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Scheduling delegate's interim decisions and invitation for further comment: ACCS/ACMS, March 2017

Scheduling medicines and poisons

17 May 2017

Book pagination

2. Summary of delegate's interim decisions

2. Joint meeting of the Advisory Committee on Chemicals and Medicines Scheduling (ACCS/ACMS #15)

Summary of delegate's interim decisions
Substance Interim decision
N-(alkylamino) cyclohexylbenzamides (opioids)

Schedule 9 – New Entries

N,N-DIALKYLAMINOCYCLOHEXYL ALKYL BENZAMIDES except when separately specified in these Schedules.

N,N-DIALKYLAMINOCYCLOHEXYLMETHYL ALKYL BENZAMIDES except when separately specified in these Schedules.

3,4-DICHLORO-N-[(1R,2R)-2-(DIMETHYLAMINO)CYCLOHEXYL]-N-METHYLBENZAMIDE (U-47700).

Index – Proposed New Entries

N,N-DIALKYLAMINOCYCLOHEXYL ALKYL BENZAMIDES
cross reference: 3,4-DICHLORO-N-[(1R,2R)-2-(DIMETHYLAMINO)
CYCLOHEXYL]-N-METHYLBENZAMIDE *(U-47700)

Schedule 9

N,N-DIALKYLAMINOCYCLOHEXYLMETHYL ALKYL BENZAMIDES
Cross reference: 3,4-DICHLORO-N-{[1-(DIMETHYLAMINO)
CYCLOHEXYL]METHYL}BENZAMIDE *(AH 7921)

Schedule 9

3,4-DICHLORO-N-[(1R,2R)-2-(DIMETHYLAMINO)CYCLOHEXYL] -N-METHYLBENZAMIDE (U-47700)
cross reference: N,N-DIALKYLAMINOCYCLOHEXYL ALKYL BENZAMIDES

Schedule 9

The proposed implementation date is 1 October 2017.

In Vitro Diagnostic and Analytical Preparations

The delegate's interim decision is that the current inclusion in Appendix A (General Exemptions) of 'IN VITRO DIAGNOSTIC AND ANALYTICAL PREPARATIONS containing 0.001 per cent or less of a poison included in Schedules 1 to 8' remains appropriate.

Anise Alcohol

The delegate has decided to defer the interim decision for anise alcohol to allow for further consideration of its use in therapeutic goods and the potential to elicit skin sensitisation reactions at very low concentrations. The advice of the scheduling committee was to create a new Schedule 6 entry with very low exemption cut-off concentrations for domestic or personal products that would result in skin contact during use due to potent skin sensitisation. Similar restrictions are likely to apply to listed therapeutic products when applied topically.

Trans-anethole

The delegate has decided to defer the interim decision for trans-anethole to allow for further consideration of its use in therapeutic goods and the potential to elicit skin sensitisation reactions at very low concentrations. The advice of the scheduling committee was to create a new Schedule 6 entry with very low exemption cut-off concentrations for domestic or personal products that would result in skin contact during use due to potent skin sensitisation. Similar restrictions are likely to apply to listed therapeutic products when applied topically.

Cinnamaldehyde

The delegate has decided to defer the interim decision for cinnemaldehyde to allow for further consideration of its use in therapeutic goods and the potential to elicit skin sensitisation reactions at very low concentrations. The advice of the scheduling committee was to create a new Schedule 6 entry with very low exemption cut-off concentrations for domestic or personal products that would result in skin contact during use due to potent skin sensitisation. Similar restrictions are likely to apply to listed therapeutic products when applied topically.

Benzyl salicylate

The delegate has decided to defer the interim decision for benzyl salicylate to allow for further consideration of its use in therapeutic goods and the potential to elicit skin sensitisation reactions at very low concentrations. The advice of the scheduling committee was to create a new Schedule 6 entry with very low exemption cut-off concentrations for domestic or personal products that would result in skin contact during use due to potent skin sensitisation. Similar restrictions are likely to apply to listed therapeutic products when applied topically.

Sodium α-olefin sulfonates

The delegate's interim decision is that no scheduling entry be created for sodium α-olefin sulfonate and sodium alkyl sulfate.

Resorcinol

The delegate has decided to defer the interim decision for resorcinol to allow for further consideration of its use in therapeutic goods and the potential to elicit skin sensitisation reactions at very low concentrations. The advice of the scheduling committee was to create a new schedule 6 entry with low exemption cut-off concentrations for domestic or personal products that would result in skin contact during use due to potent skin sensitisation. Similar restrictions are likely to apply to therapeutic products when applied topically.

Book pagination