Does Adding Vitamin B to Tirzepatide Formulations Make Them FDA-Compliant?

Following the FDA’s December announcement resolving the tirzepatide injection shortage, many compounding pharmacies have reached out to their clients to clarify how these changes impact their ability to provide compounded medications. If you’ve received emails from a compounding pharmacy regarding formulations like tirzepatide with added Vitamin B, here’s what you need to know:

Read our previous post on the FDA’s tirzepatide shortage announcement here.

Why Are Pharmacies Sending These Emails?

The FDA’s resolution of the shortage means that pharmacies must cease compounding and dispensing “essentially copies” of FDA-approved drugs such as Mounjaro and Zepbound by February 18, 2024. Compounding pharmacies are addressing this by notifying healthcare providers of updated requirements to remain compliant.

These emails often highlight:

• The pharmacy’s approach to staying compliant with FDA guidelines.
• Specific formulations (e.g., tirzepatide with Vitamin B) that they argue are not “essentially copies.”
• The need for documented medical rationale for compounded prescriptions

What Are Compounded Formulations with Vitamin B?

Some pharmacies have introduced tirzepatide formulations with added niacinamide (Vitamin B3) or similar ingredients, claiming these provide distinct clinical benefits compared to FDA-approved options.

Examples of benefits cited include:

• Reduction in gastrointestinal side effects associated with GLP-1 receptor agonists.
• Metabolic advantages from the inclusion of Vitamin B.
• Simplification of treatment by combining tirzepatide and Vitamin B into a single injection.

These modifications are presented as a way to offer personalized care and meet patient-specific needs, potentially bypassing the “essential copy” restrictions—provided there is documented medical necessity.

What Does This Mean for Healthcare Providers?

If you’re prescribing compounded tirzepatide formulations, you must:

Document Medical Necessity: Include a clear rationale for why the compounded version is needed. Examples provided by some pharmacies include:

• • Patient benefits from Vitamin B’s ability to reduce GI side effects.
  • Addressing a documented Vitamin B deficiency.
  • Meeting dosing needs not achievable with commercial products.

Verify Compliance: Ensure the pharmacy you’re working with is following FDA guidelines and properly documenting prescriptions.

Understand the Risks: Non-compliance with FDA rules could lead to regulatory scrutiny for both pharmacies and prescribing providers.

How Does This Affect Medspas?

Medspa owners who offer treatments involving compounded medications should:

• Communicate with Providers: Confirm that prescriptions include the required medical rationale to ensure compliance.
• Stay Informed: Monitor updates from the FDA and compounding pharmacies about regulatory changes.
• Educate Clients: Be transparent with patients about the changes and how they may impact their treatment options.

What’s Next?

The FDA’s February 18, 2024, deadline is fast approaching. While compounded formulations with distinct differences may remain available, strict documentation and compliance are essential. If you’ve received communications from compounding pharmacies, take the time to review their claims, consult with legal or regulatory experts if needed, and ensure your practice aligns with the new requirements.

Compounding pharmacies will continue to play a role in providing customized treatment options, but staying compliant with FDA guidelines is critical to avoiding disruptions in patient care.