Demand for unapproved peptide products has moved from the black market to compounding pharmacies. Here’s what pharmacists need to know.
Unapproved peptide products are surging in popularity across Australia. But alarming inconsistencies in counterfeit peptide products like retatrutide have been identified, including vials containing much more or less of the active ingredient than advertised, or none at all. A contaminated batch is also thought to be behind a number of recent hospitalisations due to acute liver failure.
As demand for these products grows, pharmacists are reportedly fielding scripts for compounded peptide therapies like BPC-157, a synthetic experimental peptide based on a protein naturally found in human gastric juice. While it has been studied extensively in animals for its potential to aid tissue repair, solid human safety and efficacy data are still lacking.
During the thick of the semaglutide shortage, some pharmacies were compounding the medicine, until the Therapeutics Goods Administration (TGA) removed GLP-1 RAs – including semaglutide – from the pharmacy compounding exemption.
So what’s the TGA’s position on compounded peptides?
Where responsibility sits
The TGA does not regulate clinical practice or determine whether a particular product should be prescribed or compounded for an individual patient, a spokesperson for the regulator told AP.
‘Pharmacists are responsible for ensuring that any compounding activity is undertaken in accordance with applicable Commonwealth, state and territory legislation, professional standards, and Pharmacy Board of Australia requirements,’ the spokesperson said.
‘The compounding exemption under the Therapeutic Goods Act 1989 permits pharmacists to compound small quantities of medicines for an individual patient in response to a prescription from a medical practitioner.’
Compounded products are intended to address a specific clinical need where a commercially manufactured product is unavailable, unsuitable, or otherwise not clinically appropriate.
But extemporaneously compounded medicines are not included in the Australian Register of Therapeutic Goods (ARTG) and are not subject to TGA pre-market assessment. That means the quality, stability and efficacy of the final compounded product are not independently assessed by the TGA before it is supplied to patients – with the stakes being even higher for products that are not TGA approved, like unapproved peptides.
‘There are significant uncertainties associated with compounded unapproved peptide products (such as BPC-157), particularly where the active ingredient, dosage form or formulation is not described in recognised compounding references, such as the Australian Pharmaceutical Formulary and Handbook or established professional compounding standards,’ the spokesperson said.
‘For unapproved peptide products, uncertainties may exist regarding the source and quality of starting materials, the composition and consistency of the final product, and the available evidence relating to safety, adverse effects, dosing and long-term use.’
Sterility a concern
Unapproved peptide products are designed to be injected. Among myriad other reasons, sterility was a chief factor in the ban on compounded GLP-1 RA products.
‘Particular caution is required for sterile compounded injectable products,’ the TGA spokesperson said. ‘The safe sterile compounding of injectable products is paramount given the increased risks associated with the preparation and administration of injectable products, where failures in sterility, quality or product integrity can result in significant patient harm.’
So, should you compound a peptide?
The TGA’s recently released guidance document on importing, compounding and supplying unapproved peptide products puts the onus on pharmacists.
‘Healthcare practitioners who compound, prescribe or supply unapproved peptide products must also comply with all regulatory requirements and relevant professional practice standards, including those set by Ahpra, the Australian Health Practitioner Regulation Agency.’
For more information, refer to the chapter on Compounding.
