A Veterinarian's Guide to Compliant Off-Label Prescribing of HEMP DROPS
The regulatory landscape for Australian veterinary practise is constantly evolving. This guide is designed to clarify the compliant use of HEMP PET™ HEMP DROPS™, aligning it with established best practices for off-label prescribing.
This is a best-practice guide only. Its purpose is to simplify compliance and provide a clear pathway forward. If your practise has not followed these specific procedures to date, you have not done anything wrong. Our goal is to empower you with knowledge to avoid future complexities and practise with confidence.
Clarifying the Status of HEMP DROPS™
One of the biggest sources of confusion is the regulatory classification of HEMP DROPS™. The strategy is straightforward and designed for compliance:
· Nutritional Product by Classification: HEMP DROPS™ are positioned as a nutritional supplement or beneficial feed additive. Because HEMP PET™ makes no therapeutic claims, the product is exempt from registration as a Veterinary Chemical Product (VCP) with the APVMA. This was reinforced by the APVMA's updated position on 1 May 2025, which clarified that suppliers determine a product's status based on its claims.
· Schedule 4 Substance by Content: The product contains naturally occurring cannabidiol (CBD), which is a Schedule 4 (Prescription Only) substance under the Poisons Standard.
The Dual Nature: When a veterinarian, using their professional judgement, decides to use HEMP DROPS™ for a therapeutic purpose (e.g., for anxiety, arthritis, or seizures), its S4 content means it must be prescribed and handled off-label, following all relevant state and territory regulations for a Schedule 4 substance.
Why HEMP DROPS™ Are Not Registered as a Medicine
A common question is why a product with therapeutic potential isn't registered as a medicine. The answer lies in its composition as a full-spectrum hemp extract. Currently, regulatory bodies worldwide, including Australia's APVMA and the US FDA, have frameworks designed for single-molecule drugs (isolates), not complex botanical mixtures. As a result, no full-spectrum CBD product has been registered as a medicine for animal or human use anywhere in the world.
However, a growing body of evidence suggests that full-spectrum products are superior to CBD isolates. This is due to the "entourage effect," a theory that the hundreds of compounds in the hemp plant (including cannabinoids, terpenes, and flavonoids) work synergistically to produce a greater therapeutic effect than CBD alone. Research indicates that full-spectrum extracts may offer enhanced benefits for conditions like pain and inflammation, often at lower doses compared to isolates. By providing HEMP DROPS™ as a nutritional supplement for off-label prescribing, veterinarians can access the benefits of a full-spectrum product within a compliant framework.
The Off-Label Pathway: Aligning with Familiar S4 Practises
The process for prescribing HEMP DROPS™ off-label is not new; it mirrors the established protocols veterinarians use daily for other in-pharmacy products. This pathway ensures you meet your professional obligations under AVA guidelines and state laws like the Poisons and Therapeutic Goods Act 1966 (NSW).
Consider these common examples of off-label prescribing:
· Using a human-registered antidepressant (e.g., fluoxetine) to manage separation anxiety in a dog.
· Prescribing an anti-inflammatory drug registered for dogs (e.g., meloxicam) for a cat with arthritis, often at a different dosage.
· Administering an antibiotic for a bacterial infection not specifically listed on its approved label.
In each of these cases, as with HEMP DROPS™, the veterinarian assumes responsibility and follows a standard duty of care. The compliant pathway is the same:
1. Establish Clinical Justification: Diagnose the condition and determine that an off-label product is a suitable treatment, especially if no registered alternative is available or appropriate.
2. Obtain Informed Consent: Explain to the owner that the product is being used off-label and is not registered with the APVMA for this specific purpose. Document this consent in writing.
3. Document Meticulously: Record the clinical rationale, dosage, administration instructions, and the patient's response in the clinical notes.
4. Adhere to S4 Regulations: Ensure the product is stored, labelled, and dispensed in full compliance with your state's Schedule 4 requirements.
By framing the use of HEMP DROPS™ within this familiar context, it becomes clear that this is not a new or complex burden, but an extension of existing professional practise.
