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Understanding Compounded Semaglutide: A Detailed Analysis

Mar 19, 2024
Understanding Compounded Semaglutide: A Detailed Analysis

Compounded semaglutide, an anti-obesity medication prepared by compounding pharmacies, provides a solution for patients seeking alternatives when other forms of semaglutide are unavailable or in short supply. According to the Food and Drug Administration, compounding pharmacies can prepare compounded semaglutide as long as Ozempic and Wegovy remain on the drug shortage list and compounded semaglutide meets requirements under the Federal Food, Drug, and Cosmetic (FD&C) Act.

As a GLP-1 receptor agonist, semaglutide is highly effective in treating type 2 diabetes mellitus and obesity, with approved products like Ozempic and Wegovy dominating the market. However, the increased demand and subsequent shortages for these medications have fueled the need for compounded versions, despite the FDA’s cautionary stance that it does not review these formulations for safety and efficacy.1,2

Understanding what compounded semaglutide is, including its benefits and potential risks, is crucial for individuals exploring their treatment options. Compounded semaglutide not only offers a cost-effective alternative but also provides personalized medication solutions, especially when brand-name formulations are not suitable or available. As you navigate the complexities of obtaining compounded semaglutide, including evaluating the varied compound semaglutide forms available, it’s important to weigh the risks and ensure you’re selecting a reputable compounding pharmacy to meet your health needs.

Understanding Semaglutide

Semaglutide, a key player in the management of type 2 diabetes and obesity, has seen a significant increase in demand over recent years. Here’s a closer look at its journey and impact:

FDA Approvals and Market Introduction:

  • Ozempic, introduced in 2017, is an approved treatment for type-2 diabetes.
  • Wegovy, a higher-dose formulation for obesity management, received approval in 2021 to treat obesity and, more recently, to reduce heart disease risk.

Supply and Demand Dynamics:

  • A surge in demand to treat obesity led to semaglutide shortages, prompting Novo Nordisk to manage Wegovy’s distribution carefully to support ongoing treatments. Novo Nordisk held off on releasing new starter doses of Wegovy to better ensure that people who had already started the medication could continue with their treatment.3
  • Semaglutide prescriptions have increased 40-fold over the last 5 years. About 1 in every 60 Americans was prescribed the drug in 2023.4

Clinical Efficacy and Considerations:

  • Studies highlight semaglutide’s effectiveness, showing an average weight loss of 15% from baseline, significantly higher than the placebo group’s 2.4%.
  • Like all medications, semaglutide is not appropriate for everyone who may have type 2 diabetes or obesity. A family history of medullary thyroid cancer, multiple endocrine neoplasia syndrome type 2, or a history of pancreatitis or gallbladder disease puts some people at higher risk of semaglutide side effects. 

The Rise of Compounded Semaglutide

The recent surge in the popularity of compounded semaglutide can be attributed to several factors:

  • High Demand and Shortages: With an increasing number of Americans seeking weight loss solutions, compounded versions of drugs like Ozempic, Rybelsus, Wegovy, Mounjaro, and Zepbound have seen a spike in demand. Unfortunately, manufacturers have struggled to keep up, leading to shortages and patients turning to less reliable or less well-tested sources.1
  • Celebrity Influence: The visibility and endorsement of these drugs by public figures such as Elon Musk and Andy Cohen have contributed significantly to their demand. Reports of celebrities and industry insiders discussing the benefits of these drugs for weight loss have made them even more sought-after.
  • Compounded Options Availability: Compounding pharmacies, under Section 503A of the Federal Food, Drug, and Cosmetic Act, offer a legal pathway for the creation of tailored versions of these drugs. Compounding pharmacists must obtain semaglutide and other ingredients from registered manufacturers. Compounding labs and the equipment in these labs are subject to regulation and inspection by both the state boards of pharmacy and the FDA.5 Of course, some online retailers sell semaglutide, commonly without a prescription requirement, that do not have proper licensure or oversight.

