Is Compounded Semaglutide Safe?

Introduction to Compounded Semaglutide

What Is Semaglutide?

Semaglutide is a modern treatment that has gained attention for its effectiveness in managing type 2 diabetes and aiding in weight loss. Many people have seen significant results with semaglutide weight loss treatments, making it a promising option for long-term weight management. Semaglutide for weight loss is particularly effective in individuals who combine it with lifestyle changes such as diet and exercise. It regulates blood sugar levels by stimulating insulin release when needed, slowing stomach emptying, and reducing appetite through its action on specific brain regions. Additionally, it lowers glucagon levels, a hormone that raises blood sugar when it’s not needed.

In addition to those, semaglutide also offers benefits in protecting the heart, improving outcomes in heart failure, and reducing kidney complications in individuals with diabetes and chronic kidney disease.

Compounded Medications and How They Differ From FDA-Approved Formulations

Compounded medications are custom-prepared pharmaceutical formulations created to meet specific patient needs that cannot be addressed by standard, mass-produced drugs. Just as a child might require a medication without specific allergens or in a precise dosage not commercially available, patients are increasingly seeking compounded versions of drugs like semaglutide to meet their individual requirements.

Amid the ongoing semaglutide shortages and rising costs of medications, compound formulations have emerged as a critical alternative for patients seeking diabetes and weight management treatments. Licensed pharmacists in specialized outsourcing facilities can create these versions that follow strict Current Good Manufacturing Practice (CGMP) standards, ensuring patient safety while providing a more affordable and accessible treatment option.

Unlike FDA-approved formulations, compounded medications:

• are not mass-produced, 

• may have slightly different inactive ingredients and 

• are prepared in smaller batches with more individualized specifications.

Why People Choose Compounded Semaglutide

Cost Considerations

Branded semaglutide, either as semaglutide pills or injections, is quite steep, priced at around $1,000 monthly. This has driven patients toward more affordable alternatives like semaglutide compounds. Typically, patients can obtain compounded versions for under $500 per month, with initial treatment costs of around $350 during the lower-dosage starting phase. 

Pricing depends on specific dosage requirements, shipping, and compound formulation but consistently offers substantial cost savings compared to commercial medications.

Access and Availability

Access to branded semaglutide has been challenging due to frequent shortages driven by high demand and production constraints. These supply issues have made it difficult for many patients to start or continue treatment consistently. Compounded semaglutide, prepared by licensed pharmacies, offers a more accessible option by bypassing the mass-production bottleneck. 

Personalized Dosing Options

Branded formulations of semaglutide, like Ozempic and Wegovy, begin with a dosage of 0.25 mg per week. Although this may seem like a low dose, this medication is quite potent and can cause unpleasant side effects.

Your customized initial compounded semaglutide dosage could be as low as 0.15 mg weekly.

On the other hand, if you are already using semaglutide and have experienced a reduction in side effects, you might be able to start with a dose of semaglutide as high as 1.9 mg weekly.

Safety of Compounded Semaglutide: What to Know

Quality Control and Regulation of Compounded Medications

The main question patients ask is: Is compounded semaglutide safe?

Well, compounded medications are regulated depending on where they are prepared. State boards of pharmacy oversee most local pharmacies, while the FDA focuses on facilities registered as outsourcing centers and inspects them based on risk. 

Outsourcing facilities must meet strict manufacturing standards (CGMP), but regular pharmacies and physicians follow different rules. Regardless of the setting, all compounding must maintain cleanliness to safeguard patients and prevent harm.

Risks Associated With Unapproved Formulations

Compounded drugs are not FDA-approved, meaning their safety, effectiveness, and quality are not verified before they are made available. This lack of approval can theoretically increase patients' risk of serious health issues. Poor compounding practices, such as contamination or incorrect dosages of active ingredients, can lead to potential consequences.

To minimize these risks, compounded drugs should generally only be used when FDA-approved medications are unsuitable or unavailable for a patient's specific medical needs. 

Importance of Working With a Licensed Compounding Pharmacy

Choosing a licensed compounding pharmacy ensures safety and quality when using customized medications. Licensed facilities, including FDA-registered outsourcing facilities under section 503B of the Drug Quality and Security Act, adhere to strict standards like current good manufacturing practices (CGMPs), adverse event reporting, and regular inspections.

Working with a regulated facility minimizes risks such as contamination or dosing errors, offering greater assurance of medication safety and effectiveness.

You can check which facilities are FDA-registered here and find a list of accredited compounding pharmacies here.

Possible Side Effects of Compounded Semaglutide

Common Side Effects Observed in FDA-Approved Semaglutide

Semaglutide is associated with some side effects, including:

• Gastrointestinal problems, like nausea, vomiting, diarrhea, constipation, and abdominal pain;

• Nervous system issues like fatigue, headache, dizziness;

• Respiratory complaints like nasopharyngitis and sinusitis.

Other common side effects of semaglutide include hypoglycemia (low blood sugar), alopecia (hair loss), skin rash, and abdominal distension.

Patients should also discuss potential semaglutide long-term side effects with their healthcare provider to weigh the risks and benefits of treatment, whether compounded or FDA-approved.

Potential Side Effects Specific to Compounded Versions

Compounded semaglutide poses some additional risks compared to FDA-approved versions, including:

• Dosing accuracy
  
  Errors are common due to varying concentrations, improper syringe use, and confusion over units such as milligrams, milliliters, and "units." These have sometimes led to severe overdoses and hospitalizations.  

