Can you rely on a compounding pharmacy?

compounding chemist guidelinesIt comes as a surprise to some that compounding pharmacy is one of the most highly regulated industry sectors in the country.

All compounding chemists in Australia are directed by the Pharmacy Board of Australia to follow guidelines set out in in the Extemporaneous dispensing’ section of the current edition of the Australian Pharmaceutical Formulary and Handbook.

The guidelines have been developed to, “…provide guidance to pharmacists in relation to the compounding of medicines to ensure product quality, safety and efficacy.” National Custom Compounding is committed to following these guidelines and we take all steps and measures to ensure compliance.

Laboratory and equipment testing

National Custom Compounding voluntarily participates in an independent laboratory testing of its compounds to test for potency and shelf stability under “normal” (room temperature) and “accelerated” conditions (increased relative humidity 70% and temperature 45 degrees Celsius). These tests are undertaken at zero, one(1), three(3) and six (6) months.

Testing is conducted by RTH Scientific Services, Brisbane and National Institute of Complementary Medicine, Herbal Analysis Laboratory (HAL), Penrith.

In addition, all equipment at National Custom Compounding is maintained and calibrated according to USP standards (United States Pharmacopeia) and checked annually by Filtertech Australia and CSK Group.

Each of our lab rooms are equipped with a powder containment hood with appropriately maintained HEPA filters and each room has its own air supply through individual air-conditioning units.

Stability tests

A final process that National Custom Compounding uses to ensure the compounded medications are formulated and produced correctly is through a series of stability tests.

RTH Scientific Services is contracted to review the compounded medicines. By running stability tests on compounded medication it enables National Custom Compounding to supply patients with accurate expiry dates and storage information. It is also a critical step to ensure that the current formulations are correct for compounding medications.

If you’d like to make a time to inspect our laboratories and facilities please contact head pharmacist, Matt Bellgrove at National Custom Compounding on 1300 731 755 or visit our website www.customcompounding.com.au for more details.