What the Latest FDA Update Means for Compounded Semaglutide & Tirzepatide Users

If you're currently using compounded semaglutide or tirzepatide as part of your medical weight loss journey, you've probably seen headlines recently about changes from the FDA—and you may be wondering what this means for your treatment. Here’s what’s happening, how it could affect you, and what your next steps might be.

📣 FDA Removes Semaglutide & Tirzepatide from the Shortage List

As of early April 2024, the FDA has officially removed semaglutide (Wegovy) and tirzepatide (Zepbound) from its drug shortage list. That list previously allowed compounding pharmacies to legally make custom versions of these medications from bulk powder ingredients due to the widespread shortage of brand-name products.

Now that these drugs are considered to be “available” again, the legal basis for compounding them has changed—and compounding pharmacies have been given a specific deadline to stop.

⚖️ Court Ruling + FDA Deadline = Big Changes for Compounding

Following a recent court ruling, the FDA reinforced the rules that apply to compounding pharmacies. Here’s what it means in simple terms:

🧪 503A Compounding Pharmacies (smaller, local pharmacies) and 503B Outsourcing Facilities (larger FDA-registered facilities)

Can no longer compound semaglutide or tirzepatide from bulk ingredients.
The FDA has given these pharmacies until May 22, 2024, to cease all sales and distribution of compounded versions of these drugs made from bulk API (active pharmaceutical ingredients).

⚠️ Penalties for Violating FDA Compounding Rules

FDA Warning Letter
The first step is often an official Warning Letter from the FDA, alerting the pharmacy that it is in violation of federal law and must immediately stop the unlawful activity.
Product Seizure
The FDA can seize any unapproved or misbranded drug products, including compounded medications that don’t comply with the law.
Injunctions
The Department of Justice (DOJ), at the request of the FDA, can seek a federal court injunction to shut down pharmacy operations or force compliance.
Civil or Criminal Penalties
If a pharmacy knowingly distributes unapproved compounded drugs in violation of the Food, Drug, and Cosmetic Act, they could face:
1. Fines
2. Loss of licensure
3. Criminal prosecution, in extreme cases involving fraud or patient harm
FDA Inspection & Public Listing
The pharmacy may be subject to heightened FDA inspection, and violations can be made public in the FDA’s database—potentially harming the pharmacy's reputation and ability to operate.

🩺 Are There Penalties for Physicians Who Prescribe Compounded GLP-1s After the Deadline?

Technically, the FDA regulates manufacturers and pharmacies, not individual prescribers. So as of now, there is no specific FDA penalty directly targeting physicians who write prescriptions for compounded semaglutide or tirzepatide after the May 22, 2024 deadline. However, there are still legal and professional risks to be aware of:

⚖️ Indirect Risks for Physicians:

Liability if Patient Harm Occurs
If a patient is harmed by a non-compliant compounded product, and the physician continued prescribing despite knowing it wasn’t legally produced, the provider could be at risk for medical malpractice claims or scrutiny from a medical board.
State Medical Board Review
Some state medical boards may take action if they determine that a physician is knowingly prescribing medications from a source that’s no longer legal or FDA-compliant.
Professional Credibility
Prescribing from pharmacies that are not in compliance with FDA rules (especially if public enforcement actions have occurred) may raise concerns with payers, malpractice insurers, or credentialing bodies.
Compounded Products May No Longer Be Available
Even if you write the prescription, pharmacies may refuse to fill them to avoid enforcement risk. So continued prescribing might not be practical or effective.🤔 So What Does This Mean for You?

✅ What Are My Options?

We want to make sure your care continues without interruption. Here are several options we can explore together:

1. Switch to Brand-Name Medications

Wegovy (semaglutide) and Zepbound (tirzepatide) are becoming more available at retail pharmacies.
We can help with prior authorizations, explore insurance coverage, and use manufacturer savings programs when possible.

2. Temporarily Continue Compounded Versions (if available)

Some 503B pharmacies may still legally compound from finished FDA-approved drug products but availability may vary and may not be a long-term solution.

3. Consider Non-GLP-1 Medications

There are other safe and effective FDA-approved options for weight loss, including:

Contrave
Qsymia
Phentermine
Topiramate
Metformin (off-label for weight management)

💬 What Should I Do Now?

If you’re currently using compounded GLP-1 medications, we strongly recommend scheduling a follow-up appointment before May 22 to:

Review your current source and medication plan
Evaluate brand-name options or alternatives
Ensure there are no gaps in your treatment

👉 Call the office or message us through the patient portal to schedule your visit.

💡 Our Commitment to You

For our current weight management patients, we understand this may be an unexpected change—but you're not alone. We're here to guide you, advocate for you, and help you stay on track with your health goals. While regulations are shifting, our support for your journey remains constant. For those who are not under our care, we would encourage you to contact your provider and discuss your options. And no matter where you receive care, be mindful of the growing number of unapproved GLP-1 products being marketed online—your safety depends on knowing exactly what you’re taking and where it comes from.

About Cardona Direct Primary Care & RefineMD Aesthetics

At Cardona Direct Primary Care, Dr. Cardona and Dr. Garland provide personalized healthcare, including direct primary care, obesity medicine, and aesthetic treatments. Dr. Cardona is board-certified in both family medicine and obesity medicine and has a special interest in medical weight loss. Dr. Garland is board-certified in family medicine and is a certified medical marijuana provider. She has a special interest in skincare and is eager to assist with your individual skincare needs. Located in Jacksonville, FL, we are dedicated to prioritizing you. Contact us at 904-551-4625 or visit our website at www.cardonadpc.com to learn more and schedule your appointment today!