{"id":"F2022L01766","name":"Therapeutic Goods (Medicines and OTG—Authorised Supply) Rules 2022","slug":"therapeutic-goods-medicines-and-otg-authorised-supply-rules-2022","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":103669,"registerId":"commonwealth-F2022L01766-current","compilationNumber":null,"startDate":"2026-04-03","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Name","content":"#### 1 Name\n\nThis instrument is the Therapeutic Goods (Medicines and OTG—Authorised Supply) Rules 2022.","sortOrder":0},{"sectionNumber":"3","sectionType":"section","heading":"Authority","content":"#### 3 Authority\n\nThis instrument is made under subsection 19(7A) of the Therapeutic Goods Act 1989.","sortOrder":1},{"sectionNumber":"4","sectionType":"section","heading":"Definitions","content":"#### 4 Definitions\n\nNote: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:\n\n(a) health practitioner;\n\n(b) listed goods;\n\n(c) medicine;\n\n(d) Register;\n\n(e) registered goods;\n\n(f) sponsor;\n\n(g) supply;\n\n(h) therapeutic goods.\n\nIn this instrument:\n\nAct means the Therapeutic Goods Act 1989.\n\nactive ingredient has the same meaning as in the Regulations.\n\n> adverse event means the following:\n\n (a) in relation to a medicine—an adverse event that occurs in relation to a person in Australia following the administration of a medicine;\n (b) in relation to a therapeutic good that is not a medicine—an adverse event that occurs in relation to a person in Australia following the use of the therapeutic good that led, or might have led, to the death of, a serious injury to, or serious deterioration in the health of, that person.\n\n> Note: An adverse event may not necessarily have a causal relationship with the administration or use of the therapeutic good.\n\nnurse practitioner means a person who is:\n\n(a) registered under a law of a state or internal territory as a registered nurse; and\n\n(b) endorsed as a nurse practitioner by the Nursing and Midwifery Board of Australia.\n\nNote: The Nursing and Midwifery Board of Australia works in partnership with the Australian Health Practitioner Regulation Agency.\n\nRegulations means the Therapeutic Goods Regulations 1990.\n\nTherapeutic Goods Administration has the same meaning as in the Therapeutic Goods Regulations 1990.\n\ntherapeutic vaping kit has the same meaning as in the Regulations.\n\ntherapeutic vaping pack has the same meaning as in Regulations.\n\ntherapeutic vaping substance has the same meaning as in the Regulations.","sortOrder":2},{"sectionNumber":"5","sectionType":"section","heading":"Authorisation","content":"#### 5 Authorisation\n\nSupply by a medical practitioner\n\n(1) A health practitioner who is a medical practitioner is authorised to supply a medicine to a patient of that practitioner where:\n\n(a) the medicine contains an active ingredient specified in column 2 of an item in the table in Schedule 1 and does not contain any other active ingredient; and\n\n(b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n(c) the medicine is in the dosage form specified in column 3 of that item; and\n\n(d) the medicine is to be administered by the route specified in column 4 of that item; and\n\n(e) the supply is for the indication specified in column 5 of that item; and\n\n(f) the conditions specified in subsection (2) are satisfied.\n\n(2) The medical practitioner must:\n\n(a) inform the patient, or a parent or guardian of the patient, that the medicine is not a listed good or registered good; and\n\n(b) obtain informed consent from the patient, or a parent or guardian of the patient, in relation to, and before, the supply of the medicine; and\n\n(c) supply the medicine in accordance with good medical practice; and\n\n(d) if the medical practitioner becomes aware that the patient has suffered an adverse event in relation to the medicine—notify the Therapeutic Goods Administration within 15 days of becoming aware of the adverse event; and\n\n(e) if the medical practitioner becomes aware of a defect in the medicine—notify the Therapeutic Goods Administration within 15 calendar days of becoming aware of the defect.\n\nSupply to a patient of a medical practitioner\n\n(3) A health practitioner is authorised to supply a medicine to a patient of a medical practitioner (the treating practitioner) where:\n\n(a) the medicine contains an active ingredient specified in column 2 of an item in the table in Schedule 1 and does not contain any other active ingredient; and\n\n(b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n(c) the supply is requested by the treating practitioner; and\n\n(d) the medicine is in the dosage form specified in column 3 of that item; and\n\n(e) the medicine is to be administered by the route specified in column 4 of that item; and\n\n(f) the supply is for the indication specified in column 5 of that item; and\n\n(g) the conditions specified in subsection (4) are satisfied.