No. Compounded Semaglutide isn’t the same as Ozempic.
Simply because it has no FDA approval, is custom-made in small batches, can vary in formulation, and lacks the same level of clinical evidence that supports its use.
Several individuals are dealing with Two Terrible Troubles: Diabetes and Obesity.
WHO found that in 2022:
- Over 2.5+ billion suffered from overweight problems.
- 830+ million suffered from diabetes problems.
[Source: Obesity and overweight]
The number is going up. So, you must get the right treatment at the right time.
FDA-approved semaglutide is used for diabetes management and weight-related conditions. However, compounded semaglutide is not FDA-approved and should only be used under the supervision of a licensed provider. It is not an equivalent substitute for Ozempic
Then again, 5 factors make them different from one another.
Disclaimer: This blog is for informational purposes only and should not be considered medical advice.
Primary Components: Compounded Semaglutide & Ozempic
What is Compounded Semaglutide?
A personalized peptide-infused drug.
Semaglutide is an injectible medication. The solution contains semaglutide and mimics the functions of Glucagon-like peptide-1 (GLP-1), a hormone in your body. After injection, it binds to a cell receptor and helps manage:
- Blood sugar levels
- Body weight
⚠️ Caution: Compounded semaglutide is made in pharmacies and is not FDA-approved. Its formulation may vary, and it does not go through the same rigorous testing for safety and effectiveness as FDA-approved medications
Pharmacies make the drug from scratch with the salt forms of semaglutide ingredients.
Why People Use It
- Cost-effectiveness
- Availability when branded options are scarce
- Customizable doses
Delivery Formats
- Sublingual drops
- Orally disintegrating tablets
- Nasal spray
- Solution in vial
- Pen
Concerns
A big one: non-FDA-approved treatments!
The Food and Drug Administration mainly approves medications by assessing their safety, efficiency, and quality: all together.
The case with Semaglutide is that big pharmaceutical companies manufacture it. So, the drug goes through clinical trials and rigorous testing to meet certain standards before hitting the pharmacies. That’s why FDA experts approve it with a prescription.
With compounded medication, you get a different scenario. Small pharmacies make this. It uses a variety of ingredients, not just Semaglutide, to suit someone’s needs.
Unlike Semaglutide, which is designed for a big common group, Custom Semaglutide is personalized just for one person. Moreover, it doesn’t go through the same strict testing process. This raises concerns regarding the contamination and health hazards during the making.
Hence, the FDA doesn’t guarantee the safety, efficiency, and quality of the products.
What is Ozempic?
Typically, a company.
Ozempic is a brand-name medication. It mostly comes in 1mL solution and contains 0.68 mg, 1.34 mg, or 2.68 mg semaglutide. So, you can call it a branded semaglutide.
The main goal is to manage type 2 diabetes, with weight loss being the secondary.
Apart from Semaglutide, the drug may also have other non-medicinal ingredients like:
- Propylene glycol
- Phenol
- Disodium phosphate dihydrate
- Water
Ozempic comes from the big Danish multinational pharmaceutical company, Novo Nordisk. One good thing about the drug is that it’s–
- Extensively researched
- Manufactured with thorough tests
- Validated by several clinical trials
This makes them a trusted option in the medical treatment process.
Ozempic Benefits
- Type 2 diabetes treatment
- Frequently prescribed off-label for weight loss
- FDA-approved drug
- Once-weekly routine
Delivery Method
- Pre-filled injection pens (Ozempic Pen)
Key Facts About Compounded Semaglutide
FDA Approval Status
FDA consent matters the most here.
The Food and Drug Association reviews the products and assesses whether they underwent the tests needed to meet certain standards. They approve if an item ensures efficacy, quality, and safety and reject if it doesn’t. Hence, their approval is vital.
Compounded semaglutide is not FDA-approved. Under federal law, compounding is only permitted when an FDA-approved version of the drug does not meet a patient’s specific medical needs and must be prescribed by a licensed provider
In 2017, the FDA evaluated Ozempic. They made a report that highlighted–
- Specifications
- Efficacy
- Side effects
Although they approve the medication, it’s important to have a prescription.
In contrast, Compounded Semaglutide isn’t FDA-approved. The reason is that–
- It doesn’t undergo the tests required to meet the safety and efficiency criteria.
Such a drug is custom-made by small pharmacies based on a doctor’s prescription. Each pharmacy may have different ways of making it. This may lead to variations in quality.
Such inconsistency may raise questions regarding reliability. Since Compounded Semaglutide is personalized for an individual and not tested on a larger scale, it doesn’t have FDA approval.
That said, the FDA understands the substantial consumer interest in such medications.
So, they encourage you to use it under certain conditions.
Two of them are:
- Consulting healthcare professionals beforehand.
- If FDA-approved semaglutide fails to meet your medical needs.
Composition and Customization
Because the brand-name medication is for a big common group, the solution uses certain ingredients.
Novo Nordisk mentions that the 1mL Ozempic solution has–
- Pure form of Semaglutide
- Disodium phosphate dihydrate
- Propylene glycol
- Phenol
- Water
The medication comes pre-filled in vials or pens that give you a specific dose to use every time.
