Medicines, Poisons and Therapeutic Goods Regulation 2008

1 australian capital territory Medicines, Poisons and Therapeutic Goods Regulation 2008 . SL2008-42. made under the Medicines, Poisons and Therapeutic Goods Act 2008 . Republication No 44. Effective: 5 November 2021. Republication date: 5 November 2021. Last amendment made by SL2021-28. Authorised by the ACT Parliamentary Counsel also accessible at About this republication The republished law This is a republication of the Medicines, Poisons and Therapeutic Goods Regulation 2008 , made under the Medicines, Poisons and Therapeutic Goods Act 2008 (including any amendment made under the Legislation Act 2001, part (Editorial changes)) as in force on 5 November 2021. It also includes any commencement, amendment, repeal or expiry affecting this republished law to 5 November 2021. The legislation history and amendment history of the republished law are set out in endnotes 3. and 4. Kinds of republications The Parliamentary Counsel's Office prepares 2 kinds of republications of ACT laws (see the ACT.)

2 Legislation register at ): authorised republications to which the Legislation Act 2001 applies unauthorised republications. The status of this republication appears on the bottom of each page. Editorial changes The Legislation Act 2001, part authorises the Parliamentary Counsel to make editorial amendments and other changes of a formal nature when preparing a law for republication. Editorial changes do not change the effect of the law, but have effect as if they had been made by an Act commencing on the republication date (see Legislation Act 2001, s 115 and s 117). The changes are made if the Parliamentary Counsel considers they are desirable to bring the law into line, or more closely into line, with current legislative drafting practice. This republication includes amendments made under part (see endnote 1). Uncommenced provisions and amendments If a provision of the republished law has not commenced, the symbol U appears immediately before the provision heading.

3 Any uncommenced amendments that affect this republished law are accessible on the ACT legislation register ( ). For more information, see the home page for this law on the register. Modifications If a provision of the republished law is affected by a current modification, the symbol M appears immediately before the provision heading. The text of the modifying provision appears in the endnotes. For the legal status of modifications, see the Legislation Act 2001, section 95. Penalties At the republication date, the value of a penalty unit for an offence against this law is $160 for an individual and $810 for a corporation (see Legislation Act 2001, s 133). Authorised by the ACT Parliamentary Counsel also accessible at australian capital territory Medicines, Poisons and Therapeutic Goods Regulation 2008 . made under the Medicines, Poisons and Therapeutic Goods Act 2008 . Contents Page Chapter 1 Preliminary 1 Name of Regulation 2.

4 3 Dictionary 2. 4 Notes 2. 5 Offences against Regulation application of Criminal Code etc 3. 6 Overview of things to which medicines and Poisons standard does not apply 3. R44 Medicines, Poisons and Therapeutic Goods contents 1. 05/11/21 Regulation 2008 . Effective: 05/11/21. Authorised by the ACT Parliamentary Counsel also accessible at Contents Page Chapter 2 Medicines authorisations generally Part Overview of medicines authorisations 10 General overview of authorisations for medicines 5. 11 Overview of medicines authorisations under this Regulation 6. 12 General overview of authorisation conditions for medicines 9. Part Relationship with registration laws 20 Medicines authorisations subject to Health Practitioner Regulation National Law (ACT) restrictions 10. 21 Medicines authorisations subject to Veterinary Practice Act 2018. restrictions 10. Chapter 3 Medicines supply authorities Part Prescribing medicines Division Authorisation to prescribe medicines 30 Authorisation under sch 1 to prescribe medicines Act, s 40 (1) (b), (2) (b) and (3) (b) 11.

5 31 Authorisation conditions for prescribing medicines Act, s 44 (1) (b). and (2) (b) 12. 31A Variation of authorisation condition during Commonwealth special arrangement period 14. 32 Additional requirements for prescribing controlled medicines for human use 15. Division Prescriptions 40 General requirements for written prescriptions 16. 41 Particulars for prescriptions 16. Part Requisitioning medicines Division Authorisation to issue requisitions 50 Authorisation under sch 1 to issue requisitions for medicines Act, s 41 (b) 19. 51 Authorisation conditions for issuing requisitions for medicines Act, s 44 (1) (b) and (2) (b) 19. contents 2 Medicines, Poisons and Therapeutic Goods R44. Regulation 2008 05/11/21. Effective: 05/11/21. Authorised by the ACT Parliamentary Counsel also accessible at Contents Page Division Requisitions 55 General requirements for written requisitions 20. 56 Particulars for requisitions 20.