\n\n(4) The health practitioner supplying the medicine must:\n\n(a) if the health practitioner becomes aware that the patient has suffered an adverse event in relation to the medicine—notify the Therapeutic Goods Administration within 15 days of becoming aware of the adverse event; and\n\n(b) if the health practitioner becomes aware of a defect in the medicine—notify the Therapeutic Goods Administration within 15 days of becoming aware of the defect.","sortOrder":3},{"sectionNumber":"5A","sectionType":"section","heading":"Authorisation—therapeutic vaping goods","content":"#### 5A Authorisation—therapeutic vaping goods\n\nSupply by a medical practitioner or nurse practitioner\n\n(1) A health practitioner who is a medical practitioner or a nurse practitioner is authorised to supply a therapeutic good to a patient of that practitioner where:\n\n(a) the therapeutic good is within the class of therapeutic goods specified in column 2 of an item in the table in Schedule 1A; and\n\n(b) the therapeutic good is in the dosage form specified in column 3 of that item; and\n\n(c) the therapeutic good is to be administered by the route specified in column 4 of that item; and\n\n(d) the supply is for the indication specified in column 5 of that item; and\n\n(e) the supply is to a patient who is 16 years of age or over; and\n\n(f) the conditions specified in subsection (2) are satisfied.\n\n(2) The medical practitioner or nurse practitioner must:\n\n(a) inform the patient, or a parent or a guardian of the patient, that the therapeutic good is not a listed good or registered good; and\n\n(b) obtain informed consent from the patient, or a parent or a guardian of the patient, in relation to, and before, the supply of the therapeutic good; and\n\n(c) supply the therapeutic good in accordance with good medical practice or good nursing practice (as the case requires); and\n\n(d) if the medical practitioner or nurse practitioner becomes aware that the patient has suffered an adverse event in relation to the therapeutic good—notify the Therapeutic Goods Administration within 15 days of becoming aware of the adverse event; and\n\n(e) if the medical practitioner or nurse practitioner becomes aware of a defect in the therapeutic good—notify the Therapeutic Goods Administration within 15 days of becoming aware of the defect.\n\nSupply by a pharmacist—with prescription\n\n(3) A pharmacist is authorised to supply a therapeutic good to a patient of a medical practitioner or a nurse practitioner (the treating practitioner) where:\n\n(a) the therapeutic good is within the class of therapeutic goods specified in column 2 of an item in the table in Schedule 1A; and\n\n(b) the supply is requested by the treating practitioner; and\n\n(c) the therapeutic good is in the dosage form specified in column 3 of that item; and\n\n(d) the therapeutic good is to be administered by the route specified in column 4 of that item; and\n\n(e) the supply is for the indication specified in column 5 of that item; and\n\n(f) the supply is to a patient who is 16 years of age or over; and\n\n(g) the conditions specified in subsection (4) are satisfied.\n\n(4) The pharmacist supplying the therapeutic good must:\n\n(a) if the pharmacist becomes aware that the patient has suffered an adverse event in relation to the therapeutic good—notify the Therapeutic Goods Administration within 15 days of becoming aware of the adverse event; and\n\n(b) if the pharmacist becomes aware of a defect in the therapeutic good—notify the Therapeutic Goods Administration within 15 days of becoming aware of the defect.\n\nSupply by a pharmacist—without prescription\n\n(5) A pharmacist is authorised to supply a therapeutic good to a patient where:\n\n(a) the therapeutic good is within the class of therapeutic goods specified in column 2 of an item in the table in Schedule 1A; and\n\n(b) the therapeutic good is in the dosage form specified in column 3 of that item; and\n\n(c) the therapeutic good is to be administered by the route specified in column 4 of that item; and\n\n(d) the supply is for the indication specified in column 5 of that item; and\n\n(e) the supply is to a patient who is 18 years of age or over; and\n\n(f) the pharmacist requests and sights evidence of the patient’s identity and age; and\n\n(g) the quantity of the goods does not exceed the quantity that is reasonably required for a patient’s therapeutic use for 1 month and that quantity is supplied to the patient only once in a month; and\n\n(h) the concentration of nicotine in the goods does not exceed 20 mg/mL; and\n\n(i) the conditions specified in subsections (6) and (7) are satisfied.\n\n(6) The pharmacist must:\n\n(a) inform the patient, or a parent or a guardian of the patient, that the therapeutic good is not a listed good or registered good; and\n\n(b) obtain informed consent from the patient, or a parent or a guardian of the patient, in relation to, and before, the supply of the therapeutic good; and\n\n(c) supply the therapeutic good in accordance with good pharmacy practice; and\n\n(d) provide professional advice to the patient on alternative cessation supports and therapies, appropriate dose and frequency depending on age, weight and severity of condition, length of treatment, suitable titration, and interactions with other medicines; and\n\n(e) provide contact details about smoking cessation support services to the patient; and\n\n(f) if the pharmacist becomes aware that the patient has suffered an adverse event in relation to the therapeutic good—notify the Therapeutic Goods Administration within 15 days of becoming aware of the adverse event; and\n\n(g) if the pharmacist becomes aware of a defect in the therapeutic good—notify the Therapeutic Goods Administration within 15 days of becoming aware of the defect.\n\n(7) The pharmacist must store the therapeutic good in a part of the pharmacy premises to which the public does not have access.\n\n \n\nSchedule 1—Medicines authorised for supply\n\nNote: See section 5.\n\n```html\n

