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:
Under the NSW Poisons and Therapeutic Goods Act 1966, an authority (NSW authority) is required to prescribe or supply an unregistered Schedule 8 medicine (S8):
* A drug dependent person means a person who has acquired, as a result of repeated administration of any of the following drugs, an overpowering desire for the continued administration of a drug of addiction (Schedule 8), or a prohibited drug within the meaning of the Drug Misuse and Trafficking Act 1985 (including but not limited to heroin, methylamphetamine or cocaine). A person treated under the Opioid Treatment Program is a drug dependent person.
To apply for a NSW authority, submit an Application for Authority to Prescribe or Supply an Unregistered or (Pharmacy) Extemporaneously-Compounded Schedule 8 Product for Human Therapeutic Use. (Updated form)
More information is available on prescribing or supplying Schedule 8 cannabis medicines.
The medical practitioner must write the NSW authority number on a prescription for an unregistered compounded S8 medicine (not to be confused with a ‘PBS authority number’ issued by the Commonwealth for subsidy under the Pharmaceutical Benefits Scheme). All the other requirements for an S8 prescription apply, such as adequate directions for use, handwritten, quantity in words and figures and repeat intervals, and required records (see Guide to Poisons and Therapeutic Goods Legislation for Medical, Nurse and Midwife Practitioners and Dentists).
The applicant medical practitioner would be expected to be a specialist in the management of patients with the disease being treated with the medicine. The application must include the rationale for the treatment and the available scientific evidence to support this treatment of choice.
Prescribers holding an existing general NSW authority for S8 psychostimulants such as dexamfetamine, do not need additional authority to prescribe them as compounded preparations.
A pharmacist can compound or dispense an unregistered S8 medicine only on receipt of 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.
The prescription for a compounded S8 medicine must bear the NSW authority number issued to and written by the prescriber (which has the format "AXXXXXXX" where X is a numeral).
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:
