Document ID: chunk:federal_register_of_legislation:F2025C00081:clause:2_7:p1
Version: federal_register_of_legislation:F2025C00081
Segment Type: clause
Provision Reference: sch 2 cl 7 (pt 1/2)
Character Range: 25175–28154

7  Restrictions
  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 Treatment Principles 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 subsubparagraph (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 the specific or general standards as determined by the relevant Minister under the Therapeutic Goods Act 1989.
 (e) basis for prescribing: the prescribing of therapeutic substances other than on the clinical diagnosis of a Medical Practitioner, Authorised Nurse Practitioner or Authorised Midwife shall be invalid;
Note: an RPBS prescriber who is an Authorised Midwife or an Authorised Nurse Practitioner may only prescribe a Pharmaceutical benefit listed on the PBS and a prescription by an Authorised Midwife or an Authorised Nurse Practitioner for a Pharmaceutical benefit that is not available on the PBS is not recognised under the Scheme, even if the Pharmaceutical benefit is available under the Scheme on the prescription of, say, an Approved Medical Practitioner.
 (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