In Australia, drugs and poisons are regulated with some requiring special storage requirements by law. BS3 are pharmaceutical storage specialists of scheduled medicines holding the licenses to manage many scheduled medicines.
What are the poisons schedules?
The Drug and Poison Schedules are produced by The Therapeutic Goods Agency (TGA) and are regularly updated. The scheduling of medicines and poisons is how these products are controlled to protect the public.
Each schedule has regulations around the supply and storage requirements. Some products will require the owner or custodian of the product to have a Poisons License. In other countries, a Poisons License is more commonly called a Wholesale Dealers License (WDL) and is issued by the appropriate government agency. In Australia, Poisons Licences are under the control of each state government. For example, BS3 has Poisons Licences issued by The Victorian Government. An overview of the Drug and Poison Schedule is below.
Available on the shelf in a pharmacy these are products that are low risk and are available to self-select from the shelf. This would include products such as analgesics (e.g. Paracetamol and Ibuprofen), anti-histamines (e.g. Loratadine), and anti-fungal creams (e.g. Clotrimazole Cream). Some products, in small pack sizes, are also available from supermarkets, convenience stores, and petrol stations.
These are products that require more control than a Schedule 2 product. They are only available from a pharmacist but do not require a prescription from a doctor. They are not available to self select from the shelf. Examples include Salbutamol inhaler for asthma, stronger analgesics, and topical steroid creams.
These are products that can only be supplied with a prescription from a doctor or other approved health professional such as a dentist or nurse. Examples include antibiotics, blood pressure medication and oral contraceptives.
These are substances that have a high risk of causing harm and require special precautions during manufacture, handling, or use. They are only available to specialised or authorised users who have the necessary skills to handle them safely. Examples include arsenic and cyanide products.
Substances which should be available for use but require restriction of manufacture, supply, distribution, possession and use to reduce abuse, misuse and physical or psychological dependence. Examples include opiates like morphine and medical cannabis products contacting Tetrahydrocannabinoids (THC). These products have specialist storage and security requirements including storage in a safe or vault along with security monitoring such as cameras and alarms.
These are products similar to Schedule 8 but sale is prohibited except when required for medical or scientific research, or for analytical, teaching or training purposes with approval of Commonwealth and/or State or Territory Health Authorities. Examples include heroin, some cannabis products, and Lysergic Acid (LSD). As with Schedule 8, products in Schedule 9 require specialist secure storage and security.
It’s a mechanism of how medicines and poisons are controlled to protect the public. The Schedules are produced and regularly updated by the Therapeutic Goods Administration (TGA). There are 10 Schedules of which 9 are in current use. Schedule 1 is not in use.
The Poisons Standard consists of decisions regarding the classification of medicines and poisons into Schedules for inclusion in the relevant legislation of the states and territories. The Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) is a Federal Government legislative instrument produced by the TGA. The states and territories normally adopt it but are free to have their own legislative instruments. For example, different states in Australia have different legislation around the supply of medical cannabis.
To have control of these products, you must have a Poisons License (otherwise known as a Wholesale Dealers License). If you have a Poisons License it is permitted to sell/supply pharmacists, doctors, dentists etc. with these products. BS3 has poisons licences to store and supply Schedule, 2,3,4,8 and 9 products. Pharmacist, doctors, dentists, veterinary surgeons etc. are permitted to have these products if supplying them to patients – for example by a prescription.
The cannabis plant consists of many ingredients including Cannabidiol and Tetrahydrocannabinol (THC). In Australia, growing and processing cannabis plants requires federal and state licenses. Depending upon how they are presented, they appear in Schedules 9, 8, and 4. As a generalisation, cannabidiol products are Schedule 4 and products containing THC are Schedule 8.
Medical cannabis products are Schedule 8 and Schedule 9 and require specialist storage and security. Some medical cannabis products required storage at +2.0 to +8.0C in addition to storage in a safe or vault. BS3 offers Schedule 8 storage at +2.0 to +8.0.0C in addition to +15.0 to +25.0C