​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​Preparation of pharmaceutical and advanced therapeutic products in NSW public health facilities is governed by the Policy Directive PD2023_021 Preparation of pharmaceutical and advanced therapeutic products in NSW public health facilities.

This policy directive consolidates best practice principles on the preparation, procurement, storage, transportation and waste disposal of pharmaceutical and advanced therapeutic products and provides guidance for outsourcing certain preparations. It should be used as the basis for public health facilities to develop detailed protocols and procedures specific to their local situation and circumstances.

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Who does this policy directive apply to?

The policy directive applies to all public health facilities, including:
  • hospitals 
  • clinical services 
  • outpatient clinics 
  • community health centres
  • day centres 
  • day procedure centres
  • community-based/outreach nursing services 
  • Hospital in the Home within the NSW Health system’s jurisdiction. 
Adoption of this Policy Directive is required by Directors of Pharmacy, Directors of Nursing and Midwifery, Blood and Marrow Transplant and Cellular Therapy (BMT/CT) Laboratory Medical Directors, Directors of Clinical Governance, NSW Health Pathology and all relevant staff.

Which preparations does the policy directive apply to?

This Policy Directive provides guidance on preparing aseptically and extemporaneously compounded pharmaceutical products and advanced therapeutic products to standards that are of a high quality and are safe. It provides guidance for outsourcing the following preparations for human use:

  • pharmaceutical products 
  • clinical trial investigational medicinal products (IMPs) 
  • genetically modified organism medicinal products 
  • chimeric antigen receptor (CAR) T-cell products 
  • antigen specific cell products 
  • bacteriophage products.

Which preparations does the policy directive not apply to?

This policy directive does not apply to:

  • radiopharmaceutical products
  • dose preparation by a health practitioner, outside of pharmacy, that is ready for administration as per the manufacturer’s instructions or Australian Injectable Drugs Handbook (AIDH) in a patient care area immediately before use.

Who is responsible for the risk assessment of the current facilities?

The local Chief Executive of a facility is responsible for the risk assessment of its current facilities.

The dispensing of compounded, aseptically prepared pharmaceutical products or advanced therapeutic products within a public health facility must not occur unless the Chief Executive has confirmed the facility has:

  • appropriate standards of training, skill, facilities, and 
  • preparation and quality assurance procedures have been implemented.
These requirements provide a high level of confidence that the preparations are of consistently high-quality standard.​

What happens if the facility cannot meet the appropriate standards of training, skill or facility?

Where appropriate standards are not met, the Chief Executive must establish a plan of actions and procedures required to meet the minimum facility standards for the compounding or preparation of pharmaceutical and advanced therapeutic products. These must be relevant to the scope of practice of the facility, local health district, specialty health network or affiliated health organisation.

What are the responsibilities of the Director of Pharmacy?

The responsibilities of the Director of Pharmacy include:

  • The storage, handling, dispensing, and preparation of scheduled medicines including compounded and investigational medicinal products (IMPs) as per the NSW Health Policy Directive Medication Handling (PD2022_032).
  • Delegation of tasks to the responsible pharmacist, clinical trials pharmacist, or specialist senior pharmacist if appropriate.
Once the product is supplied to the patient care area, the nurse unit manager or delegate is responsible for the product storage, handling, and administration.​

Can a pharmacist in a public hospital compound a pharmaceutical product in anticipation of a medication order?

A pharmacist in a public hospital can compound a pharmaceutical product in anticipation of a medication order, under the Therapeutic Goods Regulation 1​​​​​​​9​90​, when the pharmaceutical medicine is required urgently and a delay in treatment is detrimental to the outcome for the patient. Compounding in anticipation of an order must be approved by the Drug and Therapeutics Committee. Where there is batch preparation, sterility testing of each batch must be performed for aseptically compounded or prepared products. Refer to the Pharmacy Board of Australia (PBA) Guidelines on Compounding of Medicines​​ for further information on batch preparation.

What does my facility need to comply to if undertaking aseptic compounding or preparation of pharmaceuticals and advanced therapeutic products?

NSW Health facilities undertaking aseptic compounding or preparation of pharmaceuticals and advanced therapeutic products must be compliant with the infrastructure, personnel, documentation, processes, and quality control standards described in the PIC/S Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments (PE 010).

My facility does not have the capability to prepare a pharmaceutical produc​t onsite.

Can I source this product from a third-party supplier?​

Non-aseptically prepared compounded products can be sourced from a community compounding pharmacy on prescription for an individual patient.

Aseptically prepared products intended to be sterile must only be sourced from a Therapeutic Goods Administration manufacturing licenced facility.

​​Can I source this from another health facility?​​

​Yes, however​ it is the responsibility of the Director of Pharmacy to ensure that any products sourced from another health facility are prepared in compliance with PIC/S Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments (PE 010)​.

What are the Beyond Use Dates (BUDs) for pharmaceutical and advanced therapeutic products?

Non-aseptically prepared products follow BUDs outlined in the Australian Pharmaceutical Formulary Handbook (APF).

For aseptically prepared products without terminal sterilisation, per Section 3.1.3 Assignment of beyond use dates of PD2023_0​21​

The pharmacy service has received a request to prepare a pharmaceutical or advanced therapeutic product. What needs to be taken into consideration to prepare this?

 The Director of Pharmacy must ensure a risk assessment is completed prior to the preparation of a pharmaceutical or advanced therapeutic product by the pharmacy service, as per the Pharmacy Board of Australia (PBA) Guidelines on Compounding of Medicines​. The risk assessment must include the:

  • occupational exposure risk to staff for all aspects of product handling. This includes ordering, receipt and storage, preparation, supply, transport, and disposal, and
  • product risk. This includes ensuring there are approvals, standard operating procedures and process in place, as well as appropriate facilities, equipment and staff to prepare the product.

How often should cleanrooms and primary engineering controls be accredited?

Annual accreditation is required for all clean rooms and primary engineering controls (PECs), for example powder containment cabinets or biological safety cabinets (BSCs). This accreditation must be by the National Association of Testing Authorities (NATA)​​

Annual calibration is required for all other equipment used in the preparation of pharmaceutical products.

Are primary engineering controls mandatory when preparing non-aseptic hazardous drug products?

Yes, primary engineering controls (PECs) must be used when preparing hazardous drugs (HDs). The choice of PEC, for example powder hood, pharmaceutical isolator, or biohazard safety cabinet, should be suitable for the HD and the level of risk identified during the risk assessment.

What are the cleaning requirements for facilities preparing pharmaceutical or advanced therapeutic products?

Annex 1 and 2 of the PIC/S Guide to Good Practices​ for the Preparation of Medicinal Products in Healthcare Establishments (PE 010) provides information on the cleaning requirements for areas where sterile and non-sterile medicinal products are prepared respectively.

Can nursing staff make additions to total parenteral nutrition (TPN) on the wards?

No, any additions to total parenteral nutrition (TPN) must be in a positive pressure environment as per Section 3.3.4 Aseptically prepared pharmaceutical products of Policy Direc​tive PD20​23_021​​. Please refer to your hospital pharmacist for further advice. The nature of the TPN formulation acts as the perfect growth media for microbial proliferation. Protection of the product from microorganisms is critical to patient safety.​​




Current as at: Tuesday 9 July 2024
Contact page owner: Pharmaceutical Services