The purpose of this document is to clarify the PIC/S Guide to GMP for Medicinal Products PE-009 requirements for the manufacture of extemporaneously compounded medicines. This document is only applicable to licensable manufacturers, although may be used as guidance for pharmacists performing compounding that are considered exempt from licensing under the Therapeutic Goods Regulations 1990.
This document has been developed in relation to the PIC/S Guide of GMP for Medicinal Products PE-009-8 15 January 2009, following consultation with stakeholders.
Compounding: The preparation, mixing, assembling, altering, packaging, and labelling of a medicines, medicine-delivery device or device in accordance with a doctor’s prescription, or initiative based on the doctor/patient/pharmacist/compounder relationship in the course of professional practice. Compounding includes the following:
Preparation of medicine dosage forms for both human and animal patients
Preparation of medicines or devices in anticipation of prescription medicine orders based on routine, regularly observed prescribing patterns
Reconstitution or manipulation of commercial products that may require the addition of one or more ingredients
Preparation of medicines or devices for the purposes of, or as an incident or, research (clinical or academic), teaching, or chemical analysis
Preparation of medicines and devices for a doctor’s premises use where permitted by Commonwealth and State law.
Synthesis of a radiopharmaceutical medicine, e.g. radiolabelling of a ligand with a radioisotope.
Dispensing: The manipulation of a commercially available product, in accordance with the manufacturer’s instructions, in order to produce a medicines in a ‘ready to administer’ form. Examples include reconstitution of oral antibiotic mixtures and aseptic transfer to a sterile device. (Where a manufacturer’s instructions are not followed, for example a different diluent is used, this is considered compounding.)
Interpretation of the basic GMP requirements
Where a clause number or an Annex is not listed, there is no specific interpretation provided for manufacture of extemporaneously compounded products.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.