Compounded Semaglutide is Concerning
beware suspiciously cheap 'semaglutide' injections
Alert: The Risks of 'Compounded Semaglutide' (and Compounded Tirzepatide (Mounjaro))
From Mark J. Holland MD:
Recently, patients have been inquiring about 'compounded semaglutide,' a medication advertised at prices considerably lower than Wegovy or Ozempic. This discrepancy raised alarm bells and prompted a thorough investigation. It turns out healthcare providers nationwide are administering an unregulated, potentially dangerous product claimed to contain 'compounded semaglutide.' It's crucial to note that I offer FDA-approved semaglutide products as a healthcare provider, yet my primary concern is patient safety and upholding the medical profession's integrity, not competition.
Understanding 'Compounded' Drugs
The FDA describes compounding as creating customized medication by mixing or altering ingredients according to an individual patient's needs. However, compounded drugs aren't FDA-approved, meaning they fall under limited federal regulation, with oversight mainly by state boards of pharmacy.
Compounded Semaglutide: A Question of Source
Ideally, a compounding pharmacy could manufacture compounded semaglutide if the semaglutide source is approved for human use in the U.S. This requirement restricts permissible source drugs to three brand-name medications: Ozempic, Wegovy, or Rybelsus. These three drugs are currently the only approved forms of semaglutide for human use in the United States. The only way that a compounded product containing semaglutide can be legal in the US is if it is made from one of these three sources. As we'll see, that seems unlikely.
Legal Semaglutide Sources: A Tight Circle
Only Ozempic, Wegovy, and Rybelsus are legally allowed as semaglutide sources in the U.S. Significantly, none of these drugs are sold directly to compounding pharmacies, but to retail pharmacies like Walgreens and CVS. This fact begs the question: how are compounding pharmacies acquiring 'semaglutide'?
Tracing the Roots of 'Compounded Semaglutide'
Rybelsus is an oral medication, making it illegal and unsafe to produce injectable drugs from it. The possibility remains for 'compounded semaglutide' to be made from Ozempic or Wegovy. However, there are substantial barriers:
Ozempic and Wegovy aren't sold directly to compounding pharmacies, ruling out official supply channels. If these drugs are procured from patients with prescriptions, it would signify severe legal infringement.
The advertised prices for 'compounded semaglutide' are too low to garner profit from Ozempic or Wegovy. If sourced from insured patients, it would constitute insurance fraud.
So, the actual origin of 'compounded semaglutide' remains shrouded in mystery, but it's evident it doesn't come from a legal source.
Semaglutide Sodium and Semaglutide Acetate (Drug Salts)
Another potential concern raised by FDA is that it appears some compounding pharmacies are selling semaglutide sodium and semaglutide acetate. It is important to understand that Wegovy, Rebelsus and Ozempic all contain what is called the 'free-base' form of semaglutide (called simply "semaglutide"), not semaglutide 'salts' like the sodium or acetate salts of the drug. This is important because the only form of semaglutide that has been thoroughly studied for safety and effectiveness is the free-base form. It is unknown whether the salts actually work and above all, whether they might carry new unknown risks.
The 'Peptide' Trade: An Unregulated Nightmare?
One theory suggests illegal semaglutide might originate from the 'peptide trade,' with companies worldwide advertising 'peptides' like semaglutide at very low costs. The dubious nature of these 'peptides' poses multiple concerns:
Uncertainty about actual semaglutide content, if any.
Potential presence of unapproved, potentially dangerous 'drug salts.'
Possible harmful impurities.
The sources of these substances remain speculative, but it's clear they don't come from legal avenues.
The Misleading 'Shortage' Claim
Some clinics claim their compounded semaglutide products are legal due to a current shortage of Ozempic and Wegovy. However, a shortage doesn't negate the need for a legal, safe, and approved source drug, which in this case, ironically, are the ones in short supply.
Rising Adverse Events
The FDA recently reported receiving serious adverse events linked to 'compounded semaglutide.' The specifics are yet to be disclosed but are expected to be released soon.
Your Safety Comes First: The Bottom Line
The reality of 'compounded semaglutide' is alarming. At best, this product is a murky solution, and at worst, it's a potentially lethal scam. We urge you to prioritize your health and well-being: refuse anyone who wants to inject you with this compound. Legally approved and safe weight loss treatments from trusted medical professionals are the only reliable path forward.
Links to the Dangers of 'Compounded Semaglutide'
Supplemental: What are Protein Synthesizers?
One of the concerns I discussed above is the possibility that so-called 'compounded' GLP-1 drugs may originate from a kind of biological research machine called a "protein synthesizer" or a "peptide synthesizer" machine. These are small desktop devices used in biological research labs to manufacture relatively small amounts of proteins like semaglutide and tirzepatide. These machines are NOT approved for the manufacture of human drugs but rather are often used in research.
The concerns associated with drugs produced on these machines are many and include chemical contamination, biological contamination, low potency and cross contamination.
Additionally, semaglutide and tirzepatide are both drugs that are currently protected by US patent laws so that the sale of these agents by any unapproved entity is liable to result in a lawsuit from Novo-Nordisk or Ely Lilly.
I do not know if so-called "compounded" glp-1 drugs actually are produced on laboratory peptide synthesizers or through some other unapproved means but in all cases, the use of these drugs in humans is unethical and dangerous. The fact is that no matter what the source, "compounded" GLP-1 drugs should be avoided. The danger is too great.