Key takeaways
Compounded semaglutide is a customized Type 2 diabetes and weight-loss medication that may not have the same safety and efficacy as FDA-approved brands like Wegovy and Ozempic.
Compounding pharmacies can provide tailored solutions but are subject to less regulatory oversight, leading to potential safety concerns.
Choose a reputable pharmacy and be aware of red flags indicating a less-than-reliable source before you start taking compounded semaglutide.
If you’re looking to reduce your body weight and body mass index (BMI), your healthcare provider may prescribe a GLP-1 medication, such as Wegovy (semaglutide), as part of your weight-loss program. However, due to a national shortage of Wegovy and Ozempic (the Type 2 diabetes treatment with the same active ingredient), patients are looking for alternatives. Those may include alternative prescriptions that are approved by the U.S. Food and Drug Administration (FDA), such as Rybelsus (oral semaglutide), Mounjaro (tirzepatide), Zepbound (tirzepatide), and Saxenda (liraglutide). Compounded semaglutide is another option, and its lower cost may make it seem like an appealing alternative.
Compounded drugs can feel like a reprieve from shortages, insurance denials, or high prices. But, it’s essential to be aware of the potential risks, such as contamination or dosing errors. Here’s what you need to know before you buy compounded semaglutide online, according to experts.
What are compounding pharmacies?
While a regular pharmacy dispenses commercially manufactured FDA-approved medications, compounding pharmacies prepare customized medications tailored to individual patient needs, says Eric F. Smith, DO, a board-certified bariatric surgeon and Medical Director of POP Recovery System. Compounding pharmacies specialize in creating customized medication formulations that are not commercially available.
A drug may be compounded for patients who cannot take an FDA-approved drug due to allergies. Or, they may require another dosage, ingredient mix, or formulation. For example, pharmacists may produce a liquid or lollipop version for those who cannot swallow a pill, like older adults and pediatric patients.
Copies of brand-name medications can be compounded only if there’s a nationwide shortage. In the case of Ozempic and Wegovy, the shortage began in 2022 when the manufacturer, Novo Nordisk, could not supply adequate quantities of the drug to meet demand. Currently, injectable semaglutide is on the FDA’s drug shortages list, so compounding pharmacies can still produce it.
Compounded drugs are not FDA approved, which means they aren’t evaluated for safety, quality, or effectiveness before being dispensed to patients, says Rekha Kumar, MD, a board-certified endocrinologist with Weill Cornell Medical College in New York, New York. They may also have different dosing requirements than brand-name drugs.
What’s more, traditional compounding pharmacies, “led by a licensed pharmacist within a state-licensed pharmacy or federal facility, or by a licensed physician,” are exempt from federal Current Good Manufacturing Practice (CGMP) regulations. This means that they operate with less regulatory oversight than traditional pharmacies. As a result, there is a potential for inconsistencies in the purity and potency of compounded medications.
RELATED: Ozempic for weight loss
Key differences between compounded semaglutide and FDA-approved brands
Wegovy and Ozempic contain the same active ingredient, semaglutide, a GLP-1 receptor agonist that is FDA approved for weight management and Type 2 diabetes, respectively. Compounded semaglutide is a copy of the brand-name version, created without FDA oversight. As such, there are some key differences to be aware of.
- Potential contamination: Brand-name Wegovy and Ozempic have undergone rigorous testing for their safety and efficacy. Compounded semaglutide is not subject to the same clinical trials or research process. Without FDA oversight, there’s a greater risk of contamination. This could lead to potential side effects, such as an allergic reaction to an impure ingredient. Or, if the formulation is off, you may not experience the same weight loss or control of blood sugar levels as the brand-name version.
- Source of ingredients: Compounding pharmacies source their GLP-1 ingredients from various suppliers, which may not always be transparent. While compounded semaglutide contains the same active ingredient as brand-name Wegovy or Ozempic, its quality can vary based on the pharmacy’s practices and the quality of the sourced ingredients. For example, some online pharmacies use a salt form of semaglutide, which has not been thoroughly tested or studied.
- Administration method: Brand-name Wegovy and Ozempic are administered in prefilled injector pens. Just take off the cap, give yourself a jab, and you’re done. Compounded semaglutide is typically administered in a multi-dose glass vial with a syringe. You are responsible for drawing up the correct dosage. This can lead to dosing errors.
- Added ingredients: Some compounding pharmacies add extra ingredients, such as vitamin B12.
- Shelf life: Compounded semaglutide is typically formulated without stabilizers, so it has a shorter shelf life than brand-name products, normally 30 to 90 days.
