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Is Compounded Semaglutide FDA Approved?

When it comes to medications, safety is a top priority. That’s why the Food and Drug Administration (FDA) in the United States has strict regulations for approving new drugs. This process ensures that medications are safe and effective before being prescribed to patients. However, there are some exceptions to this rule, such as compounded medications. As a result, you may be wondering: Is compounded semaglutide FDA-approved—and if it isn’t, is it still safe to use?

 

Importance Of FDA-Approved Drugs

The FDA’s approval process serves as a crucial safeguard for public health. Before being available for use on the commercial market, a medication must undergo multiple stages of testing and evaluation to ensure it is safe for patients to use.

To obtain FDA approval, manufacturers must provide extensive data on the safety and effectiveness of their drugs before they can be approved for use. This includes rigorous clinical trials that test the drug in different populations and identify potential side effects.

As a result, patients can have confidence an FDA-approved medication has undergone thorough testing and meets high safety standards. Without FDA approval, there is no guarantee a medication is safe or effective.

 

Non-FDA Approved Drugs In The Market

While FDA approval is essential for ensuring the safety of mass-produced medications, some drugs may still be available on the market without this approval. For example, compounded medications can be prescribed to patients despite not being FDA-approved. Compound medications are drugs that are mixed or altered by a pharmacist to meet an individual patient’s specific needs.

Because compounded medications are usually made specifically for a patient rather than mass-produced for commercial use, evaluating their safety and effectiveness is challenging since the ingredients and concentrations may vary from batch to batch. Instead, compounded medications fall under the jurisdiction of State Boards of Pharmacy and may be regulated differently from state to state.

Additionally, quality requirements for compounded drugs may differ depending on the setting where compounding occurs. Compounded medications made in outsourcing facilities must adhere to current good manufacturing practice (CGMP) requirements, while those made in state-licensed pharmacies or federal facilities, or by a physician in accordance with section 503A of the Federal Food, Drug and Cosmetic (FD&C) Act, may be exempt from these requirements. However, all compounded medications must follow federal requirements, such as maintaining sanitary conditions during preparation, packaging, and storage.

 

What Is Compounded Semaglutide?

Semaglutide, which is an active ingredient found in Ozempic (a medication approved by the FDA in 2017), is used to help manage type 2 diabetes. Semaglutide achieves this by controlling blood sugar levels and reducing the risk of cardiovascular events. When used for diabetes management, semaglutide can be taken with insulin and other diabetic medications. It is usually injected once a week, and the dosage may vary depending on individual needs.

In 2021, Wegovy, which uses semaglutide as an active ingredient, was approved by the FDA for weight management in adults who are either obese or who are overweight with at least one other weight-related condition. This is because semaglutide can also help with weight loss by making the body take longer to process food, leading to a feeling of fullness and reduced appetite.

Compounded medications are drugs that have been altered by a pharmacist. This could mean changing the dosage or combining it with other medications. Compounded semaglutide is usually prescribed when standard, FDA-approved medications containing semaglutide are unsuitable for a patient due to allergies or other reasons.

 

FDA-Approval Of Semaglutide For Weight Loss

Although there are other types of medications on the market that have been approved by the FDA for the purpose of weight loss, Wegovy is currently the only medication containing semaglutide that has been FDA-approved.

While compounded semaglutide is not specifically FDA-approved for weight loss, doctors can prescribe it for this purpose. However, it is essential to note that the safety and effectiveness of compounded semaglutide for weight loss have not been evaluated by the FDA.

As a compounding pharmacy, University Compounding Pharmacy (UCP) takes every precaution to ensure our compounded medications follow every safety and legal requirement. Before prescribing compounded semaglutide for weight loss, our UCP pharmacists thoroughly review the patient’s medical history and discuss possible risks with their healthcare provider. We also follow all State Board of Pharmacy regulations, thereby ensuring the highest quality and safety of our compounded medications.

