Premixing or Individualised Dispensing – Legality

August 9, 2014 | Herbal medicine, Naturopathy

Cover page of ARGCMIt is great to see Oborne Health Supplies, in their August newsletter, reminding everybody of the regulations around extemporaneous dispensing of herbal liquids, and what we absolutely should not be doing.

Liquid extracts and tinctures are made specifically for extemporaneous dispensing by practitioners. The Australian Regulatory Guidelines for Complementary Medicines (November 2013) states the following on page 18:

The exemptions relating to extemporaneous compounding and dispensing apply where a health practitioner prepares a medicine for an individual patient either following consultation with that particular patient, or to fill a prescription for that particular patient. This allows health practitioners such as pharmacists, herbalists, naturopaths, nutritionists and homoeopaths, to prepare medicines for individual patients that do not need to be assessed or evaluated by the TGA for quality, safety or efficacy. The exemption recognises the one-off nature of such medicines and the professional training of the health practitioner to prepare a medicine for the specific needs of an individual patient.

What you Can Do

In the context of an individual patient consultation, herbalists and naturopaths can …

  • blend and dispense dry herb combinations for the specific needs of an individual patient.
  • blend and dispense liquid extracts and tinctures into specific formulae for the needs of an individual patient.
  • create and dispense other herbal preparations specifically for the needs on an individual patient.

What you Cannot Do

The TGA does not allow the following …

  • making herbal liquid formulae in bulk and selling unchanged to a range of patients or even other practitioners for their patients.
  • premixing liquid extracts or tinctures into specific formulae before a consultation (refilling a previously dispensed individualised prescription is permitted)

Copyright Ian Breakspear, 2014