1Short titleThis regulation may be cited as the Medicines and Poisons (Medicines) Amendment Regulation (No. 2) 2025.2CommencementThis regulation commences on 1 July 2025.3Regulation amendedThis regulation amends the Medicines and Poisons (Medicines) Regulation 2021.4Insertion of new ch 4, pt 8, div 1, subdiv 2A, hdgAfter section 116—insert—Subdivision 2AAmending written prescriptions5Replacement of s 117 (Amending written prescription)Section 117—omit, insert—117Restrictions on amending written prescriptionsA dispenser must not amend a written prescription for a medicine other than in accordance with this subdivision or section 229.Note—Section 229 relates to marking non-compliant paper prescriptions.117A Clarifying prescriber’s direction(1)A dispenser may amend a written prescription for a medicine before dispensing the medicine by adding additional information to the prescription to clarify the direction of the prescriber who made the prescription.(2)Before amending the prescription, the dispenser must—

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

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

(3)The dispenser must make the amendment—

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

(b)by signing and dating the amendment; and

(c)in a way that does not obscure the information originally stated on the prescription before the amendment.Note—See section 124(1)(m) about records of amendments required to be kept by dispensers.

117B Dispensing an equivalent medicine(1)This section applies to a dispenser if—

(a)the dispenser is a pharmacist; and

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

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

(2)The dispenser may amend the prescription to dispense the equivalent medicine if the dispenser assesses the amendment to be reasonably necessary for the therapeutic treatment of the patient.(3)Before amending the prescription, the dispenser must obtain consent to the amendment from the person obtaining the medicine.(4)The dispenser must make the amendment—

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

(i)the name of the dispenser;

(ii)the place where the dispenser usually practices;

(iii)the dispenser’s phone number;

(iv)the dispenser’s qualifications;

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

(b)by signing and dating the amendment; and

(c)in a way that does not obscure the information originally stated on the prescription before the amendment.Note—See section 124(1)(m) about records of amendments required to be kept by dispensers.

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

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

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

(6)In this section—equivalent medicine, to the original medicine, means a medicine that—

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

(b)is able to be dispensed in a dose and for a duration that is intended to have a therapeutic effect equivalent to the therapeutic effect of the original medicine; and

(c)has the same or similar chemical composition or pharmacological means of action as the original medicine.

indication means an indication within the meaning of the Therapeutic Goods Act 1989 (Cwlth).6Amendment of s 124 (Dispensing record for dispensed medicine)Section 124(1)(m)—omit, insert—

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

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

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

7Amendment of s 153 (Application of division)Section 153—insert—(2)However, subsection (3) applies if the medicine is sold under a Continued Dispensing Determination or an extended practice authority.(3)If a provision of this division is inconsistent with a document mentioned in subsection (2), the document prevails to the extent of any inconsistency.Note—See also schedule 9, part 1 about pharmacists repackaging medicines.8Amendment of s 155 (Definition for subdivision)(1)Section 155, heading, ‘Definition’—omit, insert—Definitions(2)Section 155—insert—pre-packed, in relation to a medicine, means the medicine is a pre-packed liquid, cream, ointment or aerosol.9Amendment of s 156 (Selling S4 oral hormonal contraceptive)(1)Section 156, note—omit.(2)Section 156—insert—(3)A pharmacist must not sell an amount of the medicine that is more than a manufacturer’s pack of the medicine.10Amendment of s 157 (Selling S4 diversion-risk medicine)(1)Section 157(1), from ‘, other’ to ‘Determination’—omit.(2)Section 157—insert—(3)A pharmacist must not sell an amount of the medicine that is—

(a)if the medicine is pre-packed—more than the smallest available size of a manufacturer’s pack of the medicine; or

(b)otherwise—more than 3 days’ supply of the medicine.

