FDA peptide rulemaking stalls as enforcement targets compounded sellers
Pharmaceutical Executive reports the agency's enforcement arm is moving against compounded peptide sellers even as the category rulemaking sits unfinished.
DO
By Daniel Okafor · Regulatory Correspondent
Sep 30 13:07 ETSource: Pharmaceutical Executive
The wire
- 01Pharmaceutical Executive's brief says FDA rulemaking on peptides has stalled while the agency's enforcement arm targets sellers of compounded peptide products.
- 02Compounders, telehealth operators and prescribers relying on the unresolved category lists face enforcement risk before any final rule clarifies what is permitted.
- 03The brief does not name targeted firms or give a rulemaking timeline, so the scope and next steps of the enforcement push remain unclear.
From the source
Read at pharmexec.comPeptide Ruling Stalls | PharmExec
Novo Nordisk data show real-world weight loss after switching to its oral semaglutide pill, FDA's peptide rulemaking stalls while its enforcement arm targets compounded peptide sellers, and Avi Pardo flags a compliance blind spot in field teams' text messages with doctors.
