05/14/2026
NEW: FDA Enforcement to stop 503B GLP-1 Compounding
The FDA published a warning letter to ProRx, a 503B compounding pharmacy specifically mentioning that 503Bs should not be compounding GLP-1s. The letter was just made public, but was initially sent to ProRx on April 7, 2026. They stopped making compounded GLP-1s on April 8.
What is different about this letter is that it directly calls out tirzepatide production not being covered under the 503B exception. “Based on this inspection, it appears you produced drugs that violate the FDCA.”
It also directly mentions seizure and injunction as the next steps in non-compliance. “You should take prompt action to address any violations. Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.” - FDA warning letter
Credit: fda.gov