a communication of information in the form of data, images or text by guided or unguided electromagnetic energy.

electronic means ...

electronic prescription means a prescription that is—

(a)in an approved electronic form; and

(b)capable of transfer electronically in the way approved by the chief executive.

endorsed ...

endorsed midwife means a midwife whose registration is endorsed under the Health Practitioner Regulation National Law, section 94 as being qualified to administer, obtain, possess, prescribe, sell, supply or use a scheduled medicine required for midwifery practice.

endorsed optometrist means an optometrist whose registration is endorsed under the Health Practitioner Regulation National Law, section 94 as being qualified to administer, obtain, possess, prescribe, sell, supply or use a scheduled medicine required for optometry practice.

endorsed podiatrist means a podiatrist, including a surgical podiatrist, whose registration is endorsed under the Health Practitioner Regulation National Law, section 94 as being qualified to administer, obtain, possess, prescribe, sell, supply or use a scheduled medicine required for podiatry practice.

endorsement means any of the following—

(a)an authority;

(b)an approval;

(d)a drug licence;

(e)a wholesale representative licence;

(f)a poison licence;

(g)a cyanide permit;

(h)a strychnine permit.

enrolled nurse means a person registered under the Health Practitioner Regulation National Law—

(a)to practise in the nursing profession, other than as a student; and

(b)in the enrolled nurses division of that profession.

expiry day see section 19.

extracorporeal circulation equipment means apparatus, connected by circuit tubing, used to carry blood outside the body.

Examples of apparatus—

mechanical blood pump, gas exchange device, heat exchanger

facilities accreditation body means a body that under a law of the State or the Commonwealth is responsible for accrediting laboratories, or other facilities, at which clinical procedures are performed, for their compliance with particular regulatory or professional standards.

health service, for chapter 3, part 9A, see section 213D.

hospital means a public sector hospital or private hospital.

Hospital and Health Service means a Hospital and Health Service established under the Hospital and Health Boards Act 2011.

hospital pharmaceutical assistant means an adult person who—

(a)has a qualification or statement of attainment recognising that the person has the skills and knowledge required to perform pharmaceutical imprest duties in a hospital; and

(b)performs pharmaceutical imprest duties in a hospital.

immunisation program means—

(a)an immunisation program carried out by the department; or

(b)an immunisation program carried out by a local government; or

(c)an immunisation program carried out by a Hospital and Health Service; or

(d)a certified immunisation program.

immunisation program nurse means a registered nurse who—

(a)immediately before 1 July 2010, held an annual licence certificate endorsed under the Nursing Act 1992 that authorised the registered nurse to practise in an immunisation program; or

(b)has obtained a qualification in immunisation approved by the chief executive.

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 a certified equivalent qualification; and

(b)has successfully completed the North Queensland Rural Health Training Unit Isolated Practice Health (Drugs and Poisons) Regulation 1996 Course or a certified equivalent course of training for the accreditation of registered nurses for practice in an isolated practice area.

indigenous health worker isolated practice area DTP means the drug therapy protocol called ‘Drug Therapy Protocol–Indigenous Health Worker Isolated Practice Area’.

influenza emergency declaration means a human biosecurity emergency declaration, within the meaning of the Biosecurity Act 2015 (Cwlth), section 9, made wholly or partly for the purpose of preventing or controlling—

(a)the entry of human influenza into the State; or

(b)the emergence, establishment or spread of human influenza in the State.

influenza epidemic proclamation ...

inspector means an inspector appointed under section 137 of the Act.

institution means a detention centre, hospital, nursing home or prison.

introduce, a controlled drug, restricted drug or poison into extracorporeal circulation equipment, means administer the drug or poison by—

(a)preparing or mixing the drug or poison to be loaded into the equipment; or

(b)preparing the equipment for the drug or poison; or

(c)loading the drug or poison into the equipment, whether or not the equipment is connected to a person.

isolated practice area means—

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

(a)a place that is—

(i)within the area of a local government mentioned in appendix 5; and

(ii)remote from pharmaceutical services; or

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

(c)a plane operated by the Royal Flying Doctor Service (Qld section).

isolated practice area paramedic means an ambulance officer who—

(a)has successfully completed the training course, from James Cook University, Graduate Certificate of Rural and Remote Paramedic Practice that includes the Isolated Practice Area Paramedic course developed by the Northern Area Health Service Workforce Directorate; and

