It regulates the possession, sale, supply and use of ‘‘stock medicines’’ (broadly, veterinary chemical products and certain pharmacist- or vet‑made preparations) used on animals, with special rules for animals that produce food for humans (see ss 3A, 3(1), 3(1) definition of food producing species).
It makes it an offence to possess or sell unregistered stock medicines except in narrowly defined professional circumstances (s 37; s 41(2)), and to use unregistered medicines on food‑producing animals (s 38) or to use a registered stock medicine contrary to its label/use instructions (s 39). Penalties are monetary (see penalties in ss 37–41).
The Act creates statutory defences and authorisations allowing veterinarians and, in some cases, other persons to use unregistered medicines or to depart from label instructions in limited circumstances (ss 39A, 39B). Those authorisations are limited to treatment in the course of professional practice, specified exempt circumstances (eg, single‑animal treatment; use under a permit; compliance with an order) and, for non‑vets, to written instructions from a vet or compliance with a permit or order (ss 39A(1)–(3); 39B(2)).
Veterinarians who prescribe or use unregistered medicines on food‑producing stock (or who prescribe registered medicines contrary to label instructions for major food species) must give written, signed instructions and explain them; they must also keep records as required by regulation (ss 39D, 39E). Others who use stock medicines on food animals (where they are not employees of the owner) must give the owner written identification and use information (s 39F).
This Act creates a statutory framework for controlling the possession, supply, advertising and use of veterinary chemical products (stock medicines) in New South Wales. It does so by defining the products and actors, setting criminal offences for unauthorised possession, improper use and mis-selling, authorising limited departures from label instructions in narrowly prescribed circumstances, imposing obligations on veterinary practitioners to provide written instructions and keep records, empowering the Secretary to make supply/use bans and recall orders, and establishing penalties and enforcement mechanisms including forfeiture and cost recovery for analysis. Key cross-references are to the Agvet Code (which supplies definitions and registration status), the Biosecurity Act 2015 (which supplies powers of authorised officers and permit machinery), the Poisons and Therapeutic Goods Act 1966 and the Therapeutic Goods Act 1989 (registration and supply regimes), and the Food Act 2003/Food Standards Code (residue standards the Act seeks to protect).
Mechanically, the Act:
Defines stock medicine and related concepts (s 3, s 3A; use instructions at s 4). The definition of stock medicine adopts the Agvet Code definition of veterinary chemical product, and specifically includes substances compounded by pharmacists or veterinary practitioners (s 3A(1)-(2)).
Prohibits possession of unregistered stock medicines except in limited professional circumstances (s 37), and prohibits use of unregistered stock medicines on food producing species (s 38).
Prohibits using a registered stock medicine contrary to the use instructions on the label (s 39), with specified statutory defences and exceptions (ss 39A-39B).
Authorises veterinary practitioners (s 39A) and non-veterinary persons acting under veterinary instructions (s 39B) to use unregistered medicines or to vary use instructions in specific, enumerated circumstances, including limited exemptions for treatment of individual animals and use under permit or order (s 39A(3)).
Current sections
Direct links to the current provisions in Stock Medicines Act 1989.
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Sellers, owners and persons in charge of treated food‑producing stock must inform buyers if a relevant withholding period (a minimum period before slaughter/harvest) has not expired; buyers are prohibited from slaughtering or harvesting before the withholding period expires (ss 40A, 40B). Section 40 also forbids vets from varying instructions in any way reasonably likely to cause residues that contravene the Food Standards Code.
The Secretary (head of Regional NSW) has administrative powers to make orders prohibiting or regulating supply and use of particular medicines, require recalls or marking/record‑keeping, set fees or exemptions, and to publish and serve such orders (s 46). Those orders are published, take effect on service or Gazette publication, and may be disobeyed only with a reasonable excuse (s 46(3)–(6)).
Enforcement and related procedures: authorised officers and authorised analysts under the Biosecurity Act 2015 exercise inspection, analytical and enforcement functions in relation to this Act (ss 2B; Schedule 2, cls 27–29; s 60A). The Act provides for forfeiture of medicines on conviction (s 56), recovery of analysts’ costs as part of prosecution costs (s 57), summary proceedings limits and penalty notice procedures (ss 60, 60A). Delegation of Secretary powers is permitted (s 64). Regulations may fill in technical detail, create offences, and set fees and label/standards requirements (s 65).
Who this affects
Veterinary practitioners: they are both constrained (must not prescribe/supply unless authorised—s 39C) and empowered (express authorisations to depart from some offences—s 6A; s 39A). They carry compliance duties to provide written instructions and keep records (ss 39D, 39E) and face penalties for breaches (ss 39C, 39D, 39E).
Farmers, owners and persons in charge of food‑producing stock: they must receive and pass on information about withholding periods (s 40A), and they must not permit slaughter/harvest before withholding periods expire (s 40B). They face penalties for non‑compliance.
Pharmacists and suppliers: regulated in relation to sale and labelling (s 41; s 4 on use instructions), can be authorised suppliers in some circumstances (s 3 definitions).
Buyers and traders of stock: must be informed about withholding periods before sale (s 40A(2)).
The Secretary and authorised officers/analysts (under the Biosecurity Act 2015): exercise administrative powers, make and enforce bans/recalls/orders, and carry out inspections and analyses (s 46; Schedule 2 cls 27–29; s 2B).
Why it matters (stated purpose, then practical implications)
The Act states its primary objects as: protecting human health by preventing illegal or unsafe chemical residues entering the human food chain; facilitating international trade by ensuring exported livestock/meat meet residue requirements; and protecting animal welfare (s 2A). These are the explicit policy aims the Act advances.
Practical implications tied to those aims include:
Direct compliance costs and record‑keeping burdens on veterinarians (written instructions, signed forms, records—ss 39D, 39E). These create an administrative cost for professional practice each time non‑standard use or unregistered medicines are involved.
Information‑passing duties on owners, persons in charge and sellers (ss 39F, 40A). These create transaction costs in sales and consignment processes and impose timing constraints on when animals/products can be sold or processed (s 40B).
