Therapeutic Goods (Medicines and OTG—Authorised Supply) Rules 2022

This instrument, titled the Therapeutic Goods (Medicines and OTG,Authorised Supply) Rules 2022, is a delegated legislative instrument made under subsection 19(7A) of the Therapeutic Goods Act 1989 (s 3). Mechanically it does two core things.

First, it creates an express, conditional authorisation permitting health practitioners to supply specific medicines listed in Schedule 1 to their patients outside the ordinary listed/registered pathways (see s 5(1)-(4)). The authorisation is tightly circumscribed: the medicine must contain only the active ingredient shown in column 2 of the relevant Schedule 1 item, at the strength and concentration specified, in the dosage form and route set out in columns 3 and 4, and supplied for the indication set out in column 5 (s 5(1)(a)-(e)). The medical practitioner-authorisation requires additional procedural duties, including advising the patient that the product is not a listed or registered good, obtaining informed consent, supplying in accordance with good medical practice, and notifying the Therapeutic Goods Administration (TGA) of adverse events or defects within 15 days (s 5(2)(a)-(e)). Section 5 also permits other health practitioners to supply medicines to a patient of a treating medical practitioner where the supply is requested by the treating practitioner, subject to notification obligations (s 5(3)-(4)).

Second, the instrument establishes an authorisation regime specifically for therapeutic vaping goods (Schedule 1A), creating three supply pathways (s 5A). Medical practitioners and nurse practitioners may supply specified therapeutic vaping goods to their own patients aged 16 or over, on conditions mirroring the medicine authorisations (s 5A(1)-(2)). Pharmacists may supply to patients of a treating medical or nurse practitioner on request (s 5A(3)-(4)). Critically, pharmacists are also authorised to supply some therapeutic vaping goods without a prescription but only subject to multiple constraints: the patient must be 18 or older, the pharmacist must sight evidence of identity and age, the quantity must be no more than reasonably required for one month’s therapeutic use and only supplied once in a month, nicotine concentration must not exceed 20 mg/mL, storage must be in a non-public area of the pharmacy, and the pharmacist must provide specified counselling and notification actions (s 5A(5)-(7)).

The instrument defines relevant terms and clarifies scope in s 4, for example the meanings of “adverse event” (which expressly may not be causally related to the product) and “nurse practitioner”. Schedule 1 lists the specific medicines (with detailed column entries for active ingredient, dosage form, route and indication) and Schedule 1A lists the classes of therapeutic vaping goods eligible under the vaping regime (noting cross-reference to notification and Secretary determination provisions in Schedule 5A to the Regulations) (Schedule 1; Schedule 1A).

In short, the Rules create narrow, product-specific exceptions to the usual registered/listed therapeutic goods regimes by authorising named supplies by named categories of health professionals, and they impose procedural obligations (informed consent, advice, professional practice standards, and TGA reporting of adverse events and defects) for each authorised supply route (see ss 5, 5A, and s 4 definitions).

The instrument rests on a small set of legal concepts and operational constraints.

Authorisation by practitioner category: The Rules differentiate by who supplies the product. Section 5 focuses on medicines and distinguishes a medical practitioner supplying their own patient (s 5(1)-(2)) from other health practitioners supplying to a patient of a medical practitioner on request of the treating practitioner (s 5(3)-(4)). Section 5A distinguishes medical practitioners and nurse practitioners (s 5A(1)) from pharmacists supplying on prescription (s 5A(3)-(4)) and pharmacists supplying without prescription under a limited OTC-type regime (s 5A(5)-(7)). The instrument refers to the Act and Regulations for definitions such as “health practitioner”, “listed goods”, “registered goods”, and “sponsor” (s 4).

Product specificity and single-ingredient requirement: For medicines under s 5, the product must contain only the active ingredient specified in Schedule 1 item’s Column 2 and no other active ingredient (s 5(1)(a)). It must match the exact strength/concentration, dosage form, administration route and indication set out in the Schedule entry (s 5(1)(b)-(e)). This limits the authorisation to specific, pre‑specified formulations and uses.

