New compounding guidelines from Tuesday

24 Apr 2015

Guidelines for compounding pharmacists take effect Tuesday, with one section that has been postponed for three months. 

The new Pharmacy Board of Australia guidelines for pharmacists who compound medicines take effect Tuesday 28 April 2015 (except for one section, which has been postponed. See note below).

The guidelines are intended to provide detailed guidance to pharmacists who compound medicines to ensure product quality, safety and efficacy.

The Board published the guidelines on its website in early March to allow pharmacists to become familiar with the content before implementation.

The guidelines were subject to wide-ranging consultation and replace Guideline 5 Extemporaneous dispensing (compounding) from the Board’s Guidelines for dispensing of medicines published on 12 August 2010.

The compounding guidelines and supporting tools are available on the Codes, Guidelines and Policies page of the Board website, and the FAQs are available on the FAQ and Fact Sheets page.

A section of the guidelines has been postponed for three months

The implementation of the expiry of compounded parenteral medicines section in the guidelines has been postponed.

This means that the Expiry of compounded parenteral medicines section of the guidelines does not come in to effect on Tuesday, and practitioners do not need to follow this guidance for now.

The Board recently received further feedback and information on its guidance about the expiry of compounded medicines that needs further investigation and review.

Over the next three months, the Board will consider this feedback in further consultation with the Therapeutic Goods Administration (TGA) who has also undertaken a review of options for reform of the regulatory framework for pharmacy compounding.

To reflect this decision, the guidelines and FAQs have been updated.

Other important information for pharmacists who compound medicines

The Board will review the information and seek further views over this three month period, and keep working closely with the TGA and other stakeholders.

Pharmacists who compound medicines are urged to read the:

• Guidelines on compounding of medicines (updated to reflect the three-month postponement of the guidance on the expiry of compounded medicines)
• Background on the regulation of compounding by pharmacists
• Professional practice profile for pharmacists undertaking complex compounding, and
• Frequently asked questions (FAQs) for pharmacists on the compounding of medicines (updated to reflect postponement of the guidance on the expiry of compounded medicines)

For more information

• Read the 2 March 2015 media release
• Lodge an online enquiry form
• For registration enquiries: 1300 419 495 (within Australia) +61 3 9275 9009 (overseas callers)
• For media enquiries: (03) 8708 9200