Therapeutic Goods (Standard for Psilocybine) (TGO 113) Order 2024

TGO 113 is structured around a set of clear taxonomies, numerical specifications and method references. The instrument distinguishes between plant derived psilocybine and synthetic psilocybine, and between isolates, extracts and finished products. Key definitional and conceptual points are in the definitions section (s4) and the standard declaration (s5).

Taxonomy and scope

• Plant derived psilocybine comprises psilocybine extract and psilocybine isolate (s4). The instrument defines psilocybine extract as material extracted from the psilocybine mushroom that contains psilocybine and psilocin and possibly other tryptamines (s4). Psilocybine isolate means psilocybine isolated from the mushroom (s4). Plant material is defined as the dried or fresh fruiting body of the psilocybine mushroom that has not been homogenised (s4).
• Synthetic psilocybine is psilocybine produced using precursor ingredients rather than mushroom-derived compounds (s4).
• Products are defined by whether they contain psilocybine extract, psilocybine isolate or synthetic psilocybine as the active ingredient and whether they are manufactured in a dosage form for human therapeutic use (s4).

Numerical assay and impurity concepts

• The instrument sets quantitative assay limits for purity and for average content in finished products. For example, psilocybine isolate purity must be between 98.0% and 102.0% on a dried basis, and synthetic psilocybine has the same purity band (s8(2)(a); s16). Psilocin content permitted in isolates and synthetic material is capped at 2.0% (s8(2)(b); s16(b)). Psilocybine extract has wider permitted ranges for psilocybine, psilocin and other tryptamines (s8(1)).
• Finished products have average content requirements assessed on a pooled sample of not fewer than 20 capsules, with stated-content acceptance bands of 90.0% to 110.0% (s13(1), s13(2), s20). Tests for related substances and uniformity are referenced to Ph Eur procedures (Schedules 2 and 4).

Identity and method concepts

• Plant material used in manufacture must be positively identified by macroscopic, microscopic and chromatographic methods (s9).
• Specified analytical methods are incorporated by reference in the Schedules. Tests generally use Ph Eur methods, with options for certain tests to use USP equivalents where specified (Schedules 1-4). The ICH Q3D guideline is the reference standard for elemental impurities for both heavy metals testing and a direct elemental impurities obligation for synthetic psilocybine products (s4, Schedules 1 and 3, s21).

Manufacturing and dosage form concepts

• All psilocybine products must be in capsule form for oral administration, and the instrument requires that the active ingredient be the only active ingredient in the product (s12(2)-(3); s19). This is a formal constraint on permitted product design.

Labelling, traceability and sponsor obligations

• Labels must carry detailed information including name of the product, active ingredient and its quantity in mg, dosage form, quantity of the product, batch number (with a specified prefix), expiry date (with prefix), sponsor name and contact details (including an Australian physical address), storage conditions and additional plant-specific information for extract products (s24). All required label information must be in English, legible, clearly visible and durable (s24(2)).

Exemptions and interaction with the Act

• Extemporaneously compounded products have narrow exemptions from some Schedule testing requirements if the active ingredient used was tested at a site covered by a manufacturing licence under Part 3‑3 of the Act (s14(2), s14(4), s22(2)). The instrument does not apply to goods subject to certain approvals under the Act or to certain items of Schedules 5 and 5A of the Therapeutic Goods Regulations 1990 (s6(2)).

Reference reliance and update mechanism

• The instrument relies on external, evolving standards: Ph Eur, USP and ICH Q3D. The ICH Q3D guideline is adopted “as in force from time to time” (s4), which means that compliance obligations may alter when those documents are updated.

Taken together, the main concepts are product categorisation, fixed dosage form and single-active-ingredient rules, explicit assay and impurity bands, mandated identification and pharmacopeial test methods, specified labelling and traceability items, and narrowly framed exemptions tied to a manufacturing licence.

TGO 113 affects multiple parties in the therapeutic goods supply chain by creating mandatory standards. The instrument itself defines who is in scope and who is excluded (s6). The key actors affected are sponsors, manufacturers (including contract manufacturers), testing laboratories, pharmacists who extemporaneously compound, and, indirectly, consumers and purchasers of regulated psilocybine products.