Practical Compliance Tools: Checklists and Consent Forms
To further simplify this process, our state-specific guides provide ready-to-use templates. For example, the NSW Guide for Veterinarians includes a compliance checklist and an informed consent form to ensure all key steps are covered.
NSW Veterinary CBD Compliance Checklist Example:
- VCPR established
- Clinical justification documented
- No suitable registered therapy identified
- Informed consent obtained (signed)
- Dosing and supply appropriate to case
- CoA recorded; batch traceable
- Product securely stored
- Clinical notes updated
NSW CBD Informed Consent Form Snippet:
I acknowledge that:
- This product is not a registered VCP with APVMA and is prescribed off-label.
- It contains cannabidiol (CBD), a Schedule 4 substance.
- Potential benefits and risks have been explained...
- I understand there are alternative, registered treatments, which have been discussed.
Working with Veterinary Practitioners Boards (VPBs)
HEMP PET™ is committed to fostering a transparent and compliant environment. We are proactively working with state VPBs to ensure our guidance aligns with their expectations. As part of this effort, we have submitted resources like the "NSW Guide for Veterinarians: Off-Label Prescribing of Beneficial Nutritional Supplements Containing Cannabidiol (CBD)" for the board's consideration, demonstrating our dedication to supporting lawful and responsible veterinary practise.
Current Tools and Resources to Simplify Compliance
At HEMP PET™, we understand that documenting clinical justifications, managing consent forms, and tracking off-label use adds to your administrative workload. We believe our role extends beyond providing a high-quality product to making compliance as straightforward as possible. To support your practise, we have developed a suite of resources designed to provide clarity and simplify your workflow.
1. Comprehensive Prescriber Guide
We are currently distributing our new comprehensive prescriber guide, "Veterinary Prescriber Reference for Cannabidiol (CBD) in Companion Animals Treatments - A Guide to Compliant Off-Label Prescribing of HEMP DROPS™," in hard copy to clinics across Australia. This guide consolidates all the essential information, from regulatory context to practical step-by-step protocols, into a single, easy-to-reference document. It is also available for download on our veterinary portal.
2. State-Specific Compliance Packs
Recognising that regulations vary between states and territories, we have created individual compliance guides for NSW, Victoria, Queensland, WA, NT, Tasmania and South Australia. Each state and territory-specific guide includes:
· A detailed breakdown of relevant local legislation (e.g.,Poisons and Therapeutic Goods Act 1966in NSW or theDrugs, Poisons and Controlled Substances Act 1981in Victoria).
· Step-by-step pathways for compliant off-label prescribing.
· Ready-to-use compliance templates, including informed consent forms tailored to each state's requirements.
3. Educational Support and Resources
Our secure veterinary portal at hemppet.au is your central hub for compliance support. Here you can access:
· All state-specific guides and compliance templates.
· Batch-specific Certificates of Analysis (CoAs) for quality assurance.
· Summaries of relevant research and clinical information.
These tools are designed to empower you to make informed decisions, streamline documentation, and confidently meet your professional obligations. To receive hard copies of the prescriber guide or for assistance accessing the portal, please contact us at info@HempPet.com.au.
Partnering to Simplify Compliance: A Look Ahead
While these resources address current needs, we are committed to continuous improvement. We are exploring the development of new software tools designed to further simplify your workflow. Imagine a paperless system that helps manage client consent for off-label use, automates record-keeping in line with state board requirements, and provides at-a-glance compliance checks. Our vision is to create a seamless, intuitive platform that integrates into your existing processes, saving you time and reducing stress.
Help Us Build the Tools You Need
Your expert opinion is crucial in shaping these tools to be genuinely useful in a clinical setting. We want to build a solution that addresses your real-world challenges. We would be grateful if you could take a moment to share your interest and insights on what features would be most valuable to your practise.
Thank you for your continued dedication to animal health and for your partnership with us. We look forward to supporting your practise through these regulatory shifts and beyond.
The Vet Team at HEMP PET™
This information is intended for registered veterinarians in Australia. The information provided is for educational purposes and does not constitute legal advice. Please consult your state veterinary board for specific guidance.