Specified therapeutic goods

Column 1

Column 2

Column 3

Column 4

Column 5

Item

Active ingredient

Dosage form

Route of administration

Indication

1

allergens—multiple, various (including control solutions)

drops

intradermal

confirmation of suspected allergic reactions

2

allergens – multiple, various (including control solutions)

drops

skin prick

confirmation of suspected allergic reactions

3

amiloride

tablet

oral

treatment of hypokalemia

4

betaxolol 0.25%
(preservative free)

eye drops

ophthalmic

treatment of elevated intraocular pressure where other treatments are inappropriate

5

bismuth subcitrate

tablet

oral

treatment of resistant Helicobacter Pylori infection

7

calcitriol

liquid

oral

prevention of hypophosphatemic rickets in children; or

treatment of hypoparathyroidism (with severe hypocalcaemia)

8

carbidopa

tablet

oral

premedication for F‑18 DOPA imaging

9

ciclosporin, 0.05%

eye drops, emulsion

ophthalmic

treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)

10

cinnarizine

tablet

oral

treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease)

11

clobetasol propionate 0.05%

cream

topical

treatment, or prolongation of flare‑free intervals, of dermatitis/eczema where other treatments have failed

12

clobetasol propionate 0.05%

lotion

topical

treatment, or prolongation of flare‑free intervals, of dermatitis/eczema where other treatments have failed

13

clobetasol propionate 0.05%

ointment

topical

treatment, or prolongation of flare‑free intervals, of dermatitis/eczema where other treatments have failed

14

clofazimine

capsule

oral

treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed mycobacterium avium paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non‑tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist

15

colecalciferol

capsule

oral

treatment of severe vitamin D deficiency and prevention of osteoporosis

16

colecalciferol

injection

intramuscular

treatment of severe vitamin D deficiency and prevention of osteoporosis

17

cyclopentolate, 0.2%, and phenylephrine, 1%

eye drops

ophthalmic

production of mydriasis

18

deflazacort

tablet

oral

treatment of Duchenne muscular dystrophy

19

dehydrated ethanol (alcohol) 96% ‑ 100%

ampoule

topical

treatment of progressive keratoconus and intra‑operative use in superficial keratectomy (single use per procedure)

20

dexamethasone (preservative free)

eye drops

ophthalmic

treatment of inflammatory conditions of the eye that are non‑infected and steroid responsive in patients sensitive to preservative‑containing formulations

21

diazoxide

capsule

oral

treatment of hypoglycaemia, hyperinsulinaemia, Beckwith‑Weiderman Syndrome or insulinoma