(b)is classified by the Queensland Ambulance Service as a paramedic 3, 3 (ECP) or 4.

isolated practice area paramedic DTP means the drug therapy protocol called ‘Drug Therapy Protocol–Queensland Ambulance Service Isolated Practice Area Paramedic’.

isolated practice area (paramedics) means—

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

(b)a place that is—

(i)within—

(A)the operational area of the Calen, Carmila, Finch Hatton, Glenden, Happy Valley Fraser Island, Marlborough, Nebo, Millaa Millaa or Wowan, Queensland Ambulance Service station; or

(B)the area of a local government mentioned in appendix 5; and

(ii)remote from pharmaceutical services; or

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

isolated practice endorsed ...

issue, a controlled drug, restricted drug or poison, means give the drug or poison to a person who is endorsed under this regulation to administer the drug or poison to another person.

licensee means—

(a)for chapter 2—

(i)a controlled drug manufacturer; or

(ii)a controlled drug wholesaler; or

(b)for chapter 3—

(i)a restricted drug manufacturer; or

(ii)a restricted drug wholesaler; or

(c)for chapter 4—

(i)a poison manufacturer; or

(ii)a poison wholesaler; or

(iii)a person who holds a poison wholesaler licence; or

(iv)a person who holds a general poison licence; or

(v)a person who holds a licence to sell S7 poisons for other than human therapeutic use.

licensee of a child care service ...

listed immunoglobulin blood product means an immunoglobulin blood product listed on the national product price list.

manufacture see section 4.

master, of a ship, see the Transport Operations (Marine Safety) Act 1994.

medicinal cannabis means a cannabis product that is used, or is intended by the manufacturer of the product to be used, for human therapeutic purposes, whether or not the product is mentioned in the Australian Register of Therapeutic Goods.

medicinal cannabis security standard means the standard made by the chief health officer called ‘Standard for security of medicinal cannabis stock’, dated July 2019 and published on the department’s website.

midwife means a person registered under the Health Practitioner Regulation National Law to practise in the midwifery profession, other than as a student.

midwives DTP means the drug therapy protocol called ‘Drug Therapy Protocol–Midwives’.

National Blood Agreement see the National Blood Authority Act 2003 (Cwlth), section 3.

national blood supply arrangements means the arrangements under, or mentioned in, the National Blood Agreement.

National Drugs and Poisons Schedule Committee ...

National Health Act means the National Health Act 1953 (Cwlth).

national podiatry scheduled medicines list means the list in attachment A of the document called ‘Registration standard: endorsement for scheduled medicines’ made by the Podiatry Board of Australia established under the Health Practitioner Regulation National Law.

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.

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%.

nominal description, of a controlled or restricted drug, means the details necessary to describe the drug, including details of its composition, form, quality and strength, and distinguish it from a controlled or restricted drug of a different description.

nuclear medicine investigation means a test that produces images to show the activity and function of tissues and organs of the body after a radionuclide or radioisotope is absorbed by the tissues or organs.

nuclear medicine technologist means a person registered under the Health Practitioner Regulation National Law to practise in the nuclear medicine technology division of the medical radiation practice profession, other than as a student.

nurse means a registered nurse or enrolled nurse.

nurse practitioner means a registered nurse whose registration is endorsed under the Health Practitioner Regulation National Law as being qualified to practise as a nurse practitioner.

nurse practitioner DTP ...

nurse practitioner standards means the document called ‘Nurse practitioner standards for practice’ made by the Nursing and Midwifery Board of Australia established under the Health Practitioner Regulation National Law.

nursing home means a facility, other than a hospital or private residence, at which accommodation and nursing or personal care is provided to persons who, because of disability, disease, illness, incapacity or infirmity, have a continuing need for care.

obtain, for a controlled or restricted drug or a poison, means acquire, buy, receive or otherwise obtain the drug or poison, and for a doctor, pharmacist or veterinary surgeon, includes offer to acquire, buy, receive or otherwise obtain.

ocular therapeutics protocol means a certified document published by the department stating—

(a)the circumstances in which, and conditions under which, an optometrist may administer, supply or prescribe a restricted drug; and

