Navigating the New World of GLP-1s: Are Compounded Medications Still a Safe and Legal Option?

The conversation around weight loss has been fundamentally changed by a class of medications known as GLP-1s, with brand names like Ozempic and Wegovy becoming household words. These drugs have delivered life-changing results for many, but their meteoric rise has been met with two significant hurdles: persistent supply shortages and staggering costs, often exceeding $1,000 per month.  

For many, the solution came from compounding pharmacies, which provided a legal and affordable alternative during the FDA-declared shortages. But in early 2025, the FDA announced the shortages were officially over, leaving many employers, brokers, and patients confused and concerned. Does this mean compounded GLP-1s are no longer available?  

The short answer is no. Compounded GLP-1s remain a legal and viable option, but the landscape has shifted. For the millions of Americans who have lost employer coverage for these medications or simply cannot afford the brand-name prices, understanding this new terrain is critical. 

The law has shifted, not closed the door

The primary reason for the confusion is a change in federal law. During the shortage, compounding pharmacies were legally permitted to produce “essential copies” of semaglutide and tirzepatide to ensure patient access. With the shortage now resolved, that broad permission has ended.  

However, a different legal pathway remains open, one rooted in the core purpose of compounding: personalized medicine. A licensed pharmacist can still compound a medication if a physician determines, for an individual patient, that a specific change to the drug's formula creates a “significant difference” that is medically necessary.  

What qualifies as a “significant difference”?

• Removing an allergen: A patient may be allergic to an inactive ingredient or preservative in the FDA-approved version, requiring a custom formulation.  
• Altering the dosage: A patient might experience significant side effects and require a “micro-dose” or a specific strength that is not commercially available.
• Adding ingredients: Some pharmacies create personalized formulas by adding other components, like Vitamin B12. This practice is intended to create a unique medication tailored to the patient. While this is a common approach, it’s important to know that drug manufacturers are challenging this in court, arguing it’s a workaround rather than a medical necessity.

This shift places the focus squarely on a documented, clinical need for a customized medication. While the desire for a more affordable option is understandable, cost savings alone is not a valid medical justification under the law.  

An essential lifeline in the face of an affordability crisis

The reality is that as many employers have stopped covering GLP-1s for weight management, a massive affordability gap has emerged. Patients who have seen incredible success are suddenly left without access to the treatments that have profoundly improved their health.

This is where responsible compounding pharmacies and the telehealth platforms that partner with them serve a vital role. They are not simply offering a cheaper product; they are providing a crucial lifeline for patients who would otherwise be forced to abandon their treatment. By working with a physician to identify a legitimate clinical need for a personalized medication, patients can continue their health journey in a way that is both safe and sustainable. For employers, helping employees navigate this system is a powerful value-add, ensuring they have access to safe, effective, and affordable care.

Safety first: Why the source of your medication matters

While personalizing medicine offers freedom, it also necessitates due diligence. Consumers must be their own advocates in a market with both reputable providers and bad actors. Because compounded drugs are not individually FDA-approved, the onus is on the consumer to verify the source and quality.

Why an employee should care: 503A vs. 503B pharmacies

When it comes to an injectable medication, understanding where it comes from is paramount. There are two main types of compounding facilities, and the difference directly impacts a patient’s safety and peace of mind.  

• 503A pharmacies: These are traditional, state-licensed pharmacies that create custom medications for individual patients based on a prescription. They are regulated primarily by State Boards of Pharmacy and must follow quality standards set by the United States Pharmacopeia (USP). While these standards are rigorous, oversight can vary from state to state.  
• 503B outsourcing facilities: This category was created to allow for the large-scale production of compounded drugs with a higher level of oversight. 503B facilities must voluntarily register with the FDA and are held to the same Current Good Manufacturing Practices (CGMP) as major pharmaceutical manufacturers. This is a significantly more stringent quality standard that includes regular FDA inspections and adverse event reporting.  

For an employee, a medication from a 503B facility provides a high degree of confidence in its sterility and consistency. However, this does not mean 503A pharmacies are an unsafe option. The key is an additional layer of verification. This is why working with a partner like CareValidate, which vets its entire network of pharmacies—including 503A facilities—through an additional compliance check protocol, is so important. This rigorous vetting process provides an essential safeguard and is the only way we would recommend using a 503A pharmacy.  

Due diligence checklist

1. Ask the right questions: A trustworthy provider will be transparent. Before starting any compounded medication, ask:

• “What is the specific medical reason—the ‘significant difference’—that makes the brand-name drug unsuitable for me?” 
• “Do you source this medication from a 503A or a 503B facility?”
• “Can you verify that the active ingredient is from an FDA-registered manufacturer and is not an unapproved salt form?” (The FDA has warned specifically against semaglutide salts).  

2. Verify the pharmacy: Never purchase from an online pharmacy without first verifying its credentials. Use the National Association of Boards of Pharmacy (NABP) Safe Site Search Tool at safe.pharmacy to check if a website is properly licensed and accredited.  

The path forward with HealthJoy

The end of the GLP-1 shortages has not ended access to compounded alternatives; it has redefined it. For the millions of Americans navigating diabetes and weight management without insurance coverage, these personalized medications remain a critical and legal option. The key is to approach the process with knowledge and caution.

Navigating this complex world alone can be daunting. That’s why at HealthJoy, we’ve partnered with CareValidate to provide a trusted pathway for our members. This partnership is designed to help members and their families navigate the system in the safest way possible. CareValidate provides an essential layer of trust by performing its own compliance checks and thoroughly vetting its network of pharmacies. This ensures that whether a medication comes from a 503A or 503B facility, it meets stringent standards for safety and quality.

By providing this guidance and support, we empower our members to make informed decisions, ensuring that when they seek affordable GLP-1 options, they are guided toward sources that prioritize their health. This gives both employers and their employees peace of mind, knowing they have a trusted partner helping them on their health journey.

Reach out to a HealthJoy expert to learn more about our partnership with CareValidate.