High-moderate risk changes to permissible ingredients – Vitamin B6 (pyridoxine hydrochloride, pyridoxal 5-phosphate, and pyridoxal 5-phosphate monohydrate)

Overview

The Therapeutic Goods Administration (TGA) is seeking public comment on proposed changes to the Therapeutic Goods (Permissible Ingredients) Determination (the Permissible Ingredients Determination) relating to listed medicines containing vitamin B6, namely pyridoxine hydrochloride, pyridoxal 5-phosphate, and pyridoxal 5-phosphate monohydrate.

Following the scheduling reclassification of pyridoxine, pyridoxal and pyridoxamine (vitamin B6) in the Poisons Standard, oral preparations providing more than 50 mg and up to 200 mg of pyridoxine per recommended daily dose will be classified as Pharmacist Only Medicines (Schedule 3) from 1 June 2027.

The TGA is proposing changes to ensure that requirements relating to listed medicines that contain vitamin B6 provide appropriate risk mitigation measures. These proposals are intended to support the safe and informed use of vitamin B6-containing listed medicines by strengthening risk communication and addressing concerns relating to visibility of the presence of vitamin B6 in a listed medicine and cumulative vitamin B6 exposure.

The proposed changes include:

• introduction of a standardised label statement for vitamin B6-containing listed medicines;
• amendment of the existing warning statement and reduction of the dose threshold at which it is required;
• clarification that vitamin B6-containing listed medicines must not be directed for use in infants under 12 months of age; and
• clarification of the age category for individuals aged 14–18 years.

The purpose of this consultation is to seek feedback on the proposed changes. This information will be taken into consideration when determining whether changes to the Permissible Ingredients Determination should be made.

The proposed changes are detailed in the Consultation document.

To respond to this consultation, please click the 'Online Survey' link below.

Responses can be provided using the available response options and accompanying comment fields. Comments should be limited to matters specifically raised in this consultation.

Why your views matter

The TGA is requesting feedback that will help ensure that the proposed changes are appropriate and support the safe use of vitamin B6-containing listed medicines.