Compounded Semaglutide: Evaluating Safety and Efficacy in Weight Management

Semaglutide, marketed as Ozempic® in its branded, patented form was originally approved by the FDA for the treatment of type 2 diabetes in its branded form. However, a side-effect seemed to have been weight-management. While the FDA does not approve compounded semaglutide for safety, efficacy, and effectiveness, Wegovy® (the branded version) does have approval for weight management.

However, many may be wondering whether compounded semaglutide is safe for weight management goals. This is an understandable concern, considering that semaglutide may cause gastrointestinal tract issues for certain patients. However, this question needs to be answered thoroughly.

‍

Understanding Compounded Semaglutide

First, let us understand what compounded semaglutide is and how it differs from FDA-approved and branded semaglutide.

Compounding means creating a medication from scratch with customized dosage for individual needs, adding or removing specific components, etc.

Some compounding pharmacies, but not all, are FDA-licensed. These pharmacies compound medications such as semaglutide using the same active ingredient found in WeGovy®. 

Compounded medication might be preferred for several reasons. First, it may be affordable.  Second, compounding allows for customization of dosage and combination with other medications such as B-12 as needed by the patient and prescribed by a licensed healthcare provider.

Another current reason is that semaglutide is currently on the FDA’s drug shortage list as the manufacturing company is facing issues with meeting current demand for the drugs.Compounding pharmacies can provide a solution for this issue through compounded semaglutide.

As with any medication, compounded semaglutide should be used only after consultation with a licensed healthcare provider. After assessing your current health condition, health history, or any drug allergies, a licensed healthcare provider can confirm whether or not semaglutide is an option for you. 

‍

The Compounding Process and Quality Control

Initially, the State Board of Pharmacy allowed the process of compounding in order to create medications for patients with specific needs which may not be FDA-approved or available. Compounding pharmacies have rights to compound medications using the same active ingredient that may be short in supply but needed by patients. 

Some, but not all, compounding pharmacies are FDA-licensed and adheres to the state board regulations. The FDA does not review compounded medications for safety, efficacy and effectiveness. However, semaglutide is an active pharmaceutical ingredient (API) that is sourced FDA-approved manufacturer. 

Similarly, the United States Pharmacopeial Convention has established standards for the compounding process. It ensures the chemical purity of compounded drugs and verifies the potency, stability, and sterility of the final product.

You can read more about regulations of compounding pharmacies.

Meanwhile, compounding is a process very similar to cooking, and each pharmacy has its own recipe, making the compounded product unique. Therefore, you should not expect compounded medications to be of the same quality and effectiveness as the original FDA-approved medication. 

‍

Regulatory Landscape of Compounded Medications

To understand which quality control processes are underlying behind FDA-approved and compounded pharmacies, here's a short overview of how those two are regulated.

When you buy an FDA-approved drug, know that it underwent testing in several phases. Manufacturers of new drugs are required to submit preclinical study results conducted on animals and clinical trials on humans to the FDA for the initial review.

Only after the drug's presenter shows valid testing results will the FDA be involved in the process. In addition, manufacturers submit data about the manufacturing process, proving they are able to produce consistent batches of that drug in case it is approved. All those submissions are done via investigational new drug application (IND) (FDA, 2020b).

In the case of compounding medications, FDCA requirements, section 503A in particular, require compounding pharmacies to label medications with adequate directions for use and follow current good manufacturing practice procedures.

Only if a licensed pharmacist prescribes a patient-specific drug can a compounded medication be free of those regulations. As already mentioned, compounding facilities should use existing FDA-approved drug products or drugs that are bulk drug substances meeting United States Pharmacopeia-National Formulary (USP-NF) standards.

‍

‍

‍

Potential Benefits of Compounded Semaglutide

Customized forms of medications do have noticeable benefits for certain individuals. If you have health conditions making it difficult to swallow pills or if you are allergic to certain ingredients found in FDA-approved drugs, a compounded medication may be a better option for you.

