New Australia
guidelines
The Pharmacy Board of Australia (PBA) released revised guidelines on the compounding of medicines, which come into effect 1 October 2024. We are here to get you up to speed quickly and effectively. Explore this page for a summary of noteworthy new requirements with the resources to support your compliance.
Quality of raw ingredients must be evaluated
Pharmacists are now responsible for ensuring raw ingredients are sourced from third parties that ensure appropriate certification and licenses of manufacturer, with valid certificate of analysis provided.
Reputable formulas
are now mandated
Products must be compounded in accordance with formulas from a reputable reference. With over 10,000 formulas in our library, Medisca formulas are not only comprehensive, they adhere to guidelines with complete referencing for compliant and reproducible compounding.
Testing is recommended on high-risk compounds
Testing on high-risk compounded medicines, such as narrow therapeutic index products, is recommended. Testing should be performed in laboratories accredited by the National Association of Testing Authorities (NATA) and licensed by the TGA. Looking for testing? We are a proud partners of the National Institute of Complementary Medicine (NICM) at the University of Western Sydney.
Demonstrated competency now required
The new guidelines not only reinforce the requirement for CPD training, but now enforce demonstrated competency to perform compounding activities with specific emphasis on activities that involve significant risk such as the compounding of sterile and hazardous medicines. Pharmacists are encouraged to engage an expert to train and evaluate competency.
Everything you
need to support
the transition
From how our products are sourced and tested, to our best-in-class CPD training activities, library of 10,000+ reputable formulas and standard operating procedures – we have the resources you need and support system in place to ensure your compliance by 1 October 2024.
Got questions?
We have answers
Complete our needs assessment form and we will reach out to you with custom-tailored solutions to meet your specific needs for achieving compliance.