Key points
- Novo Nordisk is the only pharmaceutical company with Therapeutic Goods Administration (TGA) approved products containing semaglutide, identified under the trade names Ozempic and Wegovy.
- We are aware of an emerging trend for telehealth providers to offer compounded semaglutide-like products.
- Compounded semaglutide-like products are ‘unapproved’ therapeutic goods and have not been evaluated by us for safety, quality and efficacy.
- The compounding of medicines should be reserved for exceptional clinical circumstances where all suitable alternative treatments using approved therapeutic goods, which are those included on the Australian Register of Therapeutic Goods (ARTG), are unavailable, have failed or are deemed unsuitable for the patient.
- The FDA has recently released a statement warning consumers of the safety risks associated with the use of compounded products containing a salt formulation of semaglutide, including semaglutide sodium and semaglutide acetate. This follows an increase in adverse event reports after patients have been administered compounded semaglutide-like products.
- We strongly encourage consumers to discuss their individual clinical circumstances with their doctor or pharmacist, who are best placed to recommend an alternative medicine or treatment, or may be able to arrange supply of a replacement product from overseas through one of our access schemes.
- We also regulate the advertising of therapeutic goods to the public in Australia. In Australia, it is illegal to advertise prescription-only medicine to the public. This means that if you see advertising for Ozempic or semaglutide, it is illegal and may represent a counterfeit product or a scam.
What is compounding?
Compounding is the manufacture of a medicine by a healthcare practitioner or pharmacist where the medicine is required for a particular patient, to meet the individual’s clinical needs, and a commercially manufactured medicine isn’t suitable. For example, compounding may be useful for young children or people who are unable to swallow tablets or capsules and where the liquid formulation has not been approved by us.
There are exemptions in the TGA legislation that recognise the one-off nature of such medicines and the professional training of the pharmacist who prepares it. A TGA manufacturing licence is not required because only small quantities are made specifically for the individual patient. Compounding is regulated by the states and territories in line with the Pharmacy Board’s guidelines and professional practice obligations.
We do not evaluate compounded medicines for quality, safety or efficacy.
It is unlawful for pharmacists to supply medicines that they have compounded prior to receiving a prescription for a named patient, except when practising in a hospital in certain circumstances.
Are compounded products assessed by the TGA prior to supply?
No. Compounded therapeutic goods have not been evaluated by us for safety, quality and efficacy.
In general, medicines imported into, supplied in, or exported from Australia must be entered on the ARTG, which is administered by us.
Before a prescription medicine is approved for supply, we undertake a detailed evaluation of the quality of the product to make sure that any risks to patients that may be caused by ingredients or impurities in the product or variability in the manufacturing process are understood and well controlled.
When a medicine is compounded, it can have a different strength and different ingredients from similar medicines approved by us. Pharmacists who compound medicines must follow guidelines from the Pharmacy Board to ensure the safety and quality of the products they compound. Following these guidelines is particularly important for medicines that are injected, which can more readily cause infections and side effects.
It is important to note that compounded medicines are exempt from some of the controls over the quality or efficacy of the goods when compared with medicine approved for supply in Australia, and the safety of the product has not been assessed by us.
Information for consumers
You should be aware that compounded semaglutide-like products are not identical to the approved product Ozempic. Compounded semaglutide-like products have not been evaluated for safety, quality and efficacy by us.
You should use caution when purchasing medicines from unknown websites, as these medicines:
- may contain undisclosed and potentially harmful ingredients
- may not meet the same standards of quality, safety and efficacy as those approved by us for supply in Australia.
We have previously detected fake semaglutide being illegally imported into Australia - see our alert Counterfeit semaglutide vials.
There continues to be limited supply of Ozempic in Australia and around the world. We have published advice for prescribers and patients about the shortage and will update its advice as new information becomes available.
Information for healthcare professionals
Medical practitioners and pharmacists should consider their individual legal and professional responsibilities in prescribing and dispensing an ‘unapproved’ product, including compounded semaglutide-like products.
The importation of prescription-only medicines requires the relevant authorisations and approvals prior to importing. A failure to obtain these approvals represents a breach of the Therapeutic Goods Act 1989 and can result in prosecution and forfeiture of the imported medicines.
The compounding exemptions in the Therapeutic Goods Regulations 1990 do not apply if a pharmacist, other than a pharmacist practising in a hospital in certain circumstances, is compounding products for bulk supply in anticipation of patients’ needs before receiving a prescription. Compounding medicines on a commercial-like scale has the potential to adversely affect patients, as the products’ quality and safety is unknown as they are not subject to rigorous testing for safety and quality.
Prescribing and supplying a compounded product may expose medical practitioners and pharmacists to liability if a patient has an adverse outcome, particularly if a TGA-approved product is already available to treat the patient’s initial medical condition.
Pharmacists should refer to the Pharmacy Board of Australia guidelines and the Joint statement on compounded medicines- Pharmacy Board of Australia and Medical Board of Australia (pdf, 476kb) (particularly item 3.1).