6. Restrictions6. Restrictions

6. Restrictions

7. Restrictions apply to the prescribing of certain items. These include:

(a) items — quantities and repeats: those listed in the RPBS Schedule or PBS Schedule;

(b) surgical appliances and other treatment aids: surgical appliances and other treatment aids provided under the MRCA Treatment Principles or under the Act may not be prescribed unless specifically listed in the RPBS Schedule;

(c) admixtures: the following restrictions apply to admixtures:

(i) admixture of two or more ready‑prepared items into a single combined form, or the addition of one or more supplementary ingredients to a ready‑prepared item, is not recognised as a Pharmaceutical Benefit;

(ii) the extemporaneous prescribing of two or more official formulary preparations in a single combined form, or the addition of one or more supplementary ingredients to an official formulary preparation, is a recognised Pharmaceutical Benefit; and

(iii) where one or more of the components of a preparation specified in subparagraph (ii) are non‑RPBS Schedule or non-PBS Schedule items, Prior Approval is required for their prescribing;

(d) conformity with standards: no drug or therapeutic substance shall be prescribed unless it conforms with:

(i) the specific or general standards as determined by the relevant Minister under the Therapeutic Goods Act 1989; or

(ii) the British Pharmacopoeia, the United States Pharmacopoeia, the European Pharmacopoeia, the Australian Pharmaceutical Formulary, or a prescribed Pharmacology text of international standing;

(e) basis for prescribing: the prescribing of therapeutic substances other than on the clinical diagnosis of a Medical Practitioner shall be invalid;

(f) approval for therapeutic use: it is invalid to prescribe:

(i) an item that is not approved for therapeutic use in the treatment of human illness by the relevant Commonwealth, State or Territory Government agencies, or

(ii) an item for use if it is not in accordance with the terms and conditions specified by the relevant Government agencies in approving the item as a therapeutic substance;

(g) Prior Approval for non-conforming items: any drug or medicine intended for use other than in conformity with the requirements in subparagraph (d) requires Prior Approval;

(h) PBS Schedule restricted items: the prescribing of PBS Schedule restricted items is to comply with the restrictions relating to the prescribing of such items as indicated in the PBS Schedule unless Prior Approval is obtained to prescribe otherwise;

(j) RPBS Schedule restricted items: the prescribing of RPBS Schedule restricted items under this Part is to comply with the restrictions relating to the prescribing of such items as indicated in the RPBS Schedule unless Prior Approval is obtained to prescribe otherwise;