Compounding guidelines update


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The Pharmacy Board says its work to revise the currently postponed section “Expiry of compounded parenteral medicines” of the Guidelines on compounding of medicines is nearing completion

“We expect to publish that revised guidance in the coming weeks,” Board chair William Kelly writes in the Board’s June newsletter.

An implementation period will be announced.

To coincide with publication of the guidance, the Board also plans to publish an updated FAQ that will address issues about compounded injectable medicines.

The Board says it will provide pharmacists with details once the revised guidance has been published.

In the meantime, it reminded pharmacists that when compounding medicines they are expected to comply with the published compounding guidelines, which require them to:

  • comply with all relevant practice standards, guidelines and legislation;
  • have good clinical and pharmaceutical evidence to support the quality, stability (including an appropriate ‘in use expiry’ and/or beyond use date), safety, efficacy and rationality of any extemporaneous formulation;
  • compound a medicine only where an appropriate commercial product is unavailable or unsuitable; and
  • use sound judgement based on current clinical and pharmaceutical knowledge and risk assessment, before deciding whether to prepare a formulation for which there is no precedent in a reputable reference, and have documented evidence for your decision to compound.

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