Federal Court Proceedings Demonstrate Risk To Compounding Pharmacies

MEDIA RELEASE 3rd August 2017

A recent Federal Court case highlights the very real risk and cost to Compounding Pharmacies who do not adhere to the Pharmacy Board of Australia “Guidelines on Compounding of Medicines (March 2015)” and/or who continue to supply their own compounded product when requested by a patient to fill a prescription for a medicine (in this case testosterone cream) which is commercially available.

In the case the Compounding Pharmacy concerned supplied their own compounded testosterone cream to a patient who presented with a script for the Lawley Pharmaceuticals product “AndroForte ^® 5”.

Lawley Pharmaceuticals took action against that Compounding Pharmacy for passing off and misrepresentation in trade and commerce.  The action was recently settled by the Compounding Pharmacy agreeing to pay $73,000 in damages and costs.

The Compounding Pharmacy also agreed to take reasonable steps to order and supply the Lawley product to customers who present with scripts for either a Lawley branded or a generically prescribed testosterone cream and otherwise to use reasonable endeavours to comply with the Pharmacy Board of Australia Guidelines.

Lawley Pharmaceuticals Medical Director and pharmacist, Michael Buckley, said:

“This outcome sends a strong message to the more than six hundred compounding pharmacies across Australia to comply with the Guidelines – particularly in relation to our commercially available products. We will continue to monitor the market.”

MORE INFORMATION

The Guidelines issued by the Pharmacy Board of Australia state that a compounded medicine, such as a testosterone cream, should be prepared only when a commercial product is unavailable or is unsuitable (e.g. if a patient experienced an allergy to an excipient in the commercial products).  http://www.pharmacyboard.gov.au/Codes-Guidelines.aspx

The Endocrine Society of Australia and the Australasian Menopause Society do not endorse the prescribing of compounded bioidentical hormones.

http://www.menopause.org.au/hp/position-statements/275-compounded-bioidentical-hormones-in-endocrinology-practice

Lawley Pharmaceuticals is the sponsor and supplier of AndroForte^® 5 which is registered on the Australian Register of Therapeutic Goods (AUST R 123764) and is included on the Pharmaceutical Benefits Scheme (PBS).