Australia Releases Interim Decisions to Amendments of Poisons Standard for Public Consultation

The proposed addition of ethyl lactyl retinoate to the exemption scope has been rejected while the proposed change of tranexamic acid in the exemption scope in the Poisons Standard has been approved. The approved change will take effect on October 1, 2024.

On January 5, 2024, the Therapeutic Goods Administration (TGA) of Australia launched a public consultation regarding proposed amendments to eight substances in the Poisons Standard. These amendments were discussed at the March 2024 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS). On July 26, 2024, the TGA released the interim decisions of these proposals and launched a public consultation on the decisions. Stakeholders are encouraged to participate in the consultation by August 23, 2024.

The proposed amendments focus on eight substances. Among these, ethyl lactyl retinoate and tranexamic acid are related to cosmetic use.

The proposed changes aim to introduce new exemptions within the existing entries for tretinoin and tranexamic acid in Schedule 4 Prescription Only Medicines and Prescription Animal Remedies. Below are the details of these two substances. Proposed additions are shown in green and proposed deletions are shown in red.

Industrial Chemicals

Proposed Amendments

Interim Decisions

Implementation Date

Ethyl Lactyl Retinoate (CAS No. 74534-80-8)

Schedule 4

# TRETINOIN except:

a) the ester hydroxypinacolone retinoate in preparations for dermal use containing 0.5% or less of hydroxypinacolone retinoate; or

b) ethyl lactyl retinoate in preparations for dermal use containing 0.1% or less of ethyl lactyl retinoate.

Disapproved

N/A

Tranexamic Acid (CAS No. 1197-18-8)

Schedule 4

TRANEXAMIC ACID except in preparations containing 3% or less of cetyl tranexamate Hydrochloride tranexamic acid for dermal cosmetic use.

Index

TRANEXAMIC ACID

cross reference: CETYL TRANEXAMATE

Approved

October 1, 2024

The proposed addition of ethyl lactyl retinoate to the exemption scope has been rejected while the proposed change of tranexamic in the exemption scope has been approved. The approved change will take effect on October 1, 2024.