22

diazoxide

suspension

oral

treatment of hypoglycaemia, hyperinsulinaemia, Beckwith‑Weiderman Syndrome or insulinoma

23

diazoxide

tablet

oral

treatment of hypoglycaemia, hyperinsulinaemia, Beckwith‑Weiderman Syndrome or insulinoma

24

diflunisal

tablet

oral

treatment of amyloidosis

25

dimethyl sulfoxide (DMSO)

solution

intravesical

symptomatic relief of interstitial cystitis

27

doxycycline

injection

intralesional

sclerotherapy of lymphatic malformations

27A

escherichia coli/klebsiella pneumoniae/enterococcus faecalis/proteus vulgaris

spray

sublingual

management of recurrent urinary tract infections

28

F‑18 DCFPyl (PSMA)

injection

intravenous

prostate cancer imaging study

29

F‑18 myocardial perfusion tracer (18F flurpiridaz)

injection

intravenous

myocardial perfusion study

30

F‑18 NaF (sodium fluoride)

injection

intravenous

bone study

31

flunarizine

capsule

oral

treatment of vestibular disorders or prophylactic treatment of migraine

32

flunarizine

tablet

oral

treatment of vestibular disorders or prophylactic treatment of migraine

33

furazolidone

tablet

oral

treatment of resistant Helicobacter Pylori infection

33A

gallium-68 DOTA (Tyr3) octreotate

injection

intravenous

PET imaging for localisation of somatostatin receptor positive neuroendocrine tumours (NETs)

34

gallium-68 (Ga-68)

aerosol

inhalation

lung ventilation study

35

gallium‑68 (Ga‑68) - MAA

injection

intravenous

lung perfusion study

37

ganciclovir

gel

ophthalmic

treatment of cytomegalovirus

38

glycopyrronium bromide

tablet

oral

treatment of excessive salivation in patients with neurological conditions

39

hyoscine hydrobromide

patch

transdermal

treatment of excessive salivation

40

hypertonic sodium chloride, 5%

eye drops

ophthalmic

temporary relief of corneal oedema (hypertonicity)

41

hypertonic sodium chloride, 5%

eye ointment

ophthalmic

temporary relief of corneal oedema (hypertonicity)

42

iloprost

injection

intravenous infusion

treatment of patients with severe disabling Raynaud’s phenomenon; or

treatment of peripheral ischaemia

42A

imipenem/cilastatin

injection

intravenous

treatment of non-tuberculosis mycobacteria

43

indigo carmine

injection

intravenous

intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures

44

indocyanine green dye

injection

intravenous

intra‑operative diagnostic use

45

interferon alpha-2b

eye drops

ophthalmic

treatment of ocular surface squamous neoplasia

45A

isoniazid/rifampicin

dispersible tablets

oral

treatment of latent tuberculosis infection

45B

isoniazid/rifampicin

tablets

oral

treatment of latent tuberculosis infection

45C

isoniazid/rifapentine

tablets

oral

treatment of latent tuberculosis infection

46

ketotifen

tablet

oral

treatment of allergic conditions

47

levofloxacin

tablet

oral

treatment of resistant Helicobacter Pylori infection or drug resistant tuberculosis

48

levomepromazine

injection

subcutaneous

treatment of nausea and vomiting or agitation

49

levomepromazine

tablet

oral

treatment of nausea and vomiting or agitation

50

lifitegrast

eye drops

ophthalmic

treatment of dry eye disease

53

melatonin

lozenge

oral

treatment of sleep disorders

55

metolazone

tablet

oral

treatment of fluid overload

56

mexiletine

capsule

oral

treatment of ventricular arrhythmia or myotonic disorders

57

mexiletine

tablet

oral

treatment of ventricular arrhythmia or myotonic disorders

58

moxifloxacin 0.5%

eye drops

ophthalmic

treatment of refractory bacterial conjunctivitis

58A

mycobacterium bovis (bacillus calmette and guerin (BCG) strain)

injection

intradermal

immunisation against tuberculosis

59

nadolol

tablet

oral

treatment of ventricular tachycardia or long QT Syndrome

60

natamycin 5%

eye drops

ophthalmic

treatment of refractory fungal blepharitis, conjunctivitis or keratitis

61

neomycin

tablet

oral

sepsis prevention for colorectal operation

62

nitazoxanide

suspension

oral

treatment of giardiasis, cryptosporidiosis or blastocystis

63

nitazoxanide

tablet

oral

treatment of giardiasis, cryptosporidiosis or blastocystis

64

paromomycin

capsule

oral

antiprotozoal treatment of any of the following amoebic infections:

(a) blastocystis hominis;

(b) dientomoeba fragilis;

(c) entamoeba histolytica;

(d) parasite infection

65

pimozide

tablet

oral

treatment of schizophrenia, chronic psychosis or Tourette syndrome

66

pristinamycin

tablet

oral

treatment of confirmed methicillin‑resistant Staphylococcus aureus or vancomycin‑resistant enterococci infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or

treatment of refractory or resistant mycoplasma genitalium infections; or

treatment of other infections as prescribed by an infectious disease specialist

69

pyrazinamide

tablet

oral

treatment of tuberculosis

70

riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)

eye drops

ophthalmic

intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus

71

riboflavin, 0.1% in 20% dextran

eye drops

ophthalmic

intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus

72

riboflavin, 0.1% in sodium chloride

eye drops

ophthalmic

intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus

73

riboflavin, 0.22% in sodium chloride

eye drops

ophthalmic

intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus

74

ripasudil 0.4%

eye drops

ophthalmic

treatment of refractory corneal oedema or refractory glaucoma

75

sodium benzoate

tablet

oral

treatment of urea cycle disorders

76

tacrolimus 0.03%

ointment

topical

treatment, or prolongation of flare‑free intervals, of moderate to severe atopic dermatitis/eczema in children

77

tacrolimus 0.1%

ointment

topical

treatment, or prolongation of flare‑free intervals, of moderate to severe atopic dermatitis/eczema in adults

78

technetium-99m (99m Tc) prostate specific membrane antigen (PSMA)-I&S

injection

intravenous

prostate cancer imaging study

79

tetracycline

capsule

oral

treatment of resistant Helicobacter Pylori infection

80

tetracycline

tablet

oral

treatment of resistant Helicobacter Pylori infection

81

tick‑borne encephalitis vaccine

injection

intramuscular

prevention of tick‑borne encephalitis

82

tinidazole

tablet

oral

treatment of trichomonas vaginalis infections of the genito‑urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or

treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or

prevention of infection of the surgical site

83

tizanidine

capsule

oral

treatment of spasticity where other treatments have failed

84

tizanidine

tablet

oral

treatment of spasticity where other treatments have failed

85

triamcinolone acetonide

suspension for injection

ophthalmic

treatment of non‑infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post‑operative macular oedema (cataract surgery)

86

verteporfin

powder for injection

intravenous infusion

photosensitisation for photodynamic therapy

87

yttrium‑90 (Y‑90) citrate

injection

intraarticular

radiosynovectomy treatment

\n```\n\n \n\nSchedule 1A—Therapeutic vaping goods\n\nNote: See section 5A.\n\n```html\n

Specified therapeutic goods

Column 1

Column 2

Column 3

Column 4

Column 5

Item

Class of therapeutic goods

Dosage form

Route of administration

Indication

1

therapeutic vaping substances or therapeutic vaping substance accessories that:

(a) contain nicotine as the only active ingredient;

(b) are the subject of a notification under item 15 in Schedule 5A to the Regulations; and

(c) are not the subject of a determination by the Secretary under item 15 in Schedule 5A to the Regulations

liquid or solid

inhalation

any one or more of the following:

(a) use for smoking cessation;

(b) management of nicotine dependence

2

therapeutic vaping substances or therapeutic vaping substance accessories that:

(a) do not contain any active ingredients;

(b) are the subject of a notification under item 15 in Schedule 5A to the Regulations; and

(c) are not the subject of a determination by the Secretary under item 15 in Schedule 5A to the Regulations

liquid or solid

inhalation

any one or more of the following:

(a) use for smoking cessation;

(b) management of nicotine dependence

3

therapeutic vaping kits that:

(a) contain one or more therapeutic vaping substances or therapeutic vaping substance accessories; and

(b) are the subject of a notification under item 15 in Schedule 5A to the Regulations; and