Legal risk and monetary penalties for improper possession, sale, misuse, advertising or failure to comply with orders (ss 37–43, 46). The fine and forfeiture regime creates a compliance incentive; it also imposes downside risk on businesses and individuals who fail to comply.
Administrative discretion vested in the Secretary to issue supply/use bans, recall orders, tagging/marking and record requirements, plus the ability to set fees or require authorities to purchase/use medicines under permit (s 46(1)–(2A), s 65). That discretion concentrates decision‑making power in the executive for timely responses but also places reliance on administrative processes for fairness and clarity.
Integration with the Biosecurity Act 2015 for enforcement powers and authorised officers and analysts (s 2B; Schedule 2, cls 21–29). That alignment shifts operational enforcement (inspections, analysis, permits, penalty notices) into the Biosecurity Act apparatus (see ss 60A, Schedule 2), altering who enforces and how.
Incentives, trade‑offs and implementation risks (mechanisms, not judgments)
Incentives: Monetary penalties, forfeiture (s 56) and the risk of supply/use bans (s 46) incentivise suppliers, vets and owners to follow label instructions and withholding periods. Authorisations (ss 39A, 39B) provide limited legal routes to depart from labelling where clinically needed, balancing flexibility for treatment against residue/trade risk.
Trade‑offs and opportunity costs: Allowing vets to use unregistered medicines or to vary use instructions (subject to constraints) avoids absolute prohibition that could deny necessary treatment; but it shifts monitoring and record‑keeping burdens onto vets and owners (ss 39D, 39E, 39F), and maintains the risk of residue non‑compliance that the Act seeks to prevent (s 40).
Implementation risks: effective administration depends on timely, clear Secretary orders (s 46), and consistent enforcement by authorised officers and analysts under the Biosecurity Act (s 2B; Schedule 2). Complex cross‑references to the Agvet Code and other Acts (eg, Poisons and Therapeutic Goods Act 1966, Biosecurity Act 2015) mean compliance relies on interpreting multiple instruments together (see ss 2B, 3, 6).
Who pays and who decides (summary)
Who pays: primarily owners, sellers and veterinary practitioners (compliance costs, record keeping, potential fines). Courts may also order forfeiture of stock medicines on conviction (s 56); courts may award analysts’ costs against convicted defendants (s 57).
Who decides: the Secretary (Regional NSW) holds broad ordering powers (s 46) and may delegate functions (s 64). Operational enforcement decisions are made by authorised officers and authorised analysts under the Biosecurity Act 2015 (s 2B; Schedule 2, cls 27–29). Regulations (Governor) provide detailed standards, label requirements and may create additional penalty offences (s 65).
References to key provisions: primary objects (s 2A); relationship with Biosecurity Act (s 2B); definitions and scope (ss 3, 3A, 4, 5); possession/sale/use offences (ss 37–41, 43); vet obligations and authorisations (ss 6A, 39A–39F, 40); Secretary orders (s 46); enforcement, penalties and procedures (ss 56–60A); regulations and delegation (ss 64–65).
Imposes substantive process obligations on veterinary practitioners who prescribe or supply unregistered medicines or who vary use instructions for food producing species, requiring signed, dated written instructions that include specified particulars such as withholding period, dosage, frequency, identification of stock and owner (s 39D) and record-keeping obligations (s 39E).
Imposes duties on owners and persons in charge to inform buyers about relevant withholding periods (s 40A), and prohibits slaughter, harvest or release of produce before withholding periods expire (s 40B).
Regulates the sale and advertising of stock medicines, including prohibitions on selling unregistered medicines, mislabelling, selling nonconforming products and making false or misleading efficacy claims (ss 41, 43).
Gives the Secretary power to make supply/use bans, recall orders and related orders that can regulate supply, require recovery of product, prescribe identification/tagging, record-keeping, documentation accompanying sales, disposal, authority requirements and fees (s 46); such orders are subject to publication and tabling/disallowance procedures (s 47).
Provides enforcement avenues: summary proceedings in Local Court or Supreme Court's summary jurisdiction (s 60), penalty notices issued by authorised officers under the Biosecurity Act (s 60A), forfeiture of seized stock medicines (s 56), and courts may award reasonable expenses of analysis against convicted defendants (s 57).
Establishes the Governor’s power to make regulations, including standards for stock medicines, labelling requirements, fee-setting and offences not exceeding 50 penalty units (s 65).
Requires reading in conjunction with the Biosecurity Act 2015 which provides powers of authorised officers, analysts and permit mechanisms, and carries substantial transitional and saving provisions that preserve existing permits, instruments and appointments (s 2B; Schedule 2 Parts 6 and associated clauses).
The Act’s stated primary objects (inserted at s 2A) are to protect human health by intervening early in the agricultural production process to prevent unsafe chemical residues entering the human food chain, to facilitate international trade by supporting compliance with residue requirements of trading partners, and to protect animal welfare (s 2A). Those expressed purposes are the policy claims the legislature attaches to the control mechanisms described above; the Act then operationalises these claims through criminal offences, professional authorisations and administrative powers.
The concrete effects on behaviour are: veterinarians must follow the Act’s authorisation, instruction and recordkeeping regimes when departing from label directions (ss 39A, 39D, 39E); owners and sellers must disclose withholding periods and refrain from slaughter/harvest before expiry (ss 40A, 40B); suppliers must not sell unregistered or nonconforming products or make false efficacy claims (s 41, s 43); and persons in possession of stock medicines must comply with any Agvet Code notice relating to dealing with the product (s 41A). Administrative powers allow the Secretary to impose targeted market interventions (s 46), including identification and recovery obligations that can impose costs on supply chains.
Costs, incentives and implementation risks are considered throughout this note in the sections that follow, each grounded in the statutory provisions cited.
Main concepts
The Act’s conceptual architecture turns on a small set of statutory definitions and recurring operational terms that determine when its prohibitions and obligations bite. The concepts to master are stock medicine, registered/unregistered status, use instructions, withholding period and the interaction with professional authorisations and permits.