Sponsors

• Sponsors are responsible for ensuring labelled information and compliance with TGO 113 for products they supply. The label must include the sponsor’s name and contact details, and the definition of contact details requires a physical Australian address that is not a post office or code address (s24(1)(h)-(i); s4 definition). International sponsors intending to supply into Australia will therefore need an Australian-based physical address.

Manufacturers and contract manufacturers

• Manufacturers producing plant derived or synthetic psilocybine, and manufacturers of final capsule products, must meet the assay limits, identity tests and other specified tests in the relevant Parts and Schedules (s7-s10; s15-s17; s18-s22; Schedules 1-4). The requirement for capsule dosage form for finished products means manufacturing processes must produce a capsule product for human therapeutic use (s12(2)(b), s12(3)(b), s19(b)). Manufacturing activities will be shaped by the need to apply Ph Eur and USP methods where specified.

Testing laboratories

• Laboratories that perform the tests specified in the Schedules must be competent in Ph Eur and USP analytical methods, and able to report results on the bases required by the instrument (for example dried basis calculations). Heavy metals testing must be aligned to limits in the ICH Q3D guideline document (Schedules 1 and 3; s21).

Pharmacists and extemporaneous compounding

• Pharmacists who extemporaneously compound psilocybine products are affected by a narrow exemption. If a compounded product is extemporaneously prepared for a particular patient, certain Schedule testing does not apply provided the active ingredient used in manufacture has been tested in accordance with section 10 or section 17 at a site covered by a manufacturing licence granted under Part 3‑3 of the Act (s14(2), s14(4), s22(2)). The effect is to permit compounding only where the active ingredient’s testing was performed under a manufacturing licence regime.

Regulators and compliance officers

• The Secretary and the Therapeutic Goods Regulator will use this standard when assessing whether goods meet applicable standards referenced by the Act. The instrument is made under s10 of the Act and integrates into the Act’s regulatory framework (s3, s5).

Importers and distributors

• Importers and distribution chain participants will need to ensure that labelling, batch numbering and expiry date requirements are met (s24). The definition of batch number and batch number prefix in s4 governs how traceability information must be presented.

Consumers and healthcare providers

• While not addressees for compliance duties, consumers and healthcare providers will encounter products constrained to a single active ingredient in capsule form and will see detailed labelling, especially for plant derived extract products where origin and plant weights must appear on labels (s24(1)(k)(iv-vii)).

Excluded categories

• The instrument expressly does not apply to therapeutic goods that are the subject of an approval under paragraph 19(1)(b) of the Act or to goods listed in certain items of Schedules to the Regulations, subject to their conditions (s6(2)). Entities dealing only with goods in those categories must consult the Act and Regulations to determine the applicable requirements.

In short, sponsors and manufacturers are the primary economic actors who pay to meet the testing, manufacturing and labelling obligations, testing laboratories supply the technical capability, and pharmacists have a narrow conditional route for extemporaneous compounding.

TGO 113 imposes discrete duties on sponsors, manufacturers and testing facilities and creates limited rights in the form of specified exemptions. The duties are explicit in the Parts and Schedules and can be grouped into identification, quantitative content, impurity control, test method, dosage form and labelling duties.

Duties , identity and source

• For plant derived materials, manufacturers must be able to positively identify the psilocybine mushroom used in manufacture by macroscopic, microscopic and chromatographic examination (s9). This is an affirmative quality-control duty on material sourcing and identity testing.

Duties , assay limits and content

• Manufacturers must ensure substance and product assay limits fall within specified bands. For psilocybine extract, purity bands for psilocybine and psilocin and for nominated tryptamines are set at wide ranges (for example, psilocybine 90.0%-110.0% on a dried basis; psilocin 80.0%-120.0%) (s8(1); Schedule 1 Part 1). For isolates and synthetics, narrower purity bands apply (for isolate and synthetic, psilocybine 98.0%-102.0% on a dried basis; psilocin ≤2.0%) (s8(2); s16; Schedules 1 and 3). Finished product average content for capsule batches is tested on pooled samples of not fewer than 20 capsules and must be between 90.0% and 110.0% of stated content (s13(1)-(2); s20; Schedules 2 and 4).