Therapeutic vaping goods as a class with regulatory cross-links: Schedule 1A sets out classes of therapeutic vaping substances, vaping packs and vaping kits that are eligible for the authorisations in s 5A, but each class also requires that the goods be “the subject of a notification under item 15 in Schedule 5A to the Regulations” and “are not the subject of a determination by the Secretary under item 15 in Schedule 5A to the Regulations” (Schedule 1A, columns describing items, see Schedule 1A items 1-4). That cross-reference imports regulatory processes from the Regulations into the eligibility criteria.

Procedural duties tied to supply: The instrument imposes a set of repeatable duties on suppliers: (a) inform the patient (or parent/guardian) the product is not a listed or registered good (s 5(2)(a); s 5A(2)(a); s 5A(6)(a)); (b) obtain informed consent before supply (s 5(2)(b); s 5A(2)(b); s 5A(6)(b)); (c) supply in accordance with professional standards (good medical, nursing, or pharmacy practice) (s 5(2)(c); s 5A(2)(c); s 5A(6)(c)); and (d) notify the TGA within 15 days after becoming aware of an adverse event or a defect (s 5(2)(d)-(e); s 5(4)(a)-(b); s 5A(2)(d)-(e); s 5A(4)(a)-(b); s 5A(6)(f)-(g)). The definition of “adverse event” in s 4 includes adverse events that may not be causally related to administration or use.

Age, identity, quantity and nicotine limits for OTC-style vaping supply: Where pharmacists supply therapeutic vaping goods without prescription, the Rules set specific limits: patient must be 18 or over, the pharmacist must request and sight evidence of identity and age, the amount supplied must be reasonably required for one month’s therapeutic use and provided only once in a month, nicotine concentration must not exceed 20 mg/mL, and the product must be stored in a part of the pharmacy premises to which the public does not have access (s 5A(5)(e)-(h); s 5A(7)).

Directly affected parties are set out by practitioner category, product category and regulatory interactions in the instrument.

Health practitioners and pharmacists: Medical practitioners are authorised to supply medicines listed in Schedule 1 to their own patients (s 5(1)-(2)). Other health practitioners are authorised to supply to a patient of a treating medical practitioner where the supply is requested by that treating practitioner (s 5(3)-(4)). Under the vaping regime, medical practitioners and nurse practitioners may supply therapeutic vaping goods to their patients aged 16 or over (s 5A(1)-(2)). Pharmacists are affected in two ways: (a) they may supply therapeutic vaping goods to patients of a treating practitioner on request (s 5A(3)); and (b) they may supply certain therapeutic vaping goods without prescription subject to the instrument’s identity, age, quantity, nicotine concentration, storage and counselling requirements (s 5A(5)-(7)). The Rules therefore allocate different authorities and obligations across the professions: who may initiate supply, who may receive a request, and what procedural steps each must take.

Patients and caregivers: Patients (and where relevant their parents or guardians) are direct recipients of goods and of information duties. For example, suppliers must inform the patient or parent/guardian that the product is not a listed or registered good and must obtain informed consent prior to supply (s 5(2)(a)-(b); s 5A(2)(a)-(b); s 5A(6)(a)-(b)). The instrument also creates age-based eligibility (vaping goods: 16+ for practitioner supply (s 5A(1)(e)); 16+ for pharmacist supply with prescription (s 5A(3)(f)); 18+ for supply without prescription (s 5A(5)(e))). Those age thresholds directly determine which individuals can lawfully receive supplies under the instrument.