Stock medicine
Stock medicine is defined by reference to the Agvet Code’s veterinary chemical product and is explicitly extended to substances prepared by a pharmacist under a veterinary practitioner’s instructions or prepared by a veterinary practitioner in the course of practice (s 3A(1)-(2)). The Act therefore covers both commercially manufactured veterinary chemicals and compounded preparations provided by veterinary or pharmacy professionals. The Act also uses the Agvet Code’s definitions for related terms such as substance and stock (s 3).
Registered vs unregistered
The Act repeatedly distinguishes registered stock medicines (those with registration under the Agvet Code) from unregistered stock medicines. The possession and use prohibitions and authorisations are framed around whether the medicine is registered (ss 37-39). The sale offence in s 41(1)(a) specifically prohibits selling an unregistered stock medicine, subject to the professional prescription exception in s 41(2).
Use instructions and labels
Use instructions are defined to include instructions required or permitted by the Agvet Code to be on a label, together with any instructions relating to use on stock or post-administration handling (s 4(1)-(2)). The Act treats any writing on the package as a label (s 4(3)). Use instructions include dosage, method and timing, targeted stock type, withholding period, precautions/contraindications and material under headings “Restraint” or “Restraints” (s 4(2)). A failure to read the label is not a defence to a use-contrary offence (s 39(4)). This makes label content legally determinative for many offences.
Withholding period and relevant withholding period
Withholding period is defined as the minimum interval between last administration and slaughter/harvest for human consumption (s 3). The “relevant withholding period” is the withholding period specified by the prescribing veterinary practitioner under s 39D, or, failing that, the period specified in the use instructions (s 3). This concept is central to owner/seller notification duties (s 40A) and to the prohibition on slaughter/harvest before expiry (s 40B).
Professional authorisations and defences
The Act creates a structured set of authorisations for departures from the general prohibitions. Veterinary practitioners are expressly authorised to use unregistered stock medicines or to use registered medicines contrary to use instructions, when done in the course of professional practice and in defined exempt circumstances (s 39A(1)-(3)). Persons other than vets are authorised to use unregistered stock medicines or to contravene use instructions where acting in accordance with written veterinarian instructions, a permit or an order (s 39B). Both authorisations operate only for the purpose of the s 38 (use of unregistered medicines) or s 39 (use contrary to use instructions) offences and do not remove requirements under other laws (ss 39A(4), 39B(4)).
Permits and orders
Permits under Part 21 of the Biosecurity Act 2015 are incorporated into the Act’s authorisation and compliance regime (see s 3 definition of permit and s 2B reading in conjunction with Biosecurity Act). The Secretary also has direct order-making power under s 46 to ban or regulate supply/use, require recovery and make other operational provisions such as tagging and documentation; these orders have publication, service and tabling requirements (ss 46-47). Orders may make provision for fees to hold authorities and the waiver of such fees (s 46(2A)(e)).
Enforcement concepts
Offences are mostly summary in nature with maximum penalties often set at 200 penalty units (or 400 for corporations) for serious breaches such as unregistered possession, misuse and improper sale (see ss 37-41, 46). The Act provides for forfeiture of stock medicines on conviction (s 56), court-awarded analysis costs (s 57) and administrative penalty notices by authorised officers (s 60A).
Cross-instrument concepts
The Act is to be read with the Agvet Code and Biosecurity Act 2015 (ss 2B, s 3 references). The Food Standards Code is brought into s 40(2) and (3) to frame the residue thresholds that vets must avoid causing. The Poisons and Therapeutic Goods Act can authorise conduct that would otherwise be an offence under this Act (s 6).
Market-relevant implications embedded in these concepts
Registering products, labelling and complying with use instructions create fixed compliance costs for manufacturers, importers and packagers (s 4, s 65). The authorisation regime channels discretion to veterinarians for off-label or compounding uses (ss 39A-39C), which preserves clinical flexibility but shifts compliance and record-keeping burdens onto veterinary practices (ss 39D-39E). Secretary orders (s 46) can impose one-off disruption and recovery costs on supply chains and wholesale purchasers and may impose fees for authorities to obtain or use certain stock medicines (s 46(2A)(e)). Advertising restrictions (s 43) constrain commercial speech about efficacy claims and may affect marketing strategies.
Who it affects
The Act allocates rights, duties and liabilities across a set of identifiable parties. Who is directly regulated, who bears compliance costs, and who may be exposed to enforcement are all specified in the statutory text.
Primary affected parties
Veterinary practitioners: The statute revolves significantly around veterinary professionals. They are the actors authorised to prescribe, supply and use stock medicines under professional clinical judgement (ss 39A-39C). They have explicit statutory duties when prescribing or supplying unregistered medicines or when authorising off-label uses on food producing stock, including preparing signed written instructions with enumerated particulars (s 39D), and maintaining records in accordance with regulations (s 39E). Maximum penalties apply for non-compliance (s 39C, s 39D, s 39E).
Owners and persons in charge of stock: Owners and people in charge have disclosure duties where treated stock have unexpired withholding periods (s 40A). They are prohibited from permitting slaughter/harvest/release of produce before the expiry of withholding periods (s 40B). These duties carry fines and are relevant to farmers, aggregators and stock managers.
Sellers, suppliers and packagers: Persons who sell stock medicines face prohibitions on selling unregistered products, mislabelling or selling products inconsistent with registration (s 41). Those in possession must comply with Agvet Code notices regarding handling (s 41A). Suppliers of treated stock must notify buyers of withholding periods and are subject to sales prohibitions (s 40A(2)).
Pharmacists: Pharmacists are explicitly included in definitions and exceptions. Pharmacists who prepare substances under veterinary instruction or who are authorised under the Poisons and Therapeutic Goods Act to supply restricted substances interact with the Act’s rules on possession and supply of unregistered products (s 3A(2); s 6; s 39C(3)).
Manufacturers and importers: While the Act regulates registration and sale, many registration and standard-setting functions derive from the Agvet Code and regulations (s 3, s 65). Manufacturers and importers must ensure product labelling and standards comply with the Agvet Code and this Act’s labelling/use instruction concepts, and may be affected by Secretary orders requiring recovery or disposal (s 46).
