Is compounding properly regulated?

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Pharmacy leaders have hit back at claims that pharmaceutical compounding is unregulated, after criticism from a leading medical practitioner.

Well-known media identity Dr Norman Swan questioned current compounding regulations in the aftermath of the recently broadcast Four Corners’ supplements investigation.

In an online post Dr Swan attempted to include compounding regulation into the wider debate over supplement regulations.

“Supplements are not natural. We’ve been conned into believing that. The other huge story is in freelance compounding in pharmacies. No controls whatsoever. No-one seems to care,” he said.

He was supported by Dr Helen Schultz, a Melbourne-based doctor and psychiatrist who said compounding in pharmacies is “totally unregulated”, citing the compounding of melatonin “with no evidence”.

However their comments drew a quick response from pharmacy leaders.

The Pharmacy Guild of Australia (Victoria) president Anthony Tassone responded to Dr Swan, arguing that compounding is indeed regulated by the Pharmacy Board, the TGA and state bodies.

PSA CEO Lance Emerson also joined in the debate, saying that audits are conducted on compounding pharmacies and there are enforceable Pharmacy Board standards for medicine compounding.

“There are audits and the PSA supports pharmacists only dispensing evidence based medicines,” he said, citing the organisation’s position statement on complementary medicines.

PSA Executive Director of Policy, Alison Roberts, pointed to the Pharmacy Board’s guidelines on the compounding of medicines.

Dr Swan has been contacted for further comment.

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  1. What new compounding rules???

    Truly – private scripts – who really knows except the pharmacy!!! I have seen acyclovir compounded for twice the price in April where Acivision was clearly in stock – also tadalafil 5mg capsules!!! As regulated as us holding our own PBS scripts – who really knows what is on the script but that is for another post!

  2. Michael Buckley

    Dr Norman Swan is absolutely 100% correct.
    In April 2016 the US Endocrine Society released a Position Statement published in JCEM ( on the Compounding of Bioidentical Hormones. This Position Statement has since been adopted by the International Menopause Society, The Australasian Menopause Society and the Endocrine Society of Australia. Where FDA appears the letters TGA can well be substituted as the situation in Australia is no different. Many Australian compounders show blatant disregard for the Pharmacy Board of Australia’s Guidelines on the Dispensing of Compounded Medicines released in March 2015 especially for Guideline number 2 in relation to the dispensing of a compounded product when a commercially available product is available. With Notifications before the Pharmacy Board of Australia and now a compounding pharmacy case before the courts it is high time the “compounding industry” placed patient safety and professional standards ahead of commercial motivation. Michael Buckley, Medical Director and pharmacist Lawley Pharmaceuticals.

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