In addition, compounding pharmacies may create forms of semaglutide that are not commercially available, such as transdermal gels or creams, for easier application. This opens up possibilities for people who struggle with injections but still need the benefits of this medication.

Moreover, compounding pharmacies may also adjust dosage strengths according to individual needs as prescribed by a licensed healthcare provider, which is especially helpful for children and elderly patients who may require smaller or larger doses than what is commercially available.

The semaglutide compounding pharmacy costs may be lower, especially for patients who require long-term use of semaglutide or other medications.

As with any medication, medical supervision is crucial when using compounded medication.. Only a personalized consultation with a knowledgeable healthcare provider can ensure that the compounded semaglutide is appropriate for your condition and won't interfere with any other medications you may be taking.

‍

Safety Considerations for Compounded Semaglutide

Risks associated with compounded medications may be related to proper prescribing and dosing. In case of semaglutide, right dosage is important. Mechanism of action requires a low starting dose that gradually increases over time. This helps ensure your body has time to adapt to semaglutide and its side effects. 

It's also crucial to note that a valid prescription from a licensed healthcare provider is required. Nonetheless, even if taken after a healthcare provider's prescription, semaglutide may have side effects, which differ from individual to individual,  including low blood sugar, pancreatitis, allergic reactions, and potential interference with certain medications. It can also cause diarrhea, vomiting, or nausea. Discussing these potential side effects with your healthcare provider before starting compounded semaglutide is important.

While side effects might be moderate for some or for others, they can be continuous and severe. That's why monitoring your body's response to the medication closely is important, whether you're using compounded semaglutide for weight management or managing diabetes.

‍

Comparing Compounded Semaglutide to FDA-Approved Options

Compounded semaglutide reviews show that it has been effective for patients in managing their weight and diabetes, alongside diet and exercise. Results vary from individual to individual. 

While compounded semaglutide may have benefits, it's important to discuss with your doctor the potential risks and benefits of using a compounded medication versus an FDA-approved option such as WeGovy®. 

‍

Factors to Consider When Exploring Compounded Semaglutide

If you're thinking about how to obtain compound semaglutide:

There are several factors you should consider before making this decision. Those include:

• Is there a pharmacy, platform, or source that can offer me a consultation with a licensed healthcare provider before I make this decision?
• Am I ready to be open and objective when sharing my health information with the health care consultant, especially if I apply to telehealth service?
• Am I aware of the potential risks and benefits of using compounded semaglutide versus FDA-approved options?
• Do I trust the source/compounding pharmacy to provide medication?

If all those questions are carefully considered and you still feel confident about pursuing compounded semaglutide, there's one last factor left. You should ensure that you consult your licensed healthcare provider along the way. 

‍

FAQ

What is compounded semaglutide?

Currently, FDA-approved versions of semaglutide include Ozempic and WeGovy. Compounding pharmacies use the same active ingredient for compounded semaglutide, which is not reviewed by the FDA for it’s safety, efficacy, and effectiveness. 

What Are the Potential Risks of Using Compounded Semaglutide?

Taking semaglutide in any form risks side-effects such as nauseousness, gastric tract issues, vomiting, etc. 

You should always consult with your licensed healthcare provider prior, during, and after being prescribed semaglutide in any form. 

‍

‌Disclaimer: The FDA does not approve compounded medications for safety, quality or manufacturing. Prescriptions and a medical evaluation are required for certain products. The information provided on this blog is for general informational purposes only. It is not intended as a substitute for professional advice from a qualified healthcare professional and should not be relied upon as personal health advice. The information contained in this blog is not meant to diagnose, treat, cure, or prevent any disease. Readers are advised to consult with a qualified healthcare professional for any medical concerns including side effects. Use of this blog's information is at your own risk. The blog owner is not responsible for any adverse effects, or consequences resulting from the use of any suggestions or information provided in this blog.

‍

Final Thoughts

It is recommended to consult a healthcare provider before starting any new medication. It's important to weigh the potential benefits against the risks and make an informed decision with the guidance of a medical professional. 

‍