Authorised officers and analysts: Enforcement is exercised by authorised officers and analysts under the Biosecurity Act 2015, which the Act reads in conjunction with (s 2B). The transitional provisions preserve prior inspector/analyst instruments and convert existing inspectors/analysts to authorised officers/analysts under the Biosecurity Act (Schedule 2 Pt 6, clauses 27-29). Authorised officers can issue penalty notices prescribed in regulations (s 60A).
The Secretary (Secretary of Regional NSW): The Secretary is given administrative power to make orders banning or regulating supply/use, recall stock medicines, and to make detailed operational requirements such as tagging, record-keeping, disposal and fees (s 46). The Secretary also delegates powers (s 64) and must publish and service orders (s 46(3), 47).
Secondary effects and market actors
Processors, exporters and trade intermediaries: The expressed objects (s 2A) include facilitating international trade by preventing illegal or unsafe residues. Mechanically, orders under s 46 that address trade risks and tagging/record requirements (s 46(2A)(a)-(c)) can directly affect export supply chains. Exporters will be affected if residues or record-keeping obligations cause rejection of consignments or add traceability costs.
Agricultural service providers: Third-party contractors who treat stock on behalf of owners must provide written instructions to the owner/person in charge (s 39F) and follow any veterinary instructions (s 39B), making contractors’ compliance behaviour relevant.
Who pays and who decides
Who pays: Compliance costs fall on veterinary practices (administrative time, record-keeping), stock owners and persons in charge (tagging, delay to marketing, disclosure duties), suppliers (labelling, documentation), manufacturers/importers (registration, labelling, potential product withdrawal or recall costs), and purchasers/exhibitors where withholding periods delay sale. Fines and forfeiture (ss 56, 57, 60) are direct monetary costs for offenders.
Who decides: Clinical decisions by veterinary practitioners determine authorised departures from label use (s 39A). The Secretary decides supply/use bans and recall orders (s 46) and can fix fees for authorities (s 46(2A)(e)). The Governor makes regulations implementing standards and offences (s 65). Authorised officers make enforcement decisions and may issue penalty notices under prescribed circumstances (s 60A).
Effects on private enterprise and choice
The regime restricts the free market supply of medicines that are unregistered and constrains advertising claims (s 41, s 43). It retains professional discretion through veterinary authorisations but shifts significant compliance and documentation burdens onto clinical practices (ss 39D-39E) and owners (ss 40A-40B). Secretary powers to impose identification and recovery obligations (s 46(2A)(a)-(b)) can impose compliance costs and disruption on supply chains. The possibility of fee-setting for authorities (s 46(2A)(e)) introduces a potential cost barrier to entry for small operators in specialist medicine markets.
Key duties and rights
The Act imposes specific statutory duties and confers limited statutory rights or authorisations. Below are the duties, rights and their legal character as set out in the text, with the relevant sections.
Obligations on veterinary practitioners
Authorisation and limitation: A veterinary practitioner is authorised to use an unregistered stock medicine, or to use a registered medicine contrary to label instructions, only if the use is in the course of professional practice, for animals under their care, and in specified exempt circumstances (s 39A(1)-(2)). Those exempt circumstances include treatment of an individual animal from a group where no other animal from the same property is being treated with that medicine at about the same time, use under a permit, or compliance with an order under s 46 (s 39A(3)).
Prescription and supply constraints: A veterinary practitioner must not prescribe or supply a stock medicine for use by a person unless the veterinary practitioner is authorised by this Act to use the stock medicine on that stock (s 39C(1)-(2)). There is a particular restriction on prescribing or supplying an unregistered stock medicine for use on stock (other than non-food species) unless the product is a registered human pharmaceutical or compounded by the vet or a pharmacist on the vet’s prescription (s 39C(3)). Maximum penalty for breaches is 100 penalty units (s 39C).
Written instructions and disclosure: Where a veterinary practitioner prescribes/supplies an unregistered stock medicine for a food producing species, prescribes/supplies a registered stock medicine in a manner contrary to instructions for such species, or prescribes/supplies a restricted substance for major food producing species, the practitioner must give the recipient and supplier written instructions and explain any instructions that will override use instructions (s 39D(1)-(2)). The written instructions must be signed, dated and include specified particulars: identification of stock, owner’s name, particulars identifying the medicine and active constituent, intended stock type, withholding period (explicitly including “no withholding period” if none required), dosage, frequency, length and manner of treatment, and any additional prescribed matters (s 39D(3)-(4)). Penalty up to 200 penalty units (s 39D).
Record-keeping: Practitioners must keep records, in accordance with regulations, relating to prescriptions/supply/use of unregistered medicines on food producing species, and of registered medicines used contrary to instructions on major food producing species, and of restricted substances when used on major food producing species (s 39E). Maximum penalty 100 penalty units (s 39E).
Duties on persons who use stock medicines (non-veterinary)
Use authorisation: Non-veterinary persons are authorised to use unregistered stock medicines or use medicines contrary to use instructions when the use is in accordance with written veterinary instructions, a permit, or an order under s 46 (s 39B(2)). Additional conditions apply for use on particular non-major food producing species if use instructions indicate use on major food-producing species, including compliance with dosage, contraindications, withholding periods and “Restraint” instructions (s 39B(3)).
Written advice to owner: A person who is not a veterinary practitioner and who uses a stock medicine on food producing stock where they are not an employee of the owner must ensure the owner/person in charge is given written instructions indicating how treated stock can be identified and the use instructions or any variation supplied by a vet (s 39F). Penalty up to 100 penalty units; for corporations 200 (s 39F).
Duties on owners and persons in charge of stock
Buyer information: Owners must inform any person they have made arrangements with to sell the stock if the stock has been treated and a relevant withholding period has not expired, and must inform when the period will expire (s 40A(1)). Persons in charge (who are not owners) must also inform prospective buyers (s 40A(1A)). Sellers must inform any buyer or potential buyer orally or in writing before sale that the stock was treated and when the withholding period will expire (s 40A(2)). Maximum penalties in s 40A are up to 200 penalty units (400 for corporations).