Duties , specified testing and methods

• The instrument obliges compliance with the tests in Schedules 1-4 using the test methods specified in the relevant schedule entries. These references are primarily to Ph Eur methods and to USP where alternatives are allowed (Schedules 1-4; s10, s14(1), s14(3), s17, s22(1)). Residual solvents, heavy metals and related substances tests are all specified.

Duties , elemental impurities

• Synthetic psilocybine products must comply with the ICH Q3D guideline for elemental impurities (s21). Heavy metals testing for plant derived substances is also linked to ICH Q3D limits (Schedules 1 and 3).

Duties , dosage form and active ingredient

• Finished products must contain only the named active ingredient (psilocybine in its specified form) and be manufactured as oral capsules (s12(2)(a)-(b); s12(3)(a)-(b); s19(a)-(b)). This is a prescriptive formulation duty.

Duties , labelling and traceability

• The label must include detailed content: product name, active ingredient name and quantity in mg, dosage form, quantity of product, batch number with prefix, expiry date with prefix, sponsor name and contact details (including physical Australian address), storage conditions, and for psilocybine extract products the quantity of psilocybine and psilocin in mg, quantities of nominated tryptamines, the quantity of extract and the minimum dry or fresh weight of plant material with the word “minimum”, the words “Psilocybe cubensis”, the plant part and the preparation type (s24(1)). All required label information must be in English, legible, clearly visible and durable (s24(2)).

Rights and exemptions

• Extemporaneously compounded products prepared by pharmacists for particular patients are partially exempted from some of the test requirements in Schedules 2 and 4 provided the active ingredient used was tested in accordance with section 10 or 17 and that testing was conducted at a site covered by a manufacturing licence under Part 3‑3 of the Act (s14(2), s14(4), s22(2)). This creates a limited conditional right to avoid repeating some testing for certain compounded products, contingent on upstream testing performed under manufacturing licence conditions.

Interpretive and procedural constraints

• Definitions in s4 establish required formats for batch numbers, batch number prefixes and expiry date prefixes, and the calculation basis for purity (dried basis). The ICH Q3D guideline is incorporated as in force from time to time, which means compliance obligations for elemental impurities may change as that document is updated (s4).

No penalties are set out in this instrument itself for breaches of these duties. The instrument sits within the Act’s framework (s3, s5), and enforcement consequences flow from the Act and Regulations. The duties are concrete, method-linked and mainly procedural and quantitative; the rights are narrowly framed and conditional.

TGO 113 does not itself articulate civil or criminal penalties. The instrument is made under section 10 of the Therapeutic Goods Act 1989 and declares the matters in the instrument to constitute a standard for various psilocybine substances and products (s3, s5). Consequently, enforcement and penalties for non‑compliance with the standard arise through the regulatory enforcement powers and sanctioning provisions of the Therapeutic Goods Act and its Regulations rather than through TGO 113 itself. The instrument therefore acts as a declaratory standard that will be applied by the regulator under the Act.

Practical enforcement mechanisms and pathways that follow from the instrument’s position in the Act’s architecture include:

• Regulatory assessment: The Australian regulator can assess whether a psilocybine substance or product meets the standard when making regulatory decisions under the Act, because the instrument explicitly constitutes a standard for the named goods (s5). Goods that fail to meet the standard may be found noncompliant for the purposes of registration, listing or supply obligations that the Act controls.
• Manufacturing licence link: The instrument references the manufacturing licence regime under Part 3‑3 of the Act when it permits certain testing exceptions for extemporaneous compounding (s14(2), s14(4), s22(2)). Compliance with manufacturing licence conditions and the Secretary’s oversight of licensed sites will be a locus for enforcement activity where the exemption is invoked.
• Labelling enforcement: The labelling obligations in s24 prescribe mandatory label content and presentation; failure to comply with labelling obligations typically attracts enforcement action under the Act’s labelling and consumer safety provisions, applied by the regulator.
• Reference to external standards: Because the instrument requires testing using Ph Eur, USP and ICH Q3D methods, agencies conducting inspections or assessing compliance may rely on laboratory reports and method adherence as evidence of conformity.

Limits of what TGO 113 itself prescribes about enforcement

• The instrument does not specify fines, imprisonment, civil penalties, seizure powers, or the process by which a finding of non‑compliance will lead to regulatory action. Those details are within the Therapeutic Goods Act and Regulations and not in TGO 113. For enforcement detail and the catalogue of sanctions, one must consult the Act and Regulations.

Implications for regulated parties

• While TGO 113 does not set out penalties, non‑compliance can be expected to have regulatory consequences because the instrument defines legally applicable standards to which goods must conform under the Act. Sponsors and manufacturers therefore bear the compliance risk that failure to meet the TGO 113 standard could result in regulatory action under the Act, including refusal of approvals, prohibitions on supply, corrective action requirements, or other regulatory responses administered under the Act.

To determine specific sanctions, enforcement procedures and appeal pathways, regulated parties must consult the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990. TGO 113 functions as a mandatory standard within that statutory framework.

TGO 113 is integrated into the broader Therapeutic Goods regulatory framework and expressly links to other laws, instruments and recognised pharmacopoeial and guideline documents. The text identifies several interaction points and exclusions.

Primary statutory anchor

• The instrument is made under s10 of the Therapeutic Goods Act 1989 (s3). It therefore operates as a standard for the purposes of the Act (s5). This means the Act’s registration, approval and enforcement mechanisms apply when the standard is applied.

Regulations and exclusions

• Section 6(2) provides express exclusions from TGO 113 for goods that are the subject of an approval under paragraph 19(1)(b) of the Act, and for certain therapeutic goods mentioned in specified items of Schedule 5 and Schedule 5A to the Therapeutic Goods Regulations 1990, subject to the conditions specified in those items. Those statutory references import the Regulations’ coverage and carve-outs into the instrument. The instrument itself does not list those exempt items; practitioners must consult the Regulations to determine whether a specific product is excluded from TGO 113 by virtue of those items (s6(2)).

Manufacturing licence regime

• The instrument refers to the manufacturing licence concept defined in subsection 38(1B) of the Act and to Part 3‑3 of the Act in relation to testing exemptions for extemporaneously compounded products (s4 definition; s14(2), s14(4), s22(2)). The effect is to make certain testing exemptions contingent on upstream testing performed at sites that are licensed under the Act’s manufacturing regime.

Pharmacopeial and guideline documents

• TGO 113 requires tests to be performed using methods specified in the European Pharmacopoeia, and in specified cases allows USP methods as alternatives, and it adopts the ICH Harmonised Guideline Q3D for elemental impurities by reference (s4; Schedules 1-4; s21). These documents are external instruments of technical standards, and the instrument’s compliance obligations change if those documents change. The definitions section explicitly notes that ICH Q3D is “as in force from time to time” (s4). Practitioners must therefore manage the interaction between TGO 113 and the current versions of Ph Eur, USP and ICH Q3D.

Other therapeutic goods standards

• TGO 113 cross-references other Therapeutic Goods Orders. For example, the definition of capsule uses the same meaning as in the Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019 (s4 note). This creates a network of standards where TGO 113 relies on TGO 101 for certain dosage form definitions.

Label and traceability law

• The instrument’s labelling requirements link to the Act’s overall regulatory requirements for labelling and sponsor obligations because the sponsor name and contact details must appear on labels and because the Act governs sponsor responsibilities and supply chain accountability (s24).

Interpretation and enforcement interfaces

• Because TGO 113 constitutes a standard under the Act, the Australian regulator will apply the instrument when deciding whether goods comply with statutory requirements under the Act. The instrument therefore functions as a technical annex to statutory obligations rather than as freestanding legislation.

In practice, compliance requires both mastery of TGO 113’s content and the relevant complementary sources: the Therapeutic Goods Act 1989, the Therapeutic Goods Regulations 1990 (particularly Schedules 5 and 5A for exclusions), the manufacturing licence provisions in Part 3‑3 of the Act, TGO 101 for capsules, and the current Ph Eur, USP and ICH Q3D texts for analytical methods and limits.