(b)the qualifications that an optometrist must attain before doing a thing mentioned in paragraph (a).

operating approval means an approval granted by the chief executive to a person to establish and operate a controlled drugs administration facility.

opium means any form of opium, other than the alkaloids noscapine and papaverine.

optometrist means a person registered under the Health Practitioner Regulation National Law to practise in the optometry profession, other than as a student.

optometry guidelines means the document called ‘Guidelines for use of scheduled medicines’ made by the Optometry Board of Australia established under the Health Practitioner Regulation National Law.

oral health therapist means a person registered under the Health Practitioner Regulation National Law—

(a)to practise in the dental profession, other than as a student; and

(b)in the oral health therapists division of that profession.

orthoptist means a person whose name is recorded in the Register of Orthoptists kept by the Australian Orthoptists Registration Body Pty Ltd ACN 095 117 678.

orthoptist DTP means the drug therapy protocol called ‘Drug Therapy Protocol–Orthoptist’.

outpost, of the Royal Flying Doctor Service of Australia, means a medicine chest kept at a place approved by a doctor authorised in writing by the service to approve the keeping of the medicine chest.

owner, of a ship, see the Transport Operations (Marine Safety) Act 1994.

pandemic influenza program DTP means the drug therapy protocol called ‘Drug Therapy Protocol–Pandemic Influenza Program’.

paper prescription means a prescription in paper form whether or not the prescription was generated by a computer or handwritten.

paramedic 1 means an ambulance officer who is classified by the Queensland Ambulance Service as a paramedic 1.

paramedic 2 means an ambulance officer who is classified by the Queensland Ambulance Service as a paramedic 2.

paramedic 3 means an ambulance officer who—

(a)has successfully completed a training course certified as the course for a paramedic 3; and

(b)is classified by the Queensland Ambulance Service as a paramedic 3.

paramedic 3 (ECP) means an ambulance officer who—

(a)has successfully completed a training course certified as the course for a paramedic 3 (ECP); and

(b)is classified by the Queensland Ambulance Service as a paramedic 3 (ECP).

paramedic 4 means an ambulance officer who—

(a)has successfully completed a training course certified as the course for a paramedic 4; and

(b)is classified by the Queensland Ambulance Service as a paramedic 4.

personal information, for chapter 3, part 9A, see section 213D.

personal supervision see section 5A.

pharmaceutical imprest duties means duties related to keeping an inventory of drugs obtained for use at a hospital or issued for treatment of the hospital’s patients.

pharmacist ...

pharmacist opioid DTP means the drug therapy protocol called ‘Drug Therapy Protocol–Pharmacist Opioid Treatment Program’.

pharmacist vaccination program DTP means the drug therapy protocol called ‘Drug Therapy Protocol—Pharmacist Vaccination Program’.

pharmacy ...

physician’s assistant means a person—

(a)appointed by the chief executive, and employed by the department, as a physician’s assistant; or

(b)appointed by a Hospital and Health Service, and employed by the Service, as a physician’s assistant.

physiotherapist means a person registered under the Health Practitioner Regulation National Law to practise in the physiotherapy profession, other than as a student.

podiatric procedure means a diagnostic or therapeutic procedure relating to the foot, ankle or lower leg.

podiatrist means a person registered under the Health Practitioner Regulation National Law to practise in the podiatry profession, other than as a student.

podiatry guideline ...

poison means—

(a)an S2, S3, S5, S6, S7 or S9 substance; or

(b)a substance mentioned in appendix C of the current Poisons Standard.

poison licence means—

(a)a poison manufacturer licence; or

(b)a poison wholesaler licence; or

(c)a general poison licence; or

(d)a licence to sell S7 poisons for other than human therapeutic use.

poison manufacturer means a person who holds a poison manufacturer licence.

poison wholesaler means a person who holds a poison wholesaler licence.

possess, a controlled drug, restricted drug, poison or other substance, includes—

(a)have custody or control of the drug, poison or other substance; and

(b)have an ability or right to obtain custody or control of the drug, poison or other substance.

practice plan means a document in the approved form that—

(a)for a physician’s assistant—

(i)states the circumstances and conditions for the assistant to use a controlled drug, restricted drug or poison; and

(ii)is developed and signed by the assistant and the assistant’s supervising medical officer; or

