Unregistered medicines are not assessed for quality, safety or efficacy by the Therapeutic Goods Administration (TGA). To prescribe an unregistered medicine in Australia, the prescriber must obtain an approval to supply an unregistered good issued under the Commonwealth’s Therapeutic Goods Act 1989 by the TGA (Commonwealth Approval), under one of:
A pharmacist can compound or dispense an unregistered S8 medicine only on receipt of a hard copy original written prescription (or a duplicate copy of a Pharmaceutical Benefits Scheme Hospital Medication Chart prescription, at a pharmacy contracted to supply to the hospital and named on the prescription, in accordance with Commonwealth and NSW requirements for the PBS HMC).
The unregistered S8 medicine supplied to a patient by a pharmacist or medical practitioner must have a dispensing label with the usual details as for any dispensed medicine (see Guide to Poisons and Therapeutic Goods Legislation for Pharmacists).
The requirements as for all S8 prescriptions apply, e.g. the pharmacist must verify the prescriber, report any apparently forged or fraudulently altered prescriptions, and retain the dispensed prescription, separately. All transactions must be recorded in a drug register and loss or theft reported.
Wholesale supply of pharmacy-compounded medicines is not permitted.
Unregistered S8 medicines must be stored separately and securely, as for all S8 drugs. A Schedule 8 medicine requiring refrigeration may be stored in a refrigerator.
The Secretary, NSW Ministry of Health has issued an Order which is published on Page 3708 of the NSW Government Gazette No 117 of 16 December 2016, exempting the following substances from the requirement to obtain authority to prescribe or supply an unregistered Schedule 8 medicine:
For further information please contact the Chief Pharmacist Unit on (02) 9391 9944 or MOH-PharmaceuticalServices@health.nsw.gov.au