Government targets compounding chemists

Simone Roberts

Speaking at APP2008 last month, Parliamentary Secretary to the Minister for Health and Ageing, Jan McLucas, told pharmacists to expect tighter regulation of extemporaneous compounding with a review due to be soon released by the National Co-ordinating Committee on Therapeutic Goods.

Senator McLucas said she was concerned that some pharmacies were exploiting the Therapeutic Goods Act by preparing products in commercial quantities. Compounding pharmacists are exempt from the act's controls, a move intended to allow small quantities of individualised extemporaneous preparations to continue to be manufactured by pharmacists without interference from the TGA.

"However there has recently been an increase in the number of compounding pharmacies which appear to be preparing prescriptions for many patients at the same time," Senator McLucas said.

"These include the preparation of so called bio-identical hormone compounds and various injectable vitamin B compounds used for fat removal. It is of concern to me that these injections are being compounded in commercial quantities and supplied to beauty salons and body sculpture clinics without evidence of safety, efficacy or quality."

Senator McLucas said the regulatory overhaul will mandate that the pharmacy boards continue to regulate small-scale compounding, while larger commercial levels of compounding will be regulated by the TGA.

Jenny Giam, technical and training manager at the Professional Compounding Chemists of Australia (PCCA), said that while compounding pharmacists operating in a manner more consistent with that of a drug manufacturer numbered few, there was a need for tighter regulation of the area.

"The concern is not the products that are being prepared but that they are being prepared outside of what an extemporaneous product should be – it should be for an individual person for their particular needs.

"If somebody is acting as a manufacturer than it should be the responsibility of the TGA to regulate. If someone is preparing an extemporaneous product for an individual patient's identified need then it's the professional bodies that should regulate," she said.

Other regulatory changes outlined by Senator McLucas included restrictions on advertising of compounded products, and the formulations, dosages and ingredients that pharmacists can compound.