New compounding guidelines now in effect

The Board’s revised guidance on the compounding of sterile injectable medicines kicked in on the first of the month

A revised guidance titled ‘Compounding of sterile injectable medicines’, has been incorporated into the Board’s Guidelines on compounding of medicines.

It replaces the previously postponed section ‘Expiry of compounded parenteral medicines’.

The Pharmacy Board of Australia published the guidance on 1 August 2017 to give pharmacists time to familiarise themselves with the changes, which came into effect on 1 February 2018.

“From today, pharmacists who compound sterile injectable medicines must ensure compliance with the guidance in their practice,” says the Pharmacy Board.

“[It] provides additional advice to pharmacists who compound sterile injectable medicines to help reduce the associated risks for patients.”

Sterile injectable medicines to which the guidance applies includes:

  • Injections
  • Infusions
  • Concentrates for injections or infusions
  • Powders for reconstitution for injections or infusions
  • Gels for injections

For the purpose of the guidance, ‘sterile injectable medicines’ is not restricted to scheduled medicines. It includes unscheduled medicines that contain substances such as vitamins, minerals and herbal compounds.

The Board’s frequently asked questions on the compounding of medicines were also updated on 1 August 2017 with additional information to help pharmacists apply the guidance in their practice.

It has recently added two new FAQs:

  1. The Board’s guidelines use the terms ‘commercial product’ and ‘commercially available’. How should I interpret these terms?

For the purposes of the Board’s guidelines, ‘commercial product’ and ‘commercially available’ refer to medicines that are listed on the Australian Register of Therapeutic Goods (ARTG) that are able to be accessed by pharmacists via a wholesaler or directly from the manufacturer.

  1. What should I do if I receive a prescription for a compounded medicine, but I do not think that I will be able to compound the prescribed medicine to the required standard?

As the pharmacist, it is your responsibility to ensure that any compounded medicine that you compound and supply to a patient is safe and appropriate for the patient. If you believe you will not be able to meet this professional obligation (e.g. because you do not have the required competencies and/or equipment), or you believe that supply by another compounding pharmacist would be in the patient’s best interest, you should not compound the medicine and discuss this with the patient, advising them of other more appropriate options to obtain the medicine.

See all FAQs on compounding of medicines here

Download the guidelines on compounding of medicines here

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