fda glp-1 compounding enforcement september 2025 Beyond the Headlines: Warning Letters to Compounders Out of Shortage, Into Controversy:

As per the regulators Complete Response Letter, the FDA asked for additional evidence to confirm the efficacy and safety of glepaglutide at its proposed dose and recommended that Zealand run another clinical trial to generate these data

The highest quality studies compare the outcomes of the study drug compared to an inactive placebo or a drug with proven benefits (to find out if it is better than current standard therapy)

Pregnancy and breastfeeding should be considered absolute contraindications due to unknown effects on fetal development

Hospital and ER documentation showing the timing of symptoms like abdominal pain, vomiting, or constipation leading to surgery