{"id":"F2022L00884","name":"National Health (Continued Dispensing) Determination 2022","slug":"national-health-continued-dispensing-determination-2022","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":102505,"registerId":"commonwealth-F2022L00884-current","compilationNumber":null,"startDate":"2026-04-03","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"Part 1","sectionType":"part","heading":"Preliminary","content":"## Part 1—Preliminary","sortOrder":0},{"sectionNumber":"1.01","sectionType":"section","heading":"Name","content":"#### 1.01 Name\n\n  (1) This instrument is the National Health (Continued Dispensing) Determination 2022.\n  (2) This instrument may also be cited as PB 59 of 2022.","sortOrder":1},{"sectionNumber":"1.03","sectionType":"section","heading":"Authority","content":"#### 1.03 Authority\n\n  This instrument is made under subsection 89A(3) of the National Health Act 1953.","sortOrder":2},{"sectionNumber":"1.05","sectionType":"section","heading":"Definitions","content":"#### 1.05 Definitions\n\n  (1) In this instrument:\n\n> Act means the National Health Act 1953.\n\n> electronic prescription has the meaning given by subsection 5(1) of the Regulations.\n\n> increased maximum quantity, for a pharmaceutical item, means a quantity or number of units that has been determined under paragraph 85A(2)(a) of the Act as the maximum quantity or number of units of the pharmaceutical item in the pharmaceutical benefit that may, for a relevant purpose, be directed in a prescription to be supplied on any one occasion.\n\n> patient: see subsection 3.01(1).\n\n> purposes code has the meaning given by the National Health (Listing of Pharmaceutical Benefits) Instrument 2024.\n\n> Regulations means the National Health (Pharmaceutical Benefits) Regulations 2017.\n\n> relevant purpose, for a pharmaceutical benefit, means a purpose, mentioned in Part 1 of Schedule 4 of the National Health (Listing of Pharmaceutical Benefits) Instrument 2024 for a purposes code specified in Schedule 1 of that instrument for the pharmaceutical benefit, that includes the phrase “The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient”.\n\n> requested supply: see subsection 3.01(1).\n\n  (2)\n\n    Where an expression that is used in this instrument is defined for the purposes of Part\n\n    VII of the Act, it has the same meaning in this instrument as it has in that Part. Expressions used in this instrument that are defined in Part\n\n    VII include the following:\n    (a) approved pharmacist;\n    (b) pbs prescriber;\n    (c) pharmaceutical benefit has a drug;\n    (d) pharmaceutical benefit;\n    (e) pharmaceutical item;\n    (f) schedule equivalent.","sortOrder":3},{"sectionNumber":"1.06","sectionType":"section","heading":"Purpose","content":"#### 1.06 Purpose\n\n  The purpose of this instrument is to determine:\n    (a) the pharmaceutical benefits that may be supplied by an approved pharmacist without a prescription; and\n    (b) the conditions that must be satisfied when making a supply of those pharmaceutical benefits.","sortOrder":4},{"sectionNumber":"Part 2","sectionType":"part","heading":"Pharmaceutical benefits that may be supplied without a prescription","content":"## Part 2—Pharmaceutical benefits that may be supplied without a prescription","sortOrder":5},{"sectionNumber":"2.01","sectionType":"section","heading":"Pharmaceutical benefits covered by this instrument","content":"#### 2.01 Pharmaceutical benefits covered by this instrument\n\n  For the purposes of paragraph 89A(3)(a) of the Act, each pharmaceutical benefit that has a drug mentioned in an item in Schedule 1 is determined to be a pharmaceutical benefit that may be supplied by an approved pharmacist without a prescription.\n\n> Note: A pharmaceutical benefit has the drug or medicinal preparation referred to in paragraph (a) of the definition pharmaceutical benefit in relation to that benefit – see subsection 84ABA(3).","sortOrder":6},{"sectionNumber":"Part 3","sectionType":"part","heading":"Specified conditions for supplying pharmaceutical benefits without a prescription","content":"## Part 3—Specified conditions for supplying pharmaceutical benefits without a prescription","sortOrder":7},{"sectionNumber":"3.01","sectionType":"section","heading":"General","content":"#### 3.01 General\n\n  (1) For the purposes of paragraph 89A(3)(b) of the Act, the conditions specified in this Part are determined to be the conditions that must be satisfied when making a supply (the requested supply) of a pharmaceutical benefit to a person (the patient) requesting the supply without a prescription in accordance with subsection 89A(1) of the Act.\n  (2) In this Part:\n    (a) a reference to the PBS prescriber is a reference to the PBS prescriber who most recently prescribed the supply of the pharmaceutical benefit to the patient; and\n    (b) a reference to “the pharmaceutical benefit” in sections 3.03, 3.05, 3.06 and 3.07 includes a reference to a pharmaceutical benefit that is a Schedule equivalent.","sortOrder":8},{"sectionNumber":"3.02","sectionType":"section","heading":"Condition—unable to obtain prescription","content":"#### 3.02 Condition—unable to obtain prescription\n\n  The approved pharmacist must be satisfied of either or both of the following:\n    (a) the PBS prescriber is unable to be contacted;\n    (b) the PBS prescriber is unable to provide an electronic prescription.","sortOrder":9},{"sectionNumber":"3.03","sectionType":"section","heading":"Condition—previous supply of pharmaceutical benefit","content":"#### 3.03 Condition—previous supply of pharmaceutical benefit\n\n  The approved pharmacist must be satisfied that:\n    (a) the patient has previously been supplied the pharmaceutical benefit on the basis of a prescription from a PBS prescriber; and\n    (b) the PBS prescriber prescribed the supply of the pharmaceutical benefit for the patient in at least one of the circumstances determined for that pharmaceutical benefit under paragraph 85(7)(b) of the Act.