There are established access pathways for prescribers to lawfully access unapproved therapeutic goods, including some peptide products, for patients under their care where clinically appropriate.
Importantly, as unapproved peptide products have not been assessed by us for safety, quality or effectiveness, the responsibility for determining the quality and safety of the product rests with the practitioner.
Health practitioners and businesses involved in prescribing, supplying, compounding, or advertising unapproved peptide products must understand and comply with their legal and regulatory obligations.
Before applying to access an unapproved therapeutic good, you should:
- consider approved products for your patient's medical condition
- consider the risks and potential benefits of treatment
- obtain informed consent
- comply with relevant state, territory and Commonwealth laws for prescribing, dispensing, supplying or compounding unapproved therapeutic goods
- adhere to relevant standards of good medical practice.
Applications should be supported by human studies that are relevant to the specific peptide, dosage form, route of administration and indication.
Compounded peptide products may be therapeutic goods and may be subject to manufacturing, supply, prescribing and advertising controls. For information, see Manufacturing, supplying and advertising compounded medicines lawfully.
For more information, see Understanding your responsibilities when importing, compounding and supplying unapproved peptide products.