RFK Jr. peptide plan would require compounders to report side effects
Bloomberg reports the administration's peptide expansion comes paired with an adverse-event reporting obligation for the pharmacies that make them.
DO
By Daniel Okafor · Regulatory Correspondent
Oct 22 15:13 ETSource: Bloomberg.com
The wire
- 01Under the health secretary's peptide plan, compounding pharmacies would be required to report adverse events tied to the peptides they prepare, Bloomberg reports.
- 02Adverse-event reporting would create the first systematic safety signal data for compounded peptides, a category that has expanded faster than its evidence base.
- 03Details of scope, timing and enforcement are not yet spelled out; the plan follows a July FDA advisory panel endorsement of broader peptide compounding.
From the source
Read at bloomberg.comRFK Jr.’s Peptide Plan Makes Compounders Report Side Effects
