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Why are there restrictions on prescribing and supplying pharmacist-compounded Schedule 8 medicines?

Compounded medicines are not assessed by the Therapeutic Goods Administration for quality, safety or efficacy, and should only be used where a registered medicine is inappropriate or unavailable.

There are concerns about poor practices in the manufacture, handling, storage, recording and supply of Schedule 8 substances by some retail pharmacies, the promotion of the inappropriate use of such preparations with little or no clinical justification, and the potential and actual diversion for abuse of such preparations.

For further professional practice guidance on compounding, please see the Pharmacy Board of Australia’s Guidelines on Compounding of Medicines.

Do the requirements for authority to prescribe/supply compounded Schedule 8 medicines apply to prescriptions which were written interstate?

Yes, a prescription written in a State or Territory other than NSW cannot be dispensed in NSW unless it complies with NSW law, including any requirements for the prescriber to hold authority from NSW Health and to write the authority number on the prescription.

Do the requirements apply when the prescription is written in NSW and dispensed in another jurisdiction?

The requirements apply to all prescriptions written in NSW. Seek advice of the health authority of the relevant State or Territory to determine whether and under what conditions a prescription written in NSW may be valid for dispensing in that jurisdiction.

Do I need an additional authority to prescribe a compounded Schedule 8 psychostimulant medicine?

An authority is required to prescribe/supply a S8 psychostimulant, and for a S8 medicine that is compounded. Prescribers holding an existing general NSW authority for S8 psychostimulants such as dexamfetamine, lisdexamfetamine or methylphenidate do not need an additional authority to prescribe these as compounded S8 preparations. A prescription for a compounded S8 psychostimulant bearing the NSW authority number issued to and written on the prescription by the prescriber, is valid for dispensing if it is in a form that is compliant with the law.

More information on requirements for the prescribing of psychostimulants are at Prescribe a psychostimulant medication.

A doctor already holds a NSW authority to prescribe a Schedule 8 (S8) medicine (required because the patient is drug dependent, or is using certain ('type B') S8 medicines for 2 months or more). Does the doctor need to apply for a new authority because the new medicine prescribed is pharmacist-compounded?

Although a new authority is not needed, the prescriber must write the existing NSW authority number on the prescription for it to be valid. (Only a prescription for a compounded Schedule 8 medicine, and for a psychostimulant, must be endorsed with a NSW authority reference number).

Is a NSW authority required for use of an unregistered Schedule 8 medicine in a clinical trial?

NSW Authority is required to prescribe or supply any unregistered S8 medicine for a clinical trial. Only a medical practitioner may be authorised.

What is the processing time for approval of an application for authority to prescribe a compounded Schedule 8 medicine?

Up to 30 business days, where the application is complete. Applications may be referred to an expert Medical Committee where necessary, where stop the clock provisions apply.

How will a dispensing pharmacist know what the NSW authority number is and whether it is valid?

The NSW authority number will appear on the NSW authority sent to the prescriber. The prescriber must include the NSW authority number on prescriptions for Type A drugs, including S8 psychostimulants and S8 compounded medicines. It will not be published elsewhere. If the prescriber has written a NSW authority number on the prescription, the dispensing pharmacist may assume it is a valid number for that doctor, patient and medicine unless there is evidence to the contrary.

Is there a special prescription form?

There is no requirement for any special stationery. The prescriber may use his/her usual prescription stationery. Authorities issued by the NSW Health Secretary should not be confused with any “PBS Authority” which may be required for cost subsidy under the Commonwealth’s Pharmaceutical Benefits Scheme.

Does a doctor need authority to prescribe a registered Schedule 8 (S8) medicine for an indication which is not included in the Approved Product Information?

No, a NSW authority is not required for “off-label” prescribing of a registered S8 medicine. Off-label prescribing is where the clinical indication for use is outside that approved by the Therapeutic Goods Administration as appears in the Approved Product Information.

Does a doctor need authority to prescribe a registered Schedule 8 (S8) medicine where instructing the pharmacist to re-formulate or compound the registered product?

Yes, authority is required. These re-formulations e.g. make tablets into a mixture, or make the contents of ampoules into a cream, or combine two registered medicines, one or both of which is S8, are compounding. Prescribers are legally required to clearly include in a prescription all their directions to the pharmacist about how to formulate/compound a medicine.

Can a nurse practitioner, midwife practitioner, dentist or other authorised practitioner prescribe a compounded Schedule 8 medicine?

No. Only a medical practitioner may obtain authority to prescribe a compounded S8 medicine. Other practitioners cannot prescribe them.

Can a veterinary practitioner prescribe or supply a compounded Schedule 8 medicine for the treatment of animals?

No, a veterinary practitioner cannot prescribe or supply a compounded S8 medicine.

Can a doctor instruct a pharmacist (by phone, fax, email or other communication) to compound a Schedule 8 medicine whilst awaiting a NSW authority, on the promise of later sending the prescription bearing the authority number to the pharmacist?

No. A pharmacist may not manufacture or supply a compounded S8 medicine except on a prescription bearing the authority number.

Do all compounded Schedule 8 medicines require authority to prescribe?

No, there are some exemptions under an Order issued by the Health Secretary. These include medicines prescribed, dispensed or administered in a hospital; and medicines made by an Australian licensed manufacturer under a contract with, and to a formulation specified by, a hospital, for patient/s of the hospital, where there is no substantially similar registered medicine, and the manufacturer notifies the Commonwealth Health Secretary each quarter of the details of its supply of such medicines.

See the full list of exemptions.

Page Updated: Wednesday 2 October 2019
Contact page owner: Pharmaceutical Services