TGO 113, as provided, is the original instrument and contains internal commencement information. The instrument’s commencement table states that the whole of the instrument commences on 6 January 2025 (s2). The text includes a note that the commencement table relates only to the provisions of the instrument as originally made and will not be amended to deal with any later amendments of this instrument; that is a standard drafting note about published versions (s2 note).

No subsequent amendments, variations, or prior versions are included in the provided text. The instrument itself identifies that some external documents it relies on, such as the ICH Q3D guideline, are adopted “as in force from time to time” (s4), which is a mechanism by which applicable technical standards may change without formal amendment of TGO 113. For other referenced materials such as the European Pharmacopoeia and the United States Pharmacopeia-National Formulary, the Schedules refer to particular Ph Eur and USP chapters and monographs; any changes to those external texts will affect test method expectations.

What the instrument records about amendment mechanics

• The instrument is framed so that future amendments to the external standards referenced may affect compliance expectations without an immediate textual amendment to TGO 113. For example, ICH Q3D is adopted as “as in force from time to time” (s4). Ph Eur and USP references are to specific monographs and chapters; practitioners should check whether the Schedules refer to specific numbered Ph Eur and USP sections or to the current text as amended.

Practical note for regulated parties

• Because TGO 113 depends heavily on external pharmacopeial and guideline documents, regulated parties should monitor both the Federal Register of Legislation for any amendments to TGO 113 itself and the websites and update notices for Ph Eur, USP and ICH Q3D for technical updates that could alter testing obligations. The instrument does not itself list an amendment history; any amendment history will appear in published versions of the instrument or in consolidated legislative databases.

The instrument as provided does not contain, reference or summarise any litigation. TGO 113 is presented as an administrative standard instrument and does not include case citations, judicial decisions or dispute-resolution precedents. No Decisions, appeals to courts or tribunal rulings relating to this instrument are included in the text supplied.

Implications of the absence of litigation history in the instrument

• The lack of litigation references in the instrument does not mean that disputes will not arise. Potential areas of contestation that could generate litigation or administrative review include: the scope of the manufacturing licence exemptions, interpretation of assay limits and test methods (for instance how to calculate results on a dried basis), whether a product meets the “only active ingredient” requirement for finished products, the adequacy of labelling, and reliance on external pharmacopoeial or guideline documents that change over time.
• Any enforcement actions taken under the Act in relation to goods subject to TGO 113 could be the subject of internal merits review or judicial review under the Act or administrative law principles, but those possibilities are not evidenced in the instrument itself.

If parties require an up-to-date record of litigation or regulatory determinations that interpret TGO 113, they must consult published regulatory decisions, tribunal records and court databases after the instrument commences and begins to be applied.

TGO 113 contains several precise requirements and conditional exemptions that create practical pitfalls for sponsors and manufacturers. These are concrete compliance risks and operational constraints that a regulated entity should plan for.

1. Dosage form constraint: capsules only

• Finished plant derived and synthetic psilocybine products must be manufactured in the dosage form of a capsule for oral administration, and the active ingredient must be the only active ingredient (s12(2)-(3); s19). This excludes tablets, liquids, inhaled forms, transdermals or combination products from the scope of permitted product formats under this standard.

2. Single active ingredient requirement

• The requirement that the product contain the specified psilocybine form as the only active ingredient (s12(2)(a), s12(3)(a), s19(a)) prevents formulation combinations containing other active therapeutic substances.

3. Narrow extemporaneous compounding exemption

• The Schedules’ testing requirements do not apply to some extemporaneously compounded products only where the active ingredient used was tested in accordance with sections 10 or 17 and the testing was performed at a site covered by a manufacturing licence under Part 3‑3 of the Act (s14(2), s14(4), s22(2)). The exemption therefore does not remove upstream testing obligations and ties the exemption to licensed-site testing only.

4. Detailed labelling for plant extract products

• Labels for extract products must include multiple plant-specific data points: quantity of psilocybine and psilocin in mg, quantities of nominated tryptamines in mg (if any), the quantity of the psilocybine extract and the minimum dry weight or fresh weight of the plant material with the word “minimum”, the words “Psilocybe cubensis”, the plant part and the preparation type (s24(1)(k)(i)-(vii)). These requirements will affect packaging design and may increase label real estate needs.