Manufacturers, sponsors and suppliers of products: Entities that manufacture, import or sponsor the medicines in Schedule 1 or therapeutic vaping goods in Schedule 1A are affected indirectly. The authorisation only applies where the product matches the exact active ingredient, strength, dosage form, route and indication in the Schedule entries (s 5(1)(a)-(e); Schedule 1). For therapeutic vaping goods Schedule 1A adds a regulatory precondition that the goods be the subject of a notification under item 15 in Schedule 5A to the Regulations and not the subject of a Secretary determination under the same (Schedule 1A). That means commercial parties seeking to make their products available through these authorisation channels must engage with the notification pathways in the Regulations.

The Therapeutic Goods Administration and the Secretary: The instrument imposes reportable duties to the TGA for adverse events and defects, and it references determinations the Secretary may make under the Regulations that can exclude goods from Schedule 1A eligibility (Schedule 1A). The TGA therefore becomes the central regulator to receive and potentially act on adverse event and defect reports under the 15-day rule (s 5(2)(d)-(e); s 5A(2)(d)-(e); s 5A(6)(f)-(g)). The Secretary’s determinations under Schedule 5A to the Regulations are referred to in Schedule 1A and will influence which vaping goods remain eligible.

The instrument establishes specific duties for suppliers and corresponding rights to supply in narrowly defined circumstances. The duties are operational and time-sensitive.

Rights to supply (authorisations): The Rules confer rights to supply only where product and supplier match the instrument’s criteria. For medicines, a medical practitioner is authorised to supply a patient where the product matches a Schedule 1 item’s active ingredient and specifications (s 5(1)). Other health practitioners can supply to a patient of a medical practitioner when the supply is requested by the treating practitioner (s 5(3)). For therapeutic vaping goods, medical and nurse practitioners are authorised to supply their patients 16+ where the goods match Schedule 1A descriptions and other conditions (s 5A(1)); pharmacists may supply on request of a treating practitioner (s 5A(3)) and may in some cases supply without prescription subject to the constraints in s 5A(5)-(7).

Duty to inform and obtain informed consent: Suppliers must inform the patient, or their parent or guardian, that the item is not a listed good or registered good and obtain informed consent before supply (s 5(2)(a)-(b); s 5A(2)(a)-(b); s 5A(6)(a)-(b)). That duty is repeated across practitioner categories. The instrument does not prescribe the form of the information or the record-keeping method for consent, only the substantive obligations.

Professional practice: Supplies must be made in accordance with applicable professional standards: good medical practice for medical practitioners, good nursing practice for nurse practitioners, and good pharmacy practice for pharmacists (s 5(2)(c); s 5A(2)(c); s 5A(6)(c)). These duties tether the statutory authorisation to existing professional regulatory expectations.

Adverse event and defect reporting: A uniform duty requires notification to the TGA within 15 days of becoming aware that a patient suffered an adverse event in relation to the medicine or therapeutic good, and within 15 calendar days of becoming aware of a defect in the medicine or therapeutic good (s 5(2)(d)-(e); s 5(4)(a)-(b); s 5A(2)(d)-(e); s 5A(4)(a)-(b); s 5A(6)(f)-(g)). The instrument’s definition of “adverse event” (s 4) explicitly includes events that may not necessarily have a causal relationship to the product’s administration or use.

Pharmacist-specific duties where supply without prescription: Pharmacists supplying vaping goods without prescription must (a) request and sight identity/age evidence (s 5A(5)(f)); (b) limit the quantity to no more than reasonably required for a patient’s therapeutic use for one month and supply that quantity only once in a month (s 5A(5)(g)); (c) ensure nicotine concentration does not exceed 20 mg/mL (s 5A(5)(h)); (d) inform and obtain consent (s 5A(6)(a)-(b)); (e) supply in accordance with good pharmacy practice and provide professional advice on alternative cessation supports, dose and frequency, treatment length, titration and interactions, and smoking cessation contacts (s 5A(6)(c)-(e)); (f) notify the TGA of adverse events and defects within 15 days (s 5A(6)(f)-(g)); and (g) store goods in a part of the pharmacy premises to which the public does not have access (s 5A(7)).

