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Getting started in

compounding

Overcoming challenges in medication accessibility and providing transformative options for personalized patient care, pharmaceutical compounding is an essential solution that bridges the gap in healthcare to meet critical needs.
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What is pharmaceutical compounding?

Defined as the practice of preparing customized medications in accordance to a licensed practitioner’s prescription or essential need, pharmaceutical compounding allows providers the opportunity to:
  • Combine therapeutics
  • Personalize dosing
  • Tailor dosage forms
  • Eliminate unwanted ingredients
  • Provide solutions to product unavailability
  • Enhance patient adherence
pharmacist compounding

Discover the need

Addressing shortages
365 shortages have been reported on a single day by the Society of Hospital Pharmacists Australia1. Pharmaceutical compounding acts as a critical safety net that allows providers to fill medication needs during product unavailability, like shortages. Discover how Medisca formulas and products are saving patient lives.

Providing safe medical solutions

Compounding is a highly regulated and disciplined practice that pioneered the practice of pharmacy and maintains an essential role in society today.
Governed by the Australian Therapeutic Goods Administration (TGA)
Compounded medicines are not required to be entered on the Australian Register of Therapeutic Goods. However, compounded medications are not exempt from meeting the quality standards of the Therapeutic Goods Act (1989), or the advertising requirements.
Regulated by state / territory authorities

Pharmacists must meet their obligations outlined in relevant State or Territory (and Commonwealth) legislation as
they relate to the preparation, labelling, maintenance of records, storage, dispensing, supply and advertising of compounded medicines. These guidelines also require pharmacists to meet quality standards set by (but not limited to) the PBA, Australian Pharmaceutical Formulary and Handbook, Therapeutic Goods Act 1989, Health Practitioner Regulations Law, and for sterile medicines either Pharmaceutical Inspection Convention’s publication or the United States Pharmacopeia for Pharmaceutical Compounding (sterile compounding Chapter <797>).

Standardized by the Pharmacy Board of Australia (PBA)

Detailed guidance to pharmacists who compound medicines is provided by the PBA to ensure product quality, safety and efficacy. The Therapeutic Goods Administration recommends compounding pharmacists to consider these guidelines in addition to the requirements of the therapeutic goods legislation. 

What to look for in a
compounding pharmacy

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Commitment to quality

From the supply source to the final compounded preparation, quality is a commitment at every level of the process. When selecting a compounding pharmacy, it is important to ensure that all active pharmaceutical ingredients (APIs) are sourced from TGA-approved and inspected establishments that adhere to Good Manufacturing Practices and have robust vendor qualification, testing, and documentation programs.

Discover Medisca quality
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Investment in education

It is important to ensure that all compounding pharmacy personnel are engaged in continuing education opportunities that allow them to stay up-to-date on recent advances in compounding practices and personalized medicine. This should include regular hands-on laboratory training for compounding personnel and clinical training for pharmacists involved in the clinical decision making process.

Discover LP3 Network education
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Standardized operations

Each compounding practice is required to implement and operate by a set of Standard Operation Procedures (SOPs) that identifies how they ensure compliance with standards of practice, notably compliance with the Australian Pharmaceutical Formulary and Handbook, Professional Practice Standards and where applicable USP <795> and USP <797>. Proof of SOPs is something a provider can request. 

Learn about Medisca SOPs
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Drive for innovation

Technology is moving fast and it is important that new technology be continually evaluated and implemented into practice. Compounding was once and still can be a very manual process (mortar and pestle). Today there exists various technology and equipment, such as the Medisca MAZ® Mixer, that allows for standardization in the process, reproducibility, homogenous mixing, better quality, and more efficient and simplified processes.

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  1. The Society of Hospital Pharmacists of Australia. (2017). Medication shortages in Australia. SHPA. Retrieved from: https://www.shpa.org.au/sites/default/files/uploaded-content/website-content/shpa_medicines_shortages_in_australia_report_june_2017.pdf. 
  2. McPherson, T.B. et al. (2013). Patient-centered care as a value-added service by compounding pharmacies. International Journal of Pharmaceutical Compounding, Vol 17. P 339-343.

  3. Azer, S.A., Kanugula, K., & Kshirsagar, R.K. (2023). Dysphagia NIH – National Library of Medicine. StatPearls.

  4. Beubler, E., et al. (2006). The white paper on opioids and pain: A pan-European challenge: The European white paper on the use of opioids in chronic pain management. J Pain Palliative Care Pharmacother., 20, 79-87.

  5. Branvold, A & Carvalho, M. (2014). Pain management therapy: the benefits of compounded transdermal pain medication. J Gen Practice. 2:6.

  6. Vowles KE, McEntee ML, Julnes PS, Frohe T, Ney JP, & van der Goes DN (2015). Rates of opioid misuse, abuse, and addiction in chronic pain: a systematic review and data synthesis. Pain, 156, 569–576.
  7. Simon, JA. (2014). What if the Women’s Health Initiative had used transdermal estradiol and oral progesterone instead? Menopause. 21(7):769–783.
  8. Biondi, B & Wartofsky, L. (2012). Combination treatment with T4 and T3: toward personalized replacement therapy in hypothyroidism? J Clin Endocrinol Metab. 97:2256–2271. 
  9. Bieber, T. (2013). Advances in the management of atopic dermatitis. Future Science Group.
  10. Koyama, G., Liu, J., Scaffidi, A., Khazraee, M., & Epstein, B. (2015). Novel Approaches to Topical Psoriasis Therapy. International journal of pharmaceutical compounding, 19(5), 357–365.

  11. Hay R.J., et al. (2014). The global burden of skin disease in 2010: An analysis of the prevalence and impact of skin conditions. Journal of iIvestigative Dermatology. 134(6): 1527-1534