Proposed quality standards for MDMA and psilocybin

Overview

The Therapeutic Goods Administration (TGA) is consulting on two proposed new quality standards for:

• 3,4‑methylenedioxy‑N-methylamphetamine hydrochloride (MDMA), and
• psilocybin.

The proposed standards include limits on contaminants and synthetic impurities, and accuracy in statement of active ingredients for MDMA and psilocybin. The standards would apply to both compounded and commercially manufactured medicines.

Quality standards provide medical practitioners and the Australian public confidence that these goods meet quality expectations to support their safe use and effectiveness.

Why your views matter

We are seeking comment to confirm the technical requirements outlined in the proposed quality standards for MDMA and psilocybin, specifically:

• Assay limits and specified tests for MDMA and psilocybin.
• Limits for impurities, residual solvents and heavy metals.
• A specific requirement for compounders to use an active pharmaceutical ingredient (API) tested in an Australian Good Manufacturing Practice (GMP)-licensed laboratory.

We are not seeking comment on the decision to publish new quality standards for MDMA and psilocybin.

What happens next

Submissions will be reviewed by the TGA. A summary of responses will be published and all submissions will be placed on this website (unless marked confidential or indicated otherwise in submission form).

Outcomes from the consultation will be provided to the Government for consideration.