FDA Plans July Panel to Review Peptide Compounding
The Food and Drug Administration announced plans Wednesday to convene an advisory panel in late July to evaluate whether compounding pharmacies should be permitted to produce seven specific peptide therapies, potentially reversing restrictions imposed last year amid concerns over their safety and lack of approval.
The meeting, scheduled for July 23 and 24, will focus on peptides including BPC-157 and TB-500, which have gained popularity for purported benefits such as healing injuries, reducing inflammation, building muscle and promoting anti-aging effects. These substances, short chains of amino acids that act as building blocks for proteins and trigger bodily processes like growth and metabolism, remain unapproved by the FDA for most uses. While some peptides, such as insulin and GLP-1 drugs for diabetes and obesity, have received agency approval, the ones under review lack extensive human testing and have not undergone formal safety reviews.
In 2023, during the Biden administration, the FDA removed 19 peptides from a list of substances eligible for compounding by pharmacies, which mix customized medications not commercially available. Agency advisers at the time voted...