Tirzepatide and Semaglutide Shortage Update

FAQs

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.

In the FDA’s most recent announcement, they stated that compounding “essential copies” by 503A & 503B compounding pharmacies will be allowed for a limited period of time. In all this, remember that an important role that compounding pharmacies play is compounding personalized versions of a medication when a patient has a clinically significant reason, such as added ingredients like B-12 or in-between doses, which are not  “essential copies.”

Provider Guidance

We strongly encourage all providers to document if they opt for the compounded version of GLP-1 based on a clinically significant difference compared to the commercial product. Maintaining this documentation will be essential in supporting medical necessity and compliance with regulatory expectations.

Forward Looking

We will continue to monitor developments closely and provide updates as more information becomes available. NuvaMed and its licensed pharmacy partners will continue compounding GLP-1 under the current regulatory framework.

We are also committed to joining other licensed compounding pharmacies in any legal action to ensure patient access to quality personalized medications is not hindered.

If you have any questions or need further clarification, please contact us...