Avoiding early slaughter/harvest: A person must not cause or permit slaughter for human consumption, harvest of wool/fibre/milk/eggs for human consumption, or release of honey for human consumption before the relevant withholding period expires (s 40B(1)). Penalty up to 200 penalty units (400 for corporations).
Duties on sellers and distributors of medicines
Sale restrictions and standards: A person must not sell an unregistered stock medicine, sell under the name of a registered stock medicine that does not conform with the registered composition if the seller knows the product is non-conforming, sell a medicine that fails to meet prescribed standards, or sell a registered product while making efficacy claims for unregistered uses (s 41(1)(a)-(d)). Maximum penalties are 200 penalty units (400 for corporations). s 41(2) preserves a prescription exception for sale of prescribed unregistered stock medicine by a veterinary practitioner.
Duties under Secretary orders and Agvet Code notices
Compliance with orders and notices: Persons must comply with Secretary orders under s 46 and with AGVET Code notices under s 41A if they are aware of such a notice; contravention of a s 46 order without reasonable excuse is an offence (s 46(6)). Section 41A requires persons who have a stock medicine in their possession and are aware of a s 55 Agvet Code notice to deal with the product in accordance with that notice (s 41A).
Rights and administrative mechanisms
Authorised departures: The Act grants limited statutory rights to veterinary practitioners and to persons acting under their written instructions to use medicines off-label or to use unregistered products in specified circumstances (ss 39A-39B). Those are rights conditional on recordkeeping and written instruction obligations.
Appeals, tabling and disallowance: Orders under s 46 are subject to tabling and disallowance processes under the Interpretation Act 1987 (s 47(3)). Procedural publication requirements are set out in s 46(3)-(5).
Delegation: The Secretary may delegate powers under the Act (excluding the power of delegation itself), allowing administrative decisions to be devolved within the Department (s 64).
Interaction with other legal duties
The Act does not displace requirements under other laws. Section 39A(4) and s 6A(3) expressly note that authorisations under this Act do not exempt persons from requirements of any other Act or law. Section 6 creates a carve-out that an act authorised under the Poisons and Therapeutic Goods Act 1966 does not constitute an offence under this Act, but only where that other Act authorises the conduct.
Compliance and enforcement features
Penalty notices may be issued by authorised officers for prescribed penalty notice offences (s 60A), and the Fines Act 1996 applies to penalty notices (s 60A(3)). Courts may award reasonable analysis costs against convicted defendants where an analyst prepared an analysis under the Act (s 57). Forfeiture of stock medicines is available on conviction (s 56). The usual summary proceedings, limitation periods and sentencing caps in s 60 apply.
Penalties and enforcement
The Act provides a matrix of criminal penalties, administrative enforcement tools, civil remedies such as forfeiture and court-awarded analysis costs, and administrative penalties via penalty notices. Enforcement is exercised through authorised officers under the Biosecurity Act and courts.
Monetary penalties
Most principal offences carry a maximum penalty of 200 penalty units for individuals, and 400 penalty units for corporations. These include:
Possession of unregistered stock medicines (s 37).
Use of an unregistered stock medicine on food producing species (s 38).
Use of a registered stock medicine contrary to use instructions (s 39).
Failure to provide required written instructions by veterinary practitioners in certain circumstances (s 39D carries a maximum penalty of 200 penalty units).
Owner/seller disclosure duties (s 40A) and prohibitions on slaughter/harvest before expiry of withholding period (s 40B) carry up to 200 penalty units (400 for corporations).
Sale-related offences such as selling unregistered medicines, misbranding or non-conforming products, and false efficacy statements carry up to 200 (400 for corporations) (s 41).
Contravention of a Secretary order under s 46 without reasonable excuse carries up to 200/400 penalty units (s 46(6)).
Lesser offences may be created by regulation with penalties not exceeding 50 penalty units (s 65(3)).
Forfeiture and disposal
On conviction the court may order forfeiture to the Crown of any stock medicine to which the conviction relates; forfeiture may extend to all similar articles and packages in the defendant’s possession at the time of the offence (s 56(1)-(2)). The Minister may direct disposal of forfeited stock medicines (s 56(3)).
Costs of analysis
If an analyst has analysed a substance under the Act and the person is convicted of an offence in respect of that substance, the court may award the reasonable expenses of and in connection with the analysis against the defendant as part of prosecution costs (s 57).
Summary proceedings, limitation and jurisdiction
Proceedings for offences may be dealt with summarily in the Local Court or before the Supreme Court in its summary jurisdiction (s 60(1)). If proceedings are commenced in the Local Court, the Court’s maximum monetary penalty power is the lesser of 100 penalty units or the statutory maximum for the offence (s 60(2)). The Local Court information must be laid within 12 months after the time when the offence is alleged to have been committed (s 60(4)).
Penalty notices and administrative enforcement
An authorised officer may issue a penalty notice for an offence prescribed in the regulations as a penalty notice offence (s 60A(1)-(2)). The Fines Act 1996 applies; the penalty amount is prescribed by regulation and cannot exceed the maximum court-imposed penalty for the offence (s 60A(4)). The Act preserves other enforcement options (s 60A(5)).
Service, publication and procedural safeguards
Secretary orders under s 46 must be published in the Gazette and in other manners the Secretary considers likely to reach affected persons, and must be served if they apply to named persons (s 46(3)). Orders take effect upon service to named persons or publication for general orders (s 46(5)). Orders are subject to tabling and disallowance under the Interpretation Act 1987 (s 47(3)), which provides a parliamentary oversight mechanism for such executive instruments.
Delegation and authorised officers
The Secretary may delegate powers under the Act (s 64). Enforcement on the ground is exercised by authorised officers and analysts under the Biosecurity Act 2015; Schedule 2 Pt 6 preserves and converts existing inspectors and analysts to authorised officers and analysts and continues their instruments in force where relevant (Schedule 2, clauses 27-29). This creates an integrated enforcement architecture with the Biosecurity Act.
