S3 advertising expansion

THE list of Schedule 3 items allowed to be advertised to consumers is set for a significant boost, with the Therapeutic Goods Administration proposing the addition of 24 new substances to the existing 19 items on Appendix H of the Poisons Standard.

The TGA has launched a consultation as part of the revised Scheduling Policy Framework, with a review agreeing that the “policy intent for advertising of Schedule 3 substances should allow these substances to be advertised directly to consumers unless it is determined they should not be”.

The major change will also come with a new labelling requirement for these items, stating “Ask your pharmacist - they must decide if this product is right for you” under the draft revised Therapeutic Goods Advertising Code.

The consultation is proposing the addition of adrenaline, ciclopirox, chloramphenicol, clobetasone, famciclovir, fluourides, glyceril trinitrate, glucagon, isoconazole, isosorbide dinitrate, ketoprofen, levonorgestrel and metoclopramide (for nausea linked with migraine).

Also set to be added to Appendix H are naloxone, oxiconazole, paracetamol, podophyllotoxin, podophyllum emodi, podophyllum pelpatum, salbutamol, salicylic acid, terbutaline, tioconazole and triamcinolone.

A further 42 S3 items are proposed for exclusion from Appendix H due to potential misuse, abuse or diversion, interactions or other factors.

The TGA is inviting stakeholders to comment on the substances proposed for inclusion in the Appendix H list which would allow them to be advertised.

Feedback is sought by 09 Jul 2018, with the transition to the new arrangements expected to be “largely complete by the end of 2018” - see tga.gov.au.