\n\n> Note: The circumstances determined under paragraph 85(7)(b) of the Act relate to pharmaceutical benefits that are relevant pharmaceutical benefits under section 88A of the Act.","sortOrder":10},{"sectionNumber":"3.04","sectionType":"section","heading":"Condition—stability of therapy","content":"#### 3.04 Condition—stability of therapy\n\n  The approved pharmacist must be satisfied that the patient’s therapy is stable.","sortOrder":11},{"sectionNumber":"3.05","sectionType":"section","heading":"Condition—prior clinical review by PBS prescriber","content":"#### 3.05 Condition—prior clinical review by PBS prescriber\n\n  The approved pharmacist must be satisfied that:\n    (a) the patient has been taking the pharmaceutical benefit regularly for an uninterrupted period; and\n    (b) since the start of that period, the PBS prescriber has assessed the patient’s condition and decided that there is a need for ongoing treatment with the pharmaceutical benefit.\n\n> Note: See paragraph 3.01(2)(a) for references to the PBS prescriber.","sortOrder":12},{"sectionNumber":"3.06","sectionType":"section","heading":"Condition—prescription for last supply of pharmaceutical benefit","content":"#### 3.06 Condition—prescription for last supply of pharmaceutical benefit\n\n  The approved pharmacist must be satisfied that the patient had a valid prescription under Part VII of the Act for the last supply of the pharmaceutical benefit to the patient before the requested supply.","sortOrder":13},{"sectionNumber":"3.07","sectionType":"section","heading":"Condition—no continued dispensing in previous 12 months","content":"#### 3.07 Condition—no continued dispensing in previous 12 months\n\n  The approved pharmacist must be satisfied that the patient was not supplied with the pharmaceutical benefit under subsection 89A(1) of the Act in the 12 months before the requested supply.","sortOrder":14},{"sectionNumber":"3.08","sectionType":"section","heading":"Condition—declaration for supply of pharmaceutical benefit","content":"#### 3.08 Condition—declaration for supply of pharmaceutical benefit\n\n  The approved pharmacist must ensure that the patient, or an agent of the patient (other than the approved pharmacist), signs a declaration acknowledging that the patient is being supplied with the pharmaceutical benefit without the presentation of a valid prescription under Part VII of the Act.","sortOrder":15},{"sectionNumber":"3.09","sectionType":"section","heading":"Condition—maximum quantity of supply","content":"#### 3.09 Condition—maximum quantity of supply\n\n  (1) The approved pharmacist must supply a maximum quantity or number of units of the pharmaceutical item in the pharmaceutical benefit determined under paragraph 85A(2)(a) of the Act.\n  (2) However, where an increased maximum quantity has been determined for the pharmaceutical item in the pharmaceutical benefit, the approved pharmacist may only supply that increased maximum quantity if the last supply to the patient of the pharmaceutical benefit, or a pharmaceutical benefit that is Schedule equivalent, was on the basis of a prescription written for:\n    (a) a relevant purpose for the pharmaceutical benefit; or\n    (b) a relevant purpose for a pharmaceutical benefit that is Schedule equivalent to the pharmaceutical benefit.","sortOrder":16},{"sectionNumber":"3.10","sectionType":"section","heading":"Condition—preparing and recording information","content":"#### 3.10 Condition—preparing and recording information\n\n  (1) The approved pharmacist must, when the pharmaceutical benefit is supplied:\n    (a) record the information that the pharmacist used to support the pharmacist’s decision to supply the pharmaceutical benefit; and\n    (b) prepare information about the supply to the patient that the pharmacist will send to the PBS prescriber.\n  (2) The information that must be recorded and prepared under subsection (1) must include the following:\n    (a) a statement that the pharmaceutical benefit supplied is a pharmaceutical benefit covered by Schedule 1;\n    (b) a statement that the conditions mentioned in sections 3.02 to 3.05 are satisfied;\n    (c) a statement that the approved pharmacist is satisfied that the pharmaceutical benefit needs to be supplied to the patient to facilitate continuity of treatment.","sortOrder":17},{"sectionNumber":"1","sectionType":"section","heading":"Pharmaceutical benefits that may be supplied without a prescription by an approved pharmacist — pharmaceutical benefits that have certain listed drugs","content":"#### 1 Pharmaceutical benefits that may be supplied without a prescription by an approved pharmacist – pharmaceutical benefits that have certain listed drugs\n\n| Item | Listed drug                                                           |\n| ---- | --------------------------------------------------------------------- |\n| 1    | Abacavir                                                              |\n| 2    | Abacavir with lamivudine                                              |\n| 3    | Acarbose                                                              |\n| 4    | Alogliptin                                                            |\n| 5    | Alogliptin with