FDA reviewers recommend against adding seven peptides to bulk drug list for compounding

FDA reviewers have advised that seven widely used peptides should not be added to the FDA's bulk drug substance list for compounding. Their recommendation comes before an upcoming advisory committee meeting that will examine possible easing of current restrictions.

The advisory committee is set to discuss whether the restrictions on these peptides, which are frequently compounded in pharmacies, should be lifted.

Reviewers cited safety and quality-control concerns, indicating that allowing the peptides could pose regulatory challenges. The final outcome will depend on the committee’s deliberations.