A styrofoam cool pack arrived at Louise’s front door just hours after she placed an order with her pharmacist.

Inside were four tiny, unlabelled syringes filled with compounded semaglutide — an unapproved replica of the diabetes drug Ozempic.

Louise, who did not want her real name used, had already lost 25 kilos by using brandname Ozempic prescribed by her doctor for its unofficial use as a weight loss drug.

The results were life-changing, but when supplies dwindled because of a worldwide shortage, she asked her doctor whether it was safe to use an unofficial version of the drug made at a compounding pharmacy.

“He was confident that it would be good quality,” she said.

Louise is one of a growing number of Australians turning to off-brand, unauthorised and unregistered versions of diabetes medications like Ozempic and Mounjaro for weight loss.

Eucalyptus, a large Woolworths-backed telehealth startup that sells weight loss medications, yesterday announced it would soon start selling compounded semaglutide produced under “rigorous safety standards”.

It was a bold move that surprised both regulators and the pharmaceutical companies that hold the patents to the medications.

But hundreds of Australians are already using compounded versions of semaglutide and tirzepatide (the active ingredient in Mounjaro) due to worldwide shortages of the drugs.

An ABC investigation found at least seven other compounding pharmacies and telehealth companies have been quietly selling off-brand versions of the popular weight loss medications and shipping them to consumers across Australia for months.

Australia’s medicines regulator, Therapeutic Goods Administration (TGA), said in a statement Novo Nordisk was the only pharmaceutical company authorised to supply approved products containing semaglutide.

“Compounded therapeutic goods have not been evaluated by the TGA for safety, quality and efficacy,” the TGA said in a statement.

It’s a situation that’s confusing for patients receiving conflicting information from pharmacists, GPs, drug companies and authorities on the safety of compounded medications being used for weight loss.

A ‘loophole’ allowing imitation drugs to be mass-produced

Compounding pharmacies are licensed to create medicine themselves, and can manufacture custom pharmaceuticals for patients with a prescription who cannot find a commercially made, mass produced option.

In those circumstances the medication is exempt from the normal TGA medicine approval protocols, and is not required to be tested by an independent body before being sold to patients.

Compounding is intended to let pharmacists help individual patients access medication that is in shortage or is not available in a suitable form. 

Examples include medication for a baby that needs to be administered as liquid rather than a tablet, or a strength that needs to be custom-produced.

But the widespread demand for diabetes drugs such as Ozempic and Mounjaro has tested the exemption, with some compounding pharmacies now producing replica weight loss medications on an industrial scale.

The TGA has warned it could land pharmacists in hot water.

“The compounding exemptions in the Therapeutic Goods Regulations 1990 [legislation] do not apply if a pharmacist … is compounding products for bulk supply in anticipation of patient’s needs,” a spokesperson said in a statement.

“Compounding medicines on a commercial-like scale has the potential to adversely affect many patients, as they are not subject to rigorous testing for safety and quality.”

The TGA also warned practitioners prescribing and dispensing compounded medication “should consider their individual legal and professional responsibility in prescribing and dispensing an ‘unapproved’ product, including compounded semaglutide-like products”.

“Prescribing a compounded product may expose pharmacists to liability if a patient has a negative outcome, particularly if a TGA approved product is available to treat the patient’s medical condition,” it said.

Nicole Higgins, the president of the Royal Australian College of General Practitioners, said other issues with compounded medicines included not knowing how they might interact with other medications, and whether they would be as effective.

“Unfortunately, there is a loophole which is being used — and that is something that needs to be closed for the safety of patients,” she said.

Compounding pharmacists are guided by professional standards issued by the Pharmaceutical Society of Australia and individual pharmacist conduct is regulated by the Pharmacy Board of Australia.

In a statement the Board said it did “not provide advice to pharmacists about whether it is appropriate to compound particular medicines”.

“We are aware of individual concerns about the compounding of semaglutide. To date, however, the concerns have not related to the health, conduct or performance of an individual pharmacist which would bring the concern within the jurisdiction of the Board,” the statement explained.

Patients say having options is ‘fantastic’

While authorities and pharmaceutical companies ponder how to manage the issue of compounded diabetes drugs circulating in Australia, some consumers are just relieved they have the option to take them.

Rod, who did not want his surname used, lost 10 kilos using brandname Ozempic before it went into shortage.

It took him two doctors to find one who would prescribe the compounded version but he has lost a further 14 kilograms since accessing the copycat product.

Like Louise, he gets his supply of four semaglutide syringes in a small “esky” that comes in the post.

“Since this shortage, there’s a lot of people who are now going through compounding pharmacies,” he told the ABC.

He said he had not noticed any difference between the compounded and brandname medications and had continued to lose weight, improving his overall health.

“With the amount of people going on it, the demand for that drug is so huge. And it seems like the shortages are going to be rolling on for quite some time,” he said.

“So I think it’s absolutely fantastic that compounding has stepped in and is able to provide semaglutide to people who need to be on these types of drugs.

“I think it’s absolutely great.”

He said despite compounding pharmacies operating in a regulatory grey area he wouldn’t stop using the product unless there was a strong warning from authorities.

“It would be a personal decision, but for me, I would stick with it unless it was an absolute dire warning” he said.

The pharmacist Rod orders from said compounding semaglutide and tirzepatide helped Australians access life-changing medication they could not get otherwise due to shortages.

They also said they only compounded a product in strict accordance with the Pharmacy Board and TGA guidelines.

“Australian patients have been left stranded due to ongoing supply issues,” the pharmacist said in a statement.

“We only compound a product under very strict circumstances which includes when a commercial product is unavailable.

“This is only done upon the presentation of a valid prescription and with strict adherence to the relevant compounding guidelines.”

Manufacturers warn against copycat drugs

Despite the extreme demand for alternatives, the official manufacturers have warned against taking, making and prescribing unofficial versions of their drugs.

Novo Nordisk, the manufacturer of Ozempic, told the ABC:

“Compounded semaglutide products should NOT be prescribed or dispensed to patients. These unregistered, unlicenced products present a potential significant safety risk to patients.

“Novo Nordisk is aware there are a number of entities offering compounded semaglutide and has consulted the TGA, and others, on this matter.”

Eli Lilly, the manufacturer of Mounjaro, also warned against using unofficial versions of the drug:

“Products claiming to contain tirzepatide or Mounjaro that are made and/or distributed by compounding pharmacies have not been reviewed by global regulatory agencies for safety, quality, or efficacy; are not approved by global regulatory agencies; and may expose patients to potentially serious health risks.”