Amendment to the Poisons and Therapeutic Goods Regulation 2008
The Poisons and Therapeutic Goods Regulation 2008 has been amended to regulate the following as Type A drugs of addiction:
- cannabis (when in Schedule 8)
- tetrahydrocannabinols (when in Schedule 8)
- unregistered drugs of addiction (including compounded Schedule 8 medicines).
The rules that apply to Type A drugs of addiction, such as dexamfetamine and nabiximols, now also apply to Schedule 8 cannabis medicines and unregistered drugs of addiction. The requirement remains that only medical practitioners can prescribe Schedule 8 cannabis medicines and unregistered drugs of addiction, and only if they hold an authority issued under the Poisons and Therapeutic Goods Act 1966 (NSW Health Authority). The NSW Health Authority is distinct from a PBS authority which allows payment subsidy by the PBS.
Restrictions will remain in place to reflect the fact that unregistered medicines have not been fully assessed by the Therapeutic Goods Administration (TGA) for safety, quality and efficacy.
Note that in addition to a NSW Health Authority, as currently required, a medical practitioner must be approved by the TGA under the Special Access Scheme, Authorised Prescriber scheme, or a Clinical Trial scheme (Commonwealth Approval) to prescribe an unregistered medicine.
Changes for NSW pharmacists:
- A pharmacy is no longer required to be identified as the place of supply on a prescription for an unregistered Schedule 8 cannabis medicine. However, we recommend to medical practitioners that prior arrangements are made with a pharmacist to ensure that stock may be ordered from the supplier to dispense the prescription under the Commonwealth Approval for a particular person.
- The requirement to only dispense prescriptions specifying the prescriber’s NSW Health Authority reference number remains. However, no reference number will be shown on prescriptions written under an exemption from the requirement to hold a NSW Health Authority. In these circumstances, pharmacists must take steps to check with the prescriber that the prescription was issued under an exemption.
- Schedule 8 medicines requiring refrigeration may be stored in a locked refrigerator attached to the premises rather than in a safe, and may be stored with other medicines in Schedules 2, 3, 4 and 8 requiring refrigeration, provided only a pharmacist has access to the refrigerator. Other usual Schedule 8 storage requirements apply.
Further information is available on the NSW Health website.
Reminder to return your S8 order receipts
Some licensed wholesalers have reported difficulty in obtaining Schedule 8 notifications confirming the order and receipt of Schedule 8 drugs from pharmacists.
Pharmacists are reminded that when ordering and receiving a Schedule 8 drug, the wholesale supplier must be notified of the receipt of the Schedule 8 drug within 24 hours in accordance with the requirements under clause 95 of the Poisons and Therapeutic Goods Regulation 2008
If the wholesale supplier does not receive such a notification confirming the order and receipt of a Schedule 8 drug signed and dated by the pharmacist within 7 days, they must report this to the Pharmaceutical Regulatory Unit (PRU) of the NSW Ministry of Health. PRU will then advise the wholesale supplier that they must suspend supply of Schedule 8 drugs to the pharmacist at that pharmacy, until such time that any outstanding notification forms are received.