Gazette APVMA 2, 7 February 2006 page 24

NOTICE

Scheduling of Drugs and Poisons: The APVMA and the National Drugs and Poisons Scheduling Committee (NDPSC)

All applications for registration of pesticides and veterinary medicines are assessed by the Office of Chemical Safety (OCS) for their human toxicity potential. Should these substances require scheduling, they are referred to the National Drugs and Poisons Scheduling Committee (NDPSC).

The NDPSC is made up of:
· 9 jurisdictional members representing the State Departments of Health and the Commonwealth;
· 6 representative members representing the Therapeutic Goods Administration (TGA), the APVMA, the pharmaceutical, chemical, agricultural and veterinary industries, the pharmacy profession, the New Zealand government;
· 1 consumer representative; and
· 4 experts in human and veterinary medicine, toxicology and occupational health and safety.

The NDPSC decides on the availability of drugs and poisons via a process of poison scheduling, based on:

(a) the toxicity and safety of a substance;
(b) the risks and benefits associated with the use of a substance;
(c) the potential hazards associated with the use of a substance;
(d) the extent and patterns of use of a substance;
(e) the dosage and formulation of a substance;
(f) the need for access to a substance, taking into account its toxicity compared with other substances available for a similar purpose;
(g) the potential for abuse of a substance;
(h) the purposes for which a substance is to be used;
(i) any other matters that the Committee considers necessary to protect public health, including the risks (whether imminent or long-term) of death, illness or injury resulting from its use.

The Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP) contains the scheduling decisions of the NDPSC, which are incorporated into state legislation.

The NDPSC meets quarterly. Agricultural and veterinary chemical products are on the agenda of most meetings. The scheduling process is substance-based, with the result that existing products containing those substances can be affected by a new NDPSC decision relating to scheduling, or revision of a previous scheduling decision.

Some registrants have said to the APVMA that they are not aware of substances which will be considered by the NDPSC for scheduling. The APVMA recommends that registrants regularly check the NDPSC pre-meeting gazette notices, which are available on the NDPSC website at http://www.tga.gov.au/ndpsc/ndpscgan.htm to check whether any of their products are likely to be affected by NDPSC decisions. Registrants may make a submission to the NDPSC if they wish to do so.
Alternatively, the NDPSC has an email subscription list for notification of new information available on the NDPSC website. Subscribers to this list will receive same-day notification of the publication on this website of:
· Pre and post-meeting gazette notices;
· A record of the reasons for decisions and outcomes of NDPSC meetings;
· Advice on the publication of the SUSDP and Amendments;
· Other information relating to NDPSC operations.
Anyone may subscribe by sending an email to NDPSC@health.gov.au and type subscribe ndpsc_list in the body of the message (NOT in the subject).

For enquiries please contact:

Jonathan Taylor
Team Manager, Parasiticides and Nutrition
Australian Pesticides and Veterinary Medicines Authority
PO Box E240
KINGSTON ACT 2604

Phone: (02) 6272 3754
Fax: (02) 6272 3195
email: jonathan.taylor@apvma.gov.au