Best to read the full article.
The TGA provides several cautions, concerning pharmacists exploiting what some suggest is a loop hole in regulation.
An online provider with Woolworths a major investor is one provider specifically named.
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”.
Except that the ABC article doesn’t explain just what the pharmacists are doing. The article makes it sound as though the compounding pharmacies are actually making semaglutide.
But according to the TGA,
Making Ozempic involves a complex process to produce semaglutide using specialised equipment in a unique manufacturing setting. This means that increasing supply for a global shortage is taking some time.
I’m curious about this. Are pharmacies manufacturing the stuff, or making something else that does similar things? Does anyone here know?
In the case cited they are. A ‘compounding chemist’ is a step above and able to make equivalent medications from components on hand. The term ‘equivalent’ may not be precise in context but I trust it makes the point.
Their services are most common during shortages of certain things or when a medication has been taken off market and are intended to be made in quantities in single digits for a unique customer, as required. Sometimes they provide a specific ‘mix’ per script requirements. The issue is they apparently went into larger scale production.
I have a 20ml doser antibiotic salve where the original named product was withdrawn a few years prior but remains ‘listed’ so my GP was able to write a script from the electronic database. Chemwarehouse referred me to a local compounding chemist who made it. QA is trust.
Thanks, @PhilT. I do know what compounding chemists do in general. What’s unclear to me from the ABC article is whether they are actually producing semaglutide from scratch. What the TGA site said about its requiring “specialised equipment in a unique manufacturing setting” suggests that might be a bit difficult to do without the ‘specialised’ equipment and setting. Which might or might not be something the compounding pharmacies can replicate.
But TGA might simply be quoting the manufacturer, who currently can’t make enough of the stuff to keep up with demand and is making excuses for the delay.
And of course QA does come into it: maybe purifying the output and make sure it is exactly the concentration it’s supposed to be takes some considerable effort, and that’s why the ‘specialised’ equipment and setting.
Probably not. While from the perspective of the US and references to the US FDA (that the TGA follows) this may explain it. The following is hot linked.
I very much doubt it. Pharmacists generally would not be expert in the techniques of multi-step organic synthesis nor would they have the premises nor gear.
… some health experts, including the FDA, have raised concerns about how some compounding pharmacists are producing semaglutide. The branded—and FDA-approved—versions of Ozempic, Wegovy, and Rybelsus contain semaglutide made from a specific form of the compound, known as its base. But some compounding pharmacies have used the salt forms of semaglutide to meet the surge in demand, prompting the FDA to issue a warning on May 31 … the FDA said it is “not aware of any basis for compounding using the salt forms that would meet the [Food, Drug and Cosmetic Act] requirements for active ingredients that can be compounded.”
… Some compounding pharmacists are pushing back, arguing that if the final product made with semaglutide salts does meet the FDA’s criteria for potency, sterility, and lack of endotoxins, it should be considered a legitimately compounded product. They point out that if semaglutide salts are dissolved, they form semaglutide base, so the end product is the same.
I’m guessing that this is what the Australian compounding pharmacies are doing, too.
The laboratory use only compound is available from a number of supply sources. None of these supply sources have product that is approved or designed for human or animal use. They are purely produced for research purposes. I can’t say if they are a salt or not in every case (most are amides so not salts), they are a powder that has been freeze dried and are rated only greater than 95% to 96% pure (so up to 5% impurities). Some of these products are derived from human intestinal tissue, others from E. Coli and others may be derived from other animals or processes, and so certainly may contain contaminants not safe for use in humans or animals. These contaminants may include potent endotoxins and exotoxins.
For reference purposes only: Some suppliers listings
I thought initially Pharmacists may be just repackaging but according to the AMA they are manufacturing injectables from powder RACGP - GP concern over new Ozempic copycat . This is being done for online doctors e.g https://www.myjuniper.com/ and probably others. In any case the entire process of procuring an unregistered drug into Australia and then prescribing what to do with it is done by a doctor. It’s strange that they blame the Pharmacists when most of the legal responsibilty rests with a doctor. The FDA has issues with this process in the US Medications Containing Semaglutide Marketed for Type 2 Diabetes or Weight Loss | FDA . In any case it is probably legal otherwise the TGA would have sent a desist letter. The whole issue of “off label” drugs and importation of non-registered drugs is fraught but the practice is ubquitous. Doctors are allowed to do things where is there is little or no evidence to justify it. The risks in the case of semaglutide sodium/acetate is loss of effect due to storage and the side effects of the drug. The benefits are related to weight loss in obese patients…especially those with obvious health and quality of life issues