Reasonable excuse and defences
The Act builds certain statutory defences into its enforcement contours: for example, it is a defence to some prosecutions under s 38 and s 39 if the defendant establishes authorisation under ss 39A or 39B (s 38(2); s 39(2)). Where a person did not know, and had no reasonable grounds for suspecting, that a stock medicine was unregistered, that is a defence to certain offences (s 42(1)). For sale or possession offences relating to labels, the statute contains a defence where instructions appeared on the package and the person did not know, nor had reasonable grounds to suspect, that those instructions were incorrect (s 39(3); s 40B(2)(c)).
Enforcement costs and incentive structure
The Act enables the State to seek both criminal fines and recovery of analysis costs; forfeiture also removes offending stock medicines from commerce. Authorised officers can issue penalty notices under delegated powers in the Biosecurity Act, enabling on-the-spot enforcement where the regulations prescribe the offence as a penalty notice offence (s 60A). Secretary orders under s 46 permit swift administrative interventions, including recall and recovery obligations which may displace normal commercial contract expectations. These enforcement mechanisms create deterrent incentives but also impose compliance costs that fall disproportionately on smaller operators (vets, small farmers, small packagers) who must maintain records, respond to recalls and demonstrate compliance.
How it interacts with other laws
The Act is explicitly designed to operate in a multi-instrument regulatory environment. The text sets out multiple specific interactions and incorporations.
Biosecurity Act 2015
The Act is to be read in conjunction with the Biosecurity Act 2015, which provides the operational powers of authorised officers and other administrative matters relevant to this Act (s 2B). Schedule 2 Part 6 contains provisions ensuring continuity of instruments and appointments on the repeal of certain repealed provisions and converts inspectors/analysts to authorised officers/analysts under the Biosecurity Act (Schedule 2, clauses 21, 27-29). Permits under this Act are continued and treated as permits under Part 21 of the Biosecurity Act with conditions carried across and subject to cancellation under Part 21 (Schedule 2, clause 25). Authorised officers under the Biosecurity Act may exercise functions of inspectors under repealed provisions (Schedule 2, clause 28). Penalty notice machinery relies on authorised officers under the Biosecurity Act (s 60A(6)).
Agvet Code and Agricultural and Veterinary Chemicals (New South Wales) Act 1994
The definition of Agvet Code in s 3 anchors statutory definitions and the registration regime. Many substantive standards and label requirements are those required by or under the Agvet Code and the Agricultural and Veterinary Chemicals (New South Wales) Act 1994 (s 4(1); s 41A references s 55 of the Agvet Code). Section 6A expressly treats the Agvet Code’s section 73 as permitting veterinary practitioners to do things that would otherwise constitute offences under this Act, thereby creating a specific exemption pathway for practitioners under national chemical regulatory law (s 6A). The Act requires persons to comply with notices under s 55 of the Agvet Code (s 41A).
Poisons and Therapeutic Goods Act 1966 and Therapeutic Goods Act 1989
Section 6 provides that acts authorised under the Poisons and Therapeutic Goods Act 1966 do not constitute offences under this Act, creating an operational cross-authorisation where other State controlled-substances law authorises conduct. The Act’s definition of registered human pharmaceutical and the reference in s 39C(3) to registered human pharmaceuticals shows an intended bridge to the Commonwealth Therapeutic Goods Act 1989 and its Australian Register of Therapeutic Goods.
Food Act 2003 and Food Standards Code
Section 40(2) and (3) expressly tie veterinary variation obligations to the Food Standards Code. Veterinary practitioners must not take actions that are reasonably likely to cause stock or products derived from stock to contain residues that contravene the Food Standards Code either during or after any relevant withholding period (s 40(2)). Section 40(3) states the Food Standards Code has the same meaning as in the Food Act 2003, linking residue thresholds and public health standards to the Act’s use restrictions.
Interpretation Act 1987
Orders under s 46 are subject to the tabling and disallowance provisions in the Interpretation Act 1987, specifically ss 40 and 41 (s 47(3)). This subjects Secretary-made orders to parliamentary oversight and potential disallowance.
Fines Act 1996
Penalty notices issued by authorised officers are to be administered in accordance with the Fines Act 1996 (s 60A(3)). The Fines Act provides the procedural and enforcement mechanics for penalty notices.
Veterinary Practice Act 2003
The Act imports the definition of veterinary practitioner from the Veterinary Practice Act 2003 (s 3). This creates licensing and conduct linkages between professional regulation and statutory authorisations/obligations in this Act.
Regulatory harmonisation and transitional continuity
The Act contains numerous savings and transitional provisions (Schedule 2) designed to maintain continuity of permits, instruments, appointments and obligations following repeals and the introduction of the Biosecurity Act (Schedule 2 clauses 21-26). Relevant instruments in force immediately before repeal continue to have effect and may be withdrawn, varied or cancelled in accordance with this Act as if the repealed provision remained in force (Schedule 2, clause 21). The scheme therefore preserves and migrates feet-on-the-ground enforcement and permitting into the Biosecurity Act while maintaining the Act’s substantive controls over medicines, labelling, use and trade.
Practical cross-compliance implications
Practitioners and businesses must navigate concurrent obligations: a veterinary practitioner following a permit under the Biosecurity Act still must satisfy the written instruction and record-keeping duties of this Act (s 39D, s 39E; Schedule 2, clause 25). A person authorised under the Poisons Act may be exempt from criminal liability under this Act for particular conduct, but s 39A(4) and s 6A(3) emphasise that authorisation under one instrument does not immunise one from other statutory obligations. Secretary orders that make provision for tagging, documentation and fees (s 46(2A)) must be read alongside Agvet Code notices and Biosecurity Act permit conditions.
Amendment history
The Act’s text contains embedded amendment annotations; these are the only authority used here. The Act has been amended repeatedly since its enactment and the notes indicate the years and instruments effecting change. The most relevant historical changes, as reflected in the in-text amendment notes, include:
1989: This Act was enacted as the Stock Medicines Act 1989 (s 1 notes reference the Act citation).
1993-1999: Multiple amendments in the 1990s modified definitions and inserted new provisions as evidenced by amendment notes across s 3 and elsewhere (Am 1993 No 4; Am 1994 No 53; Am 1995 No 47; Am 1998 No 116; Am 1999 No 80, Sch 3.8). These amendments included early definitional changes and labelling/use instruction clarifications.