FDA and Compounded Drugs

When considering the use of compounded semaglutide, it is important to consider the FDA’s position:

FDA Oversight on Compounded Drugs:1

  • Compounded drugs are not subject to FDA approval, meaning the FDA does not review their safety, effectiveness, or quality before they reach patients. FDA approval for each compounded medication would be impossible. This is why the FDA recommends that consumers check their online pharmacies using BeSafeRX or the Alliance for Pharmacy Compounding
  • Compounding pharmacies must require a valid, patient-specific prescription for compounded medications.
  • Outsourcing facilities producing compounded drugs operate under strict guidelines, including compliance with Current Good Manufacturing Practice (CGMP) requirements. The FDA inspects them according to a risk-based schedule.6

Risks Associated with Compounded Drugs:

  • The lack of FDA approval for compounded drugs could pose a higher risk for patients due to a lack of premarketing review for safety, quality, and effectiveness compared to approved drugs.7

Regulatory Actions and Warnings:

  • The FDA has issued warnings regarding the use of compounded products containing salt formulations of semaglutide, which do not meet FDA safety requirements.1 Semaglutide sodium is not the “active pharmaceutical ingredient (API) listed on the reference products’ labeling; it does not appear on the FDA’s bulk compounding list; and it does not have a U.S. Pharmacopeia monograph.”2
  • The Alliance for Pharmacy Compounding states that until more is known about semaglutide sodium, it is not endorsed by the board. Some compounding pharmacies are pushing back, saying that the semaglutide end product is the same whether the base or the salt form is used.
  • Reports of adverse events associated with compounded semaglutide have prompted the FDA to take actions, including sending warning letters, to halt the distribution of illegally marketed semaglutide that may be counterfeit, contain the wrong ingredients, the wrong proportion of ingredients, have no active ingredient, or contain another harmful ingredient.1

Potential Risks and Safety Concerns

When considering semaglutide compounded prescriptions, it’s essential to be aware of the potential risks and safety concerns associated with its use. Here are some crucial points to consider:

Active Ingredient Variation

Compounded semaglutide made by online companies that are not licensed and regulated and do not require a prescription from a licensed healthcare provider may not contain semaglutide or be safe to consume.

Safety and Effectiveness Concerns

Some concerns about the safety and efficacy of compounded medications such as semaglutide include the following:1

  • Adverse event reports have been linked to the use of compounded semaglutide.
  • Compounded medications are not FDA-approved.
  • Semaglutide compounds may contain undisclosed and potentially harmful ingredients.
  • Compounded semaglutide may contain added ingredients, such as vitamins, that, while not harmful, may have no proven benefit for weight loss. 
  • Storage requirements may vary between products, impacting their safety and efficacy.

Understanding these risks is pivotal in making an informed decision about whether to use compounded semaglutide and, even more importantly, where to obtain compounded semaglutide.

Infographics Semaglutide

Selecting a Reputable Compounding Pharmacy

Selecting a reputable compounding pharmacy is crucial when considering compounded semaglutide for your health needs. Here are key considerations to ensure safety and effectiveness:

  • Get a prescription from a licensed healthcare provider. Be wary of any provider who is willing to write a semaglutide prescription even if you do not meet the body mass index (BMI) requirements of 30+ or 27+ with a weight-related medical condition.
  • Check that the online telehealth company works with reputable compounding pharmacies that require a prescription to dispense compounded semaglutide. Be wary of any company that can overnight semaglutide to your home the next day or a company listing a price for semaglutide that falls significantly below comparable companies.
  • Verify that the compounding pharmacy is licensed. Ask questions about how semaglutide is compounded in the pharmacy. Verify that a salt form of semaglutide is not being used.
  • Compounded semaglutide should contain detailed instructions on how to calculate the correct semaglutide dosage and how to store your medications safely.

Conclusion

Navigating the landscape of compounded semaglutide requires weighing the potential benefits against the risks and concerns outlined by the FDA. Compounded semaglutide helps fill the supply-and-demand gap for these medications, providing a highly effective obesity treatment to more people who need it.

