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The Rise of the Semaglutide Compounding Pharmacy: Exploring Safety and Legality  

Mar 26, 2024
The Rise of the Semaglutide Compounding Pharmacy: Exploring Safety and Legality  

Very few people, especially if you are one of the 73.6% of American adults with overweight or obesity, have not heard of the enormous demand for weight loss medications such as Ozempic, Rybelsus, Wegovy, and Mounjaro, which has resulted in shortages. A semaglutide compounding pharmacy can step in and help fill this gap by producing compounded semaglutide.

Compounding pharmacies offer custom-made medications tailored to meet individual patients’ needs. These pharmacies play a vital role in healthcare by customizing medications for people who are allergic to specific components in a medication or who cannot tolerate the standard medication dose.1 However, many people have concerns regarding the safety and legality of using a compounding pharmacy for semaglutide.

As the search volume for “compound pharmacy semaglutide” and “compounding pharmacy semaglutide” continues to increase, let’s explore the safety, sourcing, and legal implications of using a semaglutide compounding pharmacy.

What are Semaglutide Compounding Pharmacies?

Semaglutide compounding pharmacies are specialized facilities that prepare custom-made medications containing semaglutide. These pharmacies serve a crucial purpose when FDA-approved medications like Ozempic and Wegovy are in short supply or when patients require personalized formulations due to allergies or other specific needs.

The FDA defines a traditional compounding pharmacy as one that combines, mixes, or alters ingredients to create a customized medication for an individual patient in response to a licensed healthcare provider’s prescription.

Some compounding pharmacies scale beyond the boundaries of traditional compounding pharmacies. They produce drugs on a much larger scale when an FDA-approved medication is not available or appropriate for a patient or it must be altered in some way.

Compounded semaglutide injections are not subject to the same rigorous testing and approval process as FDA-approved medications, raising concerns about their safety and effectiveness.

Safety Concerns and FDA Warnings

The FDA has recently issued warnings regarding the safety of certain compounded semaglutide products. Counterfeit batches of semaglutide have been seized, and their contents are being analyzed. Compounding pharmacies have been found to use semaglutide salts, such as semaglutide sodium and semaglutide acetate, which are not part of any approved formulation.

The use of semaglutide salts raises questions about the quality and effectiveness of compounded semaglutide. The Alliance of Pharmacy Consulting issued a statement regarding semaglutide compounding, advising consumers to obtain semaglutide only from pharmacies that require a prescription and are licensed U.S. pharmacies.

Legality of Using a Semaglutide Compounding Pharmacy

Compounding pharmacies are legal entities that provide important services, especially for patients who require customized medications. However, the rise of semaglutide compounding pharmacies has raised legal concerns.

FDA-approved medication, whether branded or generic, is manufactured under good manufacturing practice (GMP) regulations. These federal statutes govern the production and testing of pharmaceutical products. The FDA regulates and inspects pharmaceutical manufacturing plants to verify whether they comply with GMP regulations.

Pharmacies are primarily under the authority of the Board of Pharmacy. They are exempt from GMP regulations and rarely undergo FDA inspections.2

Compounded drugs are not clinically tested for safety and efficacy before production as brand-name medications. Unlike generic medications, they do not undergo bioequivalence testing. Compounded drugs do not have to follow the strict labeling, advertising, and promotion guidelines that FDA-approved medications do.2

In addition to compounding pharmacies, which operate under section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and compound medications based on a healthcare provider’s prescription, outsourcing facilities operate under section 503B and are subject to CGMP requirements. The FDA inspects outsourcing facilities according to a risk-based schedule. They produce compounded drugs in larger quantities.

Risks Associated with Compounded Semaglutide

The FDA states that patients have reported adverse events after using compounded semaglutide. These adverse events were similar to those associated with the brand-name medication, but no other details are available.

The FDA recommends that consumers use medications that the FDA has tested if they are available.

The Alliance for Pharmacy Compounding recommends that consumers only use U.S.-licensed semaglutide compounding pharmacies that require a prescription. Consumers can also ask the pharmacist for a certificate of analysis for their compounded medication and analytical testing labs.

A compounding pharmacist mixing a cream

Sourcing and Quality Control

The source of semaglutide used in compounded medications is a critical factor in ensuring patient safety. FDA regulations require compounding pharmacies to source active pharmaceutical ingredients (APIs) from FDA-registered and inspected facilities. The Alliance for Pharmacy Compounding states that compounders are purchasing semaglutide base from registered wholesalers who document that their supply comes from FDA-registered manufacturers.

The Role of Healthcare Providers

Healthcare providers have a responsibility to evaluate their patients’ medical histories, diagnose diseases, and offer treatment for those diseases. When medications are required to treat a medical condition, such as obesity, healthcare providers make a treatment recommendation after weighing the risks and benefits for individual patients.

If a prospective Invigor Medical patient meets the requirements for semaglutide treatment, i.e., a body mass index of thirty or higher or twenty-seven or higher with at least one weight-related medical condition, their healthcare provider will review their medical history and recommend treatment based on whether the medication benefits outweigh the risks. Semaglutide is not appropriate for all people. For example, patients with a personal or family history of thyroid tumors are at an increased risk of adverse effects from semaglutide.

Patient Education and Decision-Making

Patients should be well-informed about the risks and benefits of different treatment options, including semaglutide. When considering compounded semaglutide, patients should consult with their healthcare providers and discuss the available FDA-approved alternatives. It is essential to understand that compounded medications may carry additional risks and uncertainties compared to FDA-approved medications.

Patients should also exercise caution when purchasing medications online. Buying medications from unregulated sources can expose patients to potentially unsafe products that have not undergone appropriate evaluation or approval. Patients should only obtain semaglutide from state-licensed pharmacies or outsourcing facilities registered with the FDA.

Infographics Semaglutide

Conclusion

The rise of semaglutide compounding pharmacies has brought both opportunities and concerns. The Alliance for Pharmacy Compounding has stressed the important role compounding pharmacies play in the U.S. healthcare system and the need for healthcare providers and consumers to ensure that they only seek compounded drugs from pharmacies that are licensed in the U.S. and require a prescription.

The Alliance of Pharmacy Compounding says that pharmacies are authorized to compound under federal law. While manufactured drugs are the standard, compounded medications are not knock-offs or generics. The healthcare provider has intentionally prescribed a compounded medication.

Ultimately, patient safety should remain the top priority, and decisions regarding semaglutide should be made in consultation with healthcare professionals and based on the best available evidence. If you are ready to get started on an Invigor Medical weight-loss treatment plan, begin the process by choosing a plan and completing your medical information forms.

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.

The Rise of the Semaglutide Compounding Pharmacy: Exploring Safety and Legality  

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

  • Lisi DM, Hackensack Meridian Health Eatontown, New Jersey. (2021, October 6). Pros and Cons of Pharmacy Compounding. USPharmacist.Com. Accessed 3/26/2024. https://www.uspharmacist.com/article/pros-and-cons-of-pharmacy-compounding
  • Gudeman J, Jozwiakowski M, Chollet J, Randell M. Potential risks of pharmacy compounding. Drugs R D. 2013 Mar;13(1):1-8. doi: 10.1007/s40268-013-0005-9. PMID: 23526368; PMCID: PMC3627035.

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