This makes the drug very reliable. It’s because you know you’re taking the right amount. Dose accuracy is important for managing diabetes or body weight.
FDA lists some compounds it carries:
- Salt forms like semaglutide sodium or acetate
- Cyanocobalamin Vitamin B12
- Pyridoxine Vitamin B6
- Levocarnitine
- Nicotinamide adenine dinucleotide
The formulation varies based on the patient’s requirements and conditions.
However, the medication can come in other forms like tablets, sprays, and pens. This makes the drug flexible and convenient for different individuals.
It’s also a big benefit for patients who need a unique dose that’s not available in standard ones.
The issue is that differences in formulation can affect the strength of the medication. This can result in potential side effects and other risks.
It’s better to consult a healthcare expert. Follow their instructions regarding the formulation, dose, and other routines. That’ll keep you safe.
Availability
How easily can you grab it?
Because of its effectiveness and FDA factor, it faces high demand. This often results in shortages.
As for Compounded Semaglutide, the availability varies from one place to another.
Mostly, it’s easier to find at some online pharmacies. But it can be hard to get at local stores. So, it depends on luck.
Many online sites may raise questions about reliability.
In that case, it’s better to check the reviews and the company. Ensure they deliver compounded ones only if you have a proper prescription.
TIP
Get the medication checked by a healthcare professional after purchasing and before using it.
Safety and Efficacy
Two essentials that the medication must have.
Ozempic has a strong reputation that originates from the several clinical trials the med undergoes.
Such tests give you evidence that the drug will be effective, safe, and of quality. It’ll help manage both sugar levels and body weight.
However, many may experience side effects like:
- Nausea and vomiting
- Diarrhea or Constipation
- Fatigue
- Abdominal pain
Then again, they’re manageable. This gives doctors and patients confidence in Ozempic.
Conversely, Compounded Semaglutide’s safety and efficiency are slightly hard to understand. How well it works depends on the–
- Pharmacy
- Formulations
- Individuals
Improper doses and formulations may lead to severe side effects and other health hazards.
These are:
- Gastrointestinal effects
- Fainting
- Headache and Migraine
- Dehydration
- Acute pancreatitis
- Gallstones
To avoid this and confirm the safety and efficiency of a product, you must consider some factors.
These include where you’re getting it from, the ingredients, proper dosage, and administration.
It’s true for Ozempic, too.
Also, consult a doctor before buying the medication.
The Risks and Concerns of Using Compounded Semaglutide
Lack of FDA Approval
No guarantee of safety, purity, or efficacy.
Variability in Quality
Risk of inconsistent compounding practices.
Potential Side Effects
There is a possibility of adverse reactions due to unregulated ingredients.
Key Considerations When Choosing a GLP-1 Medication
Medical Conditions
Assess your specific medical conditions.
Ozempic or Compounded Semaglutide is primarily for managing Type 2 diabetes. It may also assist with weight loss.
However, talk to your doctor to know if you can use either of the medications or which one to buy.
Also, avoid if you have other severe medical conditions. For instance:
- Heart disease
- Pancreatitis
- Kidney problems
- Stomach issues
Such medications can make things worse.
Budget Constraints
A giant factor.
Ozempic is an FDA-approved medication, but it’s expensive. You may have to spend $12,000 a year for it, especially if there’s no insurance coverage.
Consider getting it only when money is not an issue.
Compounded semaglutide may vary in cost depending on formulation and provider. It does not have FDA approval and should only be used under the supervision of a licensed healthcare provider. Plus, there isn’t any insurance that covers it.
So buy carefully.
Think how much money you can afford for medication now and in the future. Find a balance between cost and getting the right treatment. It’s really important.
Risk Tolerance
Are you comfortable with the hassle both medications bring?
Ask yourself.
Ozempic is surely a safer option because there are a couple of manageable side effects.
However, Compounded Semaglutide doesn’t go through strict testing, so there’s no FDA approval. This means it may bring common side effects or uncommon health hazards.
To stay safe, consult a healthcare provider about these risks.
The experts can explain everything and guide you in making the best choice. They can also discuss how to monitor for side effects and ensure that your treatment is working well.
Frequently Asked Questions
What is the main difference between compounded semaglutide and Ozempic?
Composition. The main difference lies in the ingredients that make compounded semaglutide and Ozempic. Compounded semaglutide is personalized with different ingredients based on an individual and has no FDA approvals, while Ozempic is FDA-approved since it uses a fixed formulation and undergoes strict trials.
Is compounded semaglutide safe?
Using without a prescription, purchasing without research, and careless administration make compounded semaglutide unsafe. Make sure to talk to a doctor to learn about your eligibility and if it’s suitable for you.
Why is compounded semaglutide cheaper than Ozempic?
Compounded semaglutide pricing varies and is not covered by insurance. It’s because the medication is made in smaller batches. Plus, it doesn’t have all the costs for the design of injection pens, the large manufacturing facility, and distribution. This makes compounded semaglutide cheaper than Ozempic.
