FDA Compliance for Compounded Semaglutide

What the FDA’s New Ruling on Compounded Semaglutide Means for You

You may have seen headlines about a new FDA ruling on compounded semaglutide, and you might be wondering what it means for your treatment. At Eden, we're here to make it simple. Here's what’s changing, what’s not, and how we’re making sure your care continues seamlessly.
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What exactly is the FDA ruling on compounded semaglutide?

The FDA ruling is based on supply status: compounding of ‘essentially a copy' of the commercial product is only permitted when there’s a shortage of an FDA-approved medication. Now that semaglutide injections are considered to be in stable supply, compounding pharmacies must stop making “essentially a copy” of the commercial product unless a new shortage is declared.

This decision means that compounding pharmacies must wind down production of essential copies of commercial semaglutide:

• By April 22, 2025, for traditional, state-licensed pharmacies (503A pharmacies)
• By May 22, 2025, for federally registered outsourcing facilities (503B outsourcing facilities)
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Does the FDA ruling mean I won’t be able to access semaglutide anymore?

Not at all. While essential copies of the branded product will be phased out, Eden is actively working with its network of licensed healthcare providers and pharmacies to help ensure members can continue care without disruption. Our clinical team is actively transitioning eligible members to safe, legal options that align with your treatment goals. If your doctor believes changes are needed for you, they will be in touch with you directly.
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Should I stock up and order 3–6 months in advance?

We understand the instinct to plan ahead, but there's no need to rush or stockpile compounded semaglutide. Due to the upcoming FDA deadlines, essential copies of the commercial products will only be available for a limited time, and large advance orders may strain pharmacy supply chains.

Instead, we recommend continuing with your current licensed healthcare provider-based plan while your provider guides you through the transition. Eden is actively coordinating with licensed healthcare providers and pharmacies to ensure each member has a personalized path forward. If changes to your prescription are needed, your provider will reach out with clear instructions and options.
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Will this affect the cost or availability of my treatment?

It's possible, but Eden is taking proactive steps to minimize any disruption. As essential copies of semaglutide become less available, we're securing access to FDA-approved options  and exploring alternatives to support continued care. If any changes may affect your treatment or cost, we'll let you know early and provide clear guidance on your next steps.
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What is Eden doing to make sure I can continue treatment without disruption?

We have been preparing for this change as your continued care is our top priority. Eden is taking a proactive, member-first approach to ensure a smooth transition. Here's how:

• We're supporting licensed healthcare providers as they work directly with members to manage treatment transitions.
• We're exploring safe, effective alternatives in cases where a switch makes sense for your unique needs.

And throughout it all, we're committed to proactive, transparent communication—so you're never left guessing about what comes next.
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Will I need a new prescription or to switch pharmacies?

It depends. If your current pharmacy is winding down, a licensed healthcare provider may determine, after a review of your records, that you may be better suited for a new treatment plan. That may include issuing a new prescription to be filled by a different pharmacy.
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Is the compounded version still safe and effective?

Yes, compounded semaglutide has been safely used in clinical practice when produced by licensed, reputable pharmacies. However, because the FDA does not evaluate compounded medications for safety or effectiveness, The new ruling will decide whether a preliminary injunction should be in place to allow the continued compounding of essential copies. Moving forward, Eden will prioritize clinically backed treatments to ensure your care. We are committed to providing you with the best and most reliable options for your treatment.
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How will Eden keep me informed?

You'll hear from us directly. We'll share updates through:

• Email announcements
• Messages from your care team
• Posts in the Eden member community

If your medical provider determines that changes are coming to your plan, you'll get clear instructions and personal guidance on what to expect and what to do next.
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We’re here for you.

This ruling may feel like a big shift, but we've got you covered. At Eden, our top priority is to ensure that your treatment is uninterrupted. If you have questions or concerns, your care team is just a message away.

Eden matches members with licensed healthcare providers and pharmacies to support access to treatments. We're here to support your journey—every step of the way.

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