metformin                                             |\n| 6    | Amlodipine                                                            |\n| 7    | Amlodipine with atorvastatin                                          |\n| 8    | Amlodipine with valsartan                                             |\n| 9    | Amlodipine with valsartan and hydrochlorothiazide                     |\n| 10   | Atazanavir with cobicistat                                            |\n| 11   | Atenolol                                                              |\n| 12   | Atorvastatin                                                          |\n| 13   | Beclometasone                                                         |\n| 14   | Beclometasone with formoterol                                         |\n| 15   | Bictegravir with emtricitabine with tenofovir alafenamide             |\n| 16   | Bisoprolol                                                            |\n| 17   | Budesonide                                                            |\n| 18   | Budesonide with formoterol                                            |\n| 19   | Candesartan                                                           |\n| 20   | Candesartan with hydrochlorothiazide                                  |\n| 21   | Captopril                                                             |\n| 22   | Carvedilol                                                            |\n| 23   | Chlortalidone                                                         |\n| 24   | Ciclesonide                                                           |\n| 25   | Dapagliflozin                                                         |\n| 26   | Dapagliflozin with metformin                                          |\n| 27   | Dapagliflozin with sitagliptin                                        |\n| 28   | Darunavir                                                             |\n| 29   | Darunavir with cobicistat                                             |\n| 30   | Darunavir with cobicistat, emtricitabine and tenofovir alafenamide    |\n| 31   | Diltiazem                                                             |\n| 32   | Dolutegravir with abacavir and lamivudine                             |\n| 33   | Dolutegravir with lamivudine                                          |\n| 34   | Dolutegravir with rilpivirine                                         |\n| 35   | Drospirenone                                                          |\n| 36   | Drospirenone with ethinylestradiol                                    |\n| 37   | Dulaglutide                                                           |\n| 38   | Empagliflozin                                                         |\n| 39   | Empagliflozin with linagliptin                                        |\n| 40   | Empagliflozin with metformin                                          |\n| 41   | Emtricitabine with rilpivirine with tenofovir alafenamide             |\n| 42   | Emtricitabine with tenofovir alafenamide                              |\n| 43   | Enalapril                                                             |\n| 44   | Enalapril with hydrochlorothiazide                                    |\n| 45   | Entecavir                                                             |\n| 46   | Eplerenone                                                            |\n| 47   | Eprosartan                                                            |\n| 48   | Eprosartan with hydrochlorothiazide                                   |\n| 49   | Estetrol with drospirenone                                            |\n| 50   | Etonogestrel with ethinylestradiol                                    |\n| 51   | Etravirine                                                            |\n| 52   | Ezetimibe and rosuvastatin                                            |\n| 53   | Ezetimibe with atorvastatin                                           |\n| 54   | Ezetimibe with simvastatin                                            |\n| 55   | Felodipine                                                            |\n| 56   | Fluticasone furoate                                                   |\n| 57   | Fluticasone furoate with vilanterol                                   |\n| 58   | Fluticasone propionate                                                |\n| 59   | Fluticasone propionate with formoterol                                |\n| 60   | Fluticasone propionate with salmeterol                                |\n| 61   | Formoterol                                                            |\n| 62   | Fosinopril                                                            |\n| 63   | Furosemide                                                            |\n| 64   | Glibenclamide                                                         |\n| 65   | Gliclazide                                                            |\n| 66   | Glimepiride                                                           |\n| 67   | Glipizide                                                             |\n| 68   | Hydrochlorothiazide                                                   |\n| 69   | Hydrochlorothiazide with amiloride                                    |\n| 70   | Indacaterol                                                           |\n| 71   | Indacaterol with mometasone                                           |\n| 72   | Indapamide                                                            |\n| 73   | Insulin aspart                                                        |\n| 74   | Insulin aspart