Unregistered medicines
Unregistered medicines are medicines that are not included in the
Australian Register of Therapeutic Goods (ARTG)They are not assessed for quality, safety or efficacy by the Therapeutic Goods Administration (TGA).
Unregistered medicines include those that are compounded.
Prescribing or supplying unregistered or compounded Schedule 8 medicines
Commonwealth requirements
To prescribe or supply any unregistered scheduled medicine, a prescriber must obtain an approval under the Commonwealth’s Therapeutic Goods Act 1989 using one of the following pathways:
- Special Access Scheme (SAS), or
- Authorised Prescriber Scheme (AP), or
- Clinical Trial Schemes.
For further information visit the
TGA website.
Schedule 8 medicines that are extemporaneously compounded for a particular person for therapeutic application to that person are exempted from registration on the ARTG and from requiring TGA approval. However, in NSW, a prescriber must obtain approval from NSW Ministry of Health to prescribe or supply any extemporaneously compounded Schedule 8 medicine.
NSW Ministry of Health requirements
Under the NSW Poisons and Therapeutic Goods Act 1966, an approval is required to prescribe or supply an unregistered Schedule 8 medicine:
- to a drug dependent person*
- that is a compounded medicine, or
- for a clinical trial.
* A drug dependent person defined under section 27 of the Poisons and Therapeutic Goods Act 1966 (NSW) means a person who has acquired, as a result of repeated administration of:
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a drug of addiction, or
- a prohibited drug (as defined in the Drug Misuse and Trafficking Act 1985),
an overpowering desire for the continued administration of such a drug.
How to apply for an approval
To apply for an approval to prescribe or supply an unregistered or compounded Schedule 8 medicine in NSW, a prescriber is required to complete and submit an
Application for Authority to Prescribe or Supply an Unregistered or (Pharmacy) Extemporaneously-Compounded Schedule 8 Product for Human Therapeutic Use.
Only medical practitioners can apply for an approval to prescribe or supply a compounded Schedule 8 medicine. The approval number issued to the medical prescriber must be included on the prescription for it to be valid for dispensing.
A pharmacist cannot dispense a prescription for a Schedule 8 compounded medicine if the approval number issued by NSW Ministry of Health is not included on the prescription.
Dispensing unregistered Schedule 8 medicines
The following apply to dispensing unregistered and extemporaneously compounded Schedule 8 medicines:
- Prescriptions: A pharmacist can only dispense or extemporaneously compound these medicines if they have a valid prescription. Supply on a telephone, fax or email order is not permitted.
- Hospitals using the Pharmaceutical Benefits Scheme Hospital Medication Chart prescription as per the Commonwealth and
NSW requirements for the PBS HMC, may provide the duplicate copy of the medication chart for supply by the contracted pharmacy.
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Approval numbers: Prescriptions for an extemporaneously compounded Schedule 8 medicine must include the NSW approval number issued to the prescriber (which has the format "AXXXXXXX" where X is a numeral).
- Prescription verification: A pharmacist must ensure the prescription meets all Schedule 8 prescription requirements as well as ensure that they know the patient, or the prescriber, or independently verify that the prescription is valid with the prescriber.
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Record keeping: All transactions for that medicine must be recorded in a drug register on the day of that transaction. The dispensed prescription must be retained separately from other prescriptions (except those listed in
Schedule 4 Appendix B).
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Labelling: All Schedule 8 medicines supplied to a patient by a pharmacist or prescriber must be labelled with a dispensing label with the usual details as for any dispensed Schedule 8 medicine.
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Wholesale supply of pharmacy-compounded medicines is not permitted.
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Storage: They must be stored with other Schedule 8 medicines, separately and securely in a safe. For refrigerated preparations, see Storage of a Schedule 8 medicine requiring refrigeration.
Approval exceptions
An approval to prescribe or supply an unregistered Schedule 8 medicine is
not required in the following circumstances:
-
Prescribers with an existing NSW approval for a Schedule 8 medicine (such as a psychostimulant medicine) that request to prescribe or supply the approved medicine as a compounded preparation.
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Schedule 8 manufactured medicines when manufactured under a contract with a public or private hospital or institution, according to a formulation specified by the facility for its patients. The following conditions apply:
- no similar listed or registered medicine exists
- the substance must be manufactured in Australia by a licensed manufacturer under the Therapeutic Goods Act 1989
- the manufacturer must notify the Commonwealth Secretary of Health quarterly about the substances manufactured.
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Compounded Schedule 8 medicines:
- When compounded by a pharmacist in a public hospital pharmacy for patients of that hospital.
- When compounded by a pharmacist in a facility licensed under the Private Health Facilities Act 2007 for patients receiving:
- chemotherapy (parenteral cytotoxic agents)
- emergency treatments for accident-related injuries or medical emergencies
- neonatal treatment for infants under 28 days old
- palliative care medical services
- surgical procedures involving general or major regional anaesthesia. This excludes surgical procedures by a dentist.
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Topical cocaine: Compounded by a pharmacist for topical application to patients in a facility licensed under the Private Health Facilities Act 2007.
