Compounded Medications: Are They Safe?

Compounded medications have recently become a focal point in both medical and public discussions, particularly as patients and healthcare providers seek alternatives during national medication shortages. These customized formulations are created by pharmacists to address specific patient needs, offering solutions when standard, mass-produced medications are unavailable, poorly tolerated, or inappropriate. In many cases, they play a valuable role in individualized care. However, the unique nature of compounded medications also raises important concerns about quality, safety, and consistency.

This is particularly relevant in the current landscape, where ongoing shortages of GLP-1 medications such as Ozempic®, Wegovy®, and Zepbound® have led many patients to consider compounded alternatives. While these options may seem like a convenient workaround, the lack of FDA approval and regulatory oversight makes it essential to understand what you’re receiving—and who is providing it. In this post, we’ll take a closer look at how compounded medications work, the safety standards that should be in place, and how trusted partners like Strive Pharmacy ensure that patients receive high-quality, evidence-based treatment options

Understanding Compounded Medications

Compounded medications are personalized pharmaceutical preparations made by licensed pharmacists for individual patients. Unlike mass-produced medications, these formulations can be customized in dosage, delivery method, flavor, or ingredients to meet specific medical needs.

They are typically used when FDA-approved medications are unavailable, such as during national shortages, or when a patient cannot tolerate a standard formulation due to an allergy, sensitivity, or other medical concern. For example, a pharmacist might create a liquid version of a medication for someone who can’t swallow pills or remove a dye or filler that triggers a reaction.

However, it’s essential to understand that compounded medications are not FDA-approved and are not subject to the same level of regulatory oversight as commercially manufactured drugs. This makes the quality, testing, and sourcing practices of the compounding pharmacy critically essential to ensure safety and effectiveness.

Why GLP-1s Are Compounded

GLP-1 receptor agonists like semaglutide and tirzepatide are in high demand due to their proven effectiveness in treating obesity, type 2 diabetes, and metabolic syndrome. However, ongoing shortages of brand-name medications such as Ozempic®, Wegovy®, and Zepbound® have made access difficult for many patients. In response, compounding pharmacies have stepped in to fill the gap by creating customized formulations. When done correctly, compounding can provide a safe and effective alternative—but only when pharmacies use high-quality ingredients, adhere to sterile compounding standards, and follow strict regulatory guidelines.

That said, not all compounded GLP-1 medications are the same. The FDA has issued warnings about specific formulations that use semaglutide sodium or acetate salts, which differ from the FDA-approved base form and may have altered absorption or safety profiles. This is why patients should only work with trusted providers and pharmacies that use semaglutide or tirzepatide as the base, test each batch for purity and potency, and adhere to U.S. Pharmacopeia (USP) standards.

Risks Associated with Compounded Medications

While compounded medications offer significant benefits, particularly during shortages or when patients have unique medical needs, they also carry potential risks that must be considered carefully. One of the most serious concerns is the risk of contamination during the compounding process. A well-known example occurred in 2012, when a fungal meningitis outbreak caused by contaminated steroid injections from a compounding pharmacy led to nearly 800 illnesses and 76 deaths across 20 states. This tragic event underscored the critical importance of sterility, proper procedures, and quality assurance.

In addition to contamination, variability in quality control remains a significant issue across the compounding industry. Because compounded medications are not FDA-approved, they do not undergo the same rigorous clinical trials, manufacturing standards, or regulatory oversight as commercial products. This means the choice of pharmacy is essential. Patients and healthcare providers must ensure that the pharmacy adheres to established safety protocols, sources verified ingredients and provides transparency in the formulation and testing process. Unfortunately, not all compounded GLP-1 medications meet these criteria.

The FDA has warned explicitly about:

The use of semaglutide sodium or acetate salts, which differ from the semaglutide base used in FDA-approved medications, may impact safety or absorption.Unverified sourcing of active pharmaceutical ingredients (APIs), particularly from overseas suppliersClaims of efficacy or safety for compounded versions that are not supported by clinical research

What Patients Should Know

Before starting a compounded medication, patients should take the following precautions:

Ask what form is being used. In the case of GLP-1s, use only products made with a semaglutide or tirzepatide base. Avoid formulations that include sodium or acetate salt forms.Understand your pharmacy’s credentials. Ensure the compounding pharmacy is 503A licensed, such as Strive Pharmacy, and adheres to USP <797> guidelines for sterile compounding.Monitor your progress. Regular follow-up is essential. Monitor side effects, changes in blood sugar, and body composition. At PMH, we provide structured monitoring and support for every patient using compounded medications.

In a modern laboratory, pharmacists prepare and organize medications, ensuring accuracy and safety within a well-equipped pharmacy setting.

Why We Partner with Strive Pharmacy

At Phoenix Metabolic Health, patient safety is our top priority. That’s why we exclusively work with Strive Pharmacy, a 503A licensed compounding facility known for its commitment to quality, transparency, and regulatory compliance. Strive compounds pure semaglutide and tirzepatide base—not the unsafe salt forms flagged by the FDA—ensuring formulations that align with FDA-approved standards.

Strive Pharmacy:

Uses semaglutide and tirzepatide base, not sodium or acetate saltsConducts third-party testing for potency, sterility, and endotoxinsSources ingredients from FDA-registered suppliersProvides complete documentation and transparent labeling, often including glycine and B12
By choosing Strive, we offer our patients safe, high-quality alternatives when commercial medications are unavailable, without compromising clinical integrity.

Bottom Line

Is the commercial, FDA-approved medication better? Yes. Whenever possible, these are our first choices due to their rigorous clinical testing, consistent manufacturing, and regulatory oversight.

That said, compounded GLP-1 medications can be a safe and effective alternative, but only when the following conditions are met:

The medication is made with the correct base compound (not unsafe salt forms)It is sourced from a reputable, transparent compounding pharmacy.It is prescribed and monitored by a licensed, experienced healthcare provider.

At Phoenix Metabolic Health, your safety is our top priority. I prescribe the same medication I take myself, and I never compromise when it comes to quality or oversight. If you’re considering a compounded GLP-1 option, we’ll walk you through every step to ensure you receive the highest standard of care without sacrificing safety or results.