Pharmacy inspections
Your pharmacy can be inspected at any time without notice to make sure medicines and poisons are prescribed, stored and supplied correctly and lawfully.
Compliance is assessed against the Medicines, Poisons and Therapeutic Goods Regulation 2008, the Public Health Act 1997 as it relates to community pharmacies.
Inspectors assess a community pharmacy using either:
- the community pharmacy premises inspection form
- the opioid dependency treatment centre inspection form
Inspection criteria and legislation
The information below shows criteria from the inspection forms with their legislative requirements to help you to prepare for an inspection.
| Criteria and legislative requirements | ||
|---|---|---|
| Pharmacy premises | ||
| The pharmacy consists of an enclosed area with direct access to a public place. | Public Health (Community Pharmacy) Code of Practice 2016 (No 1) Schedule 1 (3) | |
| The pharmacy contains an area set aside for dispensing of items on prescription that is not less than 8 square metres (dispensary). | ||
| The community pharmacy has at least 1 square metre of free working space, which is not less than 40cm wide for the dispensing of prescriptions. | ||
| The pharmacy is appropriately ventilated and hygienic. | ||
| There adequate lighting in the pharmacy. | ||
| The pharmacy is constructed in a manner as to allow the pharmacist to supervise the sale of scheduled medicines. | ||
| The pharmacy contains appropriate equipment for compounding of extemporaneous preparations. | ||
| There is an appropriate counselling facility available in the pharmacy. | ||
| The pharmacy has a dedicated fax machine for urgent communications. | ||
| Conduct of business | ||
| The pharmacy is constantly under the control of a pharmacist while open for business. | Public Health (Community Pharmacy) Code of Practice 2016 (No 1) Schedule 1 (5) | |
| The name of the pharmacist in charge followed by the words ‘Pharmacist in Charge' is displayed prominently. | ||
| The name of all pharmacists practicing in the pharmacy is displayed in a public place. | ||
| Legislation and reference works | ||
The pharmacy has a current version of: | Public Health (Community Pharmacy) Code of Practice 2016 (No 1) Schedule 1 (2) | |
|
The pharmacy has access to: - a complementary or alternative medicine reference guide - current scheduling guide - access to legislation controlling pharmacy practice | ||
| Storage of medicines | ||
| ‘Pharmacy only’ medicines are stored appropriately in the pharmacy. | Section 520(1), MTPG Regulation 2008 | |
| 'Prescription only’ medicines are stored appropriately in the pharmacy. | Section 520(2), MTPG Regulation 2008 | |
| Controlled medicines are stored appropriately in the pharmacy. | Section 533(3)(a), MTPG Regulation 2008 | |
| The pharmacy has a compliant safe. | Schedule 5 of MTPG Regulation 2008 | |
| The safe is kept locked at all time when not in immediate use. | Section 533(3)(b), MPTG Regulation 2008 | |
| The safe key or combination is appropriately controlled. | Section 533(3)(c) or (d), MPTG Regulation 2008 | |
| The controlled medicines register is stored on the premises. | Section 540(4), MPTG Regulation 2008 | |
| The entries in the controlled medicines register are up to date. | Section 51(1), MPTG Act 2008 | |
| The controlled medicine balance is correct. | ||
| There is a dedicated refrigerator available in the pharmacy for storing cold chain medicines. | Public Health (Community Pharmacy) Code of Practice 2016 (No 1) Schedule 1 (3)(a)vi | |
| The refrigerator has an appropriate temperature monitor control. | ||
| Dispensing of medicines | ||
| Dispensed medicines are appropriately labelled. | Section 123, MPTG Regulation 2008 | |
| There is appropriate recording of dispensed medicines. | Section 125, MPTG Regulation 2008 | |
| Telephone or faxed prescriptions are followed up adequately. | Section 120(1)(g), MPTG Regulation 2008 | |
| Emergency supply is recorded appropriately. | Section 254, MPTG Regulation 2008 | |
| Dispensed prescriptions are properly endorsed. | Section 124, MPTG Regulation 2008 | |
| Dispensed prescriptions are stored appropriately in the pharmacy or CHO approved location. | Section 120, MPTG Regulation 2008 | |
| Vaccination standards (if applicable) | ||
| The pharmacist administering vaccines have undergone an accredited training course. | Medicines, Poisons and Therapeutic Goods (Vaccinations by Pharmacists) Direction 2019 (No 1) | |
| The pharmacist hold current ASCIA, CPR and First Aid Certificates. | ||
| The pharmacy has an adequate vaccine storage and temperature monitoring. | ||
| There is a designated professional services area and adequate waste disposal. | ||
| There is an in-date and complete anaphylaxis response kit. | ||
| There is an emergency response protocol and consumer information about a consumer’s right to make a complaint on display. | ||
| There are adequate hand washing or hand sanitisation facilities. | ||
| There are designated patient monitoring area. | ||
| There are adequate record of vaccinations. | ||
| Opioid dependency treatment license | ||
| Controlled medicines for opioid dependency treatment are stored appropriately. | Section 533(3)(a), MPTG Regulation 2008 | |
| The pharmacy has a compliant opioid dependency treatment medicine storage safe. | Schedule 5 of MPTG Regulation 2008 | |
| The safe is kept locked at all times when not in immediate use. | Section 533(3)(b), MPTG Regulation 2008 | |
| The safe key or combination is appropriately controlled. | Section 533(3)(c) or (d), MPTG Regulation 2008 | |
| The opioid dependency treatment medicine register is stored on premises. | Section 540(4), MPTG Regulation 2008 | |
| There are appropriate counselling or dosing facilities or facilities available in the pharmacy. | ||
| The pharmacy has a current opioid dependency treatment licence. | ||
| All prescriptions for opioid dependency treatment patients are current. | Section 120(1)(g), MPTG Regulation 2008 | |
| Entries in the opioid dependency treatment medicine register are up to date. | Section 51(1), MPTG Act 2008 | |
| The controlled medicine balance is correct. | ||
| All opioid dependency treatment dispensing pharmacist(s) have undergone training. | ||
Community pharmacy inspection guide
Inspectors take a risk-based approach to conducting inspections in accordance with the community pharmacy inspection guide.
Community pharmacy owners and staff should use the inspection guide to make sure they meet requirements and to prepare for future inspections.
For more information about community pharmacy inspections call 02 5124 9208 or email hps@act.gov.au.