The Rules create authorisations and impose duties, but they do not themselves set criminal penalties or civil sanctions within their text. The instrument prescribes required conduct (for example, notification of adverse events and defects within 15 days (s 5(2)(d)-(e); s 5A(6)(f)-(g)), and professional standards obligations), but it does not specify the enforcement mechanisms or penalties for non-compliance within its own provisions.

Regulatory enforcement pathway left to broader framework: Because the instrument is made under the Therapeutic Goods Act 1989 (s 3), enforcement and sanctions for contraventions of the Act or the Regulations (or for unauthorised supply that might contravene other prohibitions in the Act or in other legislation) would be implemented under the Act, the Regulations, or professional regulation frameworks, not by this instrument itself. The instrument does not create its own penalty scheme or specify civil liability consequences. For example, reporting duties to the TGA are set out in the Rules (s 5(2)(d)-(e); s 5A(6)(f)-(g)), but failure to comply would need to be pursued under the Act or other applicable statutory or professional mechanisms.

Professional regulation and disciplinary action: The instrument ties substantive obligations to professional standards (s 5(2)(c); s 5A(2)(c); s 5A(6)(c)). Non‑compliance could be actionable through professional boards or agencies (for example, as a breach of the duty of care or of professional obligations), but such disciplinary pathways are external to this instrument and flow from professional regulatory regimes referenced in the Definitions note (s 4).

Administrative decisions and Secretary determinations: For therapeutic vaping goods eligibility under Schedule 1A there is explicit reference to Secretary determinations under item 15 in Schedule 5A to the Regulations (Schedule 1A). Those determinations are administrative acts that can remove an item from being eligible under the Rules. The instrument does not detail appeal rights or review mechanisms for such determinations; the Act and the Regulations set the administrative law framework.

TGA action on adverse events/defects: The Rules require notification to the TGA of adverse events and defects within 15 days (s 5(2)(d)-(e); s 5A(6)(f)-(g)). The instrument does not prescribe TGA follow-up actions. The TGA’s possible investigatory, regulatory or enforcement responses to notifications are governed by the Act and the broader regulatory framework, not by the Rules themselves.

Practical enforcement risk points for suppliers: Practitioners and pharmacists who supply outside the precise scope set by Schedule 1 and Schedule 1A risk that their supply will not be authorised under these Rules, and therefore be subject to the Act and the Regulations’ usual requirements for listed/registered goods or other authorisation pathways. The instrument’s textual focus on product-specific fidelity, age and quantity limits, and notification timeframes creates discrete operational compliance points; failure at those points would expose suppliers to enforcement or professional discipline under the wider statutory and professional regimes.

This instrument is a species of delegated legislation made under the Therapeutic Goods Act 1989 (s 3). It therefore operates inside and in conjunction with existing statutory and regulatory frameworks.

Definitions and cross-references under the Act and Regulations: Section 4 of the Rules explicitly notes that a number of expressions are defined in subsection 3(1) of the Act, including “health practitioner”, “listed goods”, “medicine”, “Register”, “registered goods”, “sponsor”, “supply” and “therapeutic goods” (s 4). The instrument therefore imports foundational definitions from the Act and the Regulations (the latter defined in s 4 as the Therapeutic Goods Regulations 1990). Practitioners and suppliers must apply those definitions when determining whether a particular item falls inside or outside the instrument’s authorisations.

Schedule 5A to the Regulations: Schedule 1A of the Rules repeatedly requires that therapeutic vaping substances or accessories be “the subject of a notification under item 15 in Schedule 5A to the Regulations” and “are not the subject of a determination by the Secretary under item 15 in Schedule 5A to the Regulations” (Schedule 1A items 1-4). Those cross-references make the authorisation conditional on a separate regulatory process under the Regulations. The Rules therefore depend on a functioning Schedule 5A notification/determination process in the Regulations.

