As of 1 October 2024, the Pharmacy Board of Australia’s Guidelines on Compounding of Medicines have been updated, introducing numerous updates, with 51 noticeable key changes that stood out.

These updates introduce numerous (>50) changes to provide pharmacists and support staff with more precise guidance on safe compounding practices. The revisions align with evolving healthcare standards, emphasising critical areas such as risk management, quality assurance, legal compliance, and patient-centered care. Many of the changes stress the importance of thorough documentation, including risk assessments and ingredient sourcing, while also clarifying the professional responsibilities of pharmacists.

Notable updates include a revised definition of “commercial medicine,” enhanced requirements for veterinary compounding, guidance on informed consent and advocated third-party audits for complex compounding.

Below, we will explore a few essential updates that compounding pharmacists should incorporate into their daily practices to ensure compliance and patient safety.

Clarity in Terminology and Definitions to Compounding Guidelines

The revisions to the compounding guidelines in 2024 have improved the clarity of previously ambiguous terms. For example, the term “Commercial Medicine” is now clearly defined as any product listed or registered on the Australian Register of Therapeutic Goods (ARTG) or approved under section 19A of the Therapeutic Goods Act (p.9).

This clarification aids pharmacists in discerning the necessity of a compounded product versus the availability of a commercial alternative.

Another noteworthy update is the definition of “Supervising Pharmacist”, referring to the pharmacist responsible for direct oversight during compounding (p.17, p.18, p.32). This ensures standardisation and clarity of responsibility, promoting safer compounding practices across the profession.

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Enhanced Quality and Risk Management Framework

The updated guidelines now place a stronger emphasis on quality assurance and risk management. Pharmacists are now required to carry out and document risk assessments for facilities and equipment, addressing potential contamination risks, especially in sterile environments (p. 21).

By referring to standards such as the

PIC/S GUIDE TO GOOD PRACTICES FOR THE PREPARATION OF MEDICINAL PRODUCTS IN HEALTHCARE ESTABLISHMENTS PIC/S PE 010

and

PIC/S GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS PIC/S PE 009, the guidelines ensure that pharmacists follow Good Manufacturing Practice (GMP) principles in facilities handling sterile products.

In sterile compounding, adherence to USP-NF〈797〉 and USP-NF〈800〉is strongly advocated to ensure safety in handling sterile and hazardous materials. Regular process validation and audits are required to confirm compliance with standards, with third-party audits or laboratory testing needed for complex compounding (p. 15).

Moreover, the 2024 guidelines stress the importance of using high-quality and safe ingredients. Pharmacists must obtain ingredients from manufacturers with approved quality assurance procedures.

Australian manufacturers are mandated to have a TGA Manufacturing License, while foreign suppliers must have TGA GMP certification or an equivalent standard. These measures are in place to ensure the quality of raw materials and strengthen patient safety. Pharmacists must also actively confirm their suppliers’ credentials.

Table 1: Additional Key Updates: A Comparative Analysis

No.	Topic	2017 Version	2024 Version	Significance
1	Emphasis on Patient Safety	Mentions patient safety but doesn’t consistently emphasize it as a primary concern. (p. 3, p. 4, p. 6)	Consistently emphasises the importance of patient safety throughout the compounding process. (p. 11, p. 14, p. 22, p. 23)	Reinforces patient safety as a core focus, ensuring all practices prioritise patient well-being and reduce risk of harm.
2	Emphasis on Patient Safety	Mentions obligations but doesn’t outline consequences of non-compliance. (p. 3)	Explicitly outlines obligations and potential consequences of non-compliance. (p. 4, p. 6, p. 16)	Helps pharmacists adhere to regulations, reducing risks and enhancing professional accountability.
3	Emphasis on Quality Assurance and Standards Compliance	Briefly mentions quality assurance but lacks detailed procedures. (p. 12)	Devotes a section to quality assurance, emphasising SOPs and continuous improvement. (p. 14)	Enhances consistency, safety, and effectiveness of compounded medicines through comprehensive quality practices.
4	Mandate for Ongoing Competence and Professional Development	Mentions the importance of professional development but doesn’t strongly emphasize it. (p. 5)	Emphasizes ongoing professional development and competence maintenance, especially for complex compounding. (p. 12, p. 13)	Ensures pharmacists remain up to date with best practices, enhancing service quality provided to patients.