Selecting a reputable compounding pharmacy is not merely a recommendation but a necessary step toward ensuring quality and safety in treatment.

Ensure your health decisions are informed and safe by consulting healthcare providers on reputable telewellness platforms such as Invigor Medical, a company that partners with reputable compounding pharmacies, as your journey towards wellness should be navigated with both knowledge and caution. If you meet the BMI requirements for semaglutide and are interested in speaking with a licensed healthcare provider about semaglutide, contact a treatment specialist at Invigor Medical to get compounded semaglutide from a source that prioritizes quality and patient safety.

What are the concerns associated with compounded semaglutide?

Compounded semaglutide and other compounded prescription medications have not undergone safety, quality, and efficacy assessments by the FDA. When buying medicines from unknown sources, there is a risk that they may contain undisclosed ingredients that could be harmful.

Is compounded semaglutide as effective as branded medications like Ozempic?

Yes, compounded semaglutide is designed to work similarly to branded medications such as Ozempic and Wegovy.

Can compounded semaglutide aid in weight loss?

Studies have shown that individuals with obesity who used compounded semaglutide experienced significant weight loss. In one trial, participants lost an average of 14.9% of their body weight over 68 weeks, whereas the placebo group only lost 2.4%.

Are there any potential risks associated with semaglutide use?

Yes, there are concerns about the long-term use of semaglutide, including the risk of pancreatitis, kidney problems, and the possibility of developing certain types of cancers. These potential risks highlight the importance of considering the benefits and drawbacks of semaglutide treatment and discussing them with a licensed healthcare provider.

Disclaimer
While we strive to always provide accurate, current, and safe advice in all of our articles and guides, it’s important to stress that they are no substitute for medical advice from a doctor or healthcare provider. You should always consult a practicing professional who can diagnose your specific case. The content we’ve included in this guide is merely meant to be informational and does not constitute medical advice.

Understanding Compounded Semaglutide: A Detailed Analysis

Leann Poston, M.D.

Dr. Leann Poston is a licensed physician in the state of Ohio who holds an M.B.A. and an M. Ed. She is a full-time medical communications writer and educator who writes and researches for Invigor Medical. Dr. Poston lives in the Midwest with her family. She enjoys traveling and hiking. She is an avid technology aficionado and loves trying new things.

References

  • Center for Drug Evaluation & Research. (2024, January 9). Medications Containing Semaglutide. U.S. Food and Drug Administration. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/medications-containing-semaglutide-marketed-type-2-diabetes-or-weight-loss
  • Monaco, K. (2023, June 1). FDA Warns on Certain Forms of Compounded Semaglutide. MedpageToday. https://www.medpagetoday.com/endocrinology/obesity/104795
  • Joseph, A. (2023, May 4). Amid booming demand, Novo to hold back some doses of obesity drug Wegovy for new U.S. patients. STAT. https://www.statnews.com/2023/05/04/amid-booming-demand-novo-to-hold-back-some-doses-of-obesity-drug-wegovy-for-new-u-s-patients/
  • Weight-loss injectables enjoy exploding popularity among the 2 in 3 American adults who are overweight or obese. (n.d.). American Pharmacists Association. Retrieved March 19, 2024, from http://www.pharmacist.com/Publications/Pharmacy-Today/Article/weight-loss-injectables-enjoy-exploding-popularity-among-the-2-in-3-american-adults-who-are-overweight-or-obese
  • Brunner, S. (2021, July 27). On compounding, the FDA marches to the beat of its own biases. STAT. https://www.statnews.com/2021/07/27/fda-pharmacy-compounding-oversight/
  • Center for Drug Evaluation, & Research. (2020, September 10). Compounding Laws and Policies. U.S. Food and Drug Administration. https://www.fda.gov/drugs/human-drug-compounding/compounding-laws-and-policies
  • Center for Drug Evaluation, & Research. (2023, March 24). Drug Compounding and Drug Shortages. U.S. Food and Drug Administration. https://www.fda.gov/drugs/human-drug-compounding/drug-compounding-and-drug-shortages

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