TGA has clarified the impact of Australia’s industrial chemicals standards on medicines, medical devices, and biologicals.

Responding to stakeholder queries, TGA said therapeutic goods are not affected by prohibitions imposed under the Industrial Chemicals Environmental Management Standard (IChEMS). The framework prohibits the import, manufacture, and use of specified chemicals in Australia. Certain PFAS chemicals, UV-328, and Dechlorane Plus are among the chemicals covered by IChEMS.

TGA said IChEMS does not apply to chemicals used for therapeutic purposes. That limitation of the standard’s scope extends to the primary and secondary packaging of medicines and biologicals, as well as to the primary packaging, instructions for use, and spare parts of medical devices.

The agency posted two statements about the exemption of medical devices from the PFAS ban last year. While TGA’s second statement clarified that medicines and biologicals are exempt from the ban, neither notice addressed chemicals other than PFAS. [RAPS]