(b)for an Aboriginal and Torres Strait Islander health practitioner—

(i)states the circumstances and conditions for the practitioner to administer or supply a controlled drug, restricted drug or poison; and

(ii)is developed and signed by the practitioner and the practitioner’s clinical supervisor.

prescribe means make a written direction (other than a purchase order or written instruction) authorising a dispenser to dispense a stated controlled or restricted drug or a stated poison.

prescriber means a person who, under this regulation, is endorsed to prescribe a controlled or restricted drug or a poison.

prescription means a prescriber’s direction (other than a purchase order or written instruction) to dispense a stated controlled or restricted drug or a stated poison, and includes, for sections 79, 80, 81, 190, 191 and 192 a duplicate of a prescription attached to a repeat authorisation, under the National Health Act, issued by a dispenser.

prison see the Corrective Services Act 2006, schedule 4.

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

private hospital see the Private Health Facilities Act 1999, section 9.

private practice endorsed midwife ...

produce, a controlled or restricted drug or a poison, means—

(a)cultivate, package, prepare or produce a substance; or

(b)offer to cultivate, package, prepare or produce a substance; or

(c)do or offer to do anything for or in connection with an act mentioned in paragraph (a).

public sector hospital has the meaning given in the Hospital and Health Boards Act 2011.

purchase order means an order for the supply of a controlled or restricted drug or a poison, placed by an endorsed person under chapter 2, 3 or 4.

QCAT information notice means a notice complying with the QCAT Act, section 157(2).

QEC approved service see the Education and Care Services Act 2013, schedule 1.

QEC service see the Education and Care Services Act 2013, section 8.

QEC service premises see the Education and Care Services Act 2013, schedule 1.

qualification, for a hospital pharmaceutical assistant, means a VET qualification under the National Vocational Education and Training Regulator Act 2011 (Cwlth).

quality standard see section 4A.

Queensland approved provider see the Education and Care Services Act 2013, schedule 1.

reasonably believe means believe on grounds that are reasonable in the circumstances.

reasonably satisfied means satisfied on grounds that are reasonable in the circumstances.

receive, in relation to a prescription in an approved prescription exchange system, means the prescription, or information in the prescription, is entered into the system and is available for downloading or other retrieval.

registered nurse means a person registered under the Health Practitioner Regulation National Law—

(a)to practise in the nursing profession, other than as a student; and

(b)in the registered nurses division of that profession.

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

regulated controlled drug means a controlled drug mentioned in chapter 2, part 3.

regulated drug ...

regulated poison means a poison in appendix 7 of this regulation.

regulated restricted drug means a restricted drug mentioned in chapter 3, part 3.

related drug, in relation to a COVID-19 vaccine, for chapter 3, part 9A, see section 213D.

relevant condition, for giving a prescription or written instruction, means the condition for which the prescription or instruction is given.

repeat prescription means a prescription on which there is a direction to repeat the sale or supply of a stated controlled or restricted drug or a stated poison a stated number of times.

resident, of a nursing home, means a person receiving care or supervision at the nursing home.

respiratory function test means a test that measures lung volume, capacity, rates of flow and gas exchange to show how well lungs are working.

respiratory scientist means a person who—

(a)is employed as a respiratory scientist in—

(i)a Hospital and Health Service; or

(ii)a private health facility; or

(iii)a laboratory, or other facility, approved by the chief executive or by a facilities accreditation body approved by the chief executive; or

(b)is recognised as a respiratory scientist by the chief executive.

restricted drug means an S4 substance.

restricted drug manufacturer means a person who holds a restricted drug manufacturer licence.

restricted drug of dependency means a restricted drug in appendix 8 of this regulation.

restricted drug wholesaler means a person who holds a restricted drug wholesaler licence.

rural and isolated practice area endorsed nurse means a registered nurse whose registration is endorsed under the Health Practitioner Regulation National Law as being qualified to obtain, supply and administer S2, S3, S4 and S8 drugs or poisons for practising nursing in a rural and isolated practice area.

rural and isolated practice area endorsed nurse DTP means the drug therapy protocol called ‘Drug Therapy Protocol–Rural and Isolated Practice Area Endorsed Nurse’.

rural hospital means—

(a)a public sector hospital at a place stated in appendix 8A; or

(b)the Capricorn Sector Outpatients’ Clinic; or

(c)Maleny Soldiers Memorial Hospital; or

(d)Noosa District Community Hospital.