11Replacement of ss 158 and 159Sections 158 and 159—omit, insert—158Selling S4 restricted medicine(1)This section applies in relation to an S4 medicine that is a restricted medicine for a patient.(2)A pharmacist must not sell the medicine unless the pharmacist reasonably believes—

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

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

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

(3)A pharmacist must not sell an amount of the medicine that is—

(a)if the medicine is pre-packed—more than the smallest available size of a manufacturer’s pack of the medicine; or

(b)otherwise—more than 3 days’ supply of the medicine.

159 Selling other S4 medicines(1)This section applies in relation to an S4 medicine for a patient, other than a medicine otherwise mentioned in this subdivision.(2)A pharmacist must not sell the medicine unless the pharmacist reasonably believes—

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

(b)the medicine has been lawfully supplied to the patient in the 6 months before being sought from the pharmacist; and

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

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

(3)A pharmacist must not sell an amount of the medicine that is more than the smallest available size of a manufacturer’s pack of the medicine.12Amendment of s 160 (Record when selling S4 medicine)(1)Section 160, ‘selling a medicine’—omit, insert—selling an S4 medicine(2)Section 160(i)—omit, insert—

(i)a brief description of why the pharmacist is selling the medicine.

13Amendment of sch 1 (Extended practice authorities and departmental standards)Schedule 1, part 1, table, entries for Pharmacists and Pharmacists—community pharmacy scope of practice pilot—omit, insert—Pharmacists8Pharmacists—community pharmacy chronic conditions management pilot114Insertion of new sch 4, pt 5Schedule 4—insert—Part 5Hospital and health service dental assistantsDivision 1Preliminary14Definitions for partIn this part—dental hygienist see section 8 of this schedule.dental practitioner means a dentist, dental hygienist, dental therapist or oral health therapist.dental therapist see section 10 of this schedule.oral health therapist see section 12 of this schedule.Division 2Hospital and health service dental assistants15Class of personA person who is employed as a dental assistant by a Hospital and Health Service.16Dealing authorisedColumn 1DealingColumn 2MedicineColumn 3Scope of dealing1administeran S4 medicine that is fluoride in a preparation for human usethe medicine is administered under the supervision of a dental practitioner2possessan S4 medicine that is fluoride in a preparation for human usethe medicine is possessed under the supervision of a dental practitioner15Amendment of sch 9 (Pharmaceutical professions)(1)Schedule 9, section 4A, definition community pharmacy scope of practice pilot—omit, insert—community pharmacy chronic conditions management pilot means the program set up by the department known as the ‘community pharmacy chronic conditions management pilot’.(2)Schedule 9, section 4A, definitions participating pharmacist and participating pharmacy, ‘community pharmacy scope of practice pilot’—omit, insert—community pharmacy chronic conditions management pilot(3)Schedule 9, section 4C, table, column 2, entry for item 1, ‘Pharmacists—community pharmacy scope of practice pilot’—omit, insert—Pharmacists—community pharmacy chronic conditions management pilot(4)Schedule 9, section 4C, table, entry for items 2 and 3—omit.(5)Schedule 9, section 6, table—insert—2a dealing mentioned in the table in division 1Aa medicine mentioned in the table in division 1Athe dealing with the medicine is carried out to the extent authorised for a pharmacist under the supervision of a pharmacist(6)Schedule 9, section 8, table, entry for item 2—omit, insert—2administer(a)a medicine mentioned in the table in division 1the medicine is administered to the extent authorised for a pharmacist under the direct supervision of a pharmacist(b)a medicine mentioned in the table in division 1Athe medicine is administered to the extent authorised for a pharmacist under the direct supervision of a pharmacist(7)Schedule 9, section 8, table, entry for item 4—omit, insert—4possess(a)a medicine mentioned in the table in division 1the medicine is possessed to the extent authorised for a pharmacist under the direct supervision of a pharmacist(b)a medicine mentioned in the table in division 1Athe medicine is possessed to the extent authorised for a pharmacist under the direct supervision of a pharmacist16Amendment of sch 22 (Dictionary)(1)Schedule 22—insert—pre-packed, in relation to a medicine, for chapter 5, part 2, division 3, subdivision 3, see section 155.(2)Schedule 22, definition enrolled nurse, ‘section 16’—omit, insert—section 18