Important Updates on Compounded Semaglutide and Tirzepatide for Weight Loss

If you're currently using compounded semaglutide or tirzepatide as part of your medical weight loss journey, you've likely seen news about changes from the FDA. You may be wondering how these changes affect your treatment. Here’s what’s happening, how it might impact you, and what your next steps could 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. This list previously allowed compounding pharmacies to legally produce custom versions of these medications using bulk powder ingredients due to a widespread shortage of the brand-name products.

Now that these drugs are considered “available” again, the legal basis for compounding them has changed. 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 has reinforced the rules governing compounding pharmacies. Here’s what it means in simple terms:

🧪 Types of Pharmacies Affected

• 503A Compounding Pharmacies (smaller, local pharmacies)

• 503B Outsourcing Facilities (larger FDA-registered facilities)

  
  

These pharmacies can no longer compound semaglutide or tirzepatide from bulk ingredients. The FDA has issued a deadline of May 22, 2024, for these pharmacies 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

Pharmacies that ignore these new regulations face serious consequences, such as:

1. FDA Warning Letter

   An official Warning Letter is usually the first step, alerting the pharmacy of its violations of federal law and demanding immediate cessation of the unlawful activity.

   
   

2. Product Seizure

   The FDA has the authority to seize unapproved or misbranded drug products, including those that are compounded but fail to comply with the law.

   
   

3. Injunctions

   The Department of Justice (DOJ) can seek a federal court injunction to shut down a pharmacy's operations or enforce compliance.

   
   

4. Civil or Criminal Penalties

   Pharmacies that knowingly distribute unapproved compounded drugs could face severe repercussions, including:

• Fines

• Loss of licensure

• Criminal prosecution in extreme cases involving fraud or patient harm




5. FDA Inspection & Public Listing

   Pharmacies may face increased FDA inspections, and any violations can be made public in the FDA’s database, harming their reputation and operational viability.

   
   

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

Technically, the FDA regulates manufacturers and pharmacies, not individual prescribers. Therefore, there is no specific FDA penalty targeting physicians who prescribe compounded semaglutide or tirzepatide after the May 22, 2024 deadline. However, there are still important legal and professional risks to consider:

⚖️ Indirect Risks for Physicians

1. Liability if Patient Harm Occurs

   If a patient is harmed by a non-compliant compounded product and the physician continued prescribing it despite this knowledge, the provider might face medical malpractice claims or scrutiny from a medical board.

   
   

2. State Medical Board Review

   Some state medical boards may take action against physicians who knowingly prescribe medications from a source that is no longer FDA-compliant.

   
   

3. Professional Credibility

   Prescribing from non-compliant pharmacies may raise concerns with payers, malpractice insurers, or credentialing bodies, impacting a physician's credibility.

   
   

4. Availability of Compounded Products

   Pharmacies may refuse to fill prescriptions to avoid enforcement risks, making continued prescribing impractical or ineffective.

   
   

🤔 So What Does This Mean for You?

✅ What Are My Options?

To ensure uninterrupted care, we can explore several options together:

1. Switch to Brand-Name Medications

• Wegovy (semaglutide) and Zepbound (tirzepatide) are becoming more widely available at retail pharmacies.

• We can assist with prior authorizations, review insurance coverage, and utilize manufacturer savings programs as available.

  
  

2. Temporarily Continue Compounded Versions (if available)

Some 503B pharmacies may still legally compound using finished FDA-approved drug products. However, this availability is inconsistent and may not provide 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, it's crucial to schedule a follow-up appointment before May 22. During this visit, we can:

• 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.

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💡 Our Commitment to You

For our current weight management patients, we understand this may be an unexpected change, but you're not alone. We are committed to guiding you through this transition and helping you stay on track with your health goals. As regulations shift, our support for your journey will remain steadfast.

For those who are not yet our patients, we encourage you to contact your provider to discuss your options. Be cautious of the growing number of unapproved GLP-1 products marketed online. Your safety depends on knowing exactly what you are 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, with a special interest in medical weight loss. Dr. Garland is also board-certified in family medicine and is a certified medical marijuana provider, focusing on skincare. 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!