PDL practice alert: compliance with compounding guidelines

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PDL discusses the importance of understanding certain compounding clauses

Compounding pharmacists are reminded to be familiar with the Pharmacy Board of Australia’s (PBA) Guidelines on the Compounding of Medicines published in March 2015 and which apply to both simple and complex compounding.

A revised guidance note on the compounding of sterile injectable medicines was published by the PBA on 1 August 2017, and should be reviewed by any pharmacists involved in or planning to be involved in sterile compounding.

Recent regulatory actions, both State and Federal, have highlighted the importance for compounding pharmacists to be aware of specific clauses in the PBA’s compounding guidelines, in particular the following. 

The PBA’s Guidelines on Compounding of Medicines (March 2015) provides as follows: 

A compounded medicine should be prepared only in circumstances where: 

  • an appropriate commercial product is unavailable 
  • a commercial product is unsuitable (e.g. if a patient experienced an allergy to an excipient in the commercial product), or 
  • when undertaking research sanctioned by a recognised human research ethics committee.

The compounding of a medicine (whether prescribed or not) that would be a close formulation to an available and suitable commercial product, and would not be likely to produce a different therapeutic outcome to the commercial product, should not take place.

Complaints have been made to the Australian Health Practitioner Regulation Agency (AHPRA) alleging unprofessional conduct where pharmacists have either been unaware of newly available commercial products, or have compounded products where there has been only a slight difference between the compounded product and an equivalent commercially available product. 

A recent Federal Court case highlights the potential exposure arising from compounding practice. The case involved a compounding pharmacist who compounded a testosterone cream medication for a customer who presented with a prescription for AndroForte 5, which the pharmacist believed was unavailable in Victoria at the time. The pharmacist offered to make up the testosterone cream for the customer.

The manufacturer of AndroForte 5 then issued proceedings in the Federal Court of Australia against the pharmacist in reliance upon the above customer’s evidence, alleging the pharmacist breached the PBA’s compounding guidelines and engaged in misleading and deceptive conduct by having allegedly ‘passed off’ the compounded testosterone 5% cream medication as their own product. 

The pharmacist strongly denied the allegations and strenuously defended the litigation. The pharmacist produced documents to establish that AndroForte 5, on various dates, was not available in Victoria from its wholesale pharmaceutical supplier. The litigation also required the pharmacist to conduct a detailed audit of all scripts presented at the pharmacy for AndroForte 5 or testosterone 5% cream, since when AndroForte 5 came onto the market. 

The litigation ended up resolving at great legal cost to both parties.  
Other litigation and regulatory action has arisen from the supply of compounded medication containing the active ingredient “phentermine”, which is commercially available as “Duromine”. 

The commercial product “Duromine” is prepared in an ion-exchange resin, and compounding of phentermine in a capsule does not mimic the same release characteristics. 

The message to pharmacists, especially compounding pharmacists, is be familiar with the Compounding Guidelines and what they require, and to ensure robust counselling occurs with the customers which includes providing information regarding any compounded medication that is to be supplied and what that means. 

If a patient presents, for example, with a prescription for AndroForte 5 cream, or a generic prescription for testosterone 5% cream, pharmacists should dispense a commercial product where it is available and appropriate. Pharmacists should only compound a testosterone 5% cream where a commercial product is not available or is otherwise not appropriate for the customer (e.g. the customer has an allergy to an excipient). Pharmacists should contact the prescriber to confirm the supply of medication where there might be a deviation from what is stated on the prescription, including with respect to compounded vs commercially available product alternatives.

It is also noteworthy that not all products manufactured in a specific state can be dispensed Australia-wide. Pharmacists are encouraged to regularly check the Australian Register of Therapeutic Goods (ARTG) which can be accessed via the TGA website click here 

Several products have recently been registered by pharmaceutical companies and include, but are not limited to:

  • Progesterone oral capsules 100mg and 200mg  marketed as “Prometrium”; 
  • Progesterone vaginal pessaries 100mg and 200g  marketed as “Oripro”;
  • Progesterone vaginal capsules 100mg marketed as “Uterogestan”.

The compounding landscape is evolving and represents a particularly high regulatory concern at the present time.

Compounding pharmacists are advised to be aware of any changes by regularly reviewing the ARTG and by keeping updated by attending relevant industry events and reviewing any advice available through compounding wholesalers.

We invite you to make a comment or discuss this article via the blog which is accessible by clicking the link below using your member login. PDL Professional Officers will respond to your queries or comments.

Practice Alert Blog: Compounding

Disclaimer: This information is current as of November 2017. These articles do not constitute legal advice and do not give rise to any solicitor/client relationship between Meridian Lawyers and the reader.

Professional legal advice should be sought before acting or relying upon the content of these articles. 

Written by Kellie Dell’Oro, Principal and Tamir Katz, Senior Associate of Meridian Lawyers, and PDL. 

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1 Comment

  1. Michael Buckley

    A notice of clarification

    1. At the time the compounded product was dispensed in the case referred to, AndroForte 5 was readily available and in stock with all major Victorian state wholesalers
    2. As a consequence of its failure to comply with the Guidelines the pharmacy in question, in order to settle the case, paid Lawley $73,000 in damages and costs as well as its own substantial legal fees.
    3. Compounding pharmacies who dispense contrary to the Guidelines will inevitably face an audit of their dispensing activity as happened in this case.

    Michael Buckley
    Medical Director
    Lawley Pharmaceuticals

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