Maintain PBS approval + claim accurately for PBS-listed medicines
Pharmacy approval-to-supply under s 90 National Health Act; PBS claiming subject to compliance review.
Who must comply
PBS-approved pharmacies.
What triggers it
Dispensing PBS-listed medicines.
When due
Continuous; PBS approval reviewed periodically.
Evidence required
PBS approval certificate; dispensing records; co-payment records.
Max penalty
Recovery of incorrect claims; PBS suspension/cancellation; criminal for fraudulent claiming
Summary
Pharmacies must hold a current PBS approval (s 90 NHA) granted by the Department of Health. PBS claims are paid via Services Australia (Medicare) and subject to compliance audit. Inaccurate claiming attracts recovery + penalties under the Practitioner Review Program.
Enforced by
Source legislation
Topics
Related obligations
- CWLTHMaintain controlled drugs register (Schedule 8 / 9)Pharmacies + medical practices must keep contemporaneous register of S8/S9 medicines.
- CWLTHConduct post-market surveillance of therapeutic goodsARTG-included goods must be monitored post-market for safety + performance.
- CWLTHIn-vitro diagnostic medical device classification + ARTGIVDs classified by risk (Class 1-4); ARTG inclusion required for supply.
Frequently asked questions
- Who must comply with PBS approval + claim accurately for PBS-listed medicines?
- PBS-approved pharmacies.
- What triggers PBS approval + claim accurately for PBS-listed medicines?
- Dispensing PBS-listed medicines.
- When is PBS approval + claim accurately for PBS-listed medicines due?
- Continuous; PBS approval reviewed periodically.
- What is the maximum penalty for PBS approval + claim accurately for PBS-listed medicines?
- Recovery of incorrect claims; PBS suspension/cancellation; criminal for fraudulent claiming
- What evidence is required for PBS approval + claim accurately for PBS-listed medicines?
- PBS approval certificate; dispensing records; co-payment records.
Source: https://pbs.gov.au/info/general/pharmacist. Rules Mate is not a law firm. Always verify against the live regulator source before acting.