5. Australian physical address requirement for sponsor contact

• The contact details of the sponsor must include a physical Australian address that is not a PO box (s4 definition; s24(1)(i)). Overseas sponsors will need an Australian physical address on label information.

6. Testing method reliance and external documents

• Tests are specified by reference to Ph Eur and, in places, to USP chapters, and heavy metals/elemental impurities are tied to ICH Q3D limits (Schedules 1-4; s21). Reliance on external, evolving documents means compliance depends on keeping abreast of Ph Eur, USP and ICH updates. The instrument does not embed the analytical method text itself.

7. Pooled sample size for average content testing

• Average content for finished products is determined on pooled samples of not less than 20 capsules (s13(1)-(2); s20; Schedules 2 and 4). Small-batch manufacturers or compounding operations must ensure batches are sufficiently large or otherwise account for pooling requirements.

8. Dried basis calculations

• Purity requirements for many substances must be calculated on a dried basis (s8(1)(a), s8(2)(a), s16). The means of drying, residual moisture allowance and analytical reporting conventions will matter for compliance, and the instrument does not specify drying procedures.

9. Assay bands permit results above 100 per cent

• Several assay bands allow values above 100 per cent (for example psilocybine extract purity could be up to 110.0%; psilocin in extract up to 120.0%) (s8(1); Schedule 1 Part 1). This reflects assay variability allowances; laboratories must document and justify how they report values exceeding stated content.

10. Aflatoxin limit only for extracts

• The Schedules impose an aflatoxin sum limit of not more than 4 ppb for extracts (Schedule 1 Part 1 item 1). Isolates and synthetics do not have an equivalent aflatoxin entry in the Schedules. This creates an additional test for extract manufacturers.

11. Different heavy metals test references

• The heavy metals test method references differ by context (Ph Eur 2.4.27 for plant materials in Schedule 1 Part 2; Ph Eur 2.4.20 for synthetic material in Schedule 3); both are subject to ICH Q3D limits (Schedules 1 and 3). Laboratories must map the precise method to the product type.

12. “Not part of this instrument” note for commencement table

• The commencement table contains a Column 3 note that is “not part of this instrument” and may be edited in published versions (s2(2)). Users of published versions should confirm the authoritative text.

Planning for these gotchas requires cross-functional coordination between regulatory, quality assurance and manufacturing. Many of these constraints can be missed by parties who assume more flexible formulation options or who do not have licensed-site testing upstream.

A practical compliance checklist flow aligned to the instrument’s structure will assist sponsors and manufacturers. Below are steps, tied to specific provisions, to operationalise compliance with TGO 113.

1. Classify the product and map applicable Parts

• Determine whether the substance is plant derived (extract or isolate) or synthetic and whether the finished good is a psilocybine extract product, psilocybine isolate product or synthetic psilocybine product. TGO 113 applies to these four categories (s4 definitions; s6(1)). Consult s6(2) to verify whether the product is excluded because of an approval under paragraph 19(1)(b) of the Act or an item in Schedules 5 or 5A of the Regulations.

2. Ensure manufacturing format and active ingredient conformity

• Design the product as a capsule for oral administration and include only the named psilocybine form as the active ingredient (s12(2)-(3); s19). Update formulation and packaging schematics accordingly.

3. Establish sourcing and identification protocols for plant material

• For plant derived material, adopt a documented identity testing workflow that includes macroscopic, microscopic and chromatographic examinations (s9). Maintain records of raw material batch identification, including the defined batch number and batch number prefix formats (s4).

4. Implement analytical methods and method controls

• Align analytical testing to the Schedules, using Ph Eur or USP methods as specified (Schedules 1-4; s10, s14(1), s14(3), s17, s22(1)). Confirm that internal or contract laboratories are competent in Ph Eur 2.2.29, Ph Eur 2.4.24, Ph Eur 2.4.27, Ph Eur 2.9.1, Ph Eur 2.9.40 and USP Chapter 701 and 701 equivalents where applicable. For heavy metals and elemental impurities, apply ICH Q3D limits (s21; Schedules 1 and 3).

