Australia's Therapeutic Goods Administration (TGA) has opened a consultation on how best to address concerns that the current regulatory framework for compounding medicines does not provide adequate assurance that they meet acceptable standards of quality and safety.

The TGA notes that the expansion of pharmaceutical compound manufacturing in Australia reflects international trends, and that there are concerns locally and overseas regarding the complexity and scale of manufacture in pharmacies that was not envisaged when current regulatory arrangements were put in place.  The deadline for comments is 17 July 2013.

The options proposed in the consultation are:

• Maintain the status quo, based on professional practice standards and guidelines, and existing regulations.
• Enhance co-regulation with pharmacy and pharmacist regulators by amending the Commonwealth legislation to reference the role of professional oversight and requirements, including pharmacy approvals, and clearer requirements regarding medicines exempt from TGA processes.
• Require that specified manufacturing activity in a pharmacy requires the pharmacy to hold a manufacturing license from the TGA.

The last option includes three sub-options, based on either sterility or the complexity of the medicine, or the scale of manufacturing activity.

 

TGA Compounding Proposals

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