Tirzepatide and Semaglutide Shortage Update

NuvaMed Provider Brief: Legal & Clinical Basis for Compounded GLP-1s
Semaglutide & Tirzepatide (Dry Powder & B12-Enhanced Liquid Formulations)

Q: Will you still continue to compound GLP-1s?

A: YES! We have taken the necessary steps to continue offering providers customized compounded GLP-1 products that are personalized for their patient's specific needs.

As a licensed provider, you may have seen recent FDA advisories suggesting that compounding Semaglutide or Tirzepatide is not permitted. However, there are several key reasons why clinics can legally and ethically continue to prescribe and administer compounded GLP-1s—particularly when sourced from compliant pharmacies like those NuvaMed partners with.

1. FDA Drug Shortage Exception
The FDA permits 503A compounding pharmacies to compound medications from bulk ingredients when the branded drug is on the FDA Drug Shortage List.

  • Semaglutide has been listed on the shortage list intermittently, allowing continued compounding when applicable.
  • This exception is built into federal law and protects access for patients during times of limited commercial supply.

2. Clinical Necessity & Personalized Dosing
Providers may determine that a compounded version is medically necessary due to factors such as:

  •  Intolerance to commercial fillers or stabilizers
  • Need for non-standard dosages not available commercially
  • Cost barriers or insurance denials
  • Preference for liquid formulations enhanced with B12, which are not commercially available. NuvaMed’s liquid formulation combines GLP-1s with B12 to support energy, reduce fatigue, and improve patient adherence.

3. FDA-Registered 503A & 503B Pharmacy Partners
NuvaMed sources exclusively from licensed and fully compliant 503A and 503B pharmacies that adhere to strict quality, sterility, and potency testing standards. Every batch is independently verified for safety and consistency.

4. State-Level Authority & Lack of FDA Enforcement
While the FDA has issued guidance, enforcement is largely state-driven and focused on ensuring safe patient care—not penalizing clinicians for providing cost-effective alternatives. To date, there has been no known FDA enforcement action against providers acting in accordance with state guidelines and using properly sourced compounded GLP-1s.

5. Legal Risk Mitigation Tools Provided by NuvaMed
To support compliance and informed decision-making, NuvaMed provides:

  • Informed consent templates
  • Medical necessity documentation tools
  • Guidance on proper charting language and patient disclosures. Sample medical necessity forms and informed consent documents are available in the Customer Assets section of our website:👉 Customer Assets

Bottom Line: Providers may continue offering compounded Semaglutide and Tirzepatide—especially when supported by clinical justification, informed consent, and a trusted pharmacy partner. NuvaMed ensures that every formulation is prepared and delivered to the highest standards of safety and compliance.