A discussion paper on regulation of extemporaneously prepared medicines in non-hospital pharmacies
April 2008
This consultation closed on 23 May 2008.
A Discussion Paper on Regulation of Extemporaneously Prepared Medicines in Non-hospital Pharmacies is part of the continuing development of an appropriate regulatory response to the changes in the practice of pharmacy that have occurred over recent years. These changes have included increases in the scale of preparation and the variety of ingredients and formulations of extemporaneously compounded medicines.
The discussion paper is the work of the National Coordinating Committee on Therapeutic Goods <http://www.tga.gov.au/docs/html/ncctg.htm> (NCCTG).
Background
In 2004, the Therapeutic Goods Administration (TGA) commissioned Review of the need for further regulation of extemporaneous compounding <http://www.tga.gov.au/meds/extempcomp.htm> by Oceania Health Consulting. In 2005 the Australian Health Ministers' Advisory Council (AHMAC) acknowledged that public health concerns existed regarding the growth in the practice of extemporaneous compounding. The AHMAC also endorsed continued development by the NCCTG, in consultation with stakeholders, of an appropriate regulatory response for managing health and safety risks of extemporaneously compounded therapeutic goods.
Separately to the NCCTG, the TGA has established a Pharmacy Manufacturing Technical Expert Reference Group to consider the good manufacturing practice (GMP) issues relating to manufacturing in pharmacies. This Group draws members from peak pharmacy bodies and industry associations, as well as from the TGA's Manufacturers Assessment Branch. This group has met on four occasions since early 2007.
Information sought
The Discussion Paper is released to stakeholders for their consideration and comment on all aspects of the paper. The NCCTG recognises that there will be divergent views on some aspects of the Discussion Paper.
The NCCTG is particularly interested to receive comment and supporting data on the following:
- the proposal for non-hospital pharmacies making large quantities of medicines and/or high risk medicines (however defined) to require a TGA manufacturing licence in addition to jurisdictional approval for the pharmacy;
- the use of quantitative parameters, the proposed quantitative parameters, and the proposed limits on individual formulations and/or total quantity of a particular dosage form that could be compounded (manufactured) before the pharmacy would require a manufacturing licence from the TGA;
- for medicines provided outside of the Pharmaceutical Benefits Scheme, information on quantities of extemporaneously compounded capsules, troches, injections and other dosage forms supplied per prescription.
Further information
Questions should be directed to the TGA on telephone number 02 6232 8636 or by email to standards@tga.gov.au.