THE WHAT? US Food and Drug Administration (FDA) staff reviewers have concluded there is insufficient evidence to support allowing compounding pharmacies to manufacture seven widely used peptides ahead of an advisory committee review.
THE DETAILS In briefing documents released ahead of the FDA’s 23–24 July Pharmacy Compounding Advisory Committee meeting, reviewers cited limited human studies and inadequate evidence of the safety and efficacy of seven peptides proposed for use in compounded medicines. The substances under review include BPC-157, KPV, TB-500, MOTS-c, emideltide, semax and epitalon. The committee’s recommendations are non-binding but are expected to inform the FDA’s final decision on whether the peptides should be added to the agency’s list of permitted bulk drug substances for compounding. The meeting has also attracted attention after several advisory committee members were reported to have professional links to businesses involved in peptide therapies.
THE WHY? The FDA’s decision could influence the future availability of compounded peptide products used in wellness, regenerative medicine and aesthetic treatments. The outcome may also affect businesses operating in the growing peptide market as regulators increase scrutiny of safety and scientific evidence.
Source: Reuters