Relationship to “listed” or “registered” regimes: The Rules authorise certain supplies notwithstanding that the goods are not listed or registered; suppliers must inform patients that the goods are not listed or registered (s 5(2)(a); s 5A(2)(a); s 5A(6)(a)). The instrument does not change the statutory meaning of “listed” or “registered”; instead it creates narrow alternative supply channels for certain goods. The existence of those channels does not displace the normal regulatory requirements for listing or registration for other contexts (e.g. marketing, advertising or widespread commercial supply).

Professional regulation and other statutory duties: The instrument requires supply in accordance with “good medical practice”, “good nursing practice” or “good pharmacy practice” (s 5(2)(c); s 5A(2)(c); s 5A(6)(c)). Those standards are enforced by health practitioner boards and professional regulators under separate statutory frameworks (referred to in s 4’s note about the Nursing and Midwifery Board of Australia working with AHPRA). Compliance with these Rules is therefore co‑dependent with meeting professional obligations that are separately regulated.

State and territory laws not directly referenced: The instrument operates at the Commonwealth level under the Act and the Regulations. It does not reference state or territory laws (for example laws concerning tobacco, nicotine, controlled substances, poisons scheduling, or public health) and does not purport to override them. Suppliers must therefore be mindful of applicable state and territory obligations, even though those are not contained in the Rules. The Rules’ silence on those matters does not alter the need to comply with any relevant state or territory requirements.

The text provided is the Therapeutic Goods (Medicines and OTG,Authorised Supply) Rules 2022. The instrument contains an authority clause stating it is made under subsection 19(7A) of the Therapeutic Goods Act 1989 (s 3). The instrument itself does not contain a schedule of prior amendments, nor does it in its text display historical versions or amendment notes. The document includes comprehensive Schedules (Schedule 1 and Schedule 1A) and the operative sections (ss 1, 3-5A, and 4 definitions).

What is recorded in the instrument:

• Title: The instrument gives its name at s 1 as the Therapeutic Goods (Medicines and OTG,Authorised Supply) Rules 2022 (s 1).
• Authority: It is expressly made under s 19(7A) of the Therapeutic Goods Act 1989 (s 3).
• Content: It sets out definitions (s 4), medicine authorisation (s 5), therapeutic vaping goods authorisation (s 5A) and two Schedules listing authorised medicines (Schedule 1) and authorised vaping goods classes (Schedule 1A).

The instrument does not contain an internal amendment log or notes indicating subsequent amendments. Any amendment history therefore would be recorded in the Commonwealth Law Register, the Federal Register of Legislation, or in consolidated versions of the Act and Regulations. That external record-keeping is not reproduced in the text provided. Users seeking the historical legislative timeline (for example, commencement dates, subsequent amending instruments, or revocations) must consult the instrument’s public registry entry and the Federal Register of Legislation for the canonical amendment history and associated explanatory materials.

The instrument text contains no references to case law, appeals, judicial review proceedings, or previous litigation. It names no court decisions, and no litigation or judicial interpretation is recorded within the instrument itself.

Consequently, based on the text provided, there is no litigation history embedded in this instrument. Any judicial decisions that interpret, limit or challenge the application of these Rules would appear in external legal databases, court records, or administrative law reports and are not included in the instrument’s text.

Practitioners relying on these Rules should therefore consider searching the Federal Court and relevant tribunal and administrative law decisions, and the TGA case records, to determine whether any judicial or administrative decisions have since construed these authorisations, but such searches are outside the material contained in the instrument itself.

The Rules create tightly specified authorisations and a number of practical traps for suppliers. The instrument’s legal precision produces a set of discrete compliance-risk points.

1. Exact product-match requirement: The authorisation only covers products that match Schedule 1 (medicines) or Schedule 1A (vaping goods) precisely in active ingredient, strength/concentration, dosage form, route and indication (s 5(1)(a)-(e); Schedule 1). If the product presented for supply has any additional active ingredient, a different concentration, an alternative dosage form or is being used for a different indication, the authorisation does not apply. Practically, this means clinicians and pharmacists must verify the product’s labelling and composition against the Schedule entry before relying on the authorisation.

