Federal Court Proceedings Demonstrate Risk To Compounding Pharmacies

Categories: ,

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).

Latest News


Mindfulness May Help Lower Sexual Distress in Older Women With Low Libido Mindfulness May Help Lower Sexual Distress in Older Women With Low Libido

International Society For Sexual Medicine Mindfulness May Help Lower Sexual Distress in Older Women With Low Libido    

NEW IMS Symposium with Dr James Simon & Sharon Parish NEW IMS Symposium with Dr James Simon & Sharon Parish

Sexual Health and Treatment for Women: Fact, Fiction, the Future. At the International Menopause Society’s 19th World Congress on Menopause to be held 19th – 22nd October 2024 in… Continue Reading →

INTERNATIONAL RECOGNITION PROCEDURE OFFERS HOPE FOR UK’S POSTMENOPAUSAL WOMEN. INTERNATIONAL RECOGNITION PROCEDURE OFFERS HOPE FOR UK’S POSTMENOPAUSAL WOMEN.

Hypoactive Sexual Desire Dysfunction (HSDD) Perth, Australia: Lawley Pharmaceuticals, via UK-based commercial partner, Andro Pharmaceuticals Ltd, today submitted a Marketing Authorisation Application (MAA) for… Continue Reading →