We, the veterinarians, associations, businesses, and citizens stated below put this petition to the NSW Government.

Summary

Under section 11 of the draft Medicines, Poisons and Therapeutic Goods Regulation (New Regulation), pharmacies would no longer be permitted to supply compounded medicines to veterinarians for emergency use.

If enacted, treatment for many animals will be delayed days or even weeks, resulting in a significant impact to animal welfare. For example, vets will have to treat anxious or fractious dogs without anti-anxiety compounded medicines. A further example is the provision of medication (e.g. methocarbamol) required to treat acute intoxication, e.g. permethrin intoxication or fluoroacetate (10-80) poisoning. A third pertinent example is the ability to commence treatment of cats with feline infectious peritonitis with intravenous and oral antiviral therapy in a timely manner.

While we support the prevention of the emergency supply of untested compounded medicines made without quality assurance, veterinarians should be able to stock - and pharmacists should be able to wholesale supply – medicines compounded in compliance with a code of Good Manufacturing Practice such as the APVMA’s code of GMP.

All science is in favour of wholesale supply of GMP compounded medicines for emergency use. All animal health and welfare are in favour of it. There is no persuasive scientific or public policy argument against it.

Background

The NSW Government will be replacing the current Poisons and Therapeutic Goods Act 1966 (Current Act) and Poisons and Therapeutic Goods Regulation 2008 (Current Regulation) with the Medicines, Poisons and Therapeutic Goods Act 2022 (New Act) and the New Regulation.

The New Act has already been passed but the New Regulation has been released in draft, for consultation.

The proposed change: Prohibiting pharmacists supplying compounded veterinary medicines for emergency use.

Under the proposed section 11, relevantly, a pharmacist is authorised to supply by wholesale a schedule 4 (prescription) medicine to an authorised practitioner (e.g., medical practitioner, veterinarian), on receipt of a written order from the practitioner, for emergency use EXCEPT that authorisation does not apply where a pharmacist wishes to supply an unregistered veterinary medicine (i.e., a compounded veterinary medicine) to a veterinarian.

Regulation 46 of the Current Regulation is relevantly the same as proposed section 11, but it does not contain an exception in the case of supply of a compounded veterinary medicine to a veterinarian.

The effect of proposed section 11 is that veterinarians will need a prescription before they can obtain a compounded veterinary medicine from a pharmacist. A veterinarian will no longer be permitted to obtain or hold a compounded medicine in stock for emergency use, to have on hand for an animal whose health and welfare may depend on it.

Our position

We support permitting pharmacists to supply GMP-compliant compounded medicines for emergency use.

There is no science-based argument against the capacity of a pharmacist to supply GMP-compliant compounded veterinary medicines to veterinarians for emergency use.

Implementing proposed section 11 of the New Regulations without the suggested changes will put the health of hundreds of thousands of Australian animals at risk. It threatens timely access of vital compounded medicines, potentially leading to widespread suffering, deterioration in health, and increased fatalities. The proposed changes would be a significant setback to the current standard of animal welfare.

Section 11: proposed amendment

We propose that section 11 of the New Regulation be amended as marked:

11 Wholesale supply by pharmacists to authorised practitioners.

(1) For the Act, section 14(a), wholesale supply of a Schedule 4 or 8 substance by a pharmacist to an authorised practitioner for emergency use is authorised if the supply is in accordance with a written order of the authorised practitioner.

(2) This section does not apply to the following Schedule 4 or 8 substances—

(a) for all authorised practitioners—a Schedule 4 or 8 substance that is not a registered good, and

(b) for a veterinary practitioner—a Schedule 4 or 8 substance that is not registered under the Commonwealth Agvet Codes, unless that substance has been compounded by a pharmacist in compliance with the requirements specified in the Australian code of good manufacturing practice for veterinary chemical products, published by the Australian Pesticides and Veterinary Medicines Authority.

(3) The pharmacist must keep a record of Schedule 4 or 8 substances wholesale supplied under this section.

Maximum penalty—Tier 6 penalty.

**I understand that by signing this petition, my name will appear on the confidential version of the petition shown to the NSW Ministry of Health.**