January 24, 2025

FDA to continue enforcement discretion on compounded tirzepatide

There’s been some question about the current state of FDA’s enforcement when it comes to compounded tirzepatide copies. 

At APC’s request, FDA has reiterated that it does not plan to take action against any compounders who prepare copies of tirzepatide injection while the OFA v. FDA litigation continues. That includes 503A pharmacies and 503B outsourcing facilities. (You can read the original October letter to APC from FDA on this matter here.)

What does this mean?

This is nothing new. In simple terms, FDA does not plan to take action against compounders who prepare copies of tirzepatide injection, even though the drug has been removed from the shortage list — just as it stated in October. This applies to situations where:

  • The compounded product is similar to a commercially available drug
  • Bulk drug substances are used for compounding tirzepatide injection copies

However, the FDA’s enforcement discretion has limits. The agency can still take action if there are concerns about product quality or safety, so it’s important for all compounders to maintain the highest standards.

For details, you can review the FDA’s Declaratory Order on this issue.

Questions? Contact APC’s Tenille Davis at tenille@a4pc.org.