2. Single-active requirement: For medicines authorised in s 5, the product must “not contain any other active ingredient” (s 5(1)(a)). Combination products are excluded from these authorisations.

3. Therapeutic vaping goods depend on regulatory notifications and non-exclusion: Schedule 1A requires that therapeutic vaping substances/accessories be the subject of a notification under item 15 in Schedule 5A to the Regulations and not the subject of a Secretary determination under that same item (Schedule 1A). That creates an external dependency on regulatory processes. A product may otherwise appear to fit Schedule 1A but be ineligible because of notification status or Secretary determination.

4. Age thresholds differ by pathway: Practitioner supply of vaping goods requires patient age 16+ (s 5A(1)(e)); pharmacists supplying with a prescription must supply to patients 16+ (s 5A(3)(f)); pharmacists supplying without prescription must supply to patients 18+ (s 5A(5)(e)). These different thresholds may be a source of error in practice.

5. Identity and frequency constraints for OTC-style vaping supply: Pharmacists supplying without prescription must request and sight identity and age evidence (s 5A(5)(f)). They must also limit quantity to that “reasonably required for a patient’s therapeutic use for 1 month” and supply that quantity only once in a month (s 5A(5)(g)). The term “reasonably required” is fact‑sensitive and may create enforcement uncertainty about what quantity is acceptable in borderline cases.

6. Nicotine concentration cap: The pharmacist OTC supply route is only available where nicotine concentration ≤20 mg/mL (s 5A(5)(h)). Products over that concentration are excluded from the OTC supply channel.

The instrument establishes clear operational steps suppliers must adopt to use the authorisation safely. Compliance requires both product-level verification and process-level controls.

1. Product verification prior to supply

   • Confirm the product is precisely the item authorised in Schedule 1 (medicines) or falls within the class described in Schedule 1A (therapeutic vaping goods) and, for Schedule 1A, that it has the required notification status under item 15 in Schedule 5A to the Regulations and has not been excluded by a Secretary determination (Schedule 1; Schedule 1A). The authorisation only covers goods that match the Schedule in active ingredient, strength/concentration, dosage form, administration route and indication (s 5(1)(a)-(e); Schedule 1).
   • For medicines, ensure the product contains no other active ingredient (s 5(1)(a)).
   • For vaping goods to be supplied without prescription by a pharmacist, confirm nicotine concentration ≤20 mg/mL (s 5A(5)(h)).

2. Patient eligibility checks

   • Verify patient age against the relevant pathway: practitioner-supplied vaping goods require patients aged 16+ (s 5A(1)(e)); pharmacists supplying with prescription to patients aged 16+ (s 5A(3)(f)); pharmacists supplying without prescription to patients aged 18+ (s 5A(5)(e)).
   • When pharmacists supply without prescription, request and sight acceptable evidence of identity and age (s 5A(5)(f)). Establish a checklist of acceptable identity documents.

3. Information and consent process

   • Before supply, inform the patient (or parent/guardian where appropriate) that the medicine or therapeutic good is not a listed or registered good (s 5(2)(a); s 5A(2)(a); s 5A(6)(a)).
   • Obtain informed consent from the patient or parent/guardian in relation to, and before, supply (s 5(2)(b); s 5A(2)(b); s 5A(6)(b)). Put a standard consent form and an accompanying information sheet into practice to record that the statutory information has been provided and consent obtained.

4. Clinician and pharmacist professional practice standards

   • Supply only in accordance with good medical practice, good nursing practice, or good pharmacy practice as applicable (s 5(2)(c); s 5A(2)(c); s 5A(6)(c)). Ensure internal policies reflect the professional standards and that staff are trained on clinical assessment, contraindications and monitoring.