- Cost: Cost is a significant driver for patients to use compounded semaglutide. Compounded versions typically cost between $200 and $500 per month. Brands such as Ozempic and Wegovy have cash prices that can vary by individual pharmacy, but they are often $1,000 to $1,500 per month. However, if cost is a barrier, there are ways to save, such as using SingleCare coupons.
Wegovy coupons, Ozempic coupons, Rybelsus coupons
How to choose a reputable online compounding pharmacy
Due to the lack of regulation and oversight, ordering compounded semaglutide from an online compounding pharmacy carries several risks, including:
- Quality and safety concerns: Compounded medications may not meet the same standards as FDA-approved products, leading to inconsistencies in the medication’s potency, purity, and overall quality. There is also a risk of contamination during the compounding process.
- Lack of regulation: Compounding pharmacies are regulated primarily at the state level, so the standards can vary significantly from one state to another, making it challenging to ensure that the pharmacy adheres to best practices—especially online, where new websites seem to pop up every day.
- Inaccurate dosages: Because compounded semaglutide is not delivered in a prefilled syringe, doses may be more complicated to self-administer. Plus, dosages may not be accurate due to factors like excess dilution, potentially compromising treatment effectiveness or safety.
Remember that compounding pharmacies can create semaglutide formulations similar to Ozempic; however, they can only replicate the exact FDA-approved product with regulatory oversight. You can minimize risks and ensure that you are purchasing compounded semaglutide from a legitimate source, whether via telehealth or online, by following these tips:
- Use the NABP’s search tool: The National Association of Boards of Pharmacy (NABP) search tool allows you to verify the accreditation of compounding pharmacies. Look for pharmacies that are recognized by the NABP or that have received the Verified Internet Pharmacy Practice Sites (VIPPS) seal, which indicates adherence to good pharmacy practices.
- Check for licensing: Dr. Smith recommends ensuring that the compounding pharmacy is licensed in your state, is third-party tested, and has a licensed pharmacist available for consultation.
- Look at online reviews: Reviews and testimonials from other patients can be helpful, as reputable pharmacies typically have positive feedback regarding their services, products, and customer support.
- Seek transparency: Dr. Kumar says that a trustworthy pharmacy will be open about its compounding practices, including sourcing of ingredients, quality control measures, and the qualifications of its pharmacists.
RELATED: Zepbound vs. Wegovy for weight loss
When selecting an online pharmacy, watch out for these red flags:
- No listed address or contact information: Look for a clear physical address and accessible contact information that allows for messaging with the prescribing provider.
- No prescription required: A company that sells prescription medications online without requiring a prescription is not a licensed compounding pharmacy.
- False advertising: Compounded drugs should not use a brand name, such as “compounded Wegovy,” or claim that a compounded drug is FDA-approved.
When it comes to the top compounding pharmacies in the United States, many are one-site, small pharmacies that serve their immediate communities—meaning they’re restricted to selling and mailing prescriptions within their state of licensure. A few of these pharmacies have larger-scale operations and a multistate presence, such as Empower Pharmacy, Belmar Pharmacy, and Precision Pharmacy.
When considering quality, Dr. Kumar recommends looking for care providers that partner with either state-regulated 503A compounding pharmacies that are required to comply with United States Pharmacopeia (USP) requirements or 503B pharmacies that operate under strict FDA oversight and must comply with Current Good Manufacturing Practice (CGMP) standards.
The bottom line
Because insurance may not cover GLP-1s for weight loss, the brand-name meds can be too pricey for many, making compounded options seem more appealing. However, due to the lack of federal regulation and oversight, there are safety concerns and side effects to keep in mind. That’s why it’s crucial to conduct thorough research to choose a reputable online pharmacy and consult a licensed healthcare provider who is familiar with your medical history to determine an appropriate weight management plan for your specific needs.
If price is a barrier, SingleCare can help you save on GLP-1s and other Rx medications. Just download your free prescription discount card to start saving today!
Sources
- Compounding and the FDA: Questions and answers, U.S. Food & Drug Administration
- Human drug compounding laws, U.S. Food & Drug Administration
- Compounding inspections and oversight frequently asked questions, U.S. Food & Drug Administration
- Facts about the Current Good Manufacturing Practice (CGMP), U.S. Food & Drug Administration
- Safe pharmacy resources, National Association of Boards of Pharmacies
- 5 things you need to know about compounded GLP-1 Drugs, Alliance for Pharmacy Compounding
- Partnerships between 503A pharmacies and 503B outsourcing facilities, PCCA blog