(d) are not the subject of a determination by the Secretary under item 15 in Schedule 5A to the Regulations

liquid or solid

inhalation

any one or more of the following:

(a) use for smoking cessation;

(b) management of nicotine dependence

4

goods in a therapeutic vaping pack that:

(a) are or contain one or more therapeutic vaping substances or therapeutic vaping substance accessories; and

(b) are the subject of a notification under item 15 in Schedule 5A to the Regulations; and

(c) are not the subject of a determination by the Secretary under item 15 in Schedule 5A to the Regulations

liquid or solid

inhalation

any one or more of the following:

(a) use for smoking cessation;

(b) management of nicotine dependence

\n```","sortOrder":4}],"analysis":{"kimi_summary":{"_metrics":{"provider":"moonshot","completionTokens":2913},"content_quality":"ok","complexity_score":6,"scope_assessment":{"changed":true,"description":"The instrument originally established authorised supply pathways for specific unregistered medicines (Schedule 1). Its scope has significantly expanded to incorporate a comprehensive regulatory framework for therapeutic vaping goods (Schedule 1A), creating distinct legal supply chains for nicotine vaping products as smoking cessation aids. This extends the legislation beyond traditional pharmaceutical medicines to include medical devices and substances used for nicotine dependence, involving complex new roles for pharmacists (including non-prescription supply) and age-specific access controls."},"complexity_factors":["Cross-referencing to the Therapeutic Goods Act 1989 and Therapeutic Goods Regulations 1990 for foundational definitions (e.g., 'active ingredient', 'therapeutic vaping kit', 'supply').","10 defined terms in section 4, including specific medical practitioner categories ('nurse practitioner') and technical concepts ('adverse event').","Dual regulatory schemes within one instrument: one for traditional medicines (s 5, Schedule 1) and one for therapeutic vaping goods (s 5A, Schedule 1A), each with distinct supply pathways.","Nested conditional logic in subsections (e.g., s 5(1) contains 6 specific criteria that must all be met; s 5A(5) has 9 separate conditions for pharmacist supply without prescription).","Detailed tabular schedules specifying exact active ingredients, strengths, dosage forms, routes of administration, and approved indications (Schedule 1 has 87 items; Schedule 1A has 4 complex item classes).","Age-based distinctions (16+ versus 18+) and prescription-status distinctions creating multiple supply pathways for the same class of goods (vaping products).","Mandatory reporting obligations triggered by specific events (adverse events/defects) with strict 15-day timeframes."],"plain_english_summary":"This law creates a tightly controlled exception allowing certain health professionals to supply specified unregistered medicines and nicotine vaping products for smoking cessation. It authorises doctors (and, in limited cases, nurse practitioners and pharmacists) to provide listed unregistered drugs to patients, with informed consent and mandatory adverse‑event reporting.\n\nFor vaping, it permits prescription supply to 16+ patients and restricted pharmacist supply to adults 18+ (one‑month limit, ID checks, max nicotine strength, counselling and storage rules), improving access while protecting public health."},"flash_summary":{"complexity_score":8,"scope_assessment":{"changed":true,"description":"This instrument broadens the traditional emergency/limited-authority supply model by adding an explicit, product-level list of permitted unregistered/unlisted medicines (Schedule 1) and, notably, by creating an authorisation pathway for therapeutic vaping goods (Schedule 1A). The vaping provisions introduce new OTC-style supply conditions (pharmacist supply without prescription under strict caps and counselling duties) and tie eligibility to separate Regulatory notifications (Schedule 5A) and Secretary determinations. Compared with a narrow instrument that only listed a few emergency medicines, this version meaningfully expands scope by (a) enlarging the list of authorised medicines to many items and (b) adding a regulated pathway for nicotine-containing vaping goods with distinct supplier roles and age/quantity/concentration rules."