![]()
|
|
|
|
|
|
The Standard for the Uniform Scheduling of Drugs and Poisons is the recommendation of the National Drugs and Poisons Schedule Committee, regarding classification of drugs and poisons into Schedules for inclusion in the relevant legislation of the States and Territories. It also includes model provisions about containers and labels, a list of products recommended to be exempt from those provisions, and recommendations about other controls on drugs and poisons.
Classification
Drugs and poisons are classified according to the Schedules in which they are included. The following is a general description of the Schedules. For the legal definitions, however, it is necesary to check:
|
Schedule 1 |
[This Schedule is intentionally blank.] |
|
Schedule 2 |
Pharmacy Medicine - Substances, the safe use of which may require advice from a pharmacist and which should be available from a pharmacy or, where a pharmacy service is not available, from a licensed person. |
|
Schedule 3 |
Pharmacist Only Medicine - Substances, the safe use of which requires professional advice but which should be available to the public from a pharmacist without a prescription. |
|
Schedule 4 |
Prescription Only Medicine, or Prescription Animal Remedy - Substances, the use or supply of which should be by or on the order of persons permitted to State or Territory legislation to prescribe and should be available from a pharmacist on prescription. |
|
Schedule 5 |
Caution - Substances with a low potential for causing harm, the extent of which can be reduced through the use of appropriate packaging with simple warnings and safety directions on the label. |
|
Schedule 6 |
Poison - Substances with a moderate potential for causing harm, the extent of which can be reduced through the use of distinctive packaging with strong warnings and safety directions on the label. |
|
Schedule 7 |
Dangerous Poison - Substances with a high potential for causing harm at low exposure and which require special precautions during manufacture, handling or use. These poisons should be available only to specialised or authorised users who have the skills necessary to handle them safely. Special regulations restricting their availability, possession, storage or use may apply. |
|
Schedule 8 |
Controlled Drug - 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. |
|
Schedule 9 |
Prohibited Substance - Substances which may be abused or misused, the manufacture, possession, sale or use of which should be prohibited by law 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. |
Availability of drugs and poisons:
The purpose of classification is to group drugs and poisons into Schedules that require similar regulatory controls over their availability.
These Schedules have been developed over a long period of time and contain drugs and poisons that may be obsolete for various reasons. Also as part of the move to harmonise the Australian and New Zealand classifications many substances have been added to the Schedules for that purpose, irrespective of their availability in either country.
Inclusion of a drug or poison in a Schedule indicates the degree of control required if it is marketed. It does not indicate:
|
|
that the drug or poison is available; nor |
|
|
that is has been approved or is efficacious for any use that may be specified in a Schedule, |
Preparations containing poisons
listed in two or more schedules:
If a preparation contains two or more poisons, the provisions relating to each of the Schedules in which those poisons are included apply.
Where it is not possible to comply both with a provision relating to one of those Schedules and with a provision relating to another of those Schedules, the provision of the more restrictive Schedule applies, unless a contrary intention is indicated in the Schedules or relevant legislation.
The Schedules listed in order of greatest to least restriction are 9, 8, 4, 7, 3, 2, 6, 5. Schedule 1 is not currently in use.
Poisons are not scheduled on the basis of a universal scale of toxicity. Although toxicity is one of the factors considered, and is itself a complex of factors, the decision to include a substance in a particular Schedule also takes into account many other criteria such as the purpose of use, potential for abuse, safety in use and the need for the substance.
This Standard now lists poisons in nine Schedules according to the degree of control recommended to be exercised over their availability to the public.
Poisons for therapeutic use (drugs) are included in Schedules 2, 3, 4 and 8 with progression through these schedules signifying increasingly strict controls.
For agricultural, domestic and industrial poisons Schedules 5, 6 and 7 represent increasingly strict container and labelling requirements with special regulatory controls over the availability of the poisons listed in Schedule 7.
Shedule 9 contains substances that should be available only for medical or scientific research including clinical trials conducted with the approval of Commonwealth and/or State/Territory Health Authorities. Although appearing as a Schedule in this Standard the method by which it is implemented in the States/Territories may vary.
|
All rights reserved. |