TGA and Medsafe

Meningitis outbreak from US Compounding Pharmacy

As you may have heard in recent reports from the US, the deaths of 7 people and the illness of a further 91 from fungal meningitis have been traced to a batch of steroidal spinal injections prepared by a New England compounding company.  This article from The New York Times, discusses the incident, the background to compounding in the US, the lack of regulation and why unregulated products from compounding companies are so attractive to public hospitals and governments.

A review of US compounding product issues over the last 10 or so years, informs us that this is a very serious incident and it is far from isolated.

There are some interesting reports that can be found on the TGA website on recommended regulations that should be employed for compounding operations.  Even if these recommendations were enforced, they are still a long way from what any licensed manufacturer has to comply with.

Nearly 18,000 vials of this formulation have been distributed across the US, so there is a real likelihood that the number of infections will increase.  For those with more experience in this area, what is the likelihood that this incident will lead to more rigorous regulations for the compounding industry?