2004 Stock Medicines Amendment Act 2004: A major consolidation and reform occurred in 2004. The 2004 amendments repealed numerous parts (Parts 2-4 and many sections, see Pt 2 notes) and inserted key provisions now extant in Part 5 and Part 6. The 2004 amendments also inserted the authorisations for veterinary practitioners, the s 39-series (s 39A-39F), and replaced earlier arrangements for boards and inspectors (see Schedule 2 Pt 5 clauses 17-19 and associated repeal notes). The amendment notes across many sections reference 2004 No 89 Sch 1 and Sch 2.2, showing broad reworking.
2012 and subsequent amendments: The Act was amended in 2012 (Am 2012 No 89, Sch 5) with additions to definitions and record-keeping (s 3, s 39E). The Agvet Code-related and Biosecurity Act interactions were later expanded.
2015 Biosecurity Act integration: The Biosecurity Act 2015 triggered significant repeal and transitional provisions, creating the current reading-in relationship (s 2B, Schedule 2 Pt 6). The 2015 amendments reworked the inspector and analyst regimes and preserved continuity for existing permits and instruments (Am 2015 No 24, Sch 8.36).
2019-2022: Further amendments updated advertising offences, order tabling provisions, service provisions and delegation (Am 2019 No 14 Sch 2.22; Am 2020 No 30 Sch 1.44; Am 2022 No 59 Sch 1.35, Sch 3.64). For example, s 43’s amendments in 2019 and 2022 updated advertising-related offences.
2025: The definition of stock medicine shows an amendment note referencing 2025 No 58, Sch 11 (s 3A), indicating a legislative change to the definition as recently as that annotation.
Schedule and transitional amendments
Schedule 2 contains multiple savings and transitional provisions that followed the 2004 and 2015 amendment programs. Clause 17 dissolved the former Stock Medicines Board and dealt with its members on repeal (Schedule 2 Pt 5). Schedule 2 Pt 6 includes the Biosecurity Act consequential provisions ensuring continued effect of relevant instruments, conversion of appointments and continuation of permits (clauses 21-29).
Regulatory power expansions and procedural updates
Over time the Governor’s regulation-making power in s 65 has been maintained but expanded in how regulations can address standards, labelling and fees (s 65(2)). The Secretary’s order power (s 46) has been maintained and is subject to more recent tabling/disallowance and publication updates (s 47; amendments noted 2019 No 14 Sch 2.22).
Limitations on this amendment summary
The annotations within the Act provide the authoritative list of amending instruments and years used here. This summary highlights major points referenced in those annotations but does not purport to be a full chronological legislative history beyond the in-text amendment notes. All citations to amendments in this section are drawn from the Act’s own marginal notes and amendment footnotes.
Litigation history
The Act as provided contains no judicial decisions, citations to cases, or a litigation history within its text. The statute supplies defences, procedural rules and examples of matters that may be pleaded in court (for example, defences under ss 38(2), 39(2)-(3), 42(1)), but no court decisions are recorded in this text.
What the Act supplies for litigation practice
The Act sets out statutory defences and evidential matters that will be relevant in prosecutions: for example, s 39(3) and s 40B(2)(c) treat the presence of instructions on a package as potentially exculpatory where the defendant neither knew nor had reasonable grounds to suspect those instructions were incorrect. Section 42(1) provides a specific defence of lack of knowledge concerning unregistered status for certain offences. These statutory provisions will structure defence strategies and evidentiary enquiries where prosecutions proceed.
The enforcement architecture assigns summary jurisdiction for most offences, includes time limits for laying information in the Local Court (s 60(4)), and provides for penalty notices (s 60A). These jurisdictional and procedural aspects are material to prosecutorial decisions and defence planning.
For forfeiture and disposal of goods, s 56 gives courts power to order forfeiture and the Minister direction over disposal. Challenges in litigation may arise around whether forfeiture and disposal were properly ordered, but the Act itself does not record adjudications on these powers.
Absence of case law in the source
Because no cases are cited or summarised in the legislative text provided, no analysis of judicial interpretation, appellate decisions or precedential developments can be offered from this source. Practitioners should seek relevant case law outside this text for authoritative judicial constructions of ambiguous terms such as “reasonable grounds for suspecting”, “likely to endanger the health of the public”, or the scope of veterinary authorisations under s 39A.
Gotchas
This section identifies statutory features that commonly produce compliance risk, unintended costs or legal ambiguity for practitioners, industry participants and enforcement officers. Each point is grounded in the Act’s text.
Label as law
Use instructions are defined to include any instructions required or permitted by or under the Agvet Code to be on the label and any writing on the package (s 4(1), s 4(3)). The Act treats label content as legally determinative. Because failure to read use instructions is expressly not a defence (s 39(4)), the presence or accuracy of label statements will often decide liability. Risk: businesses cannot rely on “I did not read the label” defences.
Narrow veterinary authorisations but broad residual legal obligations
Veterinary practitioners have express authorisations to use unregistered products or deviate from label directions in certain circumstances (s 39A), but those authorisations operate only for the purposes of s 38 and s 39 and do not relieve the practitioner from other statutory obligations (s 39A(4)). Furthermore, s 6A(3) clarifies that exemptions under the Agvet Code do not exempt from other Acts or laws. Risk: a vet may be authorised to use a substance under the Act but still be required to satisfy Poisons Act, Therapeutic Goods Act, animal welfare, or export compliance obligations.
Stringent written instruction and record-keeping requirements
Where vets prescribe or supply unregistered medicines for food producing species or use registered medicines contrary to instructions on major food producing species, they must provide written instructions signed and dated with specified particulars (s 39D(2)-(3)) and maintain records as required by regulation (s 39E). Risk: failure to include required particulars such as naming the active constituent or explicitly stating the withholding period (or that none is required) can attract penalties (s 39D) and hinder downstream trade or export compliance.
Withholding period complexity and buyer disclosure obligations
The “relevant withholding period” is either the period specified by the prescribing vet under s 39D or the period in the use instructions (s 3). Owners and persons in charge must inform buyers/potential buyers of treatment and expiry of relevant withholding periods (s 40A(1)-(2)). Failure to do so is an offence with significant penalties. Risk: multiple actors (owner, person in charge, seller) may each face liability and disputes can arise about who had knowledge and responsibility.