},"complexity_factors":["Large Schedule 1 with items numbered up to 87 specifying distinct active ingredients, dosage forms, routes and indications (many product-level permutations).","Separate Schedule 1A for therapeutic vaping goods with additional conditional logic referencing regulatory notifications (Schedule 5A to the Regulations) and Secretary determinations.","Multiple supply pathways with differing duties and eligibility rules (medical practitioner supply, supply to a patient of a treating practitioner, nurse practitioner supply, pharmacist supply with and without prescription).","Age thresholds and different obligations depending on supplier type (e.g. 16+ for practitioner-supplied vaping goods; 18+ and ID checks for pharmacist OTC vaping supply).","Quantity and concentration limits for pharmacist OTC vaping supply (reasonable 1-month quantity; nicotine cap of 20 mg/mL) plus storage-location requirement.","Uniform short reporting timeline (notify TGA within 15 days) applied to adverse events and defects across supplier classes — operationally demanding.","Cross-references to the Therapeutic Goods Act 1989, the Therapeutic Goods Regulations 1990, Schedule 5A item 15 to the Regulations, and Secretary determinations — requires reading multiple instruments to confirm product eligibility.","Numerous conditional statements and nested requirements (e.g. product must contain only the listed active ingredient and only in the listed concentration/strength and form).","Differing professional-standard obligations (good medical practice, good nursing practice, good pharmacy practice) that are conceptually simple but legally open-ended and require professional judgment."],"plain_english_summary":"**What this instrument does (mechanics)\n\n- Authorises certain health professionals to supply specified unregistered or unlisted medicines and specified \"therapeutic vaping\" goods outside the usual listing/registration routes. (See section 5 and section 5A.)\n- The instrument attaches a table of specific medicines (Schedule 1) and a short table for therapeutic vaping goods (Schedule 1A). Each table entry sets the allowed active ingredient, dosage form, route of administration and the permitted clinical indication. A medicine or vaping good is only authorised if it exactly matches the relevant Schedule entry. (See Schedule 1 and Schedule 1A.)\n- Different supply pathways are authorised with different rules: a) supply directly by a medical practitioner to their patient (section 5(1)–(2)); b) supply to a patient of a treating medical practitioner when requested by that treating practitioner (section 5(3)–(4)); c) for therapeutic vaping goods, supply by a medical or nurse practitioner (section 5A(1)–(2)); d) supply of vaping goods by pharmacists with a prescription (5A(3)–(4)); and e) limited supply of vaping goods by pharmacists without a prescription to adult patients subject to quantity, age and nicotine concentration limits (5A(5)–(7)).\n- Common obligations across supplier types: tell the patient the product is not a listed/registered good, obtain informed consent before supply, act in accordance with good professional practice, and notify the Therapeutic Goods Administration (TGA) within 15 days if the supplier becomes aware of an adverse event or a defect. (See sections 5(2)(a)–(e), 5(4)(a)–(b), 5A(2)(a)–(e), 5A(4)(a)–(b), 5A(6)(f)–(g), 5A(7)(f)–(g).)\n- For pharmacists supplying vaping goods without a prescription there are extra duties: verify age/identity (18+), limit quantity to what is \"reasonably required\" for 1 month and only once per month, cap nicotine concentration at 20 mg/mL, provide counselling on cessation alternatives and dosing, provide smoking-cessation contact details, and store the goods out of public access. (See section 5A(5)(f)–(i), 5A(6)(a)–(e), 5A(7).)\n- The vaping goods entries in Schedule 1A also rely on cross-references to the Therapeutic Goods Regulations 1990 (notifications under Schedule 5A, item 15) and on possible Secretary determinations — so some products are only authorised if they have the right regulatory notification and are not the subject of a Secretary determination to the contrary. (See Schedule 1A, Column 2, and the notes referencing Schedule 5A to the Regulations.)\n\nWho this affects (stakeholders)\n\n- Patients: access to a defined list of otherwise unregistered/unlisted medicines and nicotine-containing vaping products for smoking cessation or nicotine dependence. Age limits apply (vaping goods: 16+ when supplied by practitioners; 18+ for pharmacist supply without prescription). (See section 5A(1)(e), 5A(3)(f), 5A(5)(e).)\n- Medical practitioners and nurse practitioners: ability to supply the listed goods directly under the rules, with obligations to inform, obtain consent and report adverse events/defects. (See sections 5 and 5A(1)–(2).)\n- Pharmacists: can supply therapeutic vaping goods to patients of a treating practitioner on request (prescription pathway) and can, under constrained conditions, supply certain vaping products without a prescription (ID/age checks, quantity and concentration caps, counselling and storage obligations). (See section 5A(3)–(7).)