• Contamination
  
  Compounded products lack the rigorous quality controls of FDA-approved drugs, increasing the risk of contamination during preparation. As mentioned earlier, working with FDA-registered outsourcing facilities and accredited compounding pharmacies is vital to ensure you get the safest compounding drugs possible.

• Adverse effects from added substances
  
  Substances used in compounding may cause allergic reactions, compromise the drug’s stability, or result in unpredictable side effects.

Reported adverse events include nausea, vomiting, dehydration, pancreatitis, and gallstones.

Dosage and Administration Differences

Comparing Standard Dosages With Compounded Dosages

FDA-approved semaglutide (e.g., Wegovy, Ozempic) follows a standardized dosing schedule, gradually increasing the dose to minimize side effects and optimize effectiveness. For example:

• Month 1: 0.25 mg weekly

• Month 5+: 2.4 mg weekly (or 1.0 mg weekly if indicated)

Compounded semaglutide offers more varied dosing options, often catering to individual needs but lacking the consistency of FDA-approved products. Common compounded schedules include:

• Low Dose Options: Starting as low as 0.15 mg weekly, with slower increases (e.g., up to 1.25 mg by Month 6).

• High Dose Options: More rapid escalation, reaching up to 2.4 mg weekly by Month 5 or 6.

Potential Risks With Inaccurate Dosing in Compounded Medications

As discussed earlier, compounded semaglutide carries notable risks including dosing errors caused by inconsistent concentrations, improper syringe use, and confusion over units. These issues have led to severe overdoses and hospitalizations.

• Patient Errors
  
  Patients unfamiliar with syringes have mistakenly administered 5 to 20 times the intended dose by misreading unit markings. For example, instructions to inject "5 units" (0.05 mL) were misinterpreted as 50 units (0.5 mL).

• Provider Miscalculations
  
  Errors in converting between milligrams, milliliters, and units have resulted in overdoses, with patients receiving 10 times the intended dose due to incorrect prescriptions.

Overdoses can cause severe nausea, vomiting, dehydration, pancreatitis, and gallstones. In other cases, improper or delayed dosing compromises the drug's effectiveness, hindering weight loss or glucose control.

Underdosing, on the other hand, increases the chance of reduced therapeutic benefits.

Choosing a Reliable Compounding Pharmacy

Tips for Finding Reputable Compounding Pharmacies

When choosing a pharmacy that’s involved in compounding semaglutide, look for those that comply with established safety and quality standards. Ensure pharmacies are accredited by the National Association of Boards of Pharmacy (NABP) for Compounding Pharmacy Accreditation. This accreditation confirms compliance with key United States Pharmacopeia (USP) standards:

• USP <795>: Ensures safe practices for nonsterile compounding.

• USP <797>: Regulates sterile compounding to prevent contamination.

• USP <800>: Addresses the safe handling of hazardous drugs to protect patients and pharmacy staff.

Accredited pharmacies demonstrate adherence to federal and state laws, maintain active licensure, and employ qualified pharmacists overseeing operations. These pharmacies are dedicated to reducing the risks associated with compounding and ensuring medication safety.

To locate an accredited compounding pharmacy near you, visit the NABP's Accredited Compounding Pharmacies Directory.

Questions to Ask About Safety Practices and Quality Assurance

When evaluating a compounding pharmacy, asking the right questions can help ensure safety and quality. Consider the following:

1. Accreditation and Compliance

   • Is the pharmacy accredited by a recognized organization, such as NABP, for Compounding Pharmacy Accreditation?

   • Does the pharmacy adhere to USP standards for sterile, non-sterile, or hazardous compounding (<795>, <797>, <800>)?

2. Licensing and Expertise

   • Are all licenses current and in good standing?

   • Is a licensed pharmacist in charge of operations and compliance?

3. Quality Assurance Protocols

   • What procedures are in place to prevent contamination and ensure the accuracy of compounded medications?

   • Are the medications tested for potency and sterility?

4. Ingredient Sourcing

   • Where does the pharmacy source its active ingredients?

   • Are these ingredients verified for purity and quality?

5. Patient Safety Measures

   • How are potential risks, such as dosing errors or allergies to inactive ingredients, communicated to patients?

   • What support or guidance is provided for using syringes or other devices properly?

6. Transparency

   • Can the pharmacy provide detailed documentation of its safety practices and quality checks?

   • Are they willing to share third-party testing results?

Final Considerations: Is Compounded Semaglutide Right for You?

Before starting treatment, many patients and healthcare providers discuss the question, 'Is compounded semaglutide safe for long-term use?' Well, compounded semaglutide could be a viable option to discuss with your healthcare provider if you have:

1. Type 2 diabetes, particularly if lifestyle changes and metformin have not been effective or are not suitable, or you are obese (BMI ≥30 kg/m²) or overweight (BMI ≥27 kg/m²) with at least one weight-related condition, such as hypertension or dyslipidemia;

2. Difficulty accessing FDA-approved semaglutide formulations due to shortages or high costs, and

3. Access to compounded semaglutide from accredited compounding pharmacies or licensed outsourcing facilities.

Disclaimer

The information provided in this article is for educational purposes only and not intended to replace professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health providers with any questions you may have regarding a medical condition or treatment options. For a full list of important safety information, disclaimers, and terms and conditions of use, please visit Our safety info page