Substance registration status uncertainty
Possession of unregistered stock medicines is criminal unless prescribed for non-food animals or held by pharmacists/vets for non-food use (s 37(1)). Section 42(1) provides a defence where the person did not know and had no reasonable grounds to suspect the product was unregistered. But the onus of proving reasonable ignorance lies with the defendant. Risk: supply-chain participants who accept consignments must have systems to verify registration to avoid criminal exposure.
Secretary’s order power and recall/fee provisions
Orders under s 46 can require recovery of product, tagging, record-keeping, documentation accompanying stock and establishment of authorities for purchase/use with fees or fee waivers (s 46(2)-(2A)(b),(c),(e)). Those orders take immediate effect on publication or service (s 46(5)) and are subject to parliamentary tabling/disallowance (s 47). Risk: sudden administrative orders can impose cost and operational burdens on suppliers and owners, and fees for authorities can act as an access cost for certain products.
Advertising and claims risk
Section 43 prohibits making efficacy claims for uses other than those registered and prohibits false or misleading claims. The maximum penalty is 200 (400 for corporations). Risk: marketing materials that repeat clinical anecdotes or unregistered use claims can trigger enforcement; this may constrain promotional speech and require marketing teams to align materials with registered indications.
Interplay with other statutory regimes
The Act preserves that compliance with another authorising regime like the Poisons and Therapeutic Goods Act negates an offence under this Act (s 6), but veterinary authorisations do not displace other obligations (s 39A(4)). Risk: operators must coordinate compliance across multiple statutes, such as ensuring that a medicine permitted under the Poisons Act is not nevertheless treated as unregistered for Agvet or export purposes.
Penalty notice and summary jurisdiction traps
Many offences are summary with Local Court limitations; Local Courts have capped monetary jurisdiction where proceedings are commenced there (s 60(2)). Penalty notices may be issued by authorised officers under s 60A, but only for offences prescribed by regulation as penalty notice offences (s 60A(2), (4)). Risk: businesses served with penalty notices must understand whether the offence is a penalty notice offence and the procedural consequences under the Fines Act.
Record and labelling compliance obligations may be outsourced at cost
The Act requires specific labelling, documentation and the making/keeping of records (s 65(2)(f)-(h); s 46(2A)(b)). These duties can be operationally burdensome and often require firms to upgrade IT, traceability and packaging processes. Risk: small businesses bear comparatively higher per-unit compliance costs.
Continuity and transitional instruments
Permits and appointments made under prior versions of the Act continue post-amendment by operation of Schedule 2 but may be migrated into Biosecurity Act frameworks (Schedule 2, clauses 21, 25). Risk: permit-holders must confirm whether their permits have been adapted under Part 21 of the Biosecurity Act and check for any new conditions arising from migration.
How to comply
This section sets out concrete, source-grounded steps organisations and practitioners should take to align conduct with the statutory text. Each instruction references the relevant statutory provision.
Verify registration before possession, sale or use
Check whether a stock medicine is a registered stock medicine under the Agvet Code before possessing, selling or using it, especially on food producing species. Possession of unregistered stock medicine is an offence except in narrow professional circumstances (s 37), and sale of unregistered medicines is prohibited (s 41(1)(a); s 41(2) exception for veterinary prescription). Where doubt exists, treat the product as unregistered until confirmation is obtained. Maintain supplier verification records as evidence for the s 42 defence if needed.
Ensure labels and use instructions comply with the Agvet Code and are present
Use instructions are defined to include label content and any writing on the package (s 4(1), (3)). Ensure that packaging contains the dosage, method, targeted stock types, withholding period, precautions/contraindications and any “Restraint” information (s 4(2)). Because failure to read the label is not a defence (s 39(4)), make labelling a compliance priority.
When deviating from label instructions, follow veterinary authorisation procedures
Veterinary practitioners who propose to use unregistered medicines on food producing species or to use registered medicines contrary to use instructions must confirm they are acting in the course of professional practice and within the exempt circumstances (s 39A). If use is permitted, provide the signed, dated written instructions required by s 39D and ensure those instructions include stock identification, owner details, the medicine and active constituent, the withholding period (explicitly stated), dosage, frequency, duration and manner of administration (s 39D(3)). Keep contemporaneous records in line with regulatory requirements (s 39E).
Non-veterinary users must secure written veterinary instructions and pass them on
Persons who are not veterinary practitioners must act only in accordance with written instructions from a vet, under a permit, or in compliance with a s 46 order (s 39B(2)). After treating food producing stock, they must ensure the owner or person in charge receives written instructions identifying treated stock and the applicable use instructions or veterinarian variations (s 39F).
Manage withholding periods and buyer disclosure
Record and calculate relevant withholding periods carefully. The relevant withholding period is the one specified by the prescribing vet under s 39D or, if none, the period in the use instructions (s 3). Owners and persons in charge must inform buyers/potential buyers when treated stock are subject to relevant withholding periods and cannot permit slaughter/harvest/release for human consumption before expiry (ss 40A-40B). Put processes in place for tagging treated animals or otherwise identifying them in line with any Secretary or Biosecurity Act requirements.
Prepare for Secretary orders and Agvet Code notices
Monitor for Secretary orders under s 46 and Agvet Code s 55 notices, which may require specific dealing practices, recovery and disposal actions, tagging and record-keeping, and may fix fees for authorities (s 46(2), (2A); s 41A). Where an order applies to you as a named person, it will be served; where it is general it will be published in the Gazette (s 46(3), (5)). Ensure operational capacity to respond to recall/recovery instructions.
Maintain records and be ready to produce them
Keep records required by regulation regarding prescriptions, supplies and uses of unregistered medicines on food producing species and uses of registered medicines contrary to instructions on major food producing species (s 39E). Maintain documentation of veterinary written instructions, buyer notifications, sale records showing disclosure of withholding periods (s 40A(2)), and any communications about tags or identification demanded by orders (s 46(2A)(a)). Regulations may specify forms and record-