Dose Administration Aids

​​​​​​​​​​​​​​Regulatory requirements​​​ for labelling and supplying Dose Administration Aids (DAAs)

​​From 5 November 2026, pharmacists who dispense medicines supplied in a dose administration aid (DAA) must comply with the relevant supply, labelling and packaging requirements under the Medicines, Poisons and Therapeutic Goods Regulation 2026​​​​.

​​​Labelling requirements​

A pharmacist supplying medicines to a patient must ensure the DAA is labelled with​:
  • the information required under Appendix L of the Commonwealth Poisons Standard​​​
  • the date the medicines were packed in the DAA
  • the patient’s date of birth​
  • if the DAA is packed by a third party, a reference number* that links:
    • the DAA,
    • the manufacturing instructions, and 
    • the prescriptions for the medicines included in the DAA.
​* Note: A barcode or QR code may be used to contain the reference number linking the DAA, manufacturing instructions and associated prescriptions

​Manufacturing instructions

Where a pharmacist dispenses a prescription and engages a third-party to pack medicines into a DAA, the pharmacist must provide manufacturing instructions that accurately reflect the prescription and the prescriber's directions.

Manufacturing instructions must specify:
  • the medicines to be packed in the DAA
  • the dose of each medicine
  • the directions for administration.
The pharmacist who provides the manufacturing instructions is responsible for ensuring their accuracy.
The third-party must manufacture the DAA in accordance with the manufacturing instructions.

​Supply of DAAs to patients

​The pharmacy that dispenses the prescriptions and supplies the DAA to the patient (the supplying pharmacy) is responsible for all aspects of dispensing and supply, including: 

  • providing patient counselling
  • labelling and packaging the DAA
  • making and keeping dispensing and packing records
  • ensuring the DAA is packed in accordance with the prescriber's directions
  • ensuring the DAA identifies the supplying pharmacy.

​​When a third party packs the DAA for the supplying pharmacy

​If the supplying pharmacy engages a third party to pack the DAA, the supplying pharmacy is responsible for all aspects of dispensing and supply listed above. 

The supplying pharmacy should also obtain patient consent to have a third party pack the DAA.


​When prescriptions are transferred to another pharmacy for dispensing and DAA packing

If prescriptions are sent to another pharmacy for dispensing and for packing of the DAA: 

  • patient consent must be obtained before the prescriptions are transferred
  • the original pharmacy must not label the DAA as the supplying pharmacy
  • the pharmacy that dispenses the prescriptions and packs the DAA becomes the supplying pharmacy and is responsible for all aspects of dispensing and supply.

​In these circumstances, the dispensing and packing pharmacy is the supplying pharmacy and is not considered a third-party packer.


​Manufacturing licence requirements

​For advice on whether a Therapeutic Goods Administration (TGA) manufacturing licence is required for the manufacture or packing of DAAs, contact the TGA Manufacturing Quality Branch at GMP@health.gov.au.​​

More information

Supporting information to help understand the requirements of the legislation is available on the  Medicines, Poisons and Therapeutic Goods legislation webpage.

Disclaimer

The information on this webpage is provided for general guidance only. While reasonable care has been taken to ensure the accuracy, reliability, and currency of the information, users should refer to the Medicines, Poisons and Therapeutic Goods Act 2022 and the Medicines, Poisons and Therapeutic Goods Regulation 2026 for full legal requirements.

Current as at: Friday 4 September 2026
Contact page owner: Pharmaceutical Services