\n- Manufacturers/importers/sponsors: although the instrument authorises supply, some vaping goods must be the subject of notifications under the Regulations (Schedule 5A) and are subject to Secretary determinations — so product-level regulatory steps remain relevant. (See Schedule 1A Column 2 references.)\n- The Therapeutic Goods Administration (TGA): receives adverse event and defect reports required by the instrument and must process notifications/determinations under the Regulations referred to in Schedule 1A.\n\nWhy it matters (practical effects, choices and costs)\n\n- Access pathway: The instrument creates a legally explicit, product-by-product shortcut to allow clinical supply of certain goods that are not listed or registered. That changes the practical pathway for patients and clinicians for the Schedule-listed conditions (see Schedule 1 and 1A). Practitioners and pharmacists who use these pathways take on duties (information, consent, clinical standard of care) and administrative obligations (adverse event/defect reports to the TGA within 15 days). (See sections 5(2)(a)-(d), 5A(6)(f)-(g).)\n\n- Compliance and administrative costs: The rule imposes recurring compliance tasks on suppliers — informing and counselling patients, verifying age/identity, storing goods securely, and submitting timely reports to the TGA. Pharmacists also must limit quantities and check nicotine concentration limits for OTC vaping supplies. These activities consume staff time and may require record-keeping and separate storage space. (See section 5A(5)–(7).)\n\n- Market and regulatory trade-offs: Allowing clinical and limited pharmacist supply of unregistered/unlisted medicines and certain vaping goods reduces the need for full TGA registration/listing for those specific uses. That may speed patient access and reduce upfront regulatory costs for suppliers, but shifts more responsibility for safety monitoring onto clinicians, pharmacists and the TGA's post-supply surveillance (adverse-event reporting). The instrument therefore substitutes more post‑market monitoring for less pre‑market assessment. (See sections 5, 5A and Schedules 1/1A.)\n\n- Concentration of benefits and diffusion of costs: Benefits are concentrated among patients who need a listed product and the clinicians who prescribe/supply it. Administrative, professional and storage costs fall on practitioners and pharmacists, while the TGA must handle additional reporting. Manufacturers still face regulatory steps for vaping goods where the Regulations require notifications or Secretary determinations (Schedule 1A references).\n\nImplementation and legal-interaction risks\n\n- Cross-reference risk: authorisation for vaping goods depends on the Regulations (Schedule 5A notifications, item 15) and possible Secretary determinations; users must check those separate instruments to confirm whether a particular vaping product is eligible under the Rules. (See Schedule 1A Column 2.)\n\n- Precision requirement: the authorised supply is narrow — the product must match the Schedule entry exactly (active ingredient only, specific concentration/strength, dosage form, route, and indication). A mismatch means the instrument does not authorise supply and ordinary Act/Regulations apply. (See section 5(1)(a)–(d), 5A(1)(a)–(d).)\n\n- Monitoring burden: the 15-day reporting window for adverse events or defects is short and uniform across supplier types; clinics and pharmacies will need administrative systems to meet that deadline. (See sections 5(2)(d) and 5A(6)(f), 5A(4)(a).)\n\nPractical next steps for affected parties\n\n- Clinicians and pharmacists: check Schedule 1 and 1A to confirm whether a particular product and its formulation fall within the authorised list; ensure processes for informed consent, counselling, age/ID checks (for pharmacists), limited supply rules (pharmacists), secure storage, and timely adverse-event/defect reporting are in place. (See section 5, 5A and Schedules 1/1A.)\n- Suppliers/manufacturers: review the Regulations (Therapeutic Goods Regulations 1990), particularly notifications under Schedule 5A, item 15, and any Secretary determinations that may affect a product's eligibility. (See Schedule 1A cross-references.)\n\nKey sections to consult quickly: section 5 (authorisation for medicines); section 5A (authorisation and special rules for therapeutic vaping goods); Schedule 1 (list of medicines and permitted clinical uses); Schedule 1A (classes and conditions for therapeutic vaping goods)."},"flash_summary_failed":{"failed":true,"reason":"A positive credit balance is required for all requests, including BYOK, so fallback providers remain available. 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