S2 to S9 see section 5.

scope of practice, of a nurse practitioner, means the scope of practice of the nurse practitioner under the nurse practitioner standards.

section 122 approval ...

sell ...

send, in relation to a prescription in an approved prescription exchange system, means enter the prescription, or information in the prescription, into the system.

sexual health program means—

(a)sexual or reproductive health program carried out by a Hospital and Health Service; or

(b)a certified sexual or reproductive health program.

sexual health program nurse means a registered nurse who—

(a)immediately before 1 July 2010, held an annual licence certificate endorsed under the Nursing Act 1992 that authorised the registered nurse to practise in a sexual health program; or

(b)has obtained a qualification in sexual health approved by the chief executive.

sexual health program nurse DTP means the drug therapy protocol called ‘Drug Therapy Protocol–Sexual Health Program Nurse (including Reproductive Health)’.

specialist ...

specialist health practitioner ...

specialist medical practitioner, in a specialty, means a person registered under the Health Practitioner Regulation National Law to practise in the medical profession as a specialist registrant in the specialty.

specialist physician means a person registered under the Health Practitioner Regulation National Law in the medical profession as a specialist registrant in the specialty of physician.

specified health service district ...

specified Hospital and Health Service means any of the following Hospital and Health Services—

•Cairns and Hinterland Hospital and Health Service

•North West Hospital and Health Service

•Torres and Cape Hospital and Health Service.

speech pathologist means a person who—

(a)is employed as a speech pathologist in—

(i)a Hospital and Health Service; or

(ii)another government entity under the Public Service Act 2008, section 24; or

(iii)a private health facility; or

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

standard ...

State analyst means an analyst appointed under section 153Z of the Act.

statement of attainment, for a hospital pharmaceutical assistant, means a VET statement of attainment under the National Vocational Education and Training Regulator Act 2011 (Cwlth).

strychnine, for chapter 4, part 2, means strychnine as an S7 poison.

strychnine permit means a permit granted by the chief executive under this regulation for a person to obtain, possess or use strychnine.

supervising medical officer ...

supervision see section 5A.

supply, for a controlled or restricted drug or a poison, means give, or offer to give, a person 1 or more treatment doses of the drug or poison, to be taken by the person during a certain period.

surgical podiatrist means a person registered under the Health Practitioner Regulation National Law to practise in the podiatry profession as a specialist registrant in the specialty of surgical podiatry.

trainee endorsed podiatrist ...

trainee pharmacist means a person who—

(a)is undergoing a course of training, the successful completion of which would qualify the person to hold an approved qualification for the pharmacy profession under the Health Practitioner Regulation National Law; or

(b)is undertaking a period of supervised practice required for registration as a pharmacist under the Health Practitioner Regulation National Law.

trainee State analyst means a person who is undergoing a course of training, the successful completion of which will qualify the trainee for appointment as a State analyst.

transaction see section 6.

treatment approval means any of the following approvals—

(a)an approval given to a doctor by the chief executive under section 78(1)(a);

(b)a written approval given to a relevant practitioner by the chief executive under section 122;

(c)a written approval given to a relevant practitioner by the chief executive under section 213;

(d)a written approval given to a dentist by the chief executive under section 213A.

university ...

vaccine means a restricted drug that is identified as a vaccine in the current Poisons Standard.

Veterans Entitlements Act means the Veterans’ Entitlements Act 1986 (Cwlth).

wholesale means sell for resale.

wholesale representative means a person who holds a wholesale representative licence.

wholesaling practice code means the Australian Code of Good Wholesaling Practice for Medicines in Schedules 2, 3, 4 and 8.

worker, for a declared provider of a COVID-19 vaccination service, for chapter 3, part 9A, see section 213D.

written instruction means any of the following—

(a)a written direction, other than a prescription or purchase order, signed by a dentist, doctor, nurse practitioner or surgical podiatrist and on which the date of the direction is shown;

(b)a standing order signed by a doctor or nurse practitioner and on which the date of the order is shown;

(c)a written entry on a patient’s medical records signed and dated by a doctor or nurse practitioner.