with insulin aspart protamine suspension               |\n| 75   | Insulin degludec with insulin aspart                                  |\n| 76   | Insulin detemir                                                       |\n| 77   | Insulin glargine                                                      |\n| 78   | Insulin glulisine                                                     |\n| 79   | Insulin isophane                                                      |\n| 80   | Insulin lispro                                                        |\n| 81   | Insulin lispro with insulin lispro protamine suspension               |\n| 82   | Insulin neutral                                                       |\n| 83   | Insulin neutral with insulin isophane                                 |\n| 84   | Irbesartan                                                            |\n| 85   | Irbesartan with hydrochlorothiazide                                   |\n| 86   | Labetalol                                                             |\n| 87   | Lamivudine                                                            |\n| 88   | Lamivudine with zidovudine                                            |\n| 89   | Lercanidipine                                                         |\n| 90   | Lercanidipine with enalapril                                          |\n| 91   | Levonorgestrel                                                        |\n| 92   | Levonorgestrel with ethinylestradiol                                  |\n| 93   | Linagliptin                                                           |\n| 94   | Linagliptin with metformin                                            |\n| 95   | Lisinopril                                                            |\n| 96   | Lopinavir with ritonavir                                              |\n| 97   | Maraviroc                                                             |\n| 98   | Metformin                                                             |\n| 99   | Metoprolol                                                            |\n| 100  | Metoprolol succinate                                                  |\n| 101  | Nebivolol                                                             |\n| 102  | Nevirapine                                                            |\n| 103  | Nifedipine                                                            |\n| 104  | Norethisterone                                                        |\n| 105  | Norethisterone with ethinylestradiol                                  |\n| 106  | Olmesartan                                                            |\n| 107  | Olmesartan with amlodipine                                            |\n| 108  | Olmesartan with amlodipine and hydrochlorothiazide                    |\n| 109  | Olmesartan with hydrochlorothiazide                                   |\n| 110  | Perindopril                                                           |\n| 111  | Perindopril with amlodipine                                           |\n| 112  | Perindopril with indapamide                                           |\n| 113  | Pioglitazone                                                          |\n| 114  | Pravastatin                                                           |\n| 115  | Propranolol                                                           |\n| 116  | Quinapril                                                             |\n| 117  | Ramipril                                                              |\n| 118  | Ramipril with felodipine                                              |\n| 119  | Rilpivirine                                                           |\n| 120  | Ritonavir                                                             |\n| 121  | Rosuvastatin                                                          |\n| 122  | Sacubitril with valsartan                                             |\n| 123  | Salbutamol                                                            |\n| 124  | Salmeterol                                                            |\n| 125  | Saxagliptin                                                           |\n| 126  | Saxagliptin with metformin                                            |\n| 127  | Semaglutide                                                           |\n| 128  | Simvastatin                                                           |\n| 129  | Sitagliptin                                                           |\n| 130  | Sitagliptin with metformin                                            |\n| 131  | Sotalol                                                               |\n| 132  | Spironolactone                                                        |\n| 133  | Telmisartan                                                           |\n| 134  | Telmisartan with amlodipine                                           |\n| 135  | Telmisartan with hydrochlorothiazide                                  |\n| 136  | Tenofovir                                                             |\n| 137  | Tenofovir alafenamide with emtricitabine, elvitegravir and cobicistat |\n| 138  | Tenofovir with emtricitabine                                          |\n| 139  | Tenofovir with emtricitabine and efavirenz                            |\n| 140  | Terbutaline                                                           |\n| 141  | Trandolapril                                                          |\n| 142  | Trandolapril with verapamil                                           |\n| 143  | Valsartan                                                             |\n| 144  | Valsartan with hydrochlorothiazide                                    |\n| 145  | Verapamil                                                             |\n| 146  | Vildagliptin                                                          |\n| 147  | Vildagliptin with metformin                                           |\n| 148  | Zidovudine                                                            |","sortOrder":18}],"analysis":{"kimi_summary":{"content_quality":"ok","complexity_score":5,"scope_assessment":{"changed":false,"description":"The legislation appears tightly focused on its original purpose of establishing emergency supply conditions for specific PBS medicines. The 2022 version updates the medicine list (Schedule 1) and references current external instruments, but the core mechanism — single emergency supply without prescription under strict conditions — remains consistent with the original intent of the continued dispensing framework established under section 89A of the National Health Act 1953."},"complexity_factors":["Multiple nested cross-references to external instruments (National Health (Listing of Pharmaceutical Benefits) Instrument 2024, National Health (Pharmaceutical Benefits) Regulations 2017, and National Health Act 1953)","Conditional logic in section 3.09 with an exception to the general rule about maximum quantities","Definition of 'relevant purpose' requires tracing through three layers of external documents (Schedule 4, Schedule 1, and specific phrase matching)","8 separate conditions that must all be satisfied (sections 3.02-3.10), with some containing multiple sub-conditions","Incorporation of Part VII definitions from the parent Act by reference rather than direct definition","Schedule equivalent concept creates equivalence classes between different pharmaceutical benefits that must be tracked across conditions"],"plain_english_summary":"This law creates a “continued dispensing” emergency supply system letting approved PBS pharmacists dispense one standard supply of 148 listed medicines (mostly for stable chronic conditions) without a new prescription when a prescriber cannot be contacted. It applies to patients who’ve previously had the medicine on prescription and meet strict safeguards — patient declaration, pharmacist records and prescriber notification, a 12‑month single‑use limit, and restrictions on quantity — ensuring a safety‑net, not a substitute for regular care."},"flash_summary_failed":{"failed":true,"reason":"Unauthenticated. Configure AI_GATEWAY_API_KEY or use a provider module. Learn more: https://ai-sdk.dev/unauthenticated-ai-gateway","source":"analysis-cron"},"flash_summary":{"complexity_score":7,"scope_assessment":{"changed":true,"description":"This instrument operationalises subsection 89A(3) of the Act by specifying exactly which pharmaceutical benefits may be supplied without a prescription and the conditions for such supply. Mechanically, it defines the scope of pharmacist continued dispensing for the listed drugs and sets the eligibility, quantity limits and procedural obligations that determine how the Act applies to those medicines."},"complexity_factors":["Large schedule of listed drugs (148 items) requiring pharmacists to check eligibility against a long list.","Multiple cross‑references to the National Health Act 1953, the National Health (Pharmaceutical Benefits) Regulations 2017 and the National Health (Listing of Pharmaceutical Benefits) Instrument 2024, increasing interpretive complexity.","Conditional increased maximum quantity rule: higher supply amounts allowed only where the last prescription was for a specified 'relevant purpose'.","Numerous factual satisfaction tests placed on the approved pharmacist (e.g. prescriber unreachable, therapy stability, prior clinical review, valid last prescription, no continued dispensing in prior 12 months) that are largely subjective and fact‑sensitive.","Mandatory record‑keeping and reporting requirements (statements to record and information to send to the PBS prescriber) create administrative burden and compliance risk for pharmacies.","Requirement to obtain a signed patient (or agent) declaration introduces procedural steps and potential refusal/acceptance issues.","Interplay with electronic prescription definitions and 'schedule equivalent' concepts requires additional legal/clinical verification by pharmacists."],"plain_english_summary":"This Determination names specific pharmaceutical benefits (148 listed drugs) that an approved pharmacist may supply without a prescription and sets the legal conditions for doing so — for example, prior prescription, stability of therapy, prior clinical review, limits on quantity, a patient declaration and record-keeping. It affects PBS prescribers, approved pharmacists and patients by allowing pharmacists to continue short-term supply when a prescriber cannot be contacted, while creating verification, documentation and administrative obligations for pharmacies."}},"importantCases":[],"_links":{"self":"/api/acts/national-health-continued-dispensing-determination-2022","history":"/api/acts/national-health-continued-dispensing-determination-2022/history","analysis":"/api/acts/national-health-continued-dispensing-determination-2022/analysis","conflicts":"/api/acts/national-health-continued-dispensing-determination-2022/conflicts","importantCases":"/api/acts/national-health-continued-dispensing-determination-2022/important-cases","documents":"/api/acts/national-health-continued-dispensing-determination-2022/documents"}}