6 Part Medicines purchase orders Division Authorisation to issue purchase orders 60 Authorisation under sch 1 to issue purchase orders for medicines . Act, s 38 (1) (b) and (2) (a) 21. 61 Authorisation conditions for issuing purchase orders for medicines . Act, s 44 (1) (b) and (2) (b) 21. Division Purchase orders 62 General requirements for medicines purchase orders Act, s 38 (2) (c) 22. Part Standing orders for medicines Division CHO standing orders 70 Authorisation of CHO to issue standing orders for supply of medicines in public health emergencies Act, s 42 (b) 23. 71 Authorisation of CHO to issue standing orders for administration of medicines for public health matters Act, s 42 (b) 23. 72 Particulars for CHO standing orders for administration of medicines for public health matters 23. Division Standing orders for institutions 75 Authorisation of doctors to issue standing orders for administration of medicines at institutions Act, s 42 (b) 24.

7 76 Particulars for standing orders for administration of medicines at institutions 25. Division Standing orders for walk-in centre 77 Authorisation of CHO to issue standing orders for supply and administration of medicines at walk-in centre Act, s 42 (b) 26. 78 Particulars for CHO standing orders for supply and administration of medicines at walk-in centre 26. Part Medicines supply authorities generally 80 Cancellation of invalid supply authorities Act, s 30 (2) (d) 28. 81 Information for CHO about monitored medicines supplied on supply authorities Act, s 31 (1) (b) and (4), def required information 28. R44 Medicines, Poisons and Therapeutic Goods contents 3. 05/11/21 Regulation 2008 . Effective: 05/11/21. Authorised by the ACT Parliamentary Counsel also accessible at Contents Page Chapter 4 Supplying medicines Part Preliminary 100 Overview of supply authorisations for medicines 30.

8 Part Medicines supply authorisations under sch 1. Division Sch 1 medicines supply authorisations 110 Authorisation under sch 1 to supply medicines . Act, s 26 (1) (b) and (2) (b) 31. Division Dispensing medicines 120 Authorisation conditions for dispensing medicines Act, s 44 (1) (b). and (2) (b) 32. 120A Variation of authorisation condition for dispensing medicines during Commonwealth special arrangement period 33. 121 How medicines are dispensed 34. 122 Noting changes to prescriptions on oral direction of prescriber Act, s 27 (2) (b) (ii) 35. 123 Labelling dispensed medicines Act, s 60 (1) (c) (i) and (2) (c) (i) 36. 124 Marking dispensed prescriptions 37. 125 Recording dispensing of medicines 39. Division Supplying medicines on requisitions 130 Authorisation conditions for supplying medicines on requisitions . Act, s 44 (1) (b) and (2) (b) 39. 131 Supplying medicines on requisitions 40.

9 132 Labelling medicines supplied on requisition Act, s 60 (1) (c) (i) and (2) (c) (i) 41. 133 Marking filled requisitions 42. 134 Recording supply of medicines on requisitions 42. Division Supplying medicines on purchase orders 140 Authorisation conditions for supplying medicines on purchase orders . Act, s 44 (1) (b) and (2) (b) 43. 141 Supplying medicines on purchase orders 44. 142 Recording supply of medicines on purchase orders 45. contents 4 Medicines, Poisons and Therapeutic Goods R44. Regulation 2008 05/11/21. Effective: 05/11/21. Authorised by the ACT Parliamentary Counsel also accessible at Contents Page Division Supplying medicines on standing orders 150 Authorisation conditions for supplying medicines on standing orders . Act, s 44 (1) (b) and (2) (b) 46. 151 Supplying medicines on standing orders 47. 152 Labelling medicines supplied on standing order Act, s 60 (1) (c) (i).

10 And (2) (c) (i) 47. 153 Recording supply of medicines on standing orders 48. Division Supplying medicines during consultations 160 Authorisation conditions for supplying medicines during consultations Act, s 44 (1) (b) and (2) (b) 49. 161 Labelling medicines supplied during consultations 50. 162 Recording medicines supplied during consultations 51. 163 Additional requirements for supplying controlled medicines for human use during consultations 52. 164 Information for CHO about monitored medicines supplied during consultations Act, s 31 (2) (b) and (4), def required information 53. Division Selling pseudoephedrine by retail 170 Meaning of retail sale div 53. 171 Authorisation conditions for retail sale of pseudoephedrine Act, s 44. (1) (b) and (2) (b) 53. 172 Requirement to tell buyer about pseudoephedrine sales record 54. 173 Required information for pseudoephedrine sales records 55.