5. Verify assay, impurity and average content specifications

• For active substances, ensure the purity bands in s8 and s16 are met. For finished products, establish batch sampling and pooled-sample testing processes to test not fewer than 20 capsules for average content per s13 and s20, and meet 90.0%-110.0% of stated content. Implement related-substances testing per Ph Eur 5.10 and uniformity testing per Ph Eur 2.9.40 (Schedules 2 and 4).

6. Residual solvents and aflatoxin controls

• For residual solvents test per Ph Eur 2.4.24 using limits in Ph Eur 5.4 (Schedules 1-4). For extracts, test aflatoxins to Ph Eur 2.8.18 and confirm the sum of aflatoxins B1, B2, G1 and G2 is not more than 4 ppb (Schedule 1 Part 1 item 1). Include preventive controls in cultivation, drying and storage to minimise aflatoxin risk.

7. Manage drying calculations and moisture control

• Where purity must be calculated on a dried basis (s8, s16), document drying methodology, moisture determination method and acceptance criteria in the quality system. Ensure analytical reports state whether results are on a dried basis and how moisture content was determined.

8. Label content and format

• Prepare labels that include every item in s24(1): product name, active ingredient name and mg quantity, dosage form, quantity of product, batch number with prefix, expiry date with prefix, sponsor name and contact details including an Australian physical address, storage conditions. For psilocybine extract products additionally include psilocybine mg, psilocin mg, nominated tryptamine mg (if any), extract quantity and the minimum dry or fresh weight of plant material with the word “minimum”, the words “Psilocybe cubensis”, plant part and preparation type (s24(1)(k)(i)-(vii)). Ensure label text is in English, legible, visible and durable (s24(2)). Capture label proofs in the regulatory dossier.

9. Batch documentation and traceability

• Implement batch numbering consistent with the definition of batch number and batch number prefix (s4). Maintain batch records traceable through all stages of manufacture and distribution.

10. Manufacturing licence and compounding pathway

• If relying on the extemporaneous compounding exemption, ensure that the active ingredient used in compounding was tested at a site covered by a manufacturing licence under Part 3‑3 of the Act (s14(2), s14(4), s22(2)). Confirm the status and terms of the manufacturing licence and maintain test certificates from the licensed testing site.

11. Quality system and supplier qualification

• Develop supplier qualification procedures for plant material, isolates and synthetic precursors. Require certificates of analysis that reference the specified Ph Eur/USP methods and confirm acceptance criteria. Implement stability, storage and shipping controls consistent with the label storage conditions requirement (s24(1)(j)).

12. Regulatory mapping and dossier preparation

• Map TGO 113 requirements to regulatory submissions under the Act. Retain analytical method SOPs, validation reports, test results on pooled samples, and conformity declarations referencing the specific Schedule items and methods used.

13. Monitor external standards and legal instruments

• Assign responsibilities to monitor updates to Ph Eur, USP and ICH Q3D; track any amendments to the Therapeutic Goods Act, Regulations and associated TGOs that affect exclusions or definitions (s4; s6(2); s21). Because ICH Q3D is expressly adopted “as in force from time to time” (s4), maintain a process to incorporate updates into quality systems.

14. Prepare for inspections and enforcement checks

• Ensure that records, batch testing results, label proofs, supplier and testing-site licences, and manufacturing licence documentation are inspection-ready. Keep traceability documentation for each batch to demonstrate compliance with the identity and assay requirements.

15. Legal and regulatory liaison

• Coordinate with regulatory counsel to confirm whether any approvals exist under paragraph 19(1)(b) of the Act that affect a product’s status and to determine whether any items in Schedules 5 or 5A to the Regulations apply to the specific therapeutic good (s6(2)). Legal review should also verify how TGO 113 interacts with sponsor responsibilities under the Act.

Following this sequence will convert the instrument’s prescriptions into operational controls. The central compliance levers are quality systems to meet pharmacopeial test methods, documented sourcing and identity testing for plant material, capsule formulation and manufacturing, and complete and accurate labelling that meets the detailed content requirements in s24.