Of course, it is essential to speak with your healthcare provider before starting any type of medication, including compounded semaglutide. They can provide professional guidance regarding the appropriate dosage as well as monitor any potential side effects.

 

Safety Concerns With Compounded Semaglutide

The FDA has issued alerts regarding the use of compounded semaglutide due to reports that some compounders may be using different forms of semaglutide, such as sodium or acetate salts, which are not the same active ingredients found in FDA-approved drugs. The agency has not found any basis for compounding these salt forms that would meet the requirements for compounded medications set by the FD&C Act. Therefore, it is crucial to obtain compounded semaglutide from a reputable compounding pharmacy to ensure safety and effectiveness.

Overall, patients should use caution when considering non-FDA-approved versions of semaglutide and consult their healthcare provider before starting any new medication.

Additionally, they should only obtain compounded semaglutide from a trusted source, like UCP, to ensure the highest quality and safety standards are met. With that in mind, the following are some of the general risks associated with using compounded medications from non-reputable sources:

 

Potential For Contamination

The FDA has reported cases of contamination in compounded medications, including semaglutide. When compounded drugs are not produced in a regulated facility, there is an increased risk of contamination during the compounding process. For example, non-sterile equipment or improper handling can lead to contamination of the drug, resulting in potential health hazards for patients. Contamination can also occur when improper ingredients or equipment are used to formulate the medication.

 

Patient-Specific Safety Considerations

As with any medication, there may be individual safety considerations for patients taking compounded semaglutide. Healthcare providers play an essential role in assessing the potential risks and benefits of compounded drugs for their patients. Patients should inform their healthcare provider of any allergies or medical conditions that could affect the safety of using compounded semaglutide. For example, patients with a history of kidney or liver disease may need to be closely monitored while taking the medication.

 

Why Choose A Trusted Pharmacy For Compounding Semaglutide?

At University Compounding Pharmacy, we are dedicated to delivering the most superior formulations, focusing on patient safety and quality care. We make it our top priority to stay ahead of state and national regulations, often implementing them years in advance to ensure compliance. Additionally, we prioritize investments in third-party validation and testing to consistently maintain the highest standards every day.

When it comes to obtaining compounded semaglutide, it is vital to choose a trusted and reputable pharmacy. UCP has been serving patients for over 20 years, providing high-quality compounded medications that meet FDA standards. Although compounded semaglutide may not be FDA-approved for weight loss, we do use the FDA-approved ingredient semaglutide and not its salt forms, ensuring the safety and effectiveness of the medication for our patients.

Furthermore, our team of experienced pharmacists ensures that all of our compounded medications follow all State Board of Pharmacy regulations. Patients can trust that they receive top-quality, safe, and effective medications from a reliable source at UCP.

 

Comparison With Commercially Available Semaglutide

While commercially available semaglutide may be FDA-approved, it may not suit all patients. This is because some commercially produced weight management medications (such as Wegovy) may contain ingredients that patients are allergic to or have an adverse reaction to. As such, compounded semaglutide may be safer to use for certain patients. Additionally, there is a shortage of commercially available semaglutide, making it difficult for patients to access the medication.

When it comes down to it, compounded semaglutide can be a viable option for patients in need of weight loss medication when standard forms are unsuitable or unavailable.

 

Transparency From UCP

At UCP, we prioritize transparency and safety in all aspects of our compounding process. We provide patients with information about the source of ingredients used in their compounded medications and documentation on the testing and quality assurance procedures we follow.

 

Semaglutide Compounding For Weight Loss

Compounded semaglutide remains a popular option for weight management. Patients can experience significant weight loss while using the medication, making it a valuable tool in the fight against obesity and being overweight. However, obtaining compounded semaglutide from a trusted and reputable pharmacy like UCP is crucial to ensure its safety and effectiveness.

By choosing UCP, patients can receive personalized care, transparency, and high-quality medication that meets FDA standards. Contact us today to learn more about our compounding services for weight loss.

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