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. Compounded drugs, such as compounded semaglutide, have not undergone the FDA approval process and are not FDA approved. As a result, you may be wondering: what factors should you consider before using compound semaglutide?
Importance Of FDA-Approved Drugs
The FDA’s approval process serves as a safeguard for public health. Before mass-produced medication receives FDA approval to be sold to the general public on the commercial market, it must undergo multiple stages of testing and evaluation to ensure its safety and effectiveness.
This includes 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. Since compound medications are tailored to the unique needs of individual patients, they do not go through the FDA approval process and, therefore, they have not been fully evaluated for safety and effectiveness.
Non-FDA Approved Drugs In The Market
While FDA approval is essential for ensuring the safety of mass-produced medications, some drugs, like compounded medications—customized by pharmacists to meet individual patient needs—may still be available without this approval. These compounded medications are prepared under specific conditions and should only be prescribed by qualified healthcare professionals to ensure appropriate use.
Since compounded medications are usually made for a specific patient rather than mass-produced for commercial use, evaluating their safety and effectiveness is challenging because their ingredients and concentrations may intentionally vary from batch to batch. In addition, the pharmacies that prepare compounded medications fall under the jurisdiction of State Boards of Pharmacy and may be regulated differently from state to state.
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. In contrast, those made in state-licensed pharmacies or federal facilities or by a physician per 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, is the active ingredient in an FDA-approved drug that is widely prescribed 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, another FDA-approved medication, which also uses semaglutide as an active ingredient, was approved for weight management in adults who are either obese or 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 customized by a pharmacist. or physician 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 unavailable or unsuitable for a patient due to allergies or other reasons.
FDA-Approval Of Semaglutide For Weight Loss
Although there are various FDA-approved medications for weight loss, only one drug contains semaglutide and has received FDA approval.
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.
At MediVera Compounding Pharmacy™ (formerly University Compounding Pharmacy), we prioritize safety and quality in every aspect of our operations. We are committed to the compliance with all safety and other regulatory requirements applicable to compound pharmacies to ensure that our medications meet the highest compounding standards.
Before dispensing compounded semaglutide, our pharmacists thoroughly review each patient’s medical history and discuss any potential risks with their healthcare provider. Our patients have the peace of mind knowing that we strictly follow all regulations set forth by the Michigan Board and the Boards of Pharmacy of each state where our patients are located.
For more details about our safety and quality procedures, click here.
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 exact same active ingredients found in the commercially available and FDA-approved versions of the drugs. The agency has not found any basis for compounding these salt forms to 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 that only uses the proper ingredients. One way to check this is to ensure the compounding pharmacy is PCAB Accredited, like MediVera Compounding Pharmacy™
Overall, patients should use caution when considering non-FDA-approved versions of semaglutide and consult their healthcare provider before starting any new medication. With that in mind, here are some general considerations to keep in mind when using compounded medications:
Potential For Contamination
The FDA has reported cases of contamination in compounded medications, including semaglutide. When compounded drugs are produced in a facility that does not comply with regulations, 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. Even the FDA-approved, commercial version of semaglutide may have side effects. Healthcare providers play an essential role in assessing the potential risks and benefits of FDA-approved and compounded drugs for their patients. Patients should inform their healthcare provider of any allergies or medical conditions that could affect the safety of using FDA-approved or compounded semaglutide. For example, patients with a history of kidney or liver disease may need to be closely monitored while taking either version of semaglutide.
Why Choose A Trusted Pharmacy For Compounding Semaglutide?
At MediVera Compounding Pharmacy™ (formerly known as University Compounding Pharmacy), we are dedicated to maintaining and following the highest compounding standard, such as PCAB-Accreditation. We make it our top priority to stay compliant with all state and federal regulations, often implementing them years in advance to ensure compliance. Additionally, we prioritize investments in third-party validation and testing to demonstrate our commitment to transparency and continuous improvement.
When it comes to obtaining compounded semaglutide, it is vital to choose a trusted and reputable pharmacy. MCP (formerly known as University Compounding Pharmacy) has been serving patients for over 20 years, providing compounded medications in our PCAB-Accredited facility. While compounded semaglutide is not FDA-approved, we only use ingredients from FDA-registered vendors in its formulation, excluding any salt forms. This approach helps maintain consistency.
Why Choose Compounded Semaglutide?
There is currently a shortage of commercially available semaglutide, making it difficult for patients to access the medication. Even when semaglutide becomes available as a commercially produced medication, it may not be suitable for everyone. Some weight management medications may contain inactive ingredients that certain individuals could be allergic or sensitive to. As such, compounded semaglutide may be a better choice for certain patients.
Transparency From MCP (formerly known as University Compounding Pharmacy)
At MCP, 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
By choosing MCP patients can receive personalized care, transparency, and high-quality medication from a PCAB-accredited pharmacy.
Connect with our experts today to learn more about our compounding services for weight loss management. Start your wellness journey with personalized solutions and transparent guidance at MediVera Compounding Pharmacy™ (formerly known as University Compounding Pharmacy).