Patient-Centered Care and Communication

The revised guidelines broaden the definition of “patient” to include families, carers, and communities (p. 4), recognising their essential role in healthcare decisions. This expanded definition aligns with a more holistic approach to patient-centered care.

Furthermore, the 2024 guidelines require informed consent before compounding (or supplying) a compounded medicine (p. 11). This requirement ensures transparency, allowing patients to understand the process, risks, and alternatives. Providing adequate information to patients about the quality and safety of their compounded medicine builds trust and improves the patient-pharmacist relationship.

Clearer Guidance on Regulatory Compliance and Standards

The 2024 guidelines provide more guidance on regulatory pathways, including details on section 19A, Special Access Scheme (SAS), and Authorized Prescriber (AP) pathways (p.8).
These pathways are crucial for pharmacists navigating the complex legal requirements around accessing and supplying unapproved medicines.

Additionally, pharmacists must ensure their compounding practices meet the requirements of facility design standards (p. 13), if applicable. This includes appropriately storing hazardous materials (p. 14) and maintaining workspaces that comply with GMP standards (p. 3).

Compounding vs. Manipulation

The updated guidelines clarify the distinction between compounding and manipulation of medicines. Compounding involves preparing a medicine from scratch to meet a specific patient’s needs, whereas manipulation refers to modifying a commercially available product according to manufacturer instructions (e.g., reconstituting oral antibiotics or aseptic transfer) (p. 7).

Assigning Expiry Dates to Compounded Medicines

The updated guidelines place particular emphasis on assigning expiry dates to compounded medicines. Expiry dates should be based on evidence from reputable sources like the Australian Pharmaceutical Formulary and Handbook and USP-NF <797> for sterile preparations (p. 22). The default expiry for compounded sterile injectables is now 24 hours unless extended under stringent conditions, ensuring that pharmacists minimise risks such as microbial contamination and chemical instability.

Pharmacists play a crucial role in ensuring that their facilities and processes for assigning expiry dates meet regulatory, GMP and validation standards. This is essential to guarantee the safety of compounded medicines for patient use during their assigned shelf life.

Documentation Requirements

Pharmacists must document the preparation of compounded medicines comprehensively, including the risk assessments (p. 21), and maintain records for ingredients subject to real-time prescription monitoring (RTPM). This documentation is critical for auditing and ensuring state and federal law compliance.

Supporting Resources

To assist pharmacists with the transition to these updated guidelines, the Pharmacy Board of Australia has published additional resources, including:

Consumer Fact Sheet: Information to help consumers understand how compounded medicines differ from standard medicines.
Background Document on Regulation: An overview of the regulatory framework for compounding practices.
FAQs and Additional Resources (Still to be published): Updated to reflect the new guidelines by October 2024.

Pharmacists are encouraged to review these resources to ensure compliance with the revised guidelines.

Conclusion

The revised Guidelines on Compounding (August 2024) by the Pharmacy Board of Australia provide much-needed clarity and structure to compounding practices, especially in risk management, patient communication, and compliance. These guidelines reinforce established advice on when not to compound a medicine, ensuring pharmacists maintain safe, compliant practices. Pharmacists integrating these updates into their practice will enhance the safety and efficacy of compounded drugs, aligning with evolving healthcare standards.

With the implementation date set for 1 October 2024, pharmacists must thoroughly acquaint themselves with the updated guidelines and accompanying resources, including the consumer fact sheet, updated FAQs, and background documents. For more information and access to the full